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WO2025229048A1 - Methods and devices for controlling an analyte sensor device - Google Patents

Methods and devices for controlling an analyte sensor device

Info

Publication number
WO2025229048A1
WO2025229048A1 PCT/EP2025/061808 EP2025061808W WO2025229048A1 WO 2025229048 A1 WO2025229048 A1 WO 2025229048A1 EP 2025061808 W EP2025061808 W EP 2025061808W WO 2025229048 A1 WO2025229048 A1 WO 2025229048A1
Authority
WO
WIPO (PCT)
Prior art keywords
analyte sensor
user
analyte
sensor device
data
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/061808
Other languages
French (fr)
Inventor
Harald VON CAMPENHAUSEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diabetes Care GmbH
Original Assignee
Roche Diabetes Care GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diabetes Care GmbH filed Critical Roche Diabetes Care GmbH
Publication of WO2025229048A1 publication Critical patent/WO2025229048A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7275Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0209Operational features of power management adapted for power saving
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022Monitoring a patient using a global network, e.g. telephone networks, internet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the invention relates to a computer-implemented method for controlling an analyte sensor device, to a remote controller for controlling at least one analyte sensor device and to a continuous analyte sensor system.
  • the invention further relates to a computer program and to a computer-readable storage medium.
  • the devices and method according to the present invention may mainly be used for long-term monitoring of an analyte concertation in a body fluid, such as for long-term monitoring of a blood glucose level or of the analyte concentration of one or more other types of analytes in a body fluid.
  • the invention may both be applied in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are feasible.
  • Miniaturization of a body -worn analyte sensor device in part depends on the dimension and capacity of the battery needed to supply the analyte sensor with sufficient energy during shelf life and during the active wear time when the sensor patch device actively monitors analyte levels.
  • the required capacity of the battery inter alia depends on the measuring frequency, the frequency of processing sensor data and the frequency of transmitting sensor data to a remote device or simply put, the amount of time the sensor patch device is active throughout its wear time.
  • the wear time of currently known systems lies in the range of 7 to 14 days.
  • US11369319B2 discloses a method of operating a receiver for receiving analyte data from a biosensor monitoring an analyte by detecting analyte values, the method comprising: in a receiver, receiving analyte values detected by a biosensor monitoring an analyte in intervals of time for which a first interval time is applied; receiving a present analyte value in the receiver; providing a rate of change for the analyte values; determining a future analyte value based on the present analyte value, the first interval time, and the rate of change; providing an analyte value range for the analyte values; setting a second interval time, the second interval time being shorter than the first interval time, if the future analyte value is outside the analyte value range, and longer than or equal to the first interval time, if the future analyte value is within the analyte value range; and in the receiver, receiving one or more
  • US9931037B2 discloses systems and methods for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor.
  • a method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide user access to sensor -related information comprises: activating a transceiver of a first communication device associated with an analyte sensor at a first time; and establishing a two-way communication channel with the second communication device; wherein the activating comprises waking the transceiver from a low power sleep mode using a forced wakeup from the second communication device.
  • the receiver Based on the extrapolated future analyte values the receiver sets and applies a second interval time for the receiving time interval, wherein the second interval time is shorter than the first interval time, if the future analyte value is outside of the analyte value range, and the second interval time is longer than or equal to the first interval time, if the future analyte value is within the analyte value range.
  • a computer-implemented method for controlling an analyte sensor device a remote controller for controlling at least one analyte sensor device and a continuous analyte sensor system, which allow using the analyte sensor device for a longer period than hitherto known analyte sensor devices.
  • a computer-implemented method for controlling an analyte sensor device, a remote controller for controlling at least one analyte sensor device and a continuous analyte sensor system which allow operating the analyte sensor device in a manner that it consumes less power than hitherto known analyte sensor devices.
  • a computer-implemented method for controlling an analyte sensor device configured to be body-worn by a user comprising an analyte sensor is disclosed.
  • a computer-implemented method for controlling an analyte sensor device configured to be body-worn by a user comprising an analyte sensor.
  • the computer-implemented method for controlling an analyte sensor device comprises the following steps, which may be performed in the given order. A different order, however, may also be feasible. Further, two or more of the method steps may be performed simultaneously. Thereby, the method steps may at least partly overlap in time. Further, the method steps may be performed once or repeatedly. Thus, one or more or even all of the method steps may be performed once or repeatedly. The method may comprise additional method steps, which are not listed herein.
  • the term "computer-implemented" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a method which is performed by using computer programming, and/or by using at least one computer and/or at least one computer network.
  • one or more or even all of the method steps may be performed by appropriate software, e.g. by using computer- readable instructions which, when executed on a computer or a computer network, cause the computer or computer network to perform the method steps.
  • software as used herein may, preferably, refer to a computer program.
  • the computer program may have a plurality of functions, procedures, methods and subprograms, which may be distributed over several specific hardware instances.
  • the computer and/or computer network may comprise at least one processor, which is configured for performing at least one, more than one or all of the method steps of the method according to the present disclosure. Preferably, each of the method steps is performed by the computer and/or computer network.
  • the method may be performed completely automatically, preferably without user interaction.
  • controlling as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • Controlling may comprise monitoring at least one input parameter, such as an operational parameter. Monitoring the input parameter may be performed by using a monitoring device, such as a sensor. Controlling may further comprise determining at least one control parameter by evaluating the input parameter. Determining control parameters may be performed by using an evaluation unit. The control parameters may be determined such that the system, the device or the process performs in a desired manner.
  • analyte as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to an arbitrary element, component or compound which may be present in a body fluid and a presence and/or a quantity and/or a concentration of which may be of interest for a user, a patient or medical staff such as for a medical doctor.
  • a "presence" of an analyte for example, may be a presence of said analyte in an amount above a detection limit.
  • the analyte may be or may comprise an arbitrary chemical substance or chemical compound which may take part in a metabolism of the user or the patient, such as a metabolite.
  • the analyte may be selected from the group consisting of glucose, ketones, glycerol, a hormone such as testosteron, cortisol, cholesterol, triglycerides, lactic acid, lactate or any analyte which can be measured electrochemically. Additionally or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined.
  • the analyte may be glucose.
  • analyte sensor device as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary element or article being configured for use in the field of medical technology, exemplarily in the field of medical analytics or medical diagnostics.
  • the analyte sensor device may be configured for performing a medical function and/or for being used in a medical process, such as in one or more of a therapeutic process, a diagnostic process or another medical process.
  • the analyte sensor device preferably may comprise an assembly of two or more components capable of interacting with each other, such as in order to perform one or more diagnostic and/or therapeutic purposes, such as in order to perform a medical analysis.
  • the two or more components may be capable of performing a detection of the analyte in the body fluid and/or of contributing to the detection of the analyte in the body fluid.
  • the analyte sensor device is configured to be “body -worn” by the user. Consequently, the analyte sensor device may be in contact with the body of the user, preferably during an active wear time of the analyte sensor device. During the active wear time, the analyte sensor device may generate sensor data related to the user, preferably in order to detect a presence and/or a quantity and/or a concentration of an analyte.
  • the analyte sensor device may preferably be configured to be mounted on a skin site of a body part selected from the group consisting of: an arm, exemplarily an upper arm; a stomach; a shoulder; a back; hip; a leg. Preferably, the body part may be the upper arm.
  • the housing may provide one or more interior spaces for receiving one or more further components or elements.
  • the housing may preferably be manufactured by injection molding. However, other embodiments are feasible.
  • the electronics unit may be sealed or potted as will further be described below.
  • the housing may comprise an upper side and a lower side.
  • the terms “upper side” and “lower side” may refer to two opposing sides of the housing.
  • the terms “upper side” and “lower side” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper sides and lower sides may be applied.
  • the “upper side” may refer to a distal side of the housing.
  • distal side is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an indication of a position of the side of the housing in relation to a user which is furthermost away from a skin site of the user.
  • the housing may be brought into contact with the skin site of the user.
  • the distal side may refer to a side being distant from the skin site of the user.
  • the “lower side” may refer to a proximal side of the housing.
  • proximal side is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an indication of a position of the side of the housing in relation to a user, which is closest to a skin site of the user.
  • the housing may be brought into contact with the skin site of the user.
  • the proximal side may refer to a side being in close proximity to or even in direct contact with to the skin site of the user.
  • the term “electronics unit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to an arbitrary device, which is configured for performing at least one electronic function.
  • the electronics unit may have an electronic component.
  • the electronics unit may comprise the electronic component for one or more of performing a measurement with the analyte sensor, performing a voltage measurement, performing a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another device.
  • the electronics unit may preferably be embodied as a transmitter or may comprise a transmitter, for transmitting data. Other embodiments of the electronic components are feasible. These electronic components generally are known in the art of long-term monitoring one or more analytes, such as in from one or more of the above-mentioned prior art documents.
  • the electronics unit may comprise at least one circuit carrier, preferably a printed circuit board, in one embodimenta flexible printed circuit board.
  • circuit carrier as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to an element or a combination of elements which are capable of carrying one or more electronic components and of interconnecting these one or more electronic components, such as interconnecting the one or more electronic components electrically or electronically with each other and/or with one or more contact pads.
  • the circuit carrier may comprise a base and one or more electrical traces and/or one or more electrical contact pads disposed thereon and/or therein.
  • the base may be a flat element having a lateral extension which exceeds its width by at least a factor of 10, more preferably by at least a factor of 100 or even a factor of 1000.
  • Rigid materials which may be used for the base, may be fiber-enforced plastic materials such as fiber-enforced epoxy materials like glass-fiber-enforced epoxy materials such asFR-4.
  • the base may be a flexible base, such that the circuit carrier may fully or partially be embodied as a flexible printed circuit board.
  • the flexible base may fully or partially be made of one or more flexible plastic materials such as one or more plastic foils or laminate, such as polyimides.
  • the housing may comprise an electronics compartment, preferably for receiving the electronics unit.
  • the term “compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to an arbitrary subpart of a superior element creating a partially or fully enclosed space that may be usable to contain and/or store objects.
  • the subpart may preferably be completely or at least to a large extent closed such that an interior of the compartment may be isolated from a surrounding environment.
  • the compartment may be separated from other parts of the superior element by one or more walls.
  • two or more compartments may be comprised which may fully or partially be separated from one another by one or more walls of the housing.
  • Each compartment may comprise a continuous space or lumen configured for receiving one or more objects.
  • the term “electronics compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to an arbitrary compartment, which is configured for receiving an element or a combination of elements which fulfill an electrical or electronic purpose.
  • the electronic component may be configured for receiving a circuit carrier.
  • the circuit carrier may be fixedly positioned within the electronics compartment of the housing.
  • analyte sensor device comprises an analyte sensor.
  • analyte sensor as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary device configured for performing a quantitative and/or qualitative determination of the at least one property of a sample related to the at least one analyte.
  • the determination of the at least one property may preferably comprise quantitatively or qualitatively detecting the at least one analyte in the bodily fluid.
  • detecting is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably relates to a process of determining a presence and/or a quantity and/or a concentration of an analyte.
  • the detection may be or may comprise a qualitative detection, simply determining the presence of the analyte or the absence of the analyte, and/or may be or may comprise a quantitative detection, which determines the quantity and/or the concentration of the analyte.
  • the detection may be analytespecific.
  • the analyte sensor may, preferably, be a transcutaneous sensor.
  • transcutaneous sensor as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary sensor which is adapted to be fully or at least partly arranged within a body tissue of a patient or a user.
  • the analyte sensor may comprise an insertable portion configured for being at least partially insertable into a body tissue of the user.
  • the term “insertable portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a part or component of an element configured to be insertable into an arbitrary body tissue.
  • the analyte sensor may fully or partially provide a biocompatible surface, i.e. a surface which, at least during durations of use, do not have any detrimental effects on the user, the patient or the body tissue.
  • the insertable portion of the analyte sensor may have a biocompatible surface.
  • the transcutaneous sensor preferably the insertable portion, may fully or partially be covered with a biocompatible membrane, such as a polymer membrane or gel membrane which is permeable for the analyte and/or the body fluid and which, on the other hand, retains sensor substances such as one or more analyte detection agents within the sensor and prevents a migration of these substances into the body tissue.
  • a biocompatible membrane such as a polymer membrane or gel membrane which is permeable for the analyte and/or the body fluid and which, on the other hand, retains sensor substances such as one or more analyte detection agents within the sensor and prevents a migration of these substances into the body tissue.
  • Other parts or components of the analyte sensor may stay outside of the body tissue.
  • the analyte sensor may preferably be an electrochemical analyte sensor.
  • electrochemical sensor as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a sensor which is configured to conduct an electrochemical measurement, preferably in order to detect an analyte in a body fluid of a user.
  • electrochemical measurement may refer to a detection of an electrochemically detectable property of the analyte, such as to an electrochemical detection reaction.
  • the electrochemical detection reaction may be detected by comparing one or more electrode potentials.
  • the electrochemical sensor preferably may be adapted to and/or may be usable to generate an electrical sensor signal which directly or indirectly indicates the presence and/or the extent of the electrochemical detection reaction, such as a current and/or a voltage.
  • the detection may be analyte-specific.
  • the measurement may be a qualitative and/or a quantitative measurement. Still, other embodiments are feasible.
  • the term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term exemplarily relates to a person intending to monitor an analyte value, such as a glucose value, in a person’s body tissue.
  • the term preferably may refer, without limitation, to a person using the medical device.
  • the user may be a patient suffering from a disease, such as diabetes.
  • the user may also be referred to as subject or as patient.
  • the person using the medical device is different from the user.
  • the method comprises: o receiving analyte sensor data generated by the analyte sensor; o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval, preferably when the analyte sensor device is in the active power mode.
  • the term “receiving” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a process of getting access to and/or possession of data, preferably a receiving device may get access to and/or possession of the data.
  • the data may be, preferably, the sensor data generated by the analyte sensor.
  • the data may be transmitted by a transmitting device, preferably the analyte sensor, configured for allowing access to the data. For allowing access to the data, the transmitting device may exchange the data with the receiving device, such as by providing and/or sending the data.
  • the transmitting device may be a sending device and/or a measurement device.
  • the data may be requested by the receiving device, such as by sending or transferring a query to the transmitting device.
  • Receiving the data may comprise a step of requesting the transmission of the data.
  • analyte sensor data is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to data generated by using the analyte sensor.
  • the analyte sensor data may describe a presence and/or a quantity and/or a concentration of the analyte in the bodily fluid, preferably measured at a particular interval or point in time.
  • the analyte sensor data may be preexisting data in respect to performing the method for controlling the analyte sensor device.
  • the term “preexisting dataset” may indicate that the method for controlling the analyte sensor device, typically, is free of a step of a data acquisition from the user. Consequently, the analyte sensor data may be generated by the analyte sensor device before the method for controlling an analyte sensor is performed. Consequently, the analyte sensor data may already exist at the time the method for controlling the analyte sensor device receives the analyte data.
  • the device that is performing the method for controlling the analyte sensor device may be different from the analyte sensor device.
  • the device that is performing the method for controlling the analyte sensor device may be a remote controller. As a result, the data acquisition from the user may be performed be a device that is different from the device that is performing the method for controlling the analyte sensor device.
  • the method comprises determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval.
  • determining is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a process of generating at least one representative result, in particular, by evaluating input data, such as the received analyte sensor data and/or the received event data.
  • the at least one representative result may be the prediction time interval.
  • the term determining may refer to the computer assisted processing of data, preferably in order to generate the at least one representative result.
  • the at least one representative result may be generated in such a manner that it is available or provided as data or at least one item of information on the representative result.
  • the term “information” may indicate that the representative result is described by the data. Generating the at least one representative result may be performed by using a computer program running on a computer or a computer network.
  • the prediction time interval may be associated with a risk for a glycemic excursion. Determining the prediction time interval may comprise or be based on the risk for a glycemic excursion.
  • the risk for a glycemic excursion may be determined by evaluating the analyte sensor data and the event data.
  • the term “risk for a glycemic excursion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a probability for a glycemic excursion, preferably a probability for a glycemic excursion equal to or above a threshold, such as a predetermined threshold.
  • a ’’glycemic excursion may be a fluctuation and/or a change of the analyte concentration of the user causing the analyte concentration of the user to leave the predetermined target range.
  • the at least one item of information on the prediction time interval may be determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of: a look-up table; or a machine learning model, preferably a trained machine learning model.
  • machine learning model as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a mathematical model which is trainable on at least one training dataset using machine learning, in particular deep learning or other forms of artificial intelligence.
  • machine learning is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a method of using artificial intelligence (Al) for automated model building.
  • the training may be performed using at least one machine-learning system.
  • machine-learning system as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a system or unit comprising at least one processing unit such as a processor, microprocessor, or computer system configured for machine learning, in particular for executing a logic in a given algorithm.
  • the machine-learning system may be configured for performing and/or executing at least one machine-learning algorithm, wherein the machine-learning algorithm is configured for generating the trained machine learning model.
  • prediction time interval is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a duration of time between two specific points in time.
  • the prediction time interval may be a contiguous time period elapsing between a starting point in time and an ending point in time.
  • the prediction time interval may be an uninterrupted time span.
  • the prediction time interval is an interval of between 1 min to 2 hours, preferably between 1 min to 1 hour, preferably between 1 min to 45 min, preferably between 1 min to 30 min, preferably between 1 min to 20 min, preferably between 1 min to 15 min, preferably between 1 min to 10 min, preferably between 5 min to 60 min, preferably between 10 min to 60 min, preferably between 20 min to 60 min, preferably between 30 min to 60 min, preferably between 10 min to 30 min.
  • predetermined target range is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a range of values for at least one specific health indicator, such as the analyte concentration in the bodily fluid of the user.
  • the predetermined target range may be set by a health care professional.
  • the predetermined target range may be selected in a manner that the comprised values are in agreement with at least one physiological norm of an analyte concentration in a bodily fluid, preferably of a blood glucose level.
  • the predetermined target range may be selected in a manner that the comprised values that are within a normal blood glucose range, preferably a blood glucose range that is normal for the user and in agreement or in a best possible agreement with the physiological norm of the analyte concentration in the bodily fluid.
  • the predetermined target range may exclude blood glucose concentration values that are within a hypoglycemia range.
  • the predetermined target range may blood glucose concentration exclude values that are within a hyperglycemia range.
  • the predetermined target range may comprise blood glucose concentration values between 50 milligrams per deciliter and 200 milligrams per deciliter, preferably between 70 milligrams per deciliter and 180 milligrams per deciliter.
  • the corresponding concentrations ranges when measured in milimol per liter may also be applied.
  • event data is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to data related to an arbitrary information collected about at least one action and/or at least one occurrence involving the user.
  • This data may comprise information on events related to at least one interaction, at least one behavior and/or at least one experience of the user, preferably providing an insight into the activities and preferences of the user.
  • data on events that have an influence on the analyte concentration in the bodily fluid of the user preferably the blood glucose level of the user, may be of preferred interest.
  • the event data may be received from a sensor device, which may comprise a sensor measuring a second analyte different from the first analyte or which may be a sensor which is not an analyte sensor.
  • the sensor device may be comprised by the mobile device.
  • analyte sensor data and event data are evaluated.
  • Particularly event data on events may be evaluated that are expected to still have an influence on the analyte concentration in the bodily fluid of the user.
  • Events that are expected to still have an influence on the analyte concentration in the bodily fluid of the user may be events that are expected to cause a change in the analyte concentration in the bodily fluid of the user in respect to the point in time at which the youngest received analyte concentration in the bodily fluid of the user has been generated.
  • the event data may comprise information on at least one vital sign of the, such as a heart rate, a blood pressure; a body temperature; a vigilance and/or a respiratory rate.
  • the vital sign may deviate from the analyte concentration in the bodily fluid of the user.
  • the term “vital sign” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to at least one quantifiable characteristics of the user providing information on at least one vital bodily function.
  • the event data may be received from a sensor device configured for sensing the vital sign. Particularly in case the vital sign is a heart rate, the event data may be received from a heart rate sensor, preferably a heart rate sensor configured to sensing a heart rate of the user.
  • the event data may comprise information on a location or a position of the user.
  • the location or position may be described by a geographical position of the user.
  • the position of the user may be received from a sensor device configured for sensing the at least one position of the user.
  • the sensor device configured for sensing the at least one position of the user may be a global navigation satellite system, GNSS, sensor.
  • the sensor device configured for sensing the at least one position of the user may be a Geo Positioning System, GPS, sensor.
  • the sensor device configured for sensing the at least one position of the user may be a Global Navigation Satellite System, GLONASS, sensor and/or a Galileo (satellite navigation) sensor or the like.
  • the event data may comprise information on a movement of the user.
  • the movement information is indicative of the physical activity of the user.
  • the event data may be received from an acceleration sensor; preferably an acceleration sensor configured for sensing at least one movement of the user.
  • the event data may comprise information on at least one noise at the surrounding of the user.
  • the term “noise” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to at least one environmental sound at the location of the user independent on a volume of the noise. The at least one noise may indicate that the user is consuming food, is sleeping or the like.
  • the event data may have been entered by the user into a user interface or extracted from a personal data source related to or of the user, preferably wherein the personal data source is selected from at least one of: an electronic calendar; a social media channel; a mailing account.
  • the term “user interface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary hardware component configured for receiving at least one input from the user, preferably, but not limited to, an input in form of a text, an input in form of a gesture, an input in form of a voice input.
  • the term “enter” may refer to the process of providing or generating an input by the user independent of the type or form of the input.
  • the user interface may be comprised by the mobile device.
  • the term “personal data source” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a data collection, such as a data base, that comprises event data of the user.
  • the event data may be provided in a manner that the event data can be related to the user.
  • the personal data source may be a data source exclusively used by the user.
  • the event data may paired with a tag comprising information on the person allowing an identification of the event data.
  • Such an approach may be preferred when the personal data source is a shared personal data source, such as a shared calendar that is used by the user and at least one further person.
  • the event data may comprise data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user.
  • the event data may comprise data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
  • a blood glucose concentration increasing medicament such as glucacon, steroids or antipsychotic medications to the user
  • the event data may comprise data about at least one event which decreases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
  • a blood glucose concentration decreasing medicament such as metformin, pioglitazone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray; a physical activity of the user; and an insufficient sleeping period of the user.
  • the term “behavioral pattern” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a consistent and repetitive action or habit.
  • the behavioral pattern may comprise a sequence of a plurality of actions and/or habits.
  • the information on the behavioral pattern may be comprised by the event data.
  • the event data may comprise the behavioral pattern as such.
  • the behavioral pattern may be comprised in the event data in a manner that a plurality of events is comprised by the event data, wherein the event data may be evaluated, preferably in a step of the computer-implemented method for controlling an analyte sensor device, in order to determine the behavioral pattern of the user. Consequently, the step of determining a prediction time interval may comprise determining the behavioral pattern by evaluating the event data.
  • the behavioral pattern may be predicted to occur within the prediction time by determining and/or evaluating a probability of the behavioral pattern to occur within the prediction time.
  • the probability of the behavioral pattern to occur within the prediction time may be based on historic event data, specifically on a periodic occurrence of the behavioral pattern. Alternatively or in addition, the prediction may be based on an event triggering the behavioral pattern.
  • the method comprises transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval.
  • the term “transmitting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to sending or moving data from a providing device to a receiving device. Transmitting may be performed by using a “transmitter”. Said term specifically may refer, without limitation, to an arbitrary device configured for transmitting data.
  • the transmitter may be configured for transferring information via a network, such as a local area network or internet. Alternatively or in addition, the transmitter may be configured for transferring information via a wireless communication channel, such as Bluetooth, Wi-Fi or near field communication, NFC. Alternatively or in addition, the transmitter may be configured for transferring information via a cloud server.
  • control signal is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary command configured to set at least one control parameter.
  • the control signal may be configured to bring the analyte sensor device in the low power mode. By bringing the analyte sensor device into the low power mode, the analyte sensor device may leave the active power mode.
  • the control signal may be transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value.
  • the “predetermined threshold value” may describe a minimum time period during which the sensor device remains in the low power mode.
  • switch as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to the process of changing between different operational modes within a system, such as the active power mode and the low power mode. Before the switch is being performed, the user may be notified that the switch is will take place.
  • active power mode is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a specific mode of the analyte sensor device.
  • the active power mode at least one of: a measurement frequency of the at least one analyte sensor device; a frequency of the at least one analyte sensor device to process the analyte sensor data; and a frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller may be set to an active mode value.
  • the active power mode value may be selected in order to ensure frequent monitoring of the analyte concentration, preferably when the current blood glucose concentration is in the hypoglycemia range or the hyperglycemia range.
  • low power mode is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a further specific mode of the analyte sensor device, preferably a further specific mode of the analyte sensor device differing from the active power mode.
  • a power consumption of the analyte sensor device may be lower than the power consumption of the analyte sensor device in the active power mode.
  • the analyte sensor device may be deactivated, preferably in a manner that no analyte sensor data is generated.
  • at least one of the following functions may be deactivated or may occur at a reduced frequency:
  • Analyte sensor data associated signals may be analyte sensor data related signals or analyte sensor data generated by the analyte sensor.
  • the sensor other than the analyte sensor may be selected from at least one of: a temperature sensor, a GPS sensor, a heart rate sensor. There may be further sensors other than the analyte sensor disclosed that may also be selected here.
  • failuresafe operation is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a process configured to ensure a continued functioning and/or to ensure a safe shut down of a device, preferably in the event of a failure and/or malfunction.
  • the analyte sensor When the analyte sensor is deactivated, the analyte sensor may still receive at least one first further control signal as defined below. Alternatively or in addition, during the low power mode the analyte sensor device may be configured to be in at least one mode selected from the list of
  • the decreased measurement frequency may be decreased relative to a measurement frequency in the active power mode.
  • the decreased frequency of the at least one analyte sensor device to process the analyte sensor data may be decreased relative to a frequency of the at least one analyte sensor device to process the analyte sensor data in the active power mode.
  • the frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller relative to a frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller in the active power mode.
  • the decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller may be selected in accordance with a probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval.
  • the probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval may be determined by evaluating the risk for a glycemic excursion.
  • the method further may comprise: o determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor.
  • the method further may comprise: o cancelling transmission of the control signal to the at least one analyte sensor device when the current analyte concentration of the user does not fulfill at least one criterion.
  • Said criterion may describe an analyte concentration range of the predetermined target range or a subrange of the predetermined target range.
  • the term “cancelling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to revoke and/or annul at least one intended or ongoing activity.
  • the transmission of the control signal to the at least one analyte sensor device may be canceled before the start of the transmission. Alternatively, the transmission of the control signal to the at least one analyte sensor device may be canceled during the transmission.
  • the method further may comprise: o transmitting at least one first further control signal to the at least one analyte sensor device to cause the analyte sensor device to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range, preferably when the analyte sensor device is in the low power mode.
  • the current event data indicating that the analyte concentration in the bodily fluid will leave the predetermined target range may be event data received after the analyte sensor device switched into the low power mode.
  • the current event data indicating that the analyte concentration in the bodily fluid will leave the predetermined target range may be event data comprising data about at least one event which increases the analyte concentration in the bodily fluid of the user, preferably as further defined above.
  • the method further may comprise: o transmitting at least one second further control signal to an insulin pump to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device is in the low power mode.
  • insulin pump as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary device configured for administering insulin by using at least one pump.
  • bolus may refer to a dose of a medication substance, such as insulin, administered all at once and/or over a short period.
  • dosing pattern as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a schedule for administering medication over a period of time.
  • the dosing pattern may comprise at least one of at least one frequency of a dose, at least one amount of at least one medication to be taken.
  • the dosing pattern preferably may comprise at least one of basal rate; a bolus pattern.
  • basal rate as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a rate at which a medication, such as insulin, is administered.
  • bolus pattern as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a schedule for administering one or more boluses. Thereby, the bolus pattern may define the timing and the dosage of the one or more boluses.
  • a remote controller for controlling at least one analyte sensor device is disclosed, wherein the remote controller is configured for performing the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding claims.
  • the remote controller is configured for performing the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding claims.
  • remote controller as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary device configured for managing and/or regulating the operation or performance of a system, a further device or a process.
  • the remote controller may be configured for controlling the analyte sensor device.
  • the remote controller may be configured for controlling the analyte sensor device from a distance.
  • the remote controller may be separate from the analyte sensor device, preferably in a manner that the remote controller and the analyte sensor device comprise two different and separated housings.
  • a data transfer between the remote controller and the analyte sensor device for controlling the analyte sensor device may be a wireless data transfer. The data transfer may be via a transmitter.
  • the remote controller may be or may comprised by a mobile device or an insulin pump.
  • the term “mobile device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to a mobile electronics device, preferably a personal mobile device (PDA), more preferably to a mobile communication device such as a cell phone and/or a smartphone. Additionally or alternatively, the mobile device may also refer to a notebook, a tablet computer or another type of portable computer, such as a wearable, preferably smart glasses.
  • the mobile device may comprise a transmitter.
  • the mobile devices may be selected from the group consisting of a cell phone having at least one camera, preferably a smart phone; a portable computer having at least one camera, preferably at least one of a notebook and a tablet computer.
  • a computer program comprising instructions is disclosed, which, when the program is executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • a computer-readable storage medium comprising instructions is disclosed, which, when the instructions are executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • the term “computer-readable storage medium” preferably may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions.
  • the computer-readable storage medium preferably may be or may comprise a storage medium such as a random-access memory (RAM) and/or a read-only memory (ROM).
  • a non-transient computer-readable medium including instructions is disclosed that, when the instructions are executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • instructions when executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • a continuous analyte sensor system of a user comprising a. at least one analyte sensor device comprising an analyte sensor configured to be body-worn by a user comprising an analyte sensor, wherein the analyte sensor is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller as described elsewhere herein.
  • the continuous analyte sensor system may be a continuous glucose sensor system.
  • the analyte sensor may comprise an insertable portion configured for being at least partially insertable into a body tissue of a user.
  • the analyte sensor device comprises a housing comprising an electronics unit, wherein the electronics unit is configured for receiving analyte sensor data from the analyte sensor, and wherein the electronics unit is further configured for transmitting the analyte sensor data to at least one receiving remote controller.
  • the analyte sensor device may be configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system receiving the at least one control signal causing the analyte sensor device to switch from the active power mode to the at least one low power mode transmitted by the remote controller.
  • the analyte sensor device may be configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval.
  • the analyte sensor device may be configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system receiving the at least one first further control signal causing the analyte sensor device to switch from the at least one low power mode to the active power mode transmitted by the remote controller.
  • the analyte sensor system may comprise at least one insulin pump configured for administering insulin to the user, wherein the remote controller is configured for controlling the administration of insulin to the user.
  • the remote controller may be configured for transmitting at least one second further control signal to the at least one insulin pump to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device is in the low power mode.
  • the remote controller may be or may be comprised by the insulin pump.
  • the analyte sensor system may comprise a mobile device, wherein the remote controller may be or may be comprised by the mobile device.
  • the at least one remote controller may comprise a processor and a memory with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
  • processor as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term preferably may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and/or, generally, to a device which is configured for performing calculations or logic operations.
  • the processor may be configured for processing basic instructions that drive the computer or system.
  • the processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math co-processor or a numeric co-processor, a plurality of registers, preferably registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an LI and L2 cache memory.
  • ALU arithmetic logic unit
  • FPU floating-point unit
  • a plurality of registers preferably registers configured for supplying operands to the ALU and storing results of operations
  • a memory such as an LI and L2 cache memory.
  • the processor may be a multi -core processor.
  • the processor may be or may comprise a central processing unit (CPU).
  • the processor may be or may comprise a microprocessor, thus preferably the processor’s elements may be contained in one single integrated circuitry (IC) chip.
  • the processor may be or may comprise one or more applicationspecific integrated circuits (ASICs) and/or one or more field-programmable gate arrays (FPGAs) and/or one or more tensor processing unit (TPU) and/or one or more chip, such as a dedicated machine learning optimized chip, or the like.
  • ASICs applicationspecific integrated circuits
  • FPGAs field-programmable gate arrays
  • TPU tensor processing unit
  • the processor preferably may be configured, such as by software programming, for performing one or more evaluation operations as will be outlined in further detail below.
  • the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present.
  • the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.
  • the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element.
  • the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.
  • the proposed computer-implemented method for controlling an analyte sensor device, remote controller for controlling at least one analyte sensor device and continuous analyte sensor system provide many advantages over known devices and methods.
  • the computer- implemented method for controlling an analyte sensor device, the remote controller for controlling at least one analyte sensor device and the continuous analyte sensor system may allow using the analyte sensor device for a longer period.
  • the computer-implemented method for controlling an analyte sensor device, the remote controller for controlling at least one analyte sensor device and the continuous analyte sensor system may allow operating the analyte sensor device in a manner that it consumes less power.
  • the disclosure relates to continuous analyte sensor system and method for operating a continuous analyte sensor, wherein a time period for a low power mode of the continuous analyte sensor may potentially be prolonged based on a prediction time interval associated with a risk for a glycemic excursion.
  • the prediction time interval may be determined based on historic and current received event data and received analyte data.
  • a continuous glucose sensor system of a user comprising a. an analyte sensor device comprising: o an analyte sensor having an insertable portion configured to be at least partially inserted into a body tissue of a user, the analyte sensor being configured to detect an analyte in a body fluid of a patient; o a housing comprising an electronics compartment comprising an electronics unit, wherein the electronics unit is configured to connect with the analyte sensor and further configured to communicate analyte sensor data to a remote controller; and b.
  • the remote controller comprising a processor and a memory with instructions which when executed cause the processor to: o receiving for the user for a prediction time interval associated with a risk for a glycaemic excursion of the analyte levels outside a target range, wherein the prediction time interval is determined based on historical and current collected user data of the user, wherein the collected user data comprises glucose data collected by the analyte sensor device, glucose level increase associated event data (such as meals, insulin bolus, dehydration), and glucose level decrease associated event data (such as physical activity, stress, reduced sleeping period, drinking water, certain drugs e.g.
  • a temporal period associated with a low risk for a glycemic excursion may be identified and a low power mode may be activated for the next minutes, optionally the user may be notified.
  • a temporal period associated with a medium to high risk for a glycemic excursion may be identified and the active mode may be maintained or the low power mode may be activated for the time frame, wherein a safety time range is subtracted from the time frame.
  • the invention may provide the advantage that the switching between an active mode and the low power mode of the analyte sensor device allows to reduce the capacity of the battery which in turn supports further miniaturization of the analyte sensor device.
  • the analyte sensor device may be operated for a longer period of time compared to devices which do not switch between active and low power mode.
  • the inventive method may enable a personalized and therewith more reliable management of the power consumption by prolonging low power phases during which an analyte concentration is not monitored if the risk for the individual user is sufficiently low.
  • the remote control may conduct additional checks before switching to low power mode to rule out or determine a risk factor that the user’s blood glucose level may leave the predetermined target range and depending on the risk assessment the sensor device may not switch to low power mode but remain in the active mode.
  • the remote control may conduct additional checks during low power mode to rule out or determine a risk factor that the user’s blood glucose level may leave the predetermined target range and depending on the risk assessment the sensor device may be activated prematurely.
  • the principle may be extended to the control of a pump in an automated insulin delivery, AiD, system, where the pump control may continue operation based on a preprogrammed insulin dosing pattern during the time when the continuous glucose sensor system is maintained in a low power mode.
  • Possible checks and events may trigger premature back-switching to the active mode: Carb entry by user, geolocation based meal event detection, calendar entries, eating sound detection. Physical activity entry by user, heart rate sensor, GPS sensor, sports app activation based detection, calendar entries.
  • a computer program including computer-executable instructions for performing the method according to the present invention in one or more of the embodiments enclosed herein when the instructions are executed on a computer or computer network.
  • the computer program may be stored on a computer -readable data carrier and/or on a computer-readable storage medium.
  • computer-readable data carrier and “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions.
  • the computer- readable data carrier or storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and/or a read-only memory (ROM).
  • RAM random-access memory
  • ROM read-only memory
  • one, more than one or even all of method steps i. to vii.as indicated above may be performed by using a computer or a computer network, preferably by using a computer program.
  • program code means in order to perform the method according to the present invention in one or more of the embodiments enclosed herein when the program is executed on a computer or computer network.
  • the program code means may be stored on a computer -readable data carrier and/or on a computer-readable storage medium.
  • a data carrier having a data structure stored thereon, which, after loading into a computer or computer network, such as into a working memory or main memory of the computer or computer network, may execute the method according to one or more of the embodiments disclosed herein.
  • Non-transient computer-readable medium including instructions that, when executed by one or more processors, cause the one or more processors to perform the computer-implemented method for controlling an analyte sensor device.
  • a computer program product with program code means stored on a machine-readable carrier, in order to perform the method according to one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network.
  • a computer program product refers to the program as a tradable product.
  • the product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier and/or on a computer-readable storage medium.
  • the computer program product may be distributed over a data network.
  • modulated data signal which contains instructions readable by a computer system or computer network, for performing the method according to one or more of the embodiments disclosed herein.
  • one or more of the method steps or even all of the method steps of the method according to one or more of the embodiments disclosed herein may be performed by using a computer or computer network.
  • any of the method steps including provision and/or manipulation of data may be performed by using a computer or computer network.
  • these method steps may include any of the method steps, typically except for method steps requiring manual work, such as providing the samples and/or certain aspects of performing the actual measurements.
  • a computer or computer network comprising at least one processor, wherein the processor is adapted to perform the method according to one of the embodiments described in this description, - a computer loadable data structure that is adapted to perform the method according to one of the embodiments described in this description while the data structure is being executed on a computer,
  • a data structure is stored on the storage medium and wherein the data structure is adapted to perform the method according to one of the embodiments described in this description after having been loaded into a main and/or working storage of a computer or of a computer network, and
  • program code means can be stored or are stored on a storage medium, for performing the method according to one of the embodiments described in this description, if the program code means are executed on a computer or on a computer network.
  • Embodiment 1 A computer-implemented method for controlling an analyte sensor device configured to be body-worn by a user comprising an analyte sensor, the method comprising: o receiving analyte sensor data generated by the analyte sensor; o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval.
  • Embodiment 2 The method according to the preceding Embodiment, wherein the control signal is transmitted to the sensor device if the prediction time interval is equal to or longer than
  • Embodiment 3 The method according to any one of the preceding Embodiments, wherein the event data is received from a sensor device selected from at least one of:
  • a heart rate sensor preferably a heart rate sensor configured to sensing a heart rate of the user
  • GNSS global navigation satellite system
  • sensor preferably a GNSS sensor configured for sensing at least one position of the user
  • an acceleration sensor preferably an acceleration sensor configured for sensing at least one movement of the user
  • a microphone preferably a microphone configured for sensing at least one noise of the surrounding of the user.
  • Embodiment 4 The method according to any one of the preceding Embodiments, wherein the event data has been entered by the user into a user interface or extracted from a personal data source related to or of the user.
  • Embodiment 6 The method according to the preceding Embodiment, wherein the event data comprises data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
  • a blood glucose concentration increasing medicament such as glucacon, steroids or antipsychotic medications to the user
  • Embodiment 7 The method according to any one of the two preceding Embodiments, wherein the event data comprises data about at least one event which decreases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
  • a blood glucose concentration decreasing medicament such as metformin, pioglitazone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray;
  • Embodiment 8 The method according to any one of the preceding Embodiments, the event data comprising information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user.
  • Embodiment 9 The method according to any one of the preceding Embodiments, the method further comprising: o determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor.
  • Embodiment 10 The method according to the preceding Embodiment, the method further comprising: o cancelling transmission of the control signal to the at least one analyte sensor device when the current analyte concentration of the user does not fulfill at least one criterion.
  • Embodiment 11 The method according to any one of the preceding Embodiments, the method further comprising: o transmitting at least one first further control signal to the at least one analyte sensor device to cause the analyte sensor device to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range.
  • Embodiment 12 The method according to any one of the preceding Embodiments, the method further comprising: o transmitting at least one second further control signal to an insulin pump to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device is in the low power mode.
  • Embodiment 13 The method according to any one of the preceding Embodiments, wherein during the low power mode the analyte sensor device is deactivated or at least one of the following function is deactivated or occurs at a reduced frequency:
  • Embodiment 14 The method according to any one of the preceding Embodiments, wherein during the low power mode the analyte sensor device is configured to be in at least one mode selected from the list of
  • Embodiment 15 The method according to the preceding Embodiment, wherein at least one of:
  • the decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller is selected in accordance with the probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval.
  • Embodiment 16 The method according to any one the preceding Embodiments, wherein the at least one item of information on the prediction time interval is determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of:
  • Embodiment 17 The method according to any one the preceding Embodiments, wherein the analyte sensor comprises an insertable portion configured for being at least partially insertable into a body tissue of the user.
  • Embodiment 18 A remote controller for controlling at least one analyte sensor device, wherein the remote controller is configured for performing the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments.
  • Embodiment 19 The remote controller according to the preceding Embodiment referring to a remote controller, wherein the remote controller is or is comprised by a mobile device or an insulin pump.
  • Embodiment 20 A computer program comprising instructions which, when the program is executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
  • Embodiment 21 A computer-readable storage medium comprising instructions which, when the instructions are executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
  • Embodiment 22 A non-transient computer-readable medium including instructions that, when the instructions are executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
  • Embodiment 23 A continuous analyte sensor system of a user comprising a. at least one analyte sensor device configured to be body-worn by a user comprising an analyte sensor, wherein the analyte sensor is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller according to any one of the preceding Embodiments 18 to 19.
  • Embodiment 24 The continuous analyte sensor system according to the preceding Embodiment, wherein the analyte sensor comprises an insertable portion configured for being at least partially insertable into a body tissue of a user.
  • Embodiment 25 The continuous analyte sensor system any one of the preceding Embodiments 23 or 24, wherein the analyte sensor device comprises a housing comprising an electronics unit, wherein the electronics unit is configured for receiving analyte sensor data from the analyte sensor, and wherein the electronics unit is further configured for transmitting the analyte sensor data to at least one receiving remote controller.
  • Embodiment 26 The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 25, wherein the analyte sensor device is configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system receiving the at least one control signal causing the analyte sensor device to switch from the active power mode to the at least one low power mode transmitted by the remote controller.
  • Embodiment 27 The continuous analyte sensor system according to any one of the preceding Embodiments 24 to 27, wherein the analyte sensor device is configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval.
  • Embodiment 28 The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 27, wherein the analyte sensor device is configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system receiving the at least one first further control signal causing the analyte sensor device to switch from the at least one low power mode to active power mode transmitted by the remote controller.
  • Embodiment 29 The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 28, wherein the analyte sensor system comprises at least one insulin pump configured for administering insulin to the user, wherein the remote controller is configured for controlling the administration of insulin to the user.
  • Embodiment 30 The continuous analyte sensor system according to the preceding Embodiment, wherein the remote controller is configured for transmitting at least one second further control signal to the at least one insulin pump to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device is in the low power mode.
  • Embodiment 31 The continuous analyte sensor system according to any one of the two preceding Embodiments, wherein the remote controller is or is comprised by the insulin pump.
  • Embodiment 32 The continuous analyte sensor system according to any one of the preceding Embodiments 24 to 31 referring to an analyte sensor system, wherein the analyte sensor system comprises a mobile device, wherein the remote controller is or is comprised by the mobile device.
  • Embodiment 33 The continuous analyte sensor system according to any one of the preceding Embodiments referring to a analyte sensor system, wherein the at least one remote controller comprises a processor and a memory with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
  • the at least one remote controller comprises a processor and a memory with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
  • Figure 1 shows an exemplary computer-implemented method for controlling an analyte sensor device configured to be body -worn by a user comprising an analyte sensor;
  • Figure 2 shows an exemplary continuous analyte sensor system specifically comprising at least one remote controller and at least one analyte sensor device.
  • an exemplary computer-implemented method 110 for controlling an analyte sensor 131 device 128 configured to be body -worn by a user comprising an analyte sensor 131 comprises: o (denoted by reference number 112) receiving analyte sensor data generated by the analyte sensor 131; o (denoted by reference number 114) determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o (denoted by reference number 116) transmitting a control signal to the analyte sensor device 128 to cause the analyte sensor device 128 to switch from an active power mode to a low power mode for the determined prediction time interval.
  • the control signal may be transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value.
  • the at least one item of information on the prediction time interval may be determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of: a lookup table; or a machine learning model.
  • the event data may be received from a sensor device 148 selected from at least one of: a heart rate sensor 150, preferably a heart rate sensor 150 configured to sensing a heart rate of the user; a global navigation satellite system, GNSS, sensor 152, preferably a GNSS sensor 152 configured for sensing at least one position of the user; an acceleration sensor 154; preferably an acceleration sensor 154 configured for sensing at least one movement of the user; and a microphone 156; preferably a microphone configured for sensing at least one noise of the surrounding of the user.
  • a sensor device 148 selected from at least one of: a heart rate sensor 150, preferably a heart rate sensor 150 configured to sensing a heart rate of the user; a global navigation satellite system, GNSS, sensor 152, preferably a GNSS sensor 152 configured for sensing at least one position of the user; an acceleration sensor 154; preferably an acceleration sensor 154 configured for sensing at least one movement of the user; and a microphone 156; preferably a microphone configured for
  • the event data may have been entered by the user into a user interface or extracted from a personal data source related to or of the user, preferably wherein the personal data source is selected from at least one of: an electronic calendar; a social media channel; a mailing account.
  • the event data may comprise information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user.
  • the event data may comprise data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user.
  • the event data may comprise data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of: a consumption of food by the user; an administration of a blood glucose concentration increasing medicament, such as glucacon, steroids or antipsychotic medications to the user; a dehydration of the user; an illness associated release of hormones which raise blood glucose levels; a psychological stress; pain, preferably a pain from a sunburn; and a menstrual period.
  • the event data may comprise data about at least one event which decreases the analyte concentration in the bodily fluid of the user is selected from at least one of: a consumption of water or alcohol by the user; an administration of a blood glucose concentration decreasing medicament, such as metformin, pioglita- zone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray; a physical activity of the user; and an insufficient sleeping period of the user.
  • a blood glucose concentration decreasing medicament such as metformin, pioglita- zone and/or insulin
  • the method further may comprise: o (denoted by reference number 118) determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor 131.
  • the method further may comprise: o (denoted by reference number 120) cancelling transmission of the control signal to the at least one analyte sensor device 128 when the current analyte concentration of the user does not fulfill at least one criterion.
  • the method further may comprise: o (denoted by reference number 122) transmitting at least one first further control signal to the at least one analyte sensor device 128 to cause the analyte sensor device 128 to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range.
  • the method further may comprise: o (denoted by reference number 124) transmitting at least one second further control signal to an insulin pump 138 to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device 128 is in the low power mode.
  • the analyte sensor device 128 may be deactivated.
  • at least one of the following functions may be deactivated or may occur at a reduced frequency:
  • the analyte sensor device 128 may be configured to be in at least one mode selected from the list of decreased measurement frequency of the at least one analyte sensor device 128; decreased frequency of the at least one analyte sensor device 128 to process the analyte sensor data; and decreased frequency of the at least one analyte sensor device 128 to transmit the analyte sensor data to the remote controller 126.
  • At least one of: the decreased measurement frequency; the decreased frequency of the at least one analyte sensor device 128 to process the analyte sensor data; the decreased frequency of the at least one analyte sensor device 128 to transmit the analyte sensor data to the remote controller 126 may be selected in accordance with the probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval.
  • an exemplary remote controller 126 for controlling at least one analyte sensor device 128 is shown, wherein the remote controller 126 is configured for performing the computer-implemented method for controlling the at least one analyte sensor device 128 as disclosed anywhere else herein.
  • the remote controller 126 is a mobile device, as an example.
  • the remote controller 126 may be comprised by the mobile device, may be an insulin pump 138 and/or may be comprised by an insulin pump 138. There may be further ways on how to implement the remote controller 126.
  • the at least one remote controller 126 may comprise a transmitter 142.
  • an exemplary continuous analyte sensor system 130 of a user is shown in Figure 2.
  • the exemplary continuous analyte sensor system 130 comprises: a. at least one analyte sensor device 128 configured to be body -worn by a user comprising an analyte sensor 131, wherein the analyte sensor 131 is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller 126 as described elsewhere herein.
  • the analyte sensor 131 may comprise an insertable portion configured for being at least partially insertable into a body tissue of a user.
  • the analyte sensor device 128 comprises a housing 132 comprising an electronics unit 134, wherein the electronics unit 134 is configured for receiving analyte sensor data from the analyte sensor 131, and wherein the electronics unit 134 is further configured for transmitting the analyte sensor data to at least one receiving remote controller 126.
  • the control signal causing the analyte sensor device 128 to switch from an active power mode to a low power mode and/or the first further control signal the analyte sensor device 128 may comprise a transmitter 136.
  • the analyte sensor device 128 may be configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system 130 receiving the at least one control signal causing the analyte sensor device 128 to switch from the active power mode to the at least one low power mode transmitted by the remote controller 126.
  • the analyte sensor device 128 may be configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval.
  • the analyte sensor device 128 may be configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system 130 receiving the at least one first further control signal causing the analyte sensor device 128 to switch from the at least one low power mode to active power mode transmitted by the remote controller 126.
  • the analyte sensor system 130 may comprise at least one insulin pump 138 configured for administering insulin to the user, wherein the remote controller 126 is configured for controlling the administration of insulin to the user.
  • the remote controller 126 may be configured for transmitting at least one second further control signal to the at least one insulin pump 138 to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device 128 is in the low power mode.
  • the at least one insulin pump 138 may comprise a transmitter 140.
  • the at least one remote controller 126 may comprise a sensor device 148 configured to receive at least a portion of the event data.
  • the sensor device 148 may selected from at least one of a heart rate sensor 150, preferably a heart rate sensor 150 configured to sensing a heart rate of the user; a global navigation satellite system, GNSS, sensor 152, preferably a GNSS sensor 152 configured for sensing at least one position of the user; an acceleration sensor 154; preferably an acceleration sensor 154 configured for sensing at least one movement of the user; and a microphone 156; preferably a microphone 156 configured for sensing at least one noise at the surrounding of the user.
  • a heart rate sensor 150 preferably a heart rate sensor 150 configured to sensing a heart rate of the user
  • GNSS global navigation satellite system
  • sensor 152 preferably a GNSS sensor 152 configured for sensing at least one position of the user
  • an acceleration sensor 154 preferably an acceleration sensor 154 configured for sensing at least one movement of the user
  • the at least one remote controller 126 may comprise a user interface 158 configured to receive at least a portion of the event data, preferably by the user entering the event data.
  • the at least one remote controller 126 may comprise a processor 144 and a memory 146 with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein. Further disclosed is a computer program comprising instructions, which, when the program is executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein.
  • a computer-readable storage medium comprising instructions, which, when the instructions are executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein.
  • a non-transient computer-readable medium including instructions that, when the instructions are executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein.

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Abstract

The present invention relates to a computer-implemented method for controlling an analyte sensor device (128) configured to be body-worn by a user comprising an analyte sensor (131), the method comprising: o receiving analyte sensor (131) data generated by the analyte sensor (131); o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device (128) to cause the analyte sensor device (128) to switch from an active power mode to a low power mode for the determined prediction time interval. The invention further relates to a remote controller for controlling at least one analyte sensor device (128), to a continuous analyte sensor system (130), to a computer program and to a computer-readable storage medium.

Description

Methods and devices for controlling an analyte sensor device
Technical Field
The invention relates to a computer-implemented method for controlling an analyte sensor device, to a remote controller for controlling at least one analyte sensor device and to a continuous analyte sensor system. The invention further relates to a computer program and to a computer-readable storage medium. The devices and method according to the present invention may mainly be used for long-term monitoring of an analyte concertation in a body fluid, such as for long-term monitoring of a blood glucose level or of the analyte concentration of one or more other types of analytes in a body fluid. The invention may both be applied in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are feasible.
Background art
Miniaturization of a body -worn analyte sensor device in part depends on the dimension and capacity of the battery needed to supply the analyte sensor with sufficient energy during shelf life and during the active wear time when the sensor patch device actively monitors analyte levels. The required capacity of the battery inter alia depends on the measuring frequency, the frequency of processing sensor data and the frequency of transmitting sensor data to a remote device or simply put, the amount of time the sensor patch device is active throughout its wear time. The wear time of currently known systems lies in the range of 7 to 14 days.
US11369319B2 discloses a method of operating a receiver for receiving analyte data from a biosensor monitoring an analyte by detecting analyte values, the method comprising: in a receiver, receiving analyte values detected by a biosensor monitoring an analyte in intervals of time for which a first interval time is applied; receiving a present analyte value in the receiver; providing a rate of change for the analyte values; determining a future analyte value based on the present analyte value, the first interval time, and the rate of change; providing an analyte value range for the analyte values; setting a second interval time, the second interval time being shorter than the first interval time, if the future analyte value is outside the analyte value range, and longer than or equal to the first interval time, if the future analyte value is within the analyte value range; and in the receiver, receiving one or more following analyte values in intervals of time for which the second interval time is applied. Also, a receiver is provided, comprising a receiver unit, and a processor connected to the receiver unit. Further, a computer program product is provided.
US 11303510B2 discloses a method and a system for a wireless data communication between a sensor system and a receiver capable of receiving analyte values sensed by the sensor system in a continuous analyte monitoring. The method includes establishing an unconnected mode operation for the system. The receiver receives a first data package broadcasted by the sensor system that has first status data indicative of a device status and/or an analyte value status. The first status data is processed by a receiver controller. A connected mode operation is established for the system responsive to determining at least one of a critical device status and a critical analyte value status. The establishing includes establishing a communication channel between the sensor system and the receiver and receiving a second data package transmitted by the sensor system in the receiver, the second data package comprising one or more analyte values.
EP2621339B1 discloses systems and methods for processing, transmitting, and displaying data received from continuous analyte sensor, such as a glucose sensor. In some embodiments, the continuous analyte sensor system comprises a sensor electronics module that includes power saving features. One feature includes a low power measurement circuit that can be switched between a measurement mode and a low power mode, in which charging circuitry continues to apply power to electrodes of a sensor during the low power mode. In addition, the sensor electronics module can be switched between in a low power storage mode higher power operational mode via a switch. The switch can include a reed switch or optical switch, for example. A validation routine can also be implemented to ensure an interrupt signal sent from the switch is valid. The continuous analyte sensor can be physically connected to a sensor electronics module, which is in direct wireless communication with a plurality of different display devices.
US9931037B2 discloses systems and methods for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor. In an embodiment, a method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide user access to sensor -related information comprises: activating a transceiver of a first communication device associated with an analyte sensor at a first time; and establishing a two-way communication channel with the second communication device; wherein the activating comprises waking the transceiver from a low power sleep mode using a forced wakeup from the second communication device.
US 2020/281538 Al discloses a method of operating a receiver for receiving analyte data from a biosensor monitoring an analyte by detecting analyte values. The receiver receives analyte values detected by a biosensor in intervals of time for which a first interval time is applied in a receiver. The receiving process comprises that the receiver transmits a control signal to the biosensor first, wherein the control signal defines a time delay between the end of a connection process between the receiver and the biosensor and the starting point of the biosensor transmitting the one or more analyte values to the receiver. Based on the received present analyte values, the first interval time and a rate of change the receiver extrapolates future analyte values. Based on the extrapolated future analyte values the receiver sets and applies a second interval time for the receiving time interval, wherein the second interval time is shorter than the first interval time, if the future analyte value is outside of the analyte value range, and the second interval time is longer than or equal to the first interval time, if the future analyte value is within the analyte value range.
Problem to be solved
It is therefore desirable to provide a computer-implemented method for controlling an analyte sensor device, to a remote controller for controlling at least one analyte sensor device and to a continuous analyte sensor system, which solve at least one of the problems mentioned above.
In particular, it is desirable to provide a computer-implemented method for controlling an analyte sensor device, a remote controller for controlling at least one analyte sensor device and a continuous analyte sensor system, which allow using the analyte sensor device for a longer period than hitherto known analyte sensor devices. In particular, it is further desirable to provide a computer-implemented method for controlling an analyte sensor device, a remote controller for controlling at least one analyte sensor device and a continuous analyte sensor system, which allow operating the analyte sensor device in a manner that it consumes less power than hitherto known analyte sensor devices. Summary
At least one of the above-mentioned problems is addressed by the computer-implemented method for controlling an analyte sensor device, the remote controller for controlling at least one analyte sensor device and the continuous analyte sensor system with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.
In a first aspect, a computer-implemented method for controlling an analyte sensor device configured to be body-worn by a user comprising an analyte sensor is disclosed. For this aspect, reference may be made to any disclosure herein, particularly to any definition, Embodiment and/or further aspect as disclosed elsewhere herein.
The computer-implemented method for controlling an analyte sensor device comprises the following steps, which may be performed in the given order. A different order, however, may also be feasible. Further, two or more of the method steps may be performed simultaneously. Thereby, the method steps may at least partly overlap in time. Further, the method steps may be performed once or repeatedly. Thus, one or more or even all of the method steps may be performed once or repeatedly. The method may comprise additional method steps, which are not listed herein.
The term "computer-implemented" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a method which is performed by using computer programming, and/or by using at least one computer and/or at least one computer network. Thus, as an example, one or more or even all of the method steps may be performed by appropriate software, e.g. by using computer- readable instructions which, when executed on a computer or a computer network, cause the computer or computer network to perform the method steps. The term “software” as used herein may, preferably, refer to a computer program. The computer program may have a plurality of functions, procedures, methods and subprograms, which may be distributed over several specific hardware instances. The computer and/or computer network may comprise at least one processor, which is configured for performing at least one, more than one or all of the method steps of the method according to the present disclosure. Preferably, each of the method steps is performed by the computer and/or computer network. The method may be performed completely automatically, preferably without user interaction. The term "controlling" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a process of managing and/or regulating the operation or performance of at least one system, at least one device or at least one process. Controlling may comprise monitoring at least one input parameter, such as an operational parameter. Monitoring the input parameter may be performed by using a monitoring device, such as a sensor. Controlling may further comprise determining at least one control parameter by evaluating the input parameter. Determining control parameters may be performed by using an evaluation unit. The control parameters may be determined such that the system, the device or the process performs in a desired manner.
The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an arbitrary element, component or compound which may be present in a body fluid and a presence and/or a quantity and/or a concentration of which may be of interest for a user, a patient or medical staff such as for a medical doctor. As will be understood by the skilled person, a "presence" of an analyte, for example, may be a presence of said analyte in an amount above a detection limit. Preferably, the analyte may be or may comprise an arbitrary chemical substance or chemical compound which may take part in a metabolism of the user or the patient, such as a metabolite. As an example, the analyte may be selected from the group consisting of glucose, ketones, glycerol, a hormone such as testosteron, cortisol, cholesterol, triglycerides, lactic acid, lactate or any analyte which can be measured electrochemically. Additionally or alternatively, however, other types of analytes may be used and/or any combination of analytes may be determined. However, more preferably, the analyte may be glucose.
The term “analyte sensor device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary element or article being configured for use in the field of medical technology, exemplarily in the field of medical analytics or medical diagnostics. The analyte sensor device may be configured for performing a medical function and/or for being used in a medical process, such as in one or more of a therapeutic process, a diagnostic process or another medical process. The analyte sensor device preferably may comprise an assembly of two or more components capable of interacting with each other, such as in order to perform one or more diagnostic and/or therapeutic purposes, such as in order to perform a medical analysis. Preferably, the two or more components may be capable of performing a detection of the analyte in the body fluid and/or of contributing to the detection of the analyte in the body fluid.
The analyte sensor device is configured to be “body -worn” by the user. Consequently, the analyte sensor device may be in contact with the body of the user, preferably during an active wear time of the analyte sensor device. During the active wear time, the analyte sensor device may generate sensor data related to the user, preferably in order to detect a presence and/or a quantity and/or a concentration of an analyte. The analyte sensor device may preferably be configured to be mounted on a skin site of a body part selected from the group consisting of: an arm, exemplarily an upper arm; a stomach; a shoulder; a back; hip; a leg. Preferably, the body part may be the upper arm. However, also other applications may be feasible. The analyte sensor may further comprise a surface, such as a flat or plane surface, configured for being placed on a user’s skin. The surface may be an adhesive surface. Preferably, the analyte sensor device may comprise an adhesive surface for attachment to the user’s skin. The term “adhesive surface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to a surface being capable to bind to an object and to resist separation. Exemplarily, the adhesive surface may comprise a plaster or an adhesive strip. The plaster or the adhesive strip may comprise an adhesive material.
The analyte sensor device may comprise a housing comprising an electronics unit received therein. The housing comprising the electronics unit may be configured to stay outside of the body tissue. The term “housing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an arbitrary element which is adapted to fully or partially surround and/or receive one or more elements in order to provide one or more of a mechanical protection, a mechanical stability, an environmental protection against moisture and/or ambient atmosphere, a shielding against electromagnetic influences or the like. Thus, the housing may simply provide a basis for attachment and/or holding one or more further components or elements. Additionally or alternatively, the housing may provide one or more interior spaces for receiving one or more further components or elements. The housing may preferably be manufactured by injection molding. However, other embodiments are feasible. Exemplarily, the electronics unit may be sealed or potted as will further be described below. The housing may comprise an upper side and a lower side. The terms “upper side” and “lower side” may refer to two opposing sides of the housing. The terms “upper side” and “lower side” may be considered as description without specifying an order and without excluding a possibility that several kinds of upper sides and lower sides may be applied. Preferably, the “upper side” may refer to a distal side of the housing. The term “distal side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an indication of a position of the side of the housing in relation to a user which is furthermost away from a skin site of the user. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The distal side may refer to a side being distant from the skin site of the user. Preferably, the “lower side” may refer to a proximal side of the housing. The term “proximal side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an indication of a position of the side of the housing in relation to a user, which is closest to a skin site of the user. Exemplarily, for inserting the analyte sensor, the housing may be brought into contact with the skin site of the user. The proximal side may refer to a side being in close proximity to or even in direct contact with to the skin site of the user.
The term “electronics unit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an arbitrary device, which is configured for performing at least one electronic function. Preferably, the electronics unit may have an electronic component. Preferably, the electronics unit may comprise the electronic component for one or more of performing a measurement with the analyte sensor, performing a voltage measurement, performing a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another device. The electronics unit may preferably be embodied as a transmitter or may comprise a transmitter, for transmitting data. Other embodiments of the electronic components are feasible. These electronic components generally are known in the art of long-term monitoring one or more analytes, such as in from one or more of the above-mentioned prior art documents.
The electronics unit may comprise at least one circuit carrier, preferably a printed circuit board, in one embodimenta flexible printed circuit board. The term “circuit carrier” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an element or a combination of elements which are capable of carrying one or more electronic components and of interconnecting these one or more electronic components, such as interconnecting the one or more electronic components electrically or electronically with each other and/or with one or more contact pads. As an example, the circuit carrier may comprise a base and one or more electrical traces and/or one or more electrical contact pads disposed thereon and/or therein. The base, as an example, may be a flat element having a lateral extension which exceeds its width by at least a factor of 10, more preferably by at least a factor of 100 or even a factor of 1000. Other embodiments are feasible. Rigid materials, which may be used for the base, may be fiber-enforced plastic materials such as fiber-enforced epoxy materials like glass-fiber-enforced epoxy materials such asFR-4. Other materials may be used. Preferably, the base may be a flexible base, such that the circuit carrier may fully or partially be embodied as a flexible printed circuit board. In this case, as an example, the flexible base may fully or partially be made of one or more flexible plastic materials such as one or more plastic foils or laminate, such as polyimides.
The housing may comprise an electronics compartment, preferably for receiving the electronics unit. The term “compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an arbitrary subpart of a superior element creating a partially or fully enclosed space that may be usable to contain and/or store objects. The subpart may preferably be completely or at least to a large extent closed such that an interior of the compartment may be isolated from a surrounding environment. Exemplarily, the compartment may be separated from other parts of the superior element by one or more walls. Thus, within the housing, two or more compartments may be comprised which may fully or partially be separated from one another by one or more walls of the housing. Each compartment may comprise a continuous space or lumen configured for receiving one or more objects. The term “electronics compartment” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to an arbitrary compartment, which is configured for receiving an element or a combination of elements which fulfill an electrical or electronic purpose. Preferably, the electronic component may be configured for receiving a circuit carrier. The circuit carrier may be fixedly positioned within the electronics compartment of the housing. Further, the analyte sensor device comprises an analyte sensor. The term "analyte sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary device configured for performing a quantitative and/or qualitative determination of the at least one property of a sample related to the at least one analyte. The determination of the at least one property may preferably comprise quantitatively or qualitatively detecting the at least one analyte in the bodily fluid. The term “detecting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably relates to a process of determining a presence and/or a quantity and/or a concentration of an analyte. Thus, the detection may be or may comprise a qualitative detection, simply determining the presence of the analyte or the absence of the analyte, and/or may be or may comprise a quantitative detection, which determines the quantity and/or the concentration of the analyte. The detection may be analytespecific.
The analyte sensor may, preferably, be a transcutaneous sensor. The term “transcutaneous sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary sensor which is adapted to be fully or at least partly arranged within a body tissue of a patient or a user. The analyte sensor may comprise an insertable portion configured for being at least partially insertable into a body tissue of the user. The term “insertable portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a part or component of an element configured to be insertable into an arbitrary body tissue. In order to further render the analyte sensor to be usable as a transcutaneous sensor, the analyte sensor may fully or partially provide a biocompatible surface, i.e. a surface which, at least during durations of use, do not have any detrimental effects on the user, the patient or the body tissue. Preferably, the insertable portion of the analyte sensor may have a biocompatible surface. As an example, the transcutaneous sensor, preferably the insertable portion, may fully or partially be covered with a biocompatible membrane, such as a polymer membrane or gel membrane which is permeable for the analyte and/or the body fluid and which, on the other hand, retains sensor substances such as one or more analyte detection agents within the sensor and prevents a migration of these substances into the body tissue. Other parts or components of the analyte sensor may stay outside of the body tissue. The analyte sensor may preferably be an electrochemical analyte sensor. The term “electrochemical sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a sensor which is configured to conduct an electrochemical measurement, preferably in order to detect an analyte in a body fluid of a user. The term “electrochemical measurement” may refer to a detection of an electrochemically detectable property of the analyte, such as to an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction may be detected by comparing one or more electrode potentials. The electrochemical sensor preferably may be adapted to and/or may be usable to generate an electrical sensor signal which directly or indirectly indicates the presence and/or the extent of the electrochemical detection reaction, such as a current and/or a voltage. The detection may be analyte-specific. The measurement may be a qualitative and/or a quantitative measurement. Still, other embodiments are feasible.
The term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term exemplarily relates to a person intending to monitor an analyte value, such as a glucose value, in a person’s body tissue. In an embodiment, the term preferably may refer, without limitation, to a person using the medical device. For example, the user may be a patient suffering from a disease, such as diabetes. The user may also be referred to as subject or as patient. However, in another embodiment, the person using the medical device is different from the user.
The method comprises: o receiving analyte sensor data generated by the analyte sensor; o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval, preferably when the analyte sensor device is in the active power mode.
The term “receiving” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a process of getting access to and/or possession of data, preferably a receiving device may get access to and/or possession of the data. The data may be, preferably, the sensor data generated by the analyte sensor. The data may be transmitted by a transmitting device, preferably the analyte sensor, configured for allowing access to the data. For allowing access to the data, the transmitting device may exchange the data with the receiving device, such as by providing and/or sending the data. Consequently, the transmitting device may be a sending device and/or a measurement device. For receiving the data, the data may be requested by the receiving device, such as by sending or transferring a query to the transmitting device. Receiving the data may comprise a step of requesting the transmission of the data.
The term "analyte sensor data" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to data generated by using the analyte sensor. The analyte sensor data may describe a presence and/or a quantity and/or a concentration of the analyte in the bodily fluid, preferably measured at a particular interval or point in time. The analyte sensor data may be preexisting data in respect to performing the method for controlling the analyte sensor device. The term “preexisting dataset” may indicate that the method for controlling the analyte sensor device, typically, is free of a step of a data acquisition from the user. Consequently, the analyte sensor data may be generated by the analyte sensor device before the method for controlling an analyte sensor is performed. Consequently, the analyte sensor data may already exist at the time the method for controlling the analyte sensor device receives the analyte data. The device that is performing the method for controlling the analyte sensor device may be different from the analyte sensor device. The device that is performing the method for controlling the analyte sensor device may be a remote controller. As a result, the data acquisition from the user may be performed be a device that is different from the device that is performing the method for controlling the analyte sensor device.
As further already indicated, the method comprises determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval.
The term "determining" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a process of generating at least one representative result, in particular, by evaluating input data, such as the received analyte sensor data and/or the received event data. The at least one representative result may be the prediction time interval. The term determining may refer to the computer assisted processing of data, preferably in order to generate the at least one representative result. The at least one representative result may be generated in such a manner that it is available or provided as data or at least one item of information on the representative result. The term “information” may indicate that the representative result is described by the data. Generating the at least one representative result may be performed by using a computer program running on a computer or a computer network.
The prediction time interval may be associated with a risk for a glycemic excursion. Determining the prediction time interval may comprise or be based on the risk for a glycemic excursion. The risk for a glycemic excursion may be determined by evaluating the analyte sensor data and the event data. The term “risk for a glycemic excursion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a probability for a glycemic excursion, preferably a probability for a glycemic excursion equal to or above a threshold, such as a predetermined threshold. A ’’glycemic excursion” may be a fluctuation and/or a change of the analyte concentration of the user causing the analyte concentration of the user to leave the predetermined target range.
The at least one item of information on the prediction time interval may be determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of: a look-up table; or a machine learning model, preferably a trained machine learning model. The term “machine learning model” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a mathematical model which is trainable on at least one training dataset using machine learning, in particular deep learning or other forms of artificial intelligence. The term “machine learning” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a method of using artificial intelligence (Al) for automated model building. The training may be performed using at least one machine-learning system. The term “machine-learning system” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a system or unit comprising at least one processing unit such as a processor, microprocessor, or computer system configured for machine learning, in particular for executing a logic in a given algorithm. The machine-learning system may be configured for performing and/or executing at least one machine-learning algorithm, wherein the machine-learning algorithm is configured for generating the trained machine learning model.
The term “prediction time interval” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a duration of time between two specific points in time. The prediction time interval may be a contiguous time period elapsing between a starting point in time and an ending point in time. The prediction time interval may be an uninterrupted time span. In a preferred embodiment the prediction time interval is an interval of between 1 min to 2 hours, preferably between 1 min to 1 hour, preferably between 1 min to 45 min, preferably between 1 min to 30 min, preferably between 1 min to 20 min, preferably between 1 min to 15 min, preferably between 1 min to 10 min, preferably between 5 min to 60 min, preferably between 10 min to 60 min, preferably between 20 min to 60 min, preferably between 30 min to 60 min, preferably between 10 min to 30 min.
The term “predetermined target range” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a range of values for at least one specific health indicator, such as the analyte concentration in the bodily fluid of the user. The predetermined target range may be set by a health care professional. The predetermined target range may be selected in a manner that the comprised values are in agreement with at least one physiological norm of an analyte concentration in a bodily fluid, preferably of a blood glucose level. For the preferred analyte glucose the predetermined target range may be selected in a manner that the comprised values that are within a normal blood glucose range, preferably a blood glucose range that is normal for the user and in agreement or in a best possible agreement with the physiological norm of the analyte concentration in the bodily fluid. The predetermined target range may exclude blood glucose concentration values that are within a hypoglycemia range. The predetermined target range may blood glucose concentration exclude values that are within a hyperglycemia range. The predetermined target range may comprise blood glucose concentration values between 50 milligrams per deciliter and 200 milligrams per deciliter, preferably between 70 milligrams per deciliter and 180 milligrams per deciliter. Of course, in an alternative embodiment the corresponding concentrations ranges when measured in milimol per liter may also be applied.
The term “event data” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to data related to an arbitrary information collected about at least one action and/or at least one occurrence involving the user. This data may comprise information on events related to at least one interaction, at least one behavior and/or at least one experience of the user, preferably providing an insight into the activities and preferences of the user. For the present disclosure, data on events that have an influence on the analyte concentration in the bodily fluid of the user, preferably the blood glucose level of the user, may be of preferred interest.
The event data, specifically a portion of the event data, may be received from a sensor device, which may comprise a sensor measuring a second analyte different from the first analyte or which may be a sensor which is not an analyte sensor. The sensor device may be comprised by the mobile device. For determining the prediction time interval, analyte sensor data and event data are evaluated. Particularly event data on events may be evaluated that are expected to still have an influence on the analyte concentration in the bodily fluid of the user. Events that are expected to still have an influence on the analyte concentration in the bodily fluid of the user, may be events that are expected to cause a change in the analyte concentration in the bodily fluid of the user in respect to the point in time at which the youngest received analyte concentration in the bodily fluid of the user has been generated.
The event data may comprise information on at least one vital sign of the, such as a heart rate, a blood pressure; a body temperature; a vigilance and/or a respiratory rate. The vital sign may deviate from the analyte concentration in the bodily fluid of the user. The term “vital sign” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to at least one quantifiable characteristics of the user providing information on at least one vital bodily function. The event data may be received from a sensor device configured for sensing the vital sign. Particularly in case the vital sign is a heart rate, the event data may be received from a heart rate sensor, preferably a heart rate sensor configured to sensing a heart rate of the user.
Alternatively or in addition, the event data may comprise information on a location or a position of the user. Thereby, the location or position may be described by a geographical position of the user. The position of the user may be received from a sensor device configured for sensing the at least one position of the user. The sensor device configured for sensing the at least one position of the user may be a global navigation satellite system, GNSS, sensor. Preferably, the sensor device configured for sensing the at least one position of the user may be a Geo Positioning System, GPS, sensor. I another embodiment, the sensor device configured for sensing the at least one position of the user may be a Global Navigation Satellite System, GLONASS, sensor and/or a Galileo (satellite navigation) sensor or the like.
Alternatively or in addition, the event data may comprise information on a movement of the user. Preferably, the movement information is indicative of the physical activity of the user. The event data may be received from an acceleration sensor; preferably an acceleration sensor configured for sensing at least one movement of the user. Alternatively or in addition, the event data may comprise information on at least one noise at the surrounding of the user. The term “noise” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to at least one environmental sound at the location of the user independent on a volume of the noise. The at least one noise may indicate that the user is consuming food, is sleeping or the like.
The event data, specifically a portion of the event data, may have been entered by the user into a user interface or extracted from a personal data source related to or of the user, preferably wherein the personal data source is selected from at least one of: an electronic calendar; a social media channel; a mailing account.
The term “user interface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary hardware component configured for receiving at least one input from the user, preferably, but not limited to, an input in form of a text, an input in form of a gesture, an input in form of a voice input. The term “enter” may refer to the process of providing or generating an input by the user independent of the type or form of the input. The user interface may be comprised by the mobile device.
The term “personal data source” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a data collection, such as a data base, that comprises event data of the user. In the personal data source, the event data may be provided in a manner that the event data can be related to the user. Particularly therefore, the personal data source may be a data source exclusively used by the user. Alternatively or in addition, the event data may paired with a tag comprising information on the person allowing an identification of the event data. Such an approach may be preferred when the personal data source is a shared personal data source, such as a shared calendar that is used by the user and at least one further person.
The event data may comprise data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user. The event data may comprise data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
- a consumption of food by the user;
- an administration of a blood glucose concentration increasing medicament, such as glucacon, steroids or antipsychotic medications to the user;
- a dehydration of the user;
- an illness associated release of hormones which raise blood glucose levels
- a psychological stress;
- pain, such as pain from a sunburn; and
- a menstrual period.
The event data may comprise data about at least one event which decreases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
- a consumption of water or alcohol by the user;
- an administration of a blood glucose concentration decreasing medicament, such as metformin, pioglitazone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray; a physical activity of the user; and an insufficient sleeping period of the user.
The event data may comprise information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user. Determining the prediction time interval may comprise evaluating the behavioral pattern of the user, preferably in a manner that the prediction time interval is influenced by or based on that behavioral pattern of the user. The term “behavioral pattern” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a consistent and repetitive action or habit. The behavioral pattern may comprise a sequence of a plurality of actions and/or habits. The information on the behavioral pattern may be comprised by the event data. In that sense, the event data may comprise the behavioral pattern as such. Alternatively or in addition, the behavioral pattern may be comprised in the event data in a manner that a plurality of events is comprised by the event data, wherein the event data may be evaluated, preferably in a step of the computer-implemented method for controlling an analyte sensor device, in order to determine the behavioral pattern of the user. Consequently, the step of determining a prediction time interval may comprise determining the behavioral pattern by evaluating the event data. The behavioral pattern may be predicted to occur within the prediction time by determining and/or evaluating a probability of the behavioral pattern to occur within the prediction time. The probability of the behavioral pattern to occur within the prediction time may be based on historic event data, specifically on a periodic occurrence of the behavioral pattern. Alternatively or in addition, the prediction may be based on an event triggering the behavioral pattern.
As already indicated, the method comprises transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval.
The term “transmitting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to sending or moving data from a providing device to a receiving device. Transmitting may be performed by using a “transmitter”. Said term specifically may refer, without limitation, to an arbitrary device configured for transmitting data. The transmitter may be configured for transferring information via a network, such as a local area network or internet. Alternatively or in addition, the transmitter may be configured for transferring information via a wireless communication channel, such as Bluetooth, Wi-Fi or near field communication, NFC. Alternatively or in addition, the transmitter may be configured for transferring information via a cloud server.
The term “control signal” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary command configured to set at least one control parameter. The control signal may be configured to bring the analyte sensor device in the low power mode. By bringing the analyte sensor device into the low power mode, the analyte sensor device may leave the active power mode. The control signal may be transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value. The “predetermined threshold value” may describe a minimum time period during which the sensor device remains in the low power mode.
The term “switch” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to the process of changing between different operational modes within a system, such as the active power mode and the low power mode. Before the switch is being performed, the user may be notified that the switch is will take place.
The term “active power mode” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a specific mode of the analyte sensor device. In the active power mode, at least one of: a measurement frequency of the at least one analyte sensor device; a frequency of the at least one analyte sensor device to process the analyte sensor data; and a frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller may be set to an active mode value. The active power mode value may be selected in order to ensure frequent monitoring of the analyte concentration, preferably when the current blood glucose concentration is in the hypoglycemia range or the hyperglycemia range.
The term “low power mode” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a further specific mode of the analyte sensor device, preferably a further specific mode of the analyte sensor device differing from the active power mode. In the low power mode, a power consumption of the analyte sensor device may be lower than the power consumption of the analyte sensor device in the active power mode.
During the low power mode the analyte sensor device may be deactivated, preferably in a manner that no analyte sensor data is generated. Alternatively or in addition, at least one of the following functions may be deactivated or may occur at a reduced frequency:
- transmitting signals to the remote controller, in particular analyte sensor data associated signals;
- receiving and/or processing of control signals transmitted to the analyte sensor device;
- processing of analyte sensor signals and data;
- processing of sensor signals from a sensor other than the analyte sensor; and
- processing of a failsafe operation.
Analyte sensor data associated signals may be analyte sensor data related signals or analyte sensor data generated by the analyte sensor. The sensor other than the analyte sensor may be selected from at least one of: a temperature sensor, a GPS sensor, a heart rate sensor. There may be further sensors other than the analyte sensor disclosed that may also be selected here.
The term “failsafe operation” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a process configured to ensure a continued functioning and/or to ensure a safe shut down of a device, preferably in the event of a failure and/or malfunction.
When the analyte sensor is deactivated, the analyte sensor may still receive at least one first further control signal as defined below. Alternatively or in addition, during the low power mode the analyte sensor device may be configured to be in at least one mode selected from the list of
- decreased measurement frequency of the at least one analyte sensor device;
- decreased frequency of the at least one analyte sensor device to process the analyte sensor data; and
- decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller. The decreased measurement frequency may be decreased relative to a measurement frequency in the active power mode. The decreased frequency of the at least one analyte sensor device to process the analyte sensor data may be decreased relative to a frequency of the at least one analyte sensor device to process the analyte sensor data in the active power mode. The frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller relative to a frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller in the active power mode.
At least one of:
- the decreased measurement frequency;
- the decreased frequency of the at least one analyte sensor device to process the analyte sensor data;
- the decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller, may be selected in accordance with a probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval. The probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval may be determined by evaluating the risk for a glycemic excursion.
The method further may comprise: o determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor.
The method further may comprise: o cancelling transmission of the control signal to the at least one analyte sensor device when the current analyte concentration of the user does not fulfill at least one criterion.
Said criterion may describe an analyte concentration range of the predetermined target range or a subrange of the predetermined target range. The term “cancelling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to revoke and/or annul at least one intended or ongoing activity. The transmission of the control signal to the at least one analyte sensor device may be canceled before the start of the transmission. Alternatively, the transmission of the control signal to the at least one analyte sensor device may be canceled during the transmission.
The method further may comprise: o transmitting at least one first further control signal to the at least one analyte sensor device to cause the analyte sensor device to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range, preferably when the analyte sensor device is in the low power mode.
The current event data indicating that the analyte concentration in the bodily fluid will leave the predetermined target range may be event data received after the analyte sensor device switched into the low power mode. The current event data indicating that the analyte concentration in the bodily fluid will leave the predetermined target range may be event data comprising data about at least one event which increases the analyte concentration in the bodily fluid of the user, preferably as further defined above.
The method further may comprise: o transmitting at least one second further control signal to an insulin pump to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device is in the low power mode.
The term “insulin pump” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary device configured for administering insulin by using at least one pump. The term “bolus” may refer to a dose of a medication substance, such as insulin, administered all at once and/or over a short period. The term “dosing pattern” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a schedule for administering medication over a period of time. The dosing pattern may comprise at least one of at least one frequency of a dose, at least one amount of at least one medication to be taken. The dosing pattern preferably may comprise at least one of basal rate; a bolus pattern. The term “basal rate” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a rate at which a medication, such as insulin, is administered. The term “bolus pattern” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a schedule for administering one or more boluses. Thereby, the bolus pattern may define the timing and the dosage of the one or more boluses.
In a further aspect, a remote controller for controlling at least one analyte sensor device is disclosed, wherein the remote controller is configured for performing the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding claims. For this aspect, reference may be made to any disclosure herein, preferably to any definition, Embodiment and/or further aspect as disclosed elsewhere herein.
The term “remote controller” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary device configured for managing and/or regulating the operation or performance of a system, a further device or a process. In the sense, the remote controller may be configured for controlling the analyte sensor device. The remote controller may be configured for controlling the analyte sensor device from a distance. The remote controller may be separate from the analyte sensor device, preferably in a manner that the remote controller and the analyte sensor device comprise two different and separated housings. A data transfer between the remote controller and the analyte sensor device for controlling the analyte sensor device may be a wireless data transfer. The data transfer may be via a transmitter.
The remote controller may be or may comprised by a mobile device or an insulin pump. The term “mobile device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to a mobile electronics device, preferably a personal mobile device (PDA), more preferably to a mobile communication device such as a cell phone and/or a smartphone. Additionally or alternatively, the mobile device may also refer to a notebook, a tablet computer or another type of portable computer, such as a wearable, preferably smart glasses. The mobile device may comprise a transmitter. Thus, generally, the mobile devices may be selected from the group consisting of a cell phone having at least one camera, preferably a smart phone; a portable computer having at least one camera, preferably at least one of a notebook and a tablet computer.
In a further aspect, a computer program comprising instructions is disclosed, which, when the program is executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein. For this aspect, reference may be made to any disclosure herein, preferably to any definition, Embodiment and/or further aspect as disclosed elsewhere herein.
In a further aspect, a computer-readable storage medium comprising instructions is disclosed, which, when the instructions are executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein. For this aspect, reference may be made to any disclosure herein, preferably to any definition, Embodiment and/or further aspect as disclosed elsewhere herein. As used herein, the term “computer-readable storage medium” preferably may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer-readable storage medium preferably may be or may comprise a storage medium such as a random-access memory (RAM) and/or a read-only memory (ROM).
In a further aspect, a non-transient computer-readable medium including instructions is disclosed that, when the instructions are executed by the remote controller as elsewhere disclosed herein, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein. For this aspect, reference may be made to any disclosure herein, preferably to any definition, Embodiment and/or further aspect as disclosed elsewhere herein.
In a further aspect, a continuous analyte sensor system of a user comprising a. at least one analyte sensor device comprising an analyte sensor configured to be body-worn by a user comprising an analyte sensor, wherein the analyte sensor is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller as described elsewhere herein.
The continuous analyte sensor system may be a continuous glucose sensor system. For this aspect, reference may be made to any disclosure herein, preferably to any definition, Embodiment and/or further aspect as disclosed elsewhere herein.
The analyte sensor may comprise an insertable portion configured for being at least partially insertable into a body tissue of a user. The analyte sensor device comprises a housing comprising an electronics unit, wherein the electronics unit is configured for receiving analyte sensor data from the analyte sensor, and wherein the electronics unit is further configured for transmitting the analyte sensor data to at least one receiving remote controller. The analyte sensor device may be configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system receiving the at least one control signal causing the analyte sensor device to switch from the active power mode to the at least one low power mode transmitted by the remote controller.
The analyte sensor device may be configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval. The analyte sensor device may be configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system receiving the at least one first further control signal causing the analyte sensor device to switch from the at least one low power mode to the active power mode transmitted by the remote controller.
The analyte sensor system may comprise at least one insulin pump configured for administering insulin to the user, wherein the remote controller is configured for controlling the administration of insulin to the user. The remote controller may be configured for transmitting at least one second further control signal to the at least one insulin pump to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device is in the low power mode. The remote controller may be or may be comprised by the insulin pump. Alternatively, the analyte sensor system may comprise a mobile device, wherein the remote controller may be or may be comprised by the mobile device.
The at least one remote controller may comprise a processor and a memory with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device as elsewhere disclosed herein.
The term “processor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term preferably may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and/or, generally, to a device which is configured for performing calculations or logic operations. In particular, the processor may be configured for processing basic instructions that drive the computer or system. As an example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math co-processor or a numeric co-processor, a plurality of registers, preferably registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an LI and L2 cache memory. In particular, the processor may be a multi -core processor. Preferably, the processor may be or may comprise a central processing unit (CPU). Additionally or alternatively, the processor may be or may comprise a microprocessor, thus preferably the processor’s elements may be contained in one single integrated circuitry (IC) chip. Additionally or alternatively, the processor may be or may comprise one or more applicationspecific integrated circuits (ASICs) and/or one or more field-programmable gate arrays (FPGAs) and/or one or more tensor processing unit (TPU) and/or one or more chip, such as a dedicated machine learning optimized chip, or the like. The processor preferably may be configured, such as by software programming, for performing one or more evaluation operations as will be outlined in further detail below.
As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.
Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.
Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.
The proposed computer-implemented method for controlling an analyte sensor device, remote controller for controlling at least one analyte sensor device and continuous analyte sensor system provide many advantages over known devices and methods. The computer- implemented method for controlling an analyte sensor device, the remote controller for controlling at least one analyte sensor device and the continuous analyte sensor system may allow using the analyte sensor device for a longer period. The computer-implemented method for controlling an analyte sensor device, the remote controller for controlling at least one analyte sensor device and the continuous analyte sensor system may allow operating the analyte sensor device in a manner that it consumes less power.
The disclosure relates to continuous analyte sensor system and method for operating a continuous analyte sensor, wherein a time period for a low power mode of the continuous analyte sensor may potentially be prolonged based on a prediction time interval associated with a risk for a glycemic excursion. The prediction time interval may be determined based on historic and current received event data and received analyte data.
The disclosure may be described by using the following words:
A continuous glucose sensor system of a user comprising a. an analyte sensor device comprising: o an analyte sensor having an insertable portion configured to be at least partially inserted into a body tissue of a user, the analyte sensor being configured to detect an analyte in a body fluid of a patient; o a housing comprising an electronics compartment comprising an electronics unit, wherein the electronics unit is configured to connect with the analyte sensor and further configured to communicate analyte sensor data to a remote controller; and b. the remote controller comprising a processor and a memory with instructions which when executed cause the processor to: o receiving for the user for a prediction time interval associated with a risk for a glycaemic excursion of the analyte levels outside a target range, wherein the prediction time interval is determined based on historical and current collected user data of the user, wherein the collected user data comprises glucose data collected by the analyte sensor device, glucose level increase associated event data (such as meals, insulin bolus, dehydration), and glucose level decrease associated event data (such as physical activity, stress, reduced sleeping period, drinking water, certain drugs e.g. nose spray); o transmitting a control signal to the analyte sensor device to cause the device to switch from an active mode to a low power mode for a low power mode time interval, if for the user the prediction time interval is above a predetermined interval and if the prediction time interval is associated with a low risk for a glycemic excursion of the analyte levels outside a target range; wherein the analyte sensor device switches from an active mode to a low power mode for the low power mode time interval upon receiving the control signal from the remote controller; and wherein the analyte sensor device switches from a low power mode to an active mode upon expiry of the low power mode time interval or upon receiving the control signal from the remote controller.
In case there is a high chance for the analyte concentration to be in target range during the prediction time interval that is longer than a predetermined interval, a temporal period associated with a low risk for a glycemic excursion may be identified and a low power mode may be activated for the next minutes, optionally the user may be notified. In case there is a high chance for the analyte concentration to pass hypo or hyper threshold in a time frame below the predetermined interval, a temporal period associated with a medium to high risk for a glycemic excursion may be identified and the active mode may be maintained or the low power mode may be activated for the time frame, wherein a safety time range is subtracted from the time frame.
The invention may provide the advantage that the switching between an active mode and the low power mode of the analyte sensor device allows to reduce the capacity of the battery which in turn supports further miniaturization of the analyte sensor device. Alternatively, the analyte sensor device may be operated for a longer period of time compared to devices which do not switch between active and low power mode. The inventive method may enable a personalized and therewith more reliable management of the power consumption by prolonging low power phases during which an analyte concentration is not monitored if the risk for the individual user is sufficiently low. The remote control may conduct additional checks before switching to low power mode to rule out or determine a risk factor that the user’s blood glucose level may leave the predetermined target range and depending on the risk assessment the sensor device may not switch to low power mode but remain in the active mode. The remote control may conduct additional checks during low power mode to rule out or determine a risk factor that the user’s blood glucose level may leave the predetermined target range and depending on the risk assessment the sensor device may be activated prematurely. The principle may be extended to the control of a pump in an automated insulin delivery, AiD, system, where the pump control may continue operation based on a preprogrammed insulin dosing pattern during the time when the continuous glucose sensor system is maintained in a low power mode.
Possible checks and events may trigger premature back-switching to the active mode: Carb entry by user, geolocation based meal event detection, calendar entries, eating sound detection. Physical activity entry by user, heart rate sensor, GPS sensor, sports app activation based detection, calendar entries.
Further disclosed and proposed herein is a computer program including computer-executable instructions for performing the method according to the present invention in one or more of the embodiments enclosed herein when the instructions are executed on a computer or computer network. Specifically, the computer program may be stored on a computer -readable data carrier and/or on a computer-readable storage medium.
As used herein, the terms “computer-readable data carrier” and “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer- readable data carrier or storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and/or a read-only memory (ROM).
Thus, specifically, one, more than one or even all of method steps i. to vii.as indicated above may be performed by using a computer or a computer network, preferably by using a computer program.
Further disclosed and proposed herein is a computer program product having program code means, in order to perform the method according to the present invention in one or more of the embodiments enclosed herein when the program is executed on a computer or computer network. Specifically, the program code means may be stored on a computer -readable data carrier and/or on a computer-readable storage medium.
Further disclosed and proposed herein is a data carrier having a data structure stored thereon, which, after loading into a computer or computer network, such as into a working memory or main memory of the computer or computer network, may execute the method according to one or more of the embodiments disclosed herein.
Further disclosed and proposed herein is a non-transient computer-readable medium including instructions that, when executed by one or more processors, cause the one or more processors to perform the computer-implemented method for controlling an analyte sensor device.
Further disclosed and proposed herein is a computer program product with program code means stored on a machine-readable carrier, in order to perform the method according to one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network. As used herein, a computer program product refers to the program as a tradable product. The product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier and/or on a computer-readable storage medium. Specifically, the computer program product may be distributed over a data network.
Finally, disclosed and proposed herein is a modulated data signal which contains instructions readable by a computer system or computer network, for performing the method according to one or more of the embodiments disclosed herein.
Referring to the computer-implemented aspects of the invention, one or more of the method steps or even all of the method steps of the method according to one or more of the embodiments disclosed herein may be performed by using a computer or computer network. Thus, generally, any of the method steps including provision and/or manipulation of data may be performed by using a computer or computer network. Generally, these method steps may include any of the method steps, typically except for method steps requiring manual work, such as providing the samples and/or certain aspects of performing the actual measurements.
Specifically, further disclosed herein are:
- a computer or computer network comprising at least one processor, wherein the processor is adapted to perform the method according to one of the embodiments described in this description, - a computer loadable data structure that is adapted to perform the method according to one of the embodiments described in this description while the data structure is being executed on a computer,
- a computer program, wherein the computer program is adapted to perform the method according to one of the embodiments described in this description while the program is being executed on a computer,
- a computer program comprising program means for performing the method according to one of the embodiments described in this description while the computer program is being executed on a computer or on a computer network,
- a computer program comprising program means according to the preceding embodiment, wherein the program means are stored on a storage medium readable to a computer,
- a storage medium, wherein a data structure is stored on the storage medium and wherein the data structure is adapted to perform the method according to one of the embodiments described in this description after having been loaded into a main and/or working storage of a computer or of a computer network, and
- a computer program product having program code means, wherein the program code means can be stored or are stored on a storage medium, for performing the method according to one of the embodiments described in this description, if the program code means are executed on a computer or on a computer network.
Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:
Embodiment 1 : A computer-implemented method for controlling an analyte sensor device configured to be body-worn by a user comprising an analyte sensor, the method comprising: o receiving analyte sensor data generated by the analyte sensor; o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device to cause the analyte sensor device to switch from an active power mode to a low power mode for the determined prediction time interval. Embodiment 2: The method according to the preceding Embodiment, wherein the control signal is transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value.
Embodiment 3 : The method according to any one of the preceding Embodiments, wherein the event data is received from a sensor device selected from at least one of:
- a heart rate sensor, preferably a heart rate sensor configured to sensing a heart rate of the user;
- a global navigation satellite system, GNSS, sensor, preferably a GNSS sensor configured for sensing at least one position of the user;
- an acceleration sensor; preferably an acceleration sensor configured for sensing at least one movement of the user; and
- a microphone; preferably a microphone configured for sensing at least one noise of the surrounding of the user.
Embodiment 4: The method according to any one of the preceding Embodiments, wherein the event data has been entered by the user into a user interface or extracted from a personal data source related to or of the user.
Embodiment 5: The method according to any one of the preceding Embodiments, wherein the event data comprises data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user.
Embodiment 6: The method according to the preceding Embodiment, wherein the event data comprises data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
- a consumption of food by the user;
- an administration of a blood glucose concentration increasing medicament, such as glucacon, steroids or antipsychotic medications to the user;
- a dehydration of the user;
- an illness associated release of hormones which raise blood glucose levels
- a psychological stress;
- pain, such as pain from a sunburn; and
- a menstrual period. Embodiment 7: The method according to any one of the two preceding Embodiments, wherein the event data comprises data about at least one event which decreases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
- a consumption of water or alcohol by the user;
- an administration of a blood glucose concentration decreasing medicament, such as metformin, pioglitazone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray;
- a physical activity of the user; and
- an insufficient sleeping period of the user.
Embodiment 8: The method according to any one of the preceding Embodiments, the event data comprising information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user.
Embodiment 9: The method according to any one of the preceding Embodiments, the method further comprising: o determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor.
Embodiment 10: The method according to the preceding Embodiment, the method further comprising: o cancelling transmission of the control signal to the at least one analyte sensor device when the current analyte concentration of the user does not fulfill at least one criterion.
Embodiment 11 : The method according to any one of the preceding Embodiments, the method further comprising: o transmitting at least one first further control signal to the at least one analyte sensor device to cause the analyte sensor device to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range.
Embodiment 12: The method according to any one of the preceding Embodiments, the method further comprising: o transmitting at least one second further control signal to an insulin pump to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device is in the low power mode.
Embodiment 13: The method according to any one of the preceding Embodiments, wherein during the low power mode the analyte sensor device is deactivated or at least one of the following function is deactivated or occurs at a reduced frequency:
- transmitting signals to the remote controller, in particular analyte sensor data associated signals;
- receiving and/or processing of control signals transmitted to the analyte sensor device;
- processing of analyte sensor signals and data;
- processing sensor signals from a sensor other than the analyte sensor; and
- processing of a failsafe operation.
Embodiment 14: The method according to any one of the preceding Embodiments, wherein during the low power mode the analyte sensor device is configured to be in at least one mode selected from the list of
- decreased measurement frequency of the at least one analyte sensor device;
- decreased frequency of the at least one analyte sensor device to process the analyte sensor data; and
- decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller.
Embodiment 15: The method according to the preceding Embodiment, wherein at least one of:
- the decreased measurement frequency;
- the decreased frequency of the at least one analyte sensor device to process the analyte sensor data;
- the decreased frequency of the at least one analyte sensor device to transmit the analyte sensor data to the remote controller, is selected in accordance with the probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval.
Embodiment 16: The method according to any one the preceding Embodiments, wherein the at least one item of information on the prediction time interval is determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of:
- a look-up table; or
- a machine learning model.
Embodiment 17: The method according to any one the preceding Embodiments, wherein the analyte sensor comprises an insertable portion configured for being at least partially insertable into a body tissue of the user.
Embodiment 18: A remote controller for controlling at least one analyte sensor device, wherein the remote controller is configured for performing the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments.
Embodiment 19: The remote controller according to the preceding Embodiment referring to a remote controller, wherein the remote controller is or is comprised by a mobile device or an insulin pump.
Embodiment 20: A computer program comprising instructions which, when the program is executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
Embodiment 21 : A computer-readable storage medium comprising instructions which, when the instructions are executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
Embodiment 22: A non-transient computer-readable medium including instructions that, when the instructions are executed by the remote controller according to any one of the Embodiments 18 or 19, cause the remote controller to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
Embodiment 23: A continuous analyte sensor system of a user comprising a. at least one analyte sensor device configured to be body-worn by a user comprising an analyte sensor, wherein the analyte sensor is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller according to any one of the preceding Embodiments 18 to 19.
Embodiment 24: The continuous analyte sensor system according to the preceding Embodiment, wherein the analyte sensor comprises an insertable portion configured for being at least partially insertable into a body tissue of a user.
Embodiment 25: The continuous analyte sensor system any one of the preceding Embodiments 23 or 24, wherein the analyte sensor device comprises a housing comprising an electronics unit, wherein the electronics unit is configured for receiving analyte sensor data from the analyte sensor, and wherein the electronics unit is further configured for transmitting the analyte sensor data to at least one receiving remote controller.
Embodiment 26: The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 25, wherein the analyte sensor device is configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system receiving the at least one control signal causing the analyte sensor device to switch from the active power mode to the at least one low power mode transmitted by the remote controller.
Embodiment 27: The continuous analyte sensor system according to any one of the preceding Embodiments 24 to 27, wherein the analyte sensor device is configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval.
Embodiment 28: The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 27, wherein the analyte sensor device is configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system receiving the at least one first further control signal causing the analyte sensor device to switch from the at least one low power mode to active power mode transmitted by the remote controller.
Embodiment 29: The continuous analyte sensor system according to any one of the preceding Embodiments 23 to 28, wherein the analyte sensor system comprises at least one insulin pump configured for administering insulin to the user, wherein the remote controller is configured for controlling the administration of insulin to the user.
Embodiment 30: The continuous analyte sensor system according to the preceding Embodiment, wherein the remote controller is configured for transmitting at least one second further control signal to the at least one insulin pump to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device is in the low power mode.
Embodiment 31 : The continuous analyte sensor system according to any one of the two preceding Embodiments, wherein the remote controller is or is comprised by the insulin pump.
Embodiment 32: The continuous analyte sensor system according to any one of the preceding Embodiments 24 to 31 referring to an analyte sensor system, wherein the analyte sensor system comprises a mobile device, wherein the remote controller is or is comprised by the mobile device.
Embodiment 33: The continuous analyte sensor system according to any one of the preceding Embodiments referring to a analyte sensor system, wherein the at least one remote controller comprises a processor and a memory with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device according to any one of the preceding Embodiments 1 to 17.
Short description of the Figures
Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.
In the Figures: Figure 1 shows an exemplary computer-implemented method for controlling an analyte sensor device configured to be body -worn by a user comprising an analyte sensor; and
Figure 2 shows an exemplary continuous analyte sensor system specifically comprising at least one remote controller and at least one analyte sensor device.
Detailed description of the embodiments
In Figure 1, an exemplary computer-implemented method 110 for controlling an analyte sensor 131 device 128 configured to be body -worn by a user comprising an analyte sensor 131 is shown. The method comprises: o (denoted by reference number 112) receiving analyte sensor data generated by the analyte sensor 131; o (denoted by reference number 114) determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o (denoted by reference number 116) transmitting a control signal to the analyte sensor device 128 to cause the analyte sensor device 128 to switch from an active power mode to a low power mode for the determined prediction time interval.
The control signal may be transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value. The at least one item of information on the prediction time interval may be determined by using at least one prediction model, preferably wherein the at least one prediction model is selected from at least one of: a lookup table; or a machine learning model.
The event data may be received from a sensor device 148 selected from at least one of: a heart rate sensor 150, preferably a heart rate sensor 150 configured to sensing a heart rate of the user; a global navigation satellite system, GNSS, sensor 152, preferably a GNSS sensor 152 configured for sensing at least one position of the user; an acceleration sensor 154; preferably an acceleration sensor 154 configured for sensing at least one movement of the user; and a microphone 156; preferably a microphone configured for sensing at least one noise of the surrounding of the user. The event data may have been entered by the user into a user interface or extracted from a personal data source related to or of the user, preferably wherein the personal data source is selected from at least one of: an electronic calendar; a social media channel; a mailing account. The event data may comprise information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user.
The event data may comprise data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user. The event data may comprise data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of: a consumption of food by the user; an administration of a blood glucose concentration increasing medicament, such as glucacon, steroids or antipsychotic medications to the user; a dehydration of the user; an illness associated release of hormones which raise blood glucose levels; a psychological stress; pain, preferably a pain from a sunburn; and a menstrual period. The event data may comprise data about at least one event which decreases the analyte concentration in the bodily fluid of the user is selected from at least one of: a consumption of water or alcohol by the user; an administration of a blood glucose concentration decreasing medicament, such as metformin, pioglita- zone and/or insulin to the user or an administration of blood drugs of the users, preferably a nose spray; a physical activity of the user; and an insufficient sleeping period of the user.
The method further may comprise: o (denoted by reference number 118) determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor 131.
The method further may comprise: o (denoted by reference number 120) cancelling transmission of the control signal to the at least one analyte sensor device 128 when the current analyte concentration of the user does not fulfill at least one criterion.
The method further may comprise: o (denoted by reference number 122) transmitting at least one first further control signal to the at least one analyte sensor device 128 to cause the analyte sensor device 128 to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range.
The method further may comprise: o (denoted by reference number 124) transmitting at least one second further control signal to an insulin pump 138 to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device 128 is in the low power mode.
During the low power mode the analyte sensor device 128 may be deactivated. Alternatively or in addition, at least one of the following functions may be deactivated or may occur at a reduced frequency:
- transmitting signals to the remote controller, in particular analyte sensor data associated signals;
- receiving and/or processing of control signals transmitted to the analyte sensor device;
- processing of analyte sensor signals and data;
- processing of sensor signals from a sensor other than the analyte sensor; and
- processing of a failsafe operation.
Alternatively, during the low power mode the analyte sensor device 128 may be configured to be in at least one mode selected from the list of decreased measurement frequency of the at least one analyte sensor device 128; decreased frequency of the at least one analyte sensor device 128 to process the analyte sensor data; and decreased frequency of the at least one analyte sensor device 128 to transmit the analyte sensor data to the remote controller 126. At least one of: the decreased measurement frequency; the decreased frequency of the at least one analyte sensor device 128 to process the analyte sensor data; the decreased frequency of the at least one analyte sensor device 128 to transmit the analyte sensor data to the remote controller 126, may be selected in accordance with the probability for the concentration of the analyte in the bodily fluid to leave the predetermined target range in the predicted prediction time interval.
In Figure 2, an exemplary remote controller 126 for controlling at least one analyte sensor device 128 is shown, wherein the remote controller 126 is configured for performing the computer-implemented method for controlling the at least one analyte sensor device 128 as disclosed anywhere else herein. In Figure 2, the remote controller 126 is a mobile device, as an example. Alternatively or in addition, the remote controller 126 may be comprised by the mobile device, may be an insulin pump 138 and/or may be comprised by an insulin pump 138. There may be further ways on how to implement the remote controller 126. For receiving or transmitting data, such as the analyte sensor data, the control signal causing the analyte sensor device 128 to switch from an active power mode to a low power mode, the first further control signal and/or the second further control signal, the at least one remote controller 126 may comprise a transmitter 142.
Furthermore, an exemplary continuous analyte sensor system 130 of a user is shown in Figure 2. The exemplary continuous analyte sensor system 130 comprises: a. at least one analyte sensor device 128 configured to be body -worn by a user comprising an analyte sensor 131, wherein the analyte sensor 131 is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller 126 as described elsewhere herein.
The analyte sensor 131 may comprise an insertable portion configured for being at least partially insertable into a body tissue of a user.
The analyte sensor device 128 comprises a housing 132 comprising an electronics unit 134, wherein the electronics unit 134 is configured for receiving analyte sensor data from the analyte sensor 131, and wherein the electronics unit 134 is further configured for transmitting the analyte sensor data to at least one receiving remote controller 126. For receiving or transmitting data, such as the analyte sensor data, the control signal causing the analyte sensor device 128 to switch from an active power mode to a low power mode and/or the first further control signal, the analyte sensor device 128 may comprise a transmitter 136.
The analyte sensor device 128 may be configured for switching from the active power mode to the at least one low power mode for the prediction time interval in response to the analyte sensor system 130 receiving the at least one control signal causing the analyte sensor device 128 to switch from the active power mode to the at least one low power mode transmitted by the remote controller 126. The analyte sensor device 128 may be configured for switching from the low power mode to the active power mode upon expiry of the prediction time interval. The analyte sensor device 128 may be configured for switching from the at least one low power mode to the active power mode in response to the analyte sensor system 130 receiving the at least one first further control signal causing the analyte sensor device 128 to switch from the at least one low power mode to active power mode transmitted by the remote controller 126. The analyte sensor system 130 may comprise at least one insulin pump 138 configured for administering insulin to the user, wherein the remote controller 126 is configured for controlling the administration of insulin to the user. The remote controller 126 may be configured for transmitting at least one second further control signal to the at least one insulin pump 138 to administer insulin to the user in accordance with at least one predetermined insulin dosing pattern when the analyte sensor device 128 is in the low power mode. For receiving or transmitting data, such as the at least one second further control signal, the at least one insulin pump 138 may comprise a transmitter 140.
The at least one remote controller 126 may comprise a sensor device 148 configured to receive at least a portion of the event data. The sensor device 148 may selected from at least one of a heart rate sensor 150, preferably a heart rate sensor 150 configured to sensing a heart rate of the user; a global navigation satellite system, GNSS, sensor 152, preferably a GNSS sensor 152 configured for sensing at least one position of the user; an acceleration sensor 154; preferably an acceleration sensor 154 configured for sensing at least one movement of the user; and a microphone 156; preferably a microphone 156 configured for sensing at least one noise at the surrounding of the user.
The at least one remote controller 126 may comprise a user interface 158 configured to receive at least a portion of the event data, preferably by the user entering the event data.
The at least one remote controller 126 may comprise a processor 144 and a memory 146 with instructions, which when executed cause the processor to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein. Further disclosed is a computer program comprising instructions, which, when the program is executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein. Further disclosed is a computer-readable storage medium comprising instructions, which, when the instructions are executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein. Further disclosed is a non-transient computer-readable medium including instructions that, when the instructions are executed by the remote controller 126 as elsewhere disclosed herein, cause the remote controller 126 to perform the computer-implemented method for controlling the at least one analyte sensor device 128 as elsewhere disclosed herein. List of reference numbers computer-implemented method for controlling an analyte sensor device receiving analyte sensor data generated by the analyte sensor determining a prediction time interval transmitting a control signal to the analyte sensor device determining the current analyte concentration cancelling transmission of the control signal transmitting at least one first further control signal transmitting at least one second further control signal remote controller analyte sensor device continuous analyte sensor system analyte sensor housing electronics unit transmitter of the analyte sensor device insulin pump transmitter of the insulin pump transmitter of the remote controller processor memory sensor device for event data heart rate sensor global navigation satellite system, GNSS, sensor; acceleration sensor microphone user interface

Claims

Claims
1. A computer-implemented method for controlling an analyte sensor device (128) configured to be body-worn by a user comprising an analyte sensor (131), the method comprising: o receiving analyte sensor (131) data generated by the analyte sensor (131); o determining a prediction time interval during which the analyte concentration of the user is predicted to be within a predetermined target range, wherein the prediction time interval is determined based on the received analyte sensor data and received event data, wherein the event data comprises data about at least one event which influences the analyte concentration in a bodily fluid of the user, in particular during the prediction time interval; and o transmitting a control signal to the analyte sensor device (128) to cause the analyte sensor device (128) to switch from an active power mode to a low power mode for the determined prediction time interval; o wherein during the low power mode, the analyte sensor device (128) is deactivated or at least one of the following functions is deactivated or occurs at a reduced frequency:
■ receiving and/or processing of control signals transmitted to the analyte sensor device;
■ processing of analyte sensor signals and data;
■ processing of sensor signals from a sensor other than the analyte sensor; and
■ processing of a failsafe operation.
2. The method according to the preceding claim, wherein the control signal is transmitted to the sensor device if the prediction time interval is equal to or longer than a predetermined threshold value.
3. The method according to any one of the preceding claims, wherein the event data is received from a sensor device (148) selected from at least one of:
- a heart rate sensor (150);
- a global navigation satellite system, GNSS, sensor (152);
- an acceleration sensor (154); and a microphone (156).
4. The method according to any one of the preceding claims, wherein the event data has been entered by the user into a user interface or extracted from a personal data source related to or of the user.
5. The method according to any one of the preceding claims, wherein the event data comprises data about at least one event which increases or decreases the analyte concentration in the bodily fluid of the user, wherein the event data comprises data about at least one event which increases the analyte concentration in the bodily fluid of the user, which event is selected from at least one of:
- a consumption of food by the user;
- an administration of a blood glucose concentration increasing medicament;
- a dehydration of the user;
- an illness associated release of hormones which raise blood glucose levels
- a psychological stress;
- pain; and
- a menstrual period, wherein the event data comprises data about at least one event which decreases the analyte concentration in the bodily fluid of the user, which event is selected from is selected from at least one of:
- a consumption of water or alcohol by the user;
- an administration of a blood glucose concentration decreasing medicament;
- a physical activity of the user; and
- an insufficient sleeping period of the user.
6. The method according to any one of the preceding claims, the event data comprising information on a behavioral pattern of the user, wherein the behavioral pattern is predicted to occur and influence the analyte concentration in the bodily fluid of the user.
7. The method according to any one of the preceding claims, the method further comprising: o determining the current analyte concentration of the user by using the analyte sensor data generated by the analyte sensor (131); and o cancelling transmission of the control signal to the at least one analyte sensor device (128) when the current analyte concentration of the user does not fulfill at least one criterion.
8. The method according to any one of the preceding claims, the method further comprising: o transmitting at least one first further control signal to the at least one analyte sensor device (128) to cause the analyte sensor device (128) to switch from the at least one low power mode to the active power mode when current event data indicates that the analyte concentration in the bodily fluid will leave the predetermined target range.
9. The method according to any one of the preceding claims, the method further comprising: o transmitting at least one second further control signal to an insulin pump (138) to administer insulin to the user based on at least one predetermined insulin dosing pattern for the time when the analyte sensor device (128) is in the low power mode.
10. A remote controller (126) for controlling at least one analyte sensor device (128), wherein the remote controller (126) is configured for performing the computer-implemented method for controlling the at least one analyte sensor device (128) according to any one of the preceding claims.
11. A computer program comprising instructions which, when the program is executed by the remote controller (126) according to claim 11, cause the remote controller (126) to perform the computer-implemented method for controlling the at least one analyte sensor device (128) according to any one of the preceding claims 1 to 9.
12. A computer-readable storage medium comprising instructions which, when the instructions are executed by the remote controller (126) according to claim 10, cause the remote controller (126) to perform the computer-implemented method for controlling the at least one analyte sensor device (128) according to any one of the preceding claims 1 to 9.
13. A continuous analyte sensor system (130) of a user comprising a. at least one analyte sensor device (128) configured to be body -worn by a user comprising an analyte sensor (131), wherein the analyte sensor (131) is further configured for detecting an analyte in a bodily fluid of a user; b. the at least one remote controller (126) according to claim 10.
PCT/EP2025/061808 2024-05-02 2025-04-30 Methods and devices for controlling an analyte sensor device Pending WO2025229048A1 (en)

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