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WO2025147440A1 - Systèmes, dispositifs et procédés pour systèmes de surveillance d'analyte - Google Patents

Systèmes, dispositifs et procédés pour systèmes de surveillance d'analyte Download PDF

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Publication number
WO2025147440A1
WO2025147440A1 PCT/US2024/062295 US2024062295W WO2025147440A1 WO 2025147440 A1 WO2025147440 A1 WO 2025147440A1 US 2024062295 W US2024062295 W US 2024062295W WO 2025147440 A1 WO2025147440 A1 WO 2025147440A1
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WO
WIPO (PCT)
Prior art keywords
patient
account
user
processors
verification
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Pending
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PCT/US2024/062295
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English (en)
Inventor
Bjorn LORENZO-VAN DER MEER
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Abbott Diabetes Care Inc
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Abbott Diabetes Care Inc
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Filing date
Publication date
Application filed by Abbott Diabetes Care Inc filed Critical Abbott Diabetes Care Inc
Publication of WO2025147440A1 publication Critical patent/WO2025147440A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring 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
    • A61B5/14532—Measuring 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics

Definitions

  • the subject matter described herein relates generally to systems, methods, and devices for user account verification and telesurveillance activation in analyte monitoring systems.
  • analyte levels such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like
  • analyte levels can be vitally important to the health of an individual having diabetes.
  • Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy.
  • Diabetics are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.
  • a sensor control device may be worn on the body of an individual who requires analyte monitoring.
  • the sensor control device may have a small form-factor and can be applied by the individual with a sensor applicator.
  • the application process includes inserting at least a portion of a sensor that senses a user’s analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid.
  • the sensor control device may also be configured to transmit analyte data to another device, from which the individual, her health care provider (“HCP”), or a caregiver can review the data and make therapy decisions.
  • HCP her health care provider
  • Analyte monitoring systems can also be used to improve monitoring by an HCP’s patients.
  • analyte monitoring systems can be utilized for telesurveillance (also known as telemedicine or telemonitoring), in which an HCP can directly monitor and communicate, in real time or near real-time, with patients wearing sensor control devices.
  • telesurveillance also known as telemedicine or telemonitoring
  • certain regulations and requirements associated with the use of analyte monitoring systems for telesurveillance can vary from region to region.
  • a system for managing analyte data of one or more patients comprises one or more servers, the one or more servers comprising communication circuitry configured to receive, over a network, the analyte data of the one or more patients, a database for storing the received data of the one or more patients, and one or more processors coupled with a memory.
  • the memory is configured to store software instructions that, when executed by the one or more processors, cause the one or more processors to initiate a user account creation process for a new user account, determine a region for the new user account, perform a first verification process in response to a determination of a first region for the new user account, perform a second verification process in response to a determination of a second region for the new user account, and display a home page for the new user account in response to a successful completion of either the first verification process or the second verification process.
  • the region may for example be a geographical region or an administrative region.
  • either of the first verification process or the second verification process comprises: sending a verification e-mail message to an e-mail address associated with the new user’s account; and receiving an indication that a verification button in the verification e-mail message was actuated.
  • either of the first verification process or the second verification process comprises: sending a verification text message to a mobile phone number associated with the new user’s account; and receiving an indication that a verification link in the verification text message was actuated.
  • either of the first verification process or the second verification process comprises linking the new user account with a social media account.
  • either of the first verification process or the second verification process comprises: requesting a change to a social media account or a website associated with the new user account; and monitoring the social media account or the website to detect the requested change.
  • either of the first verification process or the second verification process comprises: requesting an entry of a unique identifier; and requesting a verification of the unique identifier by a trusted third party.
  • either of the first verification process or the second verification process comprises: identifying a family member associated with the new user account; and displaying one or more questions relating to the identified family member.
  • a system for managing analyte data of one or more patients comprising one or more servers, the one or more servers comprising communication circuitry configured to receive, over a network, the analyte data of the one or more patients, a database for storing the received data of the one or more patients, and one or more processors coupled with a memory.
  • the memory is configured to store software instructions that, when executed by the one or more processors, cause the one or more processors to initiate a healthcare provider (HCP) account creation or login process, determine if the HCP account is in a region indicated for telesurveillance, and if so, display an option to activate telesurveillance features, receive inputted patient profile information, request confirmation of review of one or more exclusion criteria, and prompt a selection of a patient category and a patient level of care.
  • HCP healthcare provider
  • the systems described herein further comprise one or more sensor control units, each of which is configured to be worn on a body of a patient, wherein each sensor control unit comprises a glucose sensor comprising a proximal portion configured to be positioned above a skin surface and electrically coupled with sensor electronics, and a distal portion configured to be positioned under the skin surface and to sense an analyte level in a bodily fluid of the patient.
  • each sensor control unit further comprises the sensor electronics comprising wireless communication circuitry configured to transmit data to a reader device.
  • the region of the user account can be determined based on a user selection from a list of predetermined regions. In some embodiments, the region of the user can be determined without user intervention. In some embodiments, the region of the user can be based on a location of the user. In some embodiments, the region of the user can be determined using GPS data or geotargeting.
  • GUI features for verifying user accounts and/or activating telesurveillance features for an analyte monitoring system that are highly intuitive, user-friendly, and provide for the sharing and rapid access to physiological information of a user. More specifically, these embodiments allow a user to easily navigate through and between different user interfaces that can quickly allow patients and HCPs to manage medical data, including analyte levels and analyte data reports.
  • a first verification process of a new user account is performed in response to a determination of a first region for the new user account, and a second verification process of the new user account is performed in response to a determination of a second region for the new user account.
  • sensor control devices capable of performing each of those embodiments are covered within the scope of the present disclosure.
  • these devices and systems can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps.
  • GUIs graphical user interfaces
  • GUIs graphical user interfaces
  • disclosed herein are various embodiments of GUIs that are highly intuitive, user-friendly, and provide for rapid access to physiological information of a user.
  • these embodiments provide for a robust, user-friendly interfaces that can increase user engagement with the analyte monitoring system and provide for timely and actionable responses by the user, to name a few advantages.
  • Other improvements and advantages are provided as well.
  • the various configurations of these devices are described in detail by way of the embodiments which are only examples.
  • Continuous Analyte Monitoring systems
  • Continuous Glucose Monitoring can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule.
  • Flash Analyte Monitoring systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol.
  • NFC Near Field Communication
  • RFID Radio Frequency Identification
  • In vivo analyte monitoring systems can also operate without the need for finger stick calibration.
  • In vivo analyte monitoring systems can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user’s blood sugar level.
  • In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein.
  • the sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing.
  • the sensor control device, and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.
  • In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user.
  • This device can be referred to as a “handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few.
  • Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.
  • the user can be prompted to select or enter a “Country” or “Region of Residence” through a GUI, such as the GUI described with respect to FIG. 4C.
  • the region can be determined without user intervention, such as, by determining the user’s location via GPS data from the user’s reader device, geotargeting, IP address databases, or other similar technologies.
  • the verification process can include using information about the user from an electronic medical record or the analyte monitoring system to validate the user’s identity.
  • the verification process can include retrieving the user’s historical analyte data and other related information, which can be stored on a computing device of the analyte monitoring system, such as the sensor control device, the reader device, or the trusted computer system.
  • the user can be prompted to answer one or more questions based on information from the electronic medical record or the analyte monitoring system in order to complete the verification process.
  • a home page can be displayed to the user. From the home page, the user can view one or more reports that are based at least in part on the user’s analyte data. Further descriptions of such reports can be found in U.S. Publ. Nos. 20220409102A1, 20220338803A1, 20220092019A1, and 20220248988A1, all of which are incorporated by reference in their entireties for all purposes.
  • method 320 for creating and verifying a user account for an analyte monitoring system.
  • method 320 shares several of the same steps as method 300, as described with respect to FIG. 3A.
  • method 320 includes: initiating an account creation process at Step 322; selecting an account type at Step 324; determining a region of the user at Step 326; and receiving account information at Step 328.
  • a verification process is performed based on the region of the user that was determined at Step 326.
  • Privacy and other related regulations can differ between various countries, municipalities, and/or regions.
  • method 320 is capable of utilizing different account verification methods in accordance with a user’s particular region. For example, according to some embodiments, if the user’s region is determined to be a first region, then a first verification process can be performed and completed at Step 332. If the user’s region is determined to be a second region that is different from the first region, then a second verification process can be performed and completed at Step 334. In some embodiments, the first verification process and the second verification process can be different verification processes.
  • the first verification process and the second verification process can be the same verification process.
  • any of the verification processes described with respect to FIG. 3A can be implemented with either or both of the first verification process or the second verification process of method 320.
  • either of the first verification process or the second verification process can entail no verification process, such that Step 328 proceeds directly to Step 336.
  • a home page can be displayed to the user. From the home page, the user can view one or more reports that are based at least in part on the user’s analyte data.
  • FIGS. 4A to 41 are example embodiments of graphical user interfaces (“GUIs”) that can be used with methods for creating and verifying a user account in an analyte monitoring system, such as methods 300, 320 as described with respect to FIGS. 3A and 3B.
  • GUIs graphical user interfaces
  • any of the GUIs described herein can be for use with either a patient account or an HCP user account.
  • any of the GUIs described herein can include software instructions stored in a memory of a computing device of an analyte monitoring system 100 (e g., a reader 120, a local computer system 170, a trusted computer system 180), such that the instructions, when executed by one or more processors of the computing device, cause the one or more processors to display any one or more of the GUIs described herein.
  • the software instructions can be stored in memory on a different computing device than the computing device on which the GUI is displayed.
  • GUI 400 depicts a home page including an account field 402, a password field 404, a login button 406, a forgotten password link 408, and a sign-up button 410.
  • the sign-up button 410 can be used to initiate an account creation process, as described with Steps 302 and 322 of FIGS. 3A and 3B, respectively.
  • the user can input their login information into account field 402 and password field 404, and subsequently, login button 406 can be actuated.
  • FIG. 4B depicts GUI 415 for receiving an account type selection, which can be utilized with Steps 304 and 324 of FIGS. 3A and 3B, respectively.
  • GUI 415 can include a plurality of account types which can be selected, including a checkbox 417 for a patient account and a checkbox 419 for an HCP account.
  • a checkbox 417 for a patient account and a checkbox 419 for an HCP account.
  • other options for account types can be implemented, such as, for example: a user account for a child, a caregiver’s user account, a trial user account, a user account for non-diabetics, and/or a user account for intermittent CGM system users, to name only a few.
  • GUI 415 can utilize other features besides check boxes for receiving the user’s selection of an account type, such as, for example: radio buttons, pull down menu, sliders, and/or switches.
  • GUI 420 depicts an interface for receiving a user’s selection of a region in accordance with some embodiments, such as those described with respect to Step 306 and Step 326 of FIGS. 3 A and 3B, respectively.
  • GUI 420 can include a pulldown menu 422 configured to display a list of predetermined regions (e.g., countries) from which the user can make a selection.
  • regions e.g., countries
  • Those of skill in the art will appreciate that other features besides a pulldown menu 422 can be implemented such as, for example, radio buttons, slides, switches, check boxes, and/or free text fields, to name only a few.
  • GUI 425 depicts an interface for receiving account information in accordance with some embodiments, such as those described with respect to Step 308 and 328 of FIGS. 3 A and 3B, respectively.
  • account information can include a user’s first name 427, a user’s last name 429, a user’s e-mail address 431, a user’s password 433, a confirmation of the user’s password 435, and/or (in the case of an HCP’s user account) information relating to the user’s healthcare organization (e.g., name of the healthcare organization, address, etc.).
  • certain account information can be used by the user to login to their account.
  • GUI 455 further includes a button or link 458 to re-send the security code in case the user did not receive it, and a “Remember Me” checkbox 459 so that the user can enable or disable the two factor authentication feature in the future without having to receiving a new security code.
  • FIG. 41 depicts a new home page GUI 460 in accordance with some embodiments, such as those described with respect to Step 314 and Step 336 of FIGS. 3A and 3B, respectively.
  • home page GUI 460 can include a “Getting Started” section 462, an “Upload Devices” section 464, and a “Reports” section 466.
  • the “Getting Started” section 462 can be configured to provide further instructions and tutorials to the user.
  • the “Upload Devices” section 464 allows the user to view and manage the current and historical computing devices used with the analyte monitoring system.
  • the “Reports” section 466 allows the user to select, view, and manage various predetermined analyte reports.
  • the subject matter described herein is implemented by a software application program that is stored in a memory of and executed by a processor-based device, such as any one of the reader devices (e.g., a smart phone), drug delivery devices, trusted computer system, local computer system, or any of the other computing devices described herein.
  • the software is implemented as one or more downloadable software applications on a reader device such as a mobile communication device or a smartphone.
  • the software, and its associated features and functionalities can be implemented on a single centralized device or, in the alternative, can be distributed across multiple discrete devices in geographically dispersed locations.
  • the representations of various computer systems in the embodiments disclosed herein, as shown in FIG. 1 are intended to cover both physical computing devices and virtual computing devices (e.g., virtual servers or virtual machines).
  • a flow diagram depicts an example embodiment of a method 500 for activating and configuring telesurveillance features in an analyte monitoring system.
  • telesurveillance (sometimes also referred to as “telemonitoring” or “telemedicine”) can enable a direct one-to-one connection between an HCP and their patient by allowing direct messaging and the sharing of data and reports.
  • it can be advantageous to activate telesurveillance features in an analyte monitoring system to allow an HCP to communicate directly with their patient and remotely interpret analyte data reports and other related information.
  • window 556 Upon selection of link 558, window 556 will appear with fields for the patient name 546, a field to enter at least one email address 548a-c, and a subject field 550.
  • the message may be sent from an HCP to the patient, but may also be sent to other HCPs regarding a patient, without sending the message to the patient.
  • an HCP account creation or login process is initiated.
  • an HCP account creation process can utilize methods 300, 320, as described with respect to FIGS. 3A and 3B, respectively.
  • a determination can be made whether the HCP is in a region where telesurveillance features are supported.
  • the determination can be based on the HCP’s selection of the region, as described with respect to Step 306 and Step 326 of FIGS. 3A and 3B, respectively.
  • the determination of the region can be made without user intervention, such as, by determining the user’s location via GPS data from the user’s reader device, geotargeting, IP address databases, or other similar technologies.
  • one or more telesurveillance settings of the analyte monitoring system can be activated.
  • a telesurveillance activation button can be displayed for the HCP to enable for each patient, as described with respect to FIG. 6A.
  • the telesurveillance features may be automatically activated for each patient upon a determination that telesurveillance is supported in the HCP’s region.
  • GUI 600 depicts an interface from which an HCP can initiate an activation process for telesurveillance features in an analyte monitoring system in accordance with Step 506 of FIG. 5.
  • GUI 600 can include a navigation bar 608 that includes a telesurveillance option.
  • GUI 600 can further include a telesurveillance activation section including an activation button 602 and a “Learn More” button 604.
  • selecting the “Learn More” button 604 can provide more information to the HCP about the telesurveillance features.
  • GUI 635 can include: a first option 637 to indicate that the patient is a Type 1 diabetic using insulin for over six months; a second option 639 to indicate that the patient is a recently diagnosed Type 1 diabetic; a third option 641 to indicate that the patient is a Type 2 diabetic.
  • a first option 637 to indicate that the patient is a Type 1 diabetic using insulin for over six months
  • a second option 639 to indicate that the patient is a recently diagnosed Type 1 diabetic
  • a third option 641 to indicate that the patient is a Type 2 diabetic.
  • FIG. 6G depicts GUI 675 for receiving the HCP’s e-mail preferences relating to telesurveillance features, which can be utilized with Step 518 of FIG. 5.
  • GUI 675 can include a first option 677 for receiving a summary e-mail with all pending notifications for all patients according to a configurable schedule. In some embodiments, for example, the schedule can be on a daily basis, on a weekly basis, and/or on a monthly basis.
  • GUI 675 can include a second option 679 for receiving an e-mail every time a notification is triggered for a particular patient.
  • GUI 680 depicts GUI 680 for displaying to the HCP a patient enrollment status relating to telesurveillance, which can be utilized with Step 520 of FIG. 5.
  • GUI 680 can include a patient enrollment status section 682 that provides a current status of the patient enrollment (e.g., pending, completed).
  • the patient enrollment status section 682 can also include instructions to provide to the patient.
  • GUI 680 can also include an informational section 684 including a plurality of downloadable documents relating to telesurveillance.
  • the plurality of downloadable documents can also include forms, such as a patient enrollment form, a patient prescription form, and/or a telesurveillance program checklist.
  • forms such as a patient enrollment form, a patient prescription form, and/or a telesurveillance program checklist.
  • the software application may also have the capability of allowing users to view and download a log of events relating to a patient 702.
  • event log 704 in GUI 700 includes a list of events 706 related to the patient, an identifier of the person who performed or who is associated with the actions listed in the event 708, and the date that the events were performed 710.
  • the events in the log can include, but are not limited to, viewing a patient profile, viewing a patient’s glucose history, telesurveillance, viewing and/or sending messages, viewing and/or downloading an event log, an in-person appointment, and a prescription.
  • the identifier of the person 708 can include the person’s name or username.
  • the log may be downloadable.
  • the HCP could utilize the downloaded log of events to gain reimbursement.
  • GUIs, reports interfaces, or portions thereof, as described herein are meant to be illustrative only, and that the individual elements, or any combination of elements, depicted and/or described for a particular embodiment or figure are freely combinable with any elements, or any combination of elements, depicted and/or described with respect to any of the other embodiments.
  • GUIs, reports interfaces, or portions thereof, as described herein can be implemented in an analyte monitoring system for monitoring one or more types of analytes.
  • analytes can include one or more of glucose, ketones, lactate, alcohol, or any other analytes that are detectable in a bodily fluid of the user.
  • GUIs, reports interfaces, or portions thereof, as described herein can incorporate data received from multiple analyte monitoring systems and devices relating thereto, including the incorporation of data from devices for taking ex vivo analyte measurements and/or physiological measurements.
  • a system for managing analyte data of one or more patients comprising: one or more servers, comprising: communications circuitry configured to receive, over a network, the analyte data of the one or more patients; a database for storing the received analyte data of the one or more patients; one or more processors; a memory coupled with the one or more processors, the memory configured to store software instructions that, when executed by the one or more processors, cause the one or more processors to: initiate a user account creation process for a new user account; determine a region for the new user account; perform a first verification process in response to a determination of a first region for the new user account; perform a second verification process in response to a determination of a second region for the new user account; and display a home page for the new user account in response to a successful completion of either the first verification process or the second verification process.
  • Clause 35 The system of any of clauses 21 to 34, wherein the selection of the patient category and the patient level of care comprises selection of either: a first option to indicating a Type 1 diabetic using insulin for over six months; a second option indicating a recently diagnosed Type 1 diabetic; or a third option indicating a Type 2 diabetic.

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Abstract

Des systèmes, des dispositifs et des procédés de vérification de compte utilisateur et d'activation de caractéristiques de télésurveillance dans un système de surveillance d'analyte sont décrits. Dans certains modes de réalisation, un premier processus de vérification d'un nouveau compte utilisateur est exécuté lorsqu'une première région est déterminée pour le nouveau compte utilisateur, et un second processus de vérification du nouveau compte utilisateur est exécuté lorsqu'une seconde région est déterminé pour le nouveau compte utilisateur.
PCT/US2024/062295 2024-01-02 2024-12-30 Systèmes, dispositifs et procédés pour systèmes de surveillance d'analyte Pending WO2025147440A1 (fr)

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US63/727,415 2024-12-03

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