TW201526875A - Medical device and method operating same - Google Patents

Abstract

The present invention refers to a medical device (100) comprising a measurement unit (110) adapted to measure a value of a physiological parameter, for example a blood glucose level, a data storage (130) adapted to store a plurality of measurement values of the physiological parameter, for each measurement value an associated event tag, for each measurement value an associated time stamp, for each at least one predefined event an associated current time range for tagging preselection, a processor (140) adapted to receive from the measurement unit (110) or from the data storage (130) a new measurement value with an associated time, Comparing the associated time stamp of the new measurement value with the stored at least one time range for tagging preselection, If the time stamp is within one current time range for tagging preselection the corresponding tag of the predefined event is preselected and initiated for user confirmation, In case one particular predefined tag of one particular predefined event is then selected and confirmed with regard to the new measurement value, the associated time stamps of a predefined number of consecutive recent measurement values tagged with the one particular predefined event is received from a data storage (130), Calculate a new time range for tagging preselection for the one predefined event at least partly based on the associated time stamps of the predefined number of consecutive recent measurement values and on the associated time stamp of the new measurement value, preferably only if at least one validation criterion is met, and Initiate storing the new time range as current time range for tagging preselection for the one particular predefined event in the data storage (130), preferably only if the at least one validation criterion is met. The invention further refers to a corresponding method and computer program for operating a medical device as well as to a corresponding computer program product.

Description

Medical device and method of operation thereof

The present invention relates to a medical device, preferably a blood glucose meter, a method of operating the same, a computer program and a computer program product.

The following description of the invention primarily means that diabetes is a health problem and that the blood glucose concentration is a physiological parameter to be controlled to enable assessment of the efficacy of the specified treatment. However, the invention may also be used with respect to other health problems and for the management of other physiological parameter data such as (a) blood pressure in hypertensive heart disease, (b) cholesterol in patients with risk factors for heart disease and stroke, or Lipoprotein profile, (c) peak volume of asthmatic patients, or (d) coagulation in patients treated for hemophilia.

Diabetes is a group of metabolic diseases in which people have high blood sugar because the pancreas cannot produce enough insulin or because the cells are unable to respond to the insulin produced. The treatment of diabetes focuses on maintaining blood glucose levels as close to normal as possible (〝 normal blood sugar) without causing hypoglycemia. This is usually achieved by diet, exercise, and the use of appropriate drugs (insulin in the case of type 1 diabetes; oral medications in type 2 diabetes, and possibly insulin).

The key to managing diabetes with insulin is the periodic examination of blood glucose levels performed by the patient itself in order to be able to obtain regular information on the progress and success of the specified treatment. This understanding is important to the patient's participation, because the complexity of diabetes is very uncommon, and it is less severe for patients who have properly managed blood glucose levels. In this regard, it is necessary to consider changes in blood glucose concentration throughout the day and the direct effects of the amount of insulin administered, as well as lifestyle factors such as the amount and type of food consumed, the degree of exercise and stress.

Therefore, monitoring of the concentration of sugar in the blood serves as a dual target: on the one hand, it provides information about the current state of the patient's blood glucose control. On the other hand, the measurement can be used as information for the patient or health care professional (HCP) to determine whether to indicate the adjustment of the drug, That is, the amount of insulin used.

In order to achieve these goals or to be as close as possible to the desired glycemic control, one or more monitoring of blood glucose test (BGM) values throughout the day is routine, followed by a test mechanism normally designated by the HCP.

The so-called fasting blood glucose measurement (FBG) plays an important role. Fasting blood glucose values are obtained after several hours (6 to 8 hours) of eating. Fasting blood glucose measurements are basically measured before breakfast in the morning and are most commonly performed between insulin-treated patients because it is used to evaluate long-acting basal insulin or analogues (such as insulin glargine) The quality of the titration.

In order to adjust or modify the therapy, it is beneficial to record all blood glucose measurements and analyze the results in a data management unit. Thus, a portable monitor can basically be used, which is also capable of measuring blood glucose concentration or receiving measurements from a blood glucose measuring device. Wireless or wired data transfer can be used to transfer results from the measurement device to the data management unit.

In addition to merely monitoring blood glucose levels, diabetic patients often have to maintain strict control over their lifestyle so that they are not adversely affected by, for example, irregular food consumption or exercise. Further, HCP requires detailed information on the patient's lifestyle to provide effective treatment or treatment improvements to control the disease. In the past, one of the ways to monitor the lifestyle of patients with diabetes has left individuals to keep their lifestyles in the paper log. Currently, many portable electronic devices exist that measure the individual's blood glucose concentration and store it for recall and upload to another computer for analysis. Further, they provide the ability to store life style data, for example by using a tag or flag associated with the respective measurement.

Document EP 2085029 A1 means an analyte measuring device that operates with a display, a user interface, a processor, a memory and a user interface button. After measuring an analyte with the analyte measuring device, the measured value is displayed and the user is prompted to select a flag to correlate the flag with the value. By pressing only one of the user interface buttons, a flag with the value of the device is stored. In particular, the user is prompted whenever a measurement step indicates that an analyte value is outside of the predetermined range.

Document US 7,570,980 B2 discloses blood glucose measurement data stored in an array, packaged Contains relevant timecode information for each measurement and various other flags. These flags correspond to specific time frames, data information, calibration check information, and so on. From the measurement and the flag value, the so-called effective meal average is calculated, which includes measurements taken at a particular time, for example one hour before and after the particular meal time.

Document WO 2011/007051 A1 means a method for controlling a blood glucose measurement process of a patient, wherein a network application is arranged to collect measurement data from a measurement device (eg a blood glucose meter) and to analyze the collected data. . The measurements in it will be linked to the event, either manually or as a pair of measurements, ie, before and after the measurement, by a predetermined or adapted time window. In this regard, it is assumed that, optimally, subsequent measurements occur after a fixed time period (time window) after the earlier measurement. The fixed time period is, for example, two hours plus/minus 15 minutes.

Because flags or labels are effective tools to make the days of diabetic patients simpler, they are now widely used in data management. However, it is sometimes difficult to provide a measurement with a related tag or flag information to the patient. Further, it is important to confirm that the correct tag information is full of the relevant measurement, because if the information is confusing, it is not helpful to provide additional information with a tag for the measurement.

Accordingly, it is an object of the present invention to provide a medical device and a separate method suitable for tagging the user's habits and for making the material properly tagged.

The above problems are solved by a medical device having the features of claim 1 of the patent application.

In particular, the medical device of the present invention comprises a measuring unit adapted to measure a physiological parameter value, for example, a blood glucose concentration, a data storage, a plurality of measurement values suitable for storing the physiological parameter, for each measurement value, and a related event. a label for each measurement value, a related time stamp, for each at least one predetermined event, for a current time range associated with one of the label preselections, a processor adapted to receive from the measurement unit or from the data storage a new measured value of a related time stamp, Comparing the relevant timestamp of the new measured value with the stored at least one time range for label preselection, if the timestamp is within a current time range for label preselection, the corresponding label of the predetermined event is Preselected and activated for the user to confirm that if a particular predetermined tag of a particular predetermined event is subsequently selected and confirmed with respect to the new measurement, then a predetermined number of consecutive recent measurements are labeled with the one particular predetermined event. The associated timestamp (ie, the corresponding tag of the particular predetermined event will be validated for use in the measurements and stored in the data store) will be received from a data store, at least in part Calculating a new time range for label preselection for the one particular predetermined event based on the associated timestamp of the predetermined number of consecutive recent measurements and the associated timestamp of the new measurement, preferably as long as at least one confirmation is met Guidelines, as well as launching the store as the current timeframe for label pre-selection for this particular scheduled event This new time range in the data storage, preferably at least one acknowledgment that they meet the criterion.

The time stamp associated with each measurement includes data and time information at a particular point in time within the measurement process to cause the individual measurement, such as the completion of the measurement process.

With the event tag, additional information related to the measurement is provided as explained above. Preferably, the event label for the blood glucose measurement includes event zero (no label), and specifically includes an empty stomach, before meals, after meals, before breakfast, after breakfast, before meals, after meals, before dinner, after dinner, At least one of the following group events at night and exercise.

A time range for label pre-selection of the at least one predetermined event, which means a time range that is used to support the user during the tagging period as follows. After the measurement of the new value of the physiological parameter is completed, the time information of the relevant time stamp is compared with the time range for the label preselection. If the time information is within the time range, the corresponding tag of the predetermined event is pre-selected and provided on the display for confirmation by the user. For example, if the current time range of the fasting blood glucose label contains a range between 6 am and 8 am, the fasting label will be pre-selected for each measurement measured within that time range (better, if that day No other measurements contain a fasting label) and can later be confirmed by the user, as detailed below.

If, for example, the user/patient is now measuring changes in his habit of fasting blood glucose values, for example, later than 8 am, the time range for fasting label preselection will automatically change. This is done by considering the tag's associated timestamp of a predetermined number of consecutive recent measurements of the event (eg, a fasting event) and the associated timestamp of the new measurement. The new time range is calculated based on at least a portion of the timestamp of the consecutive most recent measurements and the associated timestamp of the new measurement. After recalculating (shifting) according to the habit of the change, the new, shifted time range is then stored as the current time range for label preselection of the relevant predetermined event in the data store. The previous time range can be deleted or rewritten.

Thus, the medical device of the present invention makes the preselected label suitable for the user's habits. It further enables the user to more easily select the correct tag with this measurement.

In an embodiment, at least one validation criterion is considered for the step of calculating a new time range and/or storage of the new time range. For example, as a validation criterion, it may be determined whether the associated time stamp associated with a predetermined number of consecutive recent measurements of the one particular predetermined event and the associated time stamp for the new measurement of the one particular predetermined event are in the same direction Outside the current time range. Only if the confirmation criterion is met, that is, if all the time stamps of the predetermined number of consecutive recent measurements and the time stamp of the new measurement are before the current time range or if (predetermined number of measured values and new measured values) After all time stamps are located within the current time range, the processor performs the steps of calculating a new time range for label preselection and/or begins the step of storing a new time range for label preselection.

Considering the above validation criteria, there is an advantage that too frequent (unexpected) changes in the time range for label pre-selection can be avoided. The time frame for label pre-selection will only change if the current time frame for label pre-selection is not suitable for the user/patient change habit at all.

In one embodiment, the time range for label pre-selection for a particular event is different between weekdays and non-working days. In this case, the decision as to whether the associated timestamp of the predetermined number of consecutive most recent measurements of the event is outside of the relevant current time range includes not only time information for the timestamp but also data information. Preferably, in this case, the timestamp of consecutive recent measurements compared to the current time range simply means The working day or non-working day based on the timestamp of the new measurement.

The above problems can also be solved by a system comprising the medical device mentioned above and a casing adapted to carry and secure the medical device and preferably a test strip and/or a lancet. The housing further additionally includes at least one flash card containing information relating to the use of the device, preferably with respect to different trend categories or tags and operations with respect to the medical device. In one embodiment, the at least one flash card is secured to the housing by a two-ring or a hinge such that the user/patient can be easily accessed by hinged down the respective card. The information contained on the back of the flash card. In this position, the card is still attached to the housing and therefore cannot be lost.

For the same reason, the above problem is also solved by a method for operating a medical device having data storage, the data storage comprising a relevant current time range for label preselection for at least one predetermined event, wherein the method comprises The following steps: receiving a new measurement value, such as a blood glucose concentration, from a measurement unit or from the data storage having a physiological parameter of a related time stamp, comparing the relevant time stamp of the new measurement with the at least for label pre-selection a current time range, if the timestamp of the new measurement is within a current time range for label pre-selection, pre-selecting the corresponding label of the predetermined event and initiating display of the corresponding label for the user to confirm, if one A particular predetermined tag of the particular predetermined event is then selected and confirmed with respect to the new measured value, then a relevant time stamp of a predetermined number of consecutive most recent measurements of the particular predetermined event tag is received from a data store, at least in part The relevant time stamp of the predetermined number of consecutive recent measurements Based on the associated timestamp of the new measurement, a new time range for label preselection for the particular predetermined event is calculated, preferably as long as at least one validation criterion is met, and the label preselection for the particular predetermined event is to be used The new time range of the current time range is stored in the data store (130), preferably as long as at least one validation criterion is met.

Similar to the medical device of the invention, the validation criteria of the method of the invention comprise a decision to make a reservation The associated timestamp of the number of consecutive most recent measurements is outside the current time range of the tag preselection for the particular predetermined event in the same direction.

In an embodiment of the medical device or method of the present invention, the predetermined number of consecutive measurements, preferably including the new measurement, are each 2 or greater, preferably 4 or greater, Resulting in at least 3 to 5 timestamps for the calculation of the associated timestamp including the new measurement. This small number of recent continuous measurements has revealed a change in habit.

In another embodiment of the medical device or method of the present invention, the time range for label preselection of the at least one event is defined by a midpoint of time and a duration, wherein the shift of the time range is a simple and effective manner of calculating a shift in the midpoint of the time corresponding to an average of the at least one portion of the predetermined number of consecutive recent measurements of the time stamp, preferably all of the predetermined number An average of the timestamps of consecutive recent measurements, wherein the duration of the time range does not change.

In an exemplary embodiment, the average is the arithmetic mean or median value of the time information of the time stamp (regardless of the date).

For the same reasons as explained above, the problem is solved by a computer program for operating a medical device having data storage containing a relevant current time range for one of each at least one predetermined event for label pre-selection. The computer program includes: code for receiving the data from a measurement unit or from a new measurement having a physiological parameter (eg, a blood glucose concentration) of a related time stamp for comparing the new measurement The associated time stamp is associated with the code for the at least one current time range preselected by the label, if the timestamp of the new measurement is within a current time range for label preselection, the corresponding label for preselecting the predetermined event and Generating a code for the display of the corresponding tag for the user to confirm, if the corresponding predetermined tag of the particular predetermined event is subsequently selected and confirmed with respect to the new measurement, for receiving a special predetermined event from a data store a code of the associated time stamp of a predetermined number of consecutive recent measurements for In this part of the continuous time stamp associated recently measured value of the predetermined number of the time stamp associated with the new measured value is calculated as the basis for a special pre- The code of the new time range pre-selected by the label of the event, preferably as long as the at least one validation criterion is met, and the new time range for the current time range to be pre-selected for the label for the particular scheduled event is stored in the data The code in storage is preferably as long as the at least one validation criterion is met.

The above computer program is implemented in the above-mentioned embodiments with respect to the above inventive method for operating a medical device.

The above problem is further solved by a computer program product comprising a computer readable medium having a computer code embodied therein for use in a computer, wherein the computer code comprises the computer program mentioned above.

The present invention not only means a time range for pre-selection of fasting labels, but is similarly suitable for other labels/flags.

The advantages of the present invention, as well as other advantages of the present invention, will be apparent to those skilled in the art in the <RTIgt; All of the features described above and/or shown in any combination or in any combination may form the subject matter of the present invention, independent of their inclusion in the scope of the claims or their subsequent references.

100‧‧‧ medical devices

110‧‧‧Measurement unit

112‧‧‧ slots

120‧‧‧ receiving unit

130‧‧‧Data storage

140‧‧‧ processor

150‧‧‧User input unit

151‧‧‧ key

152‧‧‧Confirmation button (OK button)

153‧‧‧ scroll down button (down button)

154‧‧‧Up scrolling button (up button)

160‧‧‧Display unit

162‧‧‧ display

164‧‧‧Trend indicator

166‧‧‧ Blood glucose measurements

167‧‧‧ Time stamp

168‧‧‧ mark

169‧‧‧Measurement unit

170‧‧‧ interface

180‧‧‧clock unit

201‧‧‧ horizontal arrows

202‧‧‧ pointing down arrow

500‧‧‧ Shell

502‧‧‧ box

504‧‧‧ lancet

505‧‧‧soft belt

506‧‧‧Flash card

508‧‧‧ Ring

510‧‧‧ zipper

The exemplary embodiments of the present invention are described herein with reference to the accompanying drawings, wherein FIG. 1 is a perspective view of a medical device in accordance with a preferred embodiment of the present invention; FIG. 2 is a view of the medical device shown in FIG. A first example of a display of the medical device shown in FIG. 1 in a log file mode; FIG. 4 is a second example of a display of the medical device shown in FIG. 1 in a log file mode; FIG. 5 is a tag mark Further examples (when they are displayed on the display of the medical device as shown in FIG. 1); FIG. 6 is a flow chart including a program implemented by the medical device of the present invention in which the BG〞 mode is measured; 7 is another flow diagram that includes an embodiment of the method of the present invention for indicating a trend; and FIG. 8 is a system of the present invention comprising a housing according to FIG. 1 in a top view and the medical device Set, wherein the outer casing is in an open state.

The following pages will illustrate various embodiments of the invention. For exemplary purposes only, such embodiments are related to medical devices that support health control and trend indication methods related to blood glucose concentration measurements, particularly in relation to fasting blood glucose concentration measurements. However, the terms and descriptions used in connection with the embodiments of the medical device or the health instruction method are not intended to limit the principles and concepts of the present invention to a single device or method, which is suitable for others. Physiological value.

1 is a schematic view of a medical device 100 in accordance with a preferred embodiment of the present invention, and FIG. 2 is a schematic view. Preferably, the medical device 100 includes a blood glucose measuring unit 110 that is arranged to measure blood glucose concentration. Further, the measuring unit 110 includes an interface and a slot 112 for inserting a test strip.

The blood glucose measuring unit 110 is connected to the receiving unit 120, which is arranged to transfer, for example, blood glucose measurement data received from the blood glucose measuring unit 110 to a data storage 130 (storage unit or component) or a memory, such as a flash memory. . Alternatively, the receiving unit 120 may retrieve stored data from the storage 130, such as, for example, blood glucose data, and pass it to the processor 140 (processing unit or component), such as a microcontroller or microprocessor, digital signal processing. And/or the like. Alternatively, the receiving unit 120 directly transmits the blood glucose value data received from the blood glucose measuring unit 110 to the processor 140.

The receiving unit 120 is further connected to the user input unit 150 of the user interface. The user input unit 150 is arranged to receive input from a user of the medical device 100, such as by a button 151, a confirmation button (OK button) 152, a button 153 for scrolling down (down button), and The key 154 (up button) that is scrolled up. User input data is passed from user input unit 150 to receiving unit 120, which passes it to processor 140 or data store 130.

Moreover, the user interface of the medical device 100 includes a display unit 160 having a display 162 that is also coupled to the receiving unit 120. Preferably, display unit 160 receives material from display unit 120 or processor 140 to be displayed by display 162.

Preferably, the medical device 100 additionally includes a further interface 170, such as a wired interface, such as a serial port, a universal serial bus (USB) interface, a mini USB interface, or a wireless interface, such as an infrared (eg, IRDA) interface, Bluetooth ( Bluetooth ^TM) interface and / or the like, to be able to receive data and / or transmit data. The interface 170 is preferably coupled to the receiving unit 120 to be capable of receiving data from the receiving unit 120 and/or transmitting data to the receiving unit 120.

Additionally, the medical device 100 includes a clock unit 180 that provides data and time information, preferably based on a clock generator, which can be displayed on the display 162. Further, clock unit 180 provides data and time information that is specifically used to generate a time stamp for a related blood glucose measurement.

As depicted above, the medical device 100 preferably includes a blood glucose measuring unit 110. Preferably, the blood glucose measuring unit 110 is arranged to measure, for example, a blood glucose concentration in the blood of the user by testing a drop of blood on the test strip inserted into the slot 112. This measurement can be carried out, for example, by an electrochemical method or an optical method. The fully inserted slot 112 of the test strip can be detected by a separate sensor. The measured blood glucose value is converted to blood glucose value data and preferably transmitted to the receiving unit 120 immediately or upon request. Alternatively, the blood glucose measuring unit 110 is arranged to measure the blood glucose concentration of the user via an infrared diagnostic or alternative non-contact measurement method.

According to a further alternative (not depicted in Figure 1), the blood glucose measuring unit 110 is implanted in the body of the user of the medical device and transmits the data to and via a wired connection or via a wireless connection Receiving unit 120. In one embodiment, the implanted blood glucose measuring unit 110 is a continuous measuring sensor based, for example, on a wafer that allows for a continuous closed loop control. In the latter case, the medical device comprises two components, one component comprising a measurement unit 110 and the other component comprising a remaining unit of the medical device. The blood glucose measuring unit 110 preferably transmits the blood glucose measurement data to the receiving unit 120 via the interface 170. According to a further alternative, the medical device does not contain a blood glucose measuring unit that measures blood glucose values, but receives blood glucose value data from an external unit.

The measurement of the blood glucose measurement is preferably triggered by a receiving unit 120 that transmits a separate signal to the blood glucose measuring unit 110. According to a preferred alternative, the receiving unit 120 receives the trigger signal generated by the user input via the user input unit 150 or based on the signal from the slot 112 for detecting a test strip. Or, the touch The signaling number is automatically generated by the clock unit 180 or by the processor 140.

Preferably, the receiving unit 120 is represented, for example, by an input port and an output port of a microprocessor or bus system that manages data processing between a plurality of functional units. This includes a busbar system such as, for example, an advanced microprocessor busbar architecture busbar system implemented in a microprocessor or an external busbar system connected to a microprocessor. Via the receiving unit 120, upon request, the data is retrieved from the data store 130 and passed to the processor 140, to the display unit 160, or to the interface 170. Moreover, the receiving unit 120 transmits a control signal, such as a trigger signal or a control signal, for example, to the blood glucose measuring unit 110, the display unit 160 or the interface 170.

The data store 130 is arranged to store data entered via the user input unit 150, a plurality of blood glucose measurement data received from the blood glucose measuring unit 110, together with a time stamp associated with each measurement data, and/or at least one event tag, from Data calculated by a plurality of blood glucose measurements processed by processor 140 and/or data received via interface 170.

Further, the data store 130 stores parameter data, such as an associated time range for pre-selection of the label regarding, for example, a fasting label, a pre-meal label, or a post-meal label. Preferably, such a time range is defined using a time midpoint and a duration, wherein the time range includes the time having a 1/2 duration scale in both directions before and after the midpoint of the time. For example, the time range for fasting label preselection is defined as a duration of 2 hours and a midpoint of time at 7 am, so that the time range for fasting label preselection is included between 6 am and 8 am. time.

Additionally, for example, the data store 130 stores the following predetermined time ranges for pre-meal and post-meal times, preferably pre-selected by tags:

Before breakfast: 5:00 am to 8:59 am

After breakfast: 9:00 am to 10:59 am

Before lunch: 11:00 am to 11:59 am

After lunch: 12:00 noon to 3:59 pm

Before dinner: 4:00 pm to 6:59 pm

After dinner: 7:00 pm to 8:59 pm

Night or bedtime: 9:00 pm to 11:59 pm

The meal time and fasting time range can be set by the user of the medical device. Set to the formula.

Further, the data store 130 is arranged to provide the stored data to the processor 140, to the display unit 160, and/or to the interface 170. The data store 130 is preferably implemented in a semiconductor memory such as a flash memory. Alternatively, it is implemented in hard disk memory or on-chip memory of processor 140.

Processor 140 is preferably a microprocessor or any other functional unit capable of processing data.

User input unit 150 is preferably implemented as a keyboard that includes one or more buttons 151, 152, 153, 154. The keyboard includes one or more soft keys, wherein the functionality of the soft keys can be displayed on display 162. Alternatively, the user input unit 150 is a keyboard or a touch screen. Alternatively, the user input unit 150 includes a microphone for receiving voice input so that the material can be entered via voice input.

After the blood glucose measurement, a label can be associated with the measurement of the lifestyle data by pressing the up or down keys 153, 154 to scroll up or down through different labels, the different labels. For example, a fasting label, a pre-meal label, a post-meal label, and a no-label, each of which means a measured value, which is a fasting blood glucose level, a pre-prandial blood glucose value, a postprandial blood glucose value, and one of the previous life form parameters. All have nothing to do with blood sugar levels.

Display unit 160 preferably includes a liquid crystal display (LCD) or light emitting diode (LED) display 162. Preferably, the display displays a number of word counts such that, for example, the currently measured blood glucose value can be displayed along with additional instructions to the user. Alternatively or additionally, display unit 160 includes a graphical display to enable display of graphics or graphics such as images. Further, the display of the display unit 160 includes a touch screen.

The display unit 160 also further displays a trend indicator 164 (trend indicating unit or component) that is suitable for indicating different trend categories, such as increasing trends, stabilizing trends, and decreasing trends, such as individually pointing arrows, levels The arrow 201 and the symbol pointing to the down arrow 202 are represented on the display 162 (see Figures 3 and 4). Alternatively or additionally, the trend may be communicated by a speaker, wherein the increasing trend is represented by a pitch of increased pitch, the steady trend being represented by a pitch fixed by the pitch, and the decreasing trend is caused by the pitch Reduced tone is represented.

The interface 170 is preferably a wireless interface such as infrared (IRDA), Bluetooth( ^TM ), Global System for Mobile Communications (GSM), Terrestrial Radio Access (UMTS), ZigBee or WI-FI, and the like. Alternatively, the interface is a wired interface, such as a USB port, a mini USB port, a serial port, a parallel port, etc., for receiving and transmitting data. In a further alternative embodiment, the medical device 100 does not include an interface 170.

According to another alternative embodiment, the medical device 100 includes a memory card reader or a memory card reader interface. The memory card reader is preferably adapted to read information from a memory card, such as a flash memory card or any kind of Subscriber Identity Module (SIM) card. For this purpose, the memory card includes a memory in which at least one of the selected algorithms along with corresponding parameters, a history of blood glucose values, and/or an insulin dose administered, etc., is stored. Thus, in the event that the medical device 100 is defective, the relevant data will still be stored on a memory card that can be easily removed from the memory card reader of the medical device 100 and transferred to the new medical device 100. Furthermore, the memory card 100 can be used to be able to provide information on the history of treatment to, for example, the HCP.

In the case where the memory card is a SIM card that provides user identification to the mobile communication network and the interface unit 170 is additionally a mobile communication interface, the additional functionality of the medical device 100 can be unlocked by the provider of the SIM card via the telecommunications channel. This provides the possibility that the medical device 100 can communicate with other telecommunication devices via a predetermined channel, such as UMTS or GSM. Via the International Mobile Subscriber Identity, also known as IMSI, stored on the SIM card, the medical device 100 identifies itself within the network and can therefore be addressed via the network. In this case, the medical device 100 can be easily detected, remotely controlled, updated, monitored, etc. via the interface unit 170, for example, by specifying the address of the mobile communication unit by telephone number.

Moreover, the medical device 100 is capable of transmitting data via a text message (SMS), an electronic mail, or via a mobile network connection. Moreover, this provides the possibility of placing the medical device 100 in an emergency.

In the case where the blood glucose measuring unit 110 is a continuous inductor, it is implanted, for example, with a dose delivery unit having an insulin pump to form an automatically deliverable system that can be additionally provided.

As shown in Figure 6, the medical device 100 is capable of performing a number of operational procedures. According to a preferred alternative, after the switching is turned on, for example by means of buttons 151, 152, 153 or 154, preferably for a predetermined time confirmation key 152, or for detecting a test strip in slot 112, The therapy device 100 can perform an initialization step 310 for initializing the functional components of the medical device 100. Thereafter, the different modes of operation performed in the medical device 100 are displayed in display step 320, preferably, such as measuring the operating mode of the BG, the log, and/or the setting.

In step 330, the user selects one of the display modes of operation via the user input unit 150, for example by means of keys 153, 154 for scrolling down or up, and confirms the selection using the confirm key 152.

In step 340, the selection mode of operation can be performed. As an example, a mode 〝 measurement BG tether is selected to perform blood glucose measurements. When this mode is performed, the user/patient will be asked to provide a test strip with a blood sample.

In the 〝log 〞 mode, historical and statistical results of previous measurements can be calculated and displayed. The 〝 setting mode allows the user to define and change some parameters of the medical device 100.

After selecting the mode 〝BG〞, in step 350, a drop of blood is applied to the test portion of the test strip inserted into the slot 112 of the medical device 100.

According to an alternative version of the operational procedure, steps 310 through 340 may be skipped in the event that a particular mode of operation is pre-selected. In this case, after initialization, the pre-selected mode of operation, which is pre-selected by the user or automatically selected according to a particular event, such as detecting the full insertion of the test strip in the slot 112, continues the following steps 350 And ask the user to apply a drop of blood. In step 360, it performs the pre-selected one or more modes of operation, such as mode 〝 measurement BG 〞.

Now in step 360, measurement unit 110 determines the blood glucose concentration and displays the respective new measurements on display 162, for example, by an electrochemical method. In the next step 370, clock unit 180 generates a timestamp of the current measurement including date and time information. The time stamp is also displayed in display 162, and both the current blood glucose measurement and the associated time stamp are transmitted to data store 130 by receiving unit 120.

In the next step 380, the processor 140 compares the timestamp of the current blood glucose measurement with each of the time ranges for the tag preselection of the event stored in the data store 130, the events being selected as the associated event tag. . If the time stamp of the current measured value (new measured value), in particular the time information of the time stamp, is automatically located, for example, within the current time range of the fasting event, then the fasting label is provided for the user to Acknowledgment is displayed on display 162 with a separate token 168, such as a deleted empty apple. In order to be able to display the confirmation, the label mark 168 displayed on the display 162 is blinking/flashing. The user can now confirm the fasting label, for example by pressing the confirmation button 152. Alternatively, the user can use the up and down keys 153, 154 to change the label to a pre-meal label, a post-meal label, or no label (zero point). If the correct label is selected, the user can confirm the label by pressing the enter key 152. By confirming the label with the confirmation key 152, the flash of the symbol of the display label is stopped, and the label symbol is continuously displayed without blinking. In this state, pressing the up/down keys 153, 154 will not change the label. The processor 140 then initiates the storage of the associated confirmation tag associated with the most recent measurement in the data store 130 via the receiving unit 120.

If, in step 380, the processor 140 is unable to find any range for tag preselection, which is the time information of the timestamp of the current measurement, then the no tag will be preselected.

After pressing the confirmation button 152, if the user presses the confirmation button again, the label will start flashing again, and pressing the up/down button will again allow the user to change the label, as explained above.

Further, in the log mode, the user will be allowed to change the tag in the manner explained above, but only within a predetermined time range from the associated time stamp of the blood glucose measurement, such as within 10 days.

If the timestamp of the most recent measurement is within the current time range for label preselection and there is already a measurement on the day indicated as fasting, then the fasting label will not be automatically displayed and cannot be selected and therefore with the nearest The measured value is irrelevant.

Further, if, for example, the fasting time range for label pre-selection overlaps with, for example, the time range for breakfast, the fasting label takes precedence over the pre-meal label. Therefore, in this case, if no fasting value is recorded that day, then if the time stamp of the current measurement is within the time range for the fasting label and the time range before breakfast, the fasting label will be automatically Pre-selection.

In another embodiment, after the blood glucose test or when the medical device enters the sleep mode, the flashing label is not only confirmed by the user by pressing the confirmation button 152 but also by removing the bar from the file 112.

In the next option step 390, the annotation of the current measurement can be selected by the user using the up and down keys 153, 154. The annotation is then confirmed with a confirmation key 152, wherein the selected annotation is then also stored in the data store 130 associated with the current measurement.

In step 400, after each measurement (and the completion of the tag at step 380), the processor 140 compares the persistent (eg, three consecutive) measurements labeled with the same event tag (eg, labeled with a fasting tag) (if applicable, Whether the time information including the time stamp of the current measurement) is outside the current time range for label preselection of the fasting event in the same direction. If not, all three related timestamps are outside the current time range in the same direction, and the current time range for label pre-selection of the fasting tags stored in the data store 130 does not change. Suppose the processor 140 detects that all three timestamps of the three consecutive previous measurements marked with the fasting tag are outside the current time range in the same direction (ie, all three timestamps exceed the time range) Or all three are below) and the time range will be shifted.

Thus, for example, the arithmetic mean of the time information for the three timestamps will be calculated and used as the new time midpoint for the time range for label preselection of the fasting label. The duration of this time range can remain the same.

For example, the time information for the timestamp of the last 3 measurements of the fasting label is 8:10 am, 8:27 am, and 8:23 am, and the current time range for fasting label preselection means the midpoint of time. At 7 am and for 2 hours. Then, in step 400, the processor 140 determines that all of the time information is outside of the current time range for fasting label preselection in the same direction. In this case, the time range for the fasting label preselection will be changed to the midpoint of time at 8:20 am, which is the arithmetic mean of the three time stamps. This new current time range midpoint value is then stored in the data store 130. Therefore, the current time range is between 7:20 am and 9:20 am, because the duration has not changed, so that if the user now measures the blood glucose level within this time range, the fasting label will be completely The measurement for user confirmation is automatically displayed.

The method of adjusting the above explained time range for fasting label pre-selection provides an easy way to cope with user/patient needs and easy labeling procedures. Therefore, The program supports correct tagging.

The adjustments explained above can also be similarly applied to other tags as well as individual time frames.

When the medical device 100 is measuring the BG〞 mode, the device can automatically return to the sleep state after, for example, 120 seconds without new action. Once the device has returned to a new measurement, such as 60 seconds without any user interaction, the device automatically returns to sleep.

As explained above, the medical device 100 provides at least one memory review mode, referred to as a log mode. The respective display and calculations are explained below.

When the user activates the medical device 100 by pressing, for example, the confirmation button 152, the log mode can be entered. Then, the display as described in Figures 3 and 4 will be displayed.

In the log file, the measurements are preferably displayed in that order, wherein the entries enter the device or, alternatively, based on the time and data assigned to the measurements. In particular, the latest blood glucose measurements are displayed when entering the log mode. Pressing the up and down keys 153, 154, the user can scroll through the records, for example by pressing the down button 153, the user can scroll backwards in time, and by pressing the up button 154, the user moves forward in time. Scrolling.

An example of a display 162 that displays a measured value is shown in Figures 3 and 4. The user knows from the 左 〞 165 in the lower left foot of the display that he/she has entered the log mode.

Display 162 in the log mode further displays the maximum number of blood glucose measurements 166 in the center of the screen. Above the measured value 166, a timestamp 167 including the date and time will be displayed. On the right side, a relevant label for the token 168 can be provided, wherein if it is an associated fasting label, the token can display, for example, an empty apple as shown in Figures 3 and 4, if it is a related pre-meal label, as in the figure A complete apple shown in 5b), if it is an associated postprandial label, such as a bitten apple as shown in Figure 5c), or if it is a related unlabeled, is in Figure 5a) Show a deleted circle. Additionally, in the lower right corner of display 162, a measurement unit 169 for blood glucose values is provided.

A mark is displayed in the upper left corner of the display 162 in the log mode, which represents the trend of the fasting blood glucose value controlled by the trend indicator 164 activated in the log mode. The trend indicator 164 displays the use of the pointing up arrow and the horizontal pointing arrow 201 (see Figure 3). Or point to the trend of the individual fasting blood glucose measurements for the down arrow 202 (see Figure 4).

The operational procedure of the medical device 100 for trend indication is explained below and is depicted in FIG.

For each fasting measurement, in step 410, the processor 140 selects a second set of measurements from the data store 130 via the receiving unit 120, which contains the most recent (eg, three days) fasting tag, such as today and two days ago. Fasting measurements (days 0, -1, and -2) in which at least two fasting measurements over a three-day period must be valid. If, during the three-day period, less than two fasting measurements, i.e., only one fasting measurement is valid, then the program moves to step 415 and the trend indicator 164 does not calculate and display a separate The trend arrow, and the display 162 is still empty in the upper left corner or displays an error mark.

Then, in step 420, the arithmetic mean is determined from the 3 or 2 fasting measurements as a second average CURR_FAST_AVG.

Further in step 430, the processor 140 selects a first set of measurements from the data store 130 via the receiving unit 120 based on the relevant time stamps containing seven days prior to the last three days, ie, the recent fasting measurements. The previous three to nine days (days -3 to -9), wherein at least the first number of limits of, for example, five fasting measurements over the seven day period must be valid. Additionally, the program moves to step 415, and the processor 140 does not calculate the trend, and the trend indicator 164 does not display any trend arrows or displays an error token.

In step 440, if there is sufficient fasting measurement, then from the first set of fasting measurements, the median is determined as the first average PAST_FAST_MED.

Now, in the next step 450, the trend is calculated and displayed in a subsequent manner using separate arrows.

Suppose the second average value CURR_FAST_AVG is greater than the lower limit of 125 mg/dl, and the difference between the second average value and the first average value is 20% larger than the second average value (corresponding to the relevant allowable range), that is, (CURR_FAST_AVG-PAST_FAST_MED) > (CURR_FAST_AVG ^* 20%), the fasting trend up arrow is displayed on the display 162.

Similarly, if the second average CURR_FAST_AVG is less than or equal to 125mg/dl The lower limit, and the difference between the second average value and the first average value is greater than 25 mg/dl (corresponding to an absolute allowable range), and the fasting trend up arrow is displayed on the display 162, that is, (CURR_FAST_AVG-PAST_FAST_MED)> 25mg/dl

Suppose the second average value CURR_FAST_AVG is greater than the lower limit of 125 mg/dl, and the difference between the first average value and the second average value is 20% larger than the second average value (corresponding to the relevant allowable range), that is, (PAST_FAST_MED- CURR-FAST_AVG) > (CURR_FAST_AVG ^* 20%), the fasting trend down arrow 202 is displayed on the display 162.

Similarly, if the second average value CURR_FAST_AVG is less than or equal to the lower limit of 125 mg/dl, and the difference between the first average value and the second average value is greater than 25 mg/dl (corresponding to an absolute allowable range), then the fasting trend is The down arrow 202 is displayed on the display 162, that is, (CURR_FAST_MED-CURR_FAST_AVG) > 25 mg/dl

If there is a valid calculation, that is, at least two fasting measurements in the second group and at least 5 fasting measurements in the first set of measurements, in all other cases, the fasting trend stabilizing arrow 201 is borrowed Displayed on display 162 by trend indicator 164.

The fasting trend arrows displayed in the up, down or horizontal directions are readily understood by the patient and provide a reliable and narrative assessment of the development of fasting blood glucose values over a range of approximately 1.5 weeks.

In an example embodiment, the device 100 is implemented in a two-part device, wherein the data storage 130, the receiving unit 120, the processor 140, the user input unit 150, the display unit 160 having the trend indicator 164, and the interface The unit 170 and the clock unit 180 are implemented by a software program (application or 〝app〞) running on the hardware of the smart phone. In this case, the keys 151, 152, 153 and 154 are implemented as button fields on the display of the touch screen.

Figure 8 shows a housing 500 for a medical device in an open state that includes the medical device 100, a cassette 502 having a test strip, and a lancet 504. In the example embodiment of Figure 8, the outer casing 500 is made of a woven material. In an alternative embodiment, the outer casing is Made of a plastic material, a sheath material, or a combination of any of these materials and/or the like. The medical device 100, the cassette 502 and the lancet 504 are secured to the left side of the case 500 by a flexible tape 505 such that each of these elements can be easily removed from the outer casing 500.

On the left side of the housing, a plurality of flash cards 506 are hingedly secured to the outer casing 500 by two loops 508. Each ring 508 can be opened such that one or more cards 506 can be removed from the outer casing 500. Each flash card 506 provides important information to the user/patient, such as an explanation and picture of the buttons, displays, symbols of the display and their meaning, or the operation of the medical device 100 (eg, how to tag a measurement). Flash card 506 provides this information in front, but can also provide information on the back. To obtain information printed on the back of each card 506, it can be hinged downwardly (rotated about the axis of ring 508) by the patient/user so that back information can be seen. Therefore, the information on the back side can be reversely printed so that when the card is hinged downward as shown in Fig. 8, it can be easily read. For simple positioning, each flash card 506 is labeled with a different color in the top region. The ring 508 further has the advantage that the card is still secured to the housing when the patient/user reads the back side so that the card cannot be lost. The entire flash card 506 can be pivoted such that they can be fully placed in the state of the outer casing 500, which can be closed using the zipper 510. In the state in which the outer casing 500 is closed, the interior is properly protected from environmental influences.

100‧‧‧ medical devices

112‧‧‧ slots

151‧‧‧ key

152‧‧‧Confirmation button (OK button)

153‧‧‧ scroll down button (down button)

154‧‧‧Up scrolling button (up button)

162‧‧‧ display

Claims (15)

A medical device (100) comprising: a measuring unit (110) adapted to measure a value of a physiological parameter, for example, a blood glucose concentration, a data storage (130) adapted to store a plurality of measurements of the physiological parameter a value, an event tag for one of the measurements, an associated timestamp for each of the measurements, a relevant current time range for tag preselection for each of the at least one predetermined event, a processor (140), Suitably receiving a new measurement from the measurement unit (110) or from the data store (130) having an associated timestamp, comparing the associated timestamp of the new measurement with at least the storage for label preselection a time range, if the time stamp is within a current time range for label pre-selection, then the corresponding label of the predetermined event is pre-selected and activated for the user to confirm if a special reservation for a particular scheduled event The tag then selects and confirms with the new measurement, then labels the predetermined number of consecutive recent measurements of the phase with the one particular predetermined event. The timestamp is received from a data store (130), based at least in part on the associated timestamp of the predetermined number of consecutive most recent measurements and the associated timestamp of the new measurement, for the predetermined event The label is preselected for a new time range, preferably as long as the at least one validation criterion is met, and the new time range for initiating the storage of the current time range for the label preselection for the particular predetermined event is in the data store (130) Preferably, as long as at least one validation criterion is met. The medical device (100) of claim 1, wherein the processor is further adapted to determine as a confirmation criterion whether the relevant time stamp of the predetermined number of consecutive recent measurements and the associated time stamp of the new measurement are The current time range of the pre-selection of the label for the one particular predetermined event in the same direction. A medical device (100) according to any one of the preceding claims, wherein the predetermined number of consecutive measurements is 2 or greater, preferably 4 or greater. A medical device (100) according to any one of the preceding claims, wherein the time range for label preselection of the at least one event is defined by a midpoint of time and a duration, wherein the shift of the time range Calculated by shifting the midpoint of the time corresponding to the average of the at least one portion of the predetermined number of consecutive recent measurements of the timestamp, preferably all of the predetermined number of consecutive recent An average of the time stamp of the measured value, wherein the duration of the time range does not change. The medical device (100) of claim 4, wherein the average value is the arithmetic mean value or the median value of one of the time stamps of the time stamp regardless of the date. A medical device (100) according to any one of the preceding claims, wherein the event label for blood glucose measurement comprises the event zero and includes the following fasting, before breakfast, after breakfast, before, after, after dinner, before dinner, At least one of the events after dinner, night and sports. A method for operating a medical device (100) having a data store (130), the data store comprising an associated current time range for tag preselection for each at least one predetermined event, wherein the method comprises the following steps Receiving, from a measurement unit (110) or from the data storage (130), a new measurement having a physiological parameter of a related time stamp, such as a blood glucose concentration, comparing the relevant time stamp of the new measurement with The tag preselects the at least one current time range, if the timestamp of the new measurement is within a current time range for tag preselection, then preselecting the corresponding tag of the predetermined event and initiating display of the corresponding tag to For the user to confirm that if a particular predetermined tag of a particular predetermined event is subsequently selected and confirmed with respect to the new measurement, then a predetermined number of consecutive ones of the tags are received from the data store (130) with the one particular predetermined event The relevant time stamp of the most recent measurement, at least in part, the correlation time of the predetermined number of consecutive recent measurements Stamp and Based on the associated timestamp of the new measurement, a new time range for label preselection for the one particular predetermined event is calculated, preferably as long as at least one validation criterion is met and will be used as the special predetermined event The new time range of the current time range of the tag preselection is stored in the data store, preferably as long as at least one validation criterion is met. The method of claim 7, wherein the confirmation criterion comprises the step of: determining whether the relevant time stamp of the predetermined number of consecutive recent measurements and the associated time stamp of the new measurement are in the same direction The current time range for the pre-selection of the label for the particular scheduled event. The method of any one of clauses 7 to 8, wherein the predetermined number of consecutive measurements is 2 or greater, preferably 4 or greater. The method of any one of clauses 7 to 9, wherein the time range for label preselection of the at least one event is defined by a time midpoint and a duration, wherein the time range is The shifting is calculated by shifting the midpoint of the time corresponding to the average of the time stamp of the predetermined number of consecutive recent measurements of the at least one portion, preferably all of the predetermined number An average of the timestamp of successive consecutive measurements, wherein the duration of the time range does not change. The method of claim 10, wherein the average is the arithmetic mean or the median value of the time information that does not take into account the time stamp of the date. The method of any one of clauses 7 to 11, wherein the event label for blood glucose measurement includes the event zero, and includes the following fasting, pre-breakfast, post-meal, pre-meal, post-meal, At least one of the group events before dinner, after dinner, at night and during sports. A computer program for operating a medical device (100) having a data store (130), the data store including an associated current time range for tag preselection for each at least one predetermined event, the computer program comprising: a code for receiving the data from a measurement unit or from a new measurement having one of a physiological parameter (eg, a blood glucose concentration) of a related time stamp, The associated timestamp for comparing the new measured value with the code for the at least one time range of the label preselection, if the timestamp of the new measurement is within a current time range for label preselection, for preselecting the The corresponding label of the predetermined event and the code for initiating the display of the corresponding label for confirmation by the user, if the corresponding predetermined label of the one particular predetermined event is subsequently selected and confirmed with respect to the new measured value, for storing from a data ( 130) receiving, by a particular predetermined event, a code of the associated timestamp of a predetermined number of consecutive most recent measurements, for at least a portion of the associated timestamp of the predetermined number of consecutive most recent measurements and the new measurement The associated timestamp of the value is used as a basis for calculating a code for a new time range for the pre-selection of the label of the particular predetermined event, preferably as long as at least one validation criterion is met, and is used to be deemed to be used for the one particular predetermined event The new time range of the current time range of the pre-selected label is stored in the code in the data store (130), Goodlands are only required to meet at least one validation criteria. A computer program product comprising a computer readable medium having a computer code embodied therein for use in a computer, wherein the computer code comprises the computer program as claimed in claim 13. A medical device (100) according to any one of claims 1 to 6 and a casing (500) adapted to carry and fix the medical device (100) and preferably having a test strip a box (502) and/or a lancet (504), wherein the housing includes at least one flash card (506) containing information relating to use of one of the medical devices (100), preferably in relation to the difference Trend category or label.