JP2020125952A - Method for analyzing blood sugar control information, method for displaying analysis result of blood sugar control information, and system for analyzing blood sugar control information - Google Patents

Abstract

To provide a method for analyzing blood sugar control information, which allows an easy grasp of the degree of influence that external factors have on a blood sugar value.SOLUTION: The method for analyzing blood sugar control information includes the steps of: dividing the axis of external factor information related to a user into a plurality of ranges, and relating and grouping the blood sugar control information in each of the ranges; and analyzing the blood sugar control information for each of the groups.SELECTED DRAWING: Figure 7

Description

The present invention relates to a blood sugar control information analysis method, a blood sugar control information analysis result display method, and a blood sugar control information analysis system.

As a treatment method for diabetic patients, a method of semi-automatically administering insulin to a patient by using a continuous glucose meter (CGM: Continuous Glucose Monitoring) and an insulin pump in combination has attracted attention. In this treatment method, it is important to accurately grasp the fluctuation of the glucose level during the day from the glucose data measured by the continuous glucose meter.

A method of evaluating and displaying glucose data obtained with a continuous glucose meter is to analyze the glucose data using a computing device and target the glucose data of the patient including upper and lower limits together with the patient's glucose data over a modal day. There is disclosed a method of displaying a line indicating the median value of G, and lines of the lower and upper boundaries of glucose data (see Patent Document 1 below).

US2014/0206970A1

By the way, the blood glucose level and insulin administration effect of a user, who is a patient, are affected by external factors such as the environment in which the user is placed, the amount of activity of the user, and the user's body temperature. different. Therefore, it is important for each user to understand what external factors influence the blood glucose level and insulin administration effect to the extent that accurate blood glucose control is performed.

Therefore, the present invention provides a blood sugar control information analysis method, a blood sugar control information analysis result display method, and a blood sugar control information analysis system that enable easy understanding of the degree of influence of external factors on blood sugar levels. The purpose is to

The present invention to achieve such an object, the axis of the external factor information that influences the blood glucose level is divided into a plurality of ranges, and the blood sugar control information is associated with each range and grouped, And a step of analyzing the blood sugar control information for each group. The present invention is also a method of displaying an analysis result of blood sugar control information, which displays an analysis result obtained by the method of analyzing blood sugar control information. Furthermore, the present invention is also a blood sugar control information analysis system for implementing this blood sugar control information analysis method.

According to the present invention, it is possible to easily grasp the degree of influence of an external factor on a blood glucose level.

It is a block diagram of the analysis system of the blood sugar control information which concerns on embodiment. It is a block diagram of a blood sugar control information analysis system according to an embodiment. 3 is a flowchart showing a data acquisition method performed prior to the blood sugar control information analysis method according to the embodiment. 6 is a flowchart showing a method of analyzing blood sugar control information according to the embodiment. FIG. 6 is a diagram illustrating grouping above blood glucose control in the blood glucose control information analysis method according to the embodiment. It is a schematic diagram which shows an example of the blood glucose control information analyzed by AGP. It is a figure which shows an example of the setting information calculated|required from the analysis result of AGP of each group. It is a flow chart which shows the analysis result display method of blood sugar control information concerning an embodiment. It is a radar chart (the 1) which shows the analysis result of the blood glucose control information which concerns on embodiment. It is a radar chart (the 2) which shows the analysis result of the blood glucose control information which concerns on embodiment. It is a figure which shows the example of a display which shows the analysis result of the blood sugar control information which concerns on embodiment by a line graph (the 1). It is a figure which shows the example of a display which shows the analysis result of the blood glucose control information which concerns on embodiment by a line graph (the 2).

Hereinafter, an embodiment to which the present invention is applied will be described in detail in the order of a blood sugar control information analysis system, a blood sugar control information analysis method, and a blood sugar control information analysis result display method based on the drawings. Here, the blood glucose control information is information that directly or indirectly represents the glucose level in the blood (blood glucose level), and includes the glucose level in the interstitial fluid, the blood glucose level, and the like.

<< Blood sugar control information analysis system >>
FIG. 1 is a configuration diagram of a blood sugar control information analysis system according to an embodiment. FIG. 2 is a block diagram of the blood sugar control information analysis system according to the embodiment. As shown in these figures, the blood sugar control information analysis system (hereinafter, simply referred to as the analysis system 1) includes a pump body 10, a blood sugar control information measurement device 20, an external factor information measurement device 30, a control device 40, and an analysis device. A device 50 is provided. The details of these components will be described below.

<Pump body 10>
The pump body 10 is a medical device that is used by being worn on the skin of a patient who is a user and that administers a drug solution (insulin as an example) to the patient for several days. The pump body 10 as described above includes a pump side communication unit 11, a drug solution administration unit 12, an administration control unit 13, and an administration history storage unit 14. Of these, the administration control unit 13 and the administration history storage unit 14 are configured by a computer such as a microcomputer. The computer includes a storage unit such as a CPU (Central Processing Unit), a ROM (Read Only Memory) and a RAM (Random Access Memory), and the CPU executes a program recorded in the ROM or the RAM. The functions of the administration control unit 13 and the administration history storage unit 14 are realized.

Further, the pump main body 10 including the above-described parts is configured such that the administration of the liquid medicine is controlled by the administration controller 13 in accordance with an instruction from the control device 40 described below. The pump body 10 may be provided with a user interface such as an operation unit and a display unit. Hereinafter, each element constituting the pump body 10 will be described.

[Pump side communication unit 11]
The pump-side communication unit 11 is a unit that performs short-range wireless communication with the control device 40. The short-distance wireless communication is, for example, a short-distance wireless communication with a communication distance of 100 m or less, and communication for controlling the driving of the pump body 10 is performed by the short-distance wireless communication. Such short-range wireless communication is specifically performed by ZigBee (registered trademark IEEE802.15.4: frequency 868 MHz band, 915 MHz band, 2.4 GHz band), Bluetooth (registered trademark: IEEE802.15.1: frequency 2). .4 GHz band), wireless LAN (IEEE802.11a/b/g/n/ac: frequency 2.4 GHz band, 5 GHz band) and other standardized wireless communication technologies are applied. In such short-range wireless communication, by transmitting/receiving the identification information, a wireless communication connection is established between the individually identified communication units. The pump-side communication unit 11 may directly communicate with the blood glucose control information measuring device 20 and the external factor information measuring device 30 described later.

[Medicinal solution administration part 12]
The drug solution administration part 12 is a part for performing drug solution administration to a patient wearing the pump body 10, and is in contact with a syringe containing a drug solution to be administered, a pusher slid in the syringe, and a drug solution. Together with this, it is composed of a gasket connected to the pusher, a motor for moving the pusher, a gear mechanism, and the like.

[Administration controller 13]
The administration control unit 13 controls the driving of the motor of the drug solution administration unit 12 according to the basic administration plan, and thereby controls the administration of the drug solution by the drug solution administration unit 12. The basic administration plan may be transmitted from the control device 40 to the pump-side communication unit 11. Alternatively, the basic administration plan may be set according to an instruction from the blood glucose control information measuring device 20 described later.

[Dose history storage unit 14]
The administration history storage unit 14 stores the administration history of the drug solution actually performed in the drug solution administration unit 12 of the pump body 10.

<Blood glucose control information measuring device 20>
The blood glucose control information measuring device 20 may be any device that directly or indirectly measures the glucose level (blood glucose level) in blood. Such a blood glucose control information measuring device 20 is, for example, a continuous glucose measuring device (CGM: Continuous Glucose Monitoring), a flash glucose measuring device (FGM: Flash Glucose Monitoring), or a blood glucose self measuring device (SMBG: Self Monitoring of Blood Glucose). Is. Among these, CGM or FGM capable of continuous glucose level measurement is preferable. The CGM or FGM is used by inserting the sensor into the skin of the user who is the user and mounting the signal processing unit from the sensor on the skin to continuously measure the glucose level in the interstitial fluid for multiple days. It is possible to know the fluctuation of blood glucose level from the measured glucose level.

The blood glucose control information measuring device 20 includes a measurement side communication unit 21, a setting unit 22, a data storage unit 23, and a measurement unit 24. Of these, the setting unit 22 and the data storage unit 23 are, for example, a microcomputer. It is composed of a computer.

[Measurement side communication unit 21]
The measurement-side communication unit 21 is a unit that performs short-range wireless communication with the control device 40, and may be the same as the pump-side communication unit 11. The measurement side communication unit 21 transmits the information measured by the measurement unit 24 to the control device 40 and receives the setting information regarding the measurement transmitted from the control device 40. Further, the measurement side communication unit 21 may have a portion that communicates with the analysis device 50 via the network 60, and sends measurement data (blood glucose control information) and setting information regarding measurement via the network 60. It may be configured to directly transmit/receive to/from the analysis device 50.

[Setting unit 22]
The setting unit 22 is a unit that manages the operation setting information of the blood glucose control information measuring device 20, and is also a control unit that controls the measuring operation of the measuring unit 24.

[Data storage unit 23]
The data storage unit 23 stores the data measured by the measurement unit 24, that is, blood glucose control information. The blood glucose control information measuring device 20 includes a date and time management unit (not shown), and the data storage unit 23 stores the blood glucose control information measured by the measurement unit 24 in the data storage unit 23 in association with the date and time information. Will be done. The date/time management unit may be a real-time clock (RTC) mounted on a general microcomputer.

[Measuring section 24]
The measurement unit 24 is a unit that measures glucose in blood or interstitial fluid, and includes, for example, a sensor that emits fluorescence according to the amount of glucose, and a measurement chip that includes a measurement reagent containing a dye that develops color according to the blood glucose level. Is.

<External factor information measuring device 30>
The external factor information measuring device 30 is a device for measuring information about external factors related to the user. Information about external factors is information other than the user's blood sugar level, insulin dose, and diabetes drug, and the physiological data of the user, data based on the user's behavior, and the surrounding areas that affect the user's physiological data. It is environmental data. The type of external factor information acquired by the external factor information measuring device 30 is preferably related to the blood glucose level of the user and the insulin administration effect. In this case, as an example of the external factor information measuring device 30, a thermometer 30 a And a pedometer 30b. The external factor information measuring device 30 may be a pulse oximeter, a sphygmomanometer, an activity meter, a body composition monitor, etc., which are not shown here, and may be any one of them. There may be a plurality of two or more. Each such external factor information measuring device 30 includes a measuring side communication unit 31, a data storage unit 33, and a measuring unit 34. Hereinafter, each element constituting each external factor information measuring device 30 will be described.

[Measurement side communication unit 31]
The measurement-side communication unit 31 is a unit that performs short-range wireless communication with the control device 40, and may be the same as the pump-side communication unit 11. The measurement side communication unit 31 as described above transmits the information measured by the measurement unit 34 to the control device 40. Further, the measurement side communication unit 31 may have a portion that communicates with the analysis device 50 via the network 60, and is configured to directly transmit the measurement data to the analysis device 50 via the network 60. It may be.

[Data storage unit 33]
The data storage unit 33 has a function of storing the data measured by the measurement unit 34, that is, external factor information such as the body temperature and the number of steps as the activity amount, as the measurement date when the measurement is performed or the measurement date and time. Is. The external factor information measuring device 30 includes, for example, a date/time management unit (not shown), and the data storage unit 33 stores the data measured by the measurement unit 34 in association with the date/time information.

[Measuring unit 34]
The measurement unit 34 is a unit that measures information regarding external factors. The measurement unit 34 may be configured to continuously measure the information regarding the external factor, or may be configured to be measured by the user himself/herself. When the external factor information measuring device 30 is the thermometer 30a, the measuring unit 34 is, for example, a temperature sensor. When the external factor information measuring device 30 is the pedometer 30b, the measuring unit 34 may be, for example, an acceleration sensor or a pendulum type.

<Control device 40>
The control device 40 is a device that is used by a user without carrying it on the skin of a patient, and is a device for operating the pump body 10 by wireless communication. The control device 40 is used for setting a basal administration of insulin and a bolus administration of insulin based on a user's instruction. The pump body 10 administers insulin into the subcutaneous tissue of the patient based on these setting information.

Such a control device 40 includes a control device side communication unit 41, a display unit 42, an operation unit 43, a user information setting unit 44, a basic administration plan setting unit 45, a data storage unit 46, and a control unit 47. Of these, the user information setting unit 44, the basic administration plan setting unit 45, the data storage unit 46, and the control unit 47 are configured by a computer such as a microcomputer, and the CPU of the computer executes the program recorded in the ROM or RAM. By doing so, each function is realized. The control device 40 may be one in which a dedicated program is installed in a mobile terminal such as a smartphone. Details of each component are as follows.

[Control device side communication unit 41]
The control device side communication unit 41 communicates with the pump body 10, the blood glucose control information measuring device 20, and each external factor information measuring device 30 at a short distance, and the analysis device 50 via the network 60. And a portion that communicates with. Of these, the short-range wireless communication may be the same as that of the pump-side communication unit 11.

[Display 42]
The display unit 42 displays various setting contents, operation contents of the operating unit 43, administration history of the liquid medicine carried out in the pump body 10, control status of the pump body 10, and the like.

[Operation unit 43]
The operation unit 43 is a user interface unit for the user to input conditions for administering the liquid medicine by the pump body 10, execution or stop of control of the pump body 10, selection of display contents on the display unit 42, and the like. Such an operation unit 43 may be, for example, a keypad or a touch panel provided on the display surface of the display unit 42. When the operation unit 43 is a touch panel, the display unit 42 displays touch panel selection buttons, numeric keys, and the like.

[User information setting unit 44]
The user information setting unit 44 is a unit that sets information about a user who wears the pump body 10 controlled by the control device 40. The user information set here is information that affects the administration of insulin, such as the user's name, age, and weight. The user information setting unit 44 acquires user information by operating the operation unit 43, or acquires user information from an external management device (not shown here) via the network 60, and acquires the acquired user information. Save the information in a predetermined format.

The external management device may be a portable terminal device such as a smartphone or a tablet terminal owned by a doctor in charge of the user who wears the pump body 10, or a personal computer. Such a management device may also serve as the analysis device 50 described below.

[Basic administration plan setting unit 45]
The basic administration plan setting unit 45 is a part that sets a planned dose of insulin for each time of day performed by the pump body 10, that is, a basic administration plan. The basic administration plan setting unit 45 is a unit that sets a basic administration plan by operating the operation unit 43. Further, the basic administration plan setting unit 45 may be configured to set the basic administration plan based on information acquired from an external management device (not shown here) via the network 60 as necessary.

[Data storage unit 46]
The data storage unit 46 stores the administration history transmitted from the pump body 10, the measurement data (blood glucose control information) transmitted from the blood glucose control information measuring device 20, and the measurement data transmitted from each external factor information measuring device 30. To do. The administration history and the measurement data held in the data storage unit 46 are, for example, at the time point when the respective connections of the controller communication unit 41, the pump communication unit 11, and the measurement communication units 21 and 31 are established. The data is transmitted to the control device side communication unit 41 at any time. In addition, the administration history and the measurement data held in the data storage unit 46 are, for example, in accordance with a request for data transmission based on an operation from the operation unit 43 of the control device 40, the pump-side communication unit 11, each measurement-side communication unit 21, It may be data transmitted from 31 to the control device side communication unit 41.

[Control unit 47]
The control unit 47 is a unit that manages control of the pump body 10 by the control device 40 and transmission of measurement data to the analysis device 50. The procedure of management by the control unit 47 will be described in detail in the following method of analyzing blood sugar control information.

<Analysis device 50>
The analysis device 50 is a device for analyzing the blood glucose control information obtained by the blood glucose control information measuring device 20 using the measurement data obtained by the external factor information measuring device 30, and is controlled via the network 60. The configuration is connectable to the device 40. The analysis device 50 may be one in which a dedicated program is installed in a management device owned by a doctor in charge of a user who wears the pump body 10.

Such an analysis device 50 includes an analysis device side communication unit 51, a display unit 52, an operation unit 53, a data storage unit 54, a data analysis unit 55, an analysis result storage unit 56, and an analysis control unit 57. Of these, the data storage unit 54, the data analysis unit 55, the analysis result storage unit 56, and the analysis control unit 57 are configured by a computer such as a microcomputer, and the CPU of the computer executes the program recorded in the ROM or RAM. By doing so, each function is realized. Details of each component are as follows.

[Analysis device side communication unit 51]
The analysis device side communication unit 51 includes a portion that communicates with the control device 40 via the network 60. If the measurement-side communication unit 21 of the blood glucose control information measuring device 20 and the measurement-side communication unit 31 of the external factor information measuring device 30 are configured to be able to communicate via the network 60, the analyzer-side communication unit 51. Also performs communication with the blood glucose control information measuring device 20 and the external factor information measuring device 30.

[Display 52]
The display unit 52 displays the operation content of the operation unit 53, the analysis result stored in the analysis result storage unit 56, and the like. The method of displaying the analysis result on the display unit 52 will be described in detail in the method of displaying the analysis result of the blood glucose control information that follows.

[Operation unit 53]
The operation section 53 is a user interface section for a user to input selection of display contents on the display section 52 and the like. Such an operation unit 53 may be, for example, a keyboard or a touch panel provided on the display surface of the display unit 52. When the operation unit 53 is a touch panel, the display unit 52 displays a selection button for the touch panel, a numeric keypad, and the like.

[Data storage unit 54]
The data storage unit 54 is a unit that stores data acquired from the control device 40. The data stored in the data storage unit 54 is the administration history transmitted from the pump body 10, the blood glucose control information transmitted from the blood glucose control information measuring device 20, and the measurement data transmitted from each external factor information measuring device 30. That is, the data is stored in the data storage unit 46 of the control device 40. When each of the pump body 10, the blood glucose control information measuring device 20, and each external factor information measuring device 30 is connected to the analysis device 50 via the network 60, these data do not go through the control device 40. In some cases, the data may be directly transmitted to the analysis device side communication unit 51 of the analysis device 50.

[Data analysis unit 55]
The data analysis unit 55 is a unit that analyzes the blood glucose control information stored in the data storage unit 54 based on the operation of the operation unit 53. The procedure of data analysis performed by the data analysis unit 55 will be described in detail in the method of analyzing blood sugar control information that will be described later.

[Analysis result storage unit 56]
The analysis result storage unit 56 stores the analysis result in the data analysis unit 55.

[Analysis control unit 57]
The analysis control unit 57 is a unit that controls the analysis of blood glucose control information and the display of the analysis result by the display unit 63 based on the operation of the operation unit 53. The procedure of control by the analysis control unit 57 will be described in detail in the method of analyzing blood glucose control information below.

≪Glucose control information analysis method≫
FIG. 3 is a flowchart (No. 1) showing the blood sugar control information analysis method according to the embodiment, and is a flowchart showing the data acquisition method performed prior to the blood sugar control information analysis method. Further, FIG. 4 is a flowchart showing a blood sugar control information analysis method (No. 2) according to the embodiment. The method according to the embodiment described with reference to these drawings is realized by the CPU of the analysis device 50 executing a program recorded in each ROM or RAM. Hereinafter, the method of analyzing blood glucose control information according to the embodiment will be described in the order shown in the flowcharts of FIGS. 3 and 4.

<Data acquisition>
First, based on FIG. 3, a data acquisition method performed prior to the blood sugar control information analysis method will be described with reference to FIGS. 1 and 2.

[Step S101]
In step S101, the analysis control unit 57 of the analysis device 50 determines whether the operation unit 53 has performed an operation requesting data acquisition. The analysis control unit 57 waits until it is determined that a data acquisition request is made (YES), and proceeds to step S102 when it is determined that a data acquisition request is made (YES).

[Step S102]
In step S102, the analysis control unit 57 of the analysis device 50 causes the analysis device-side communication unit 51 to execute the process of establishing communication with the control device-side communication unit 41 of the control device 40.

[Step S103]
In step S103, the analysis control unit 57 requests the control device 40 to transmit unacquired data from the analysis device side communication unit 51. Here, the unacquired data is the date and time data of the blood glucose control information and the external factor information that are managed by date and time that are not stored in the data storage unit 54, and are stored in the data storage unit 46 of the control device 40. It is the collected data. Such unacquired data may be all of the data stored in the data storage unit 46 of the control device 40.

[Step S104]
In step S104, the control unit 47 of the control device 40, which is requested to transmit the unacquired data, determines whether or not the untransmitted data remains in the analysis device 50 in the data storage unit 46. To do. When the control unit 47 determines that untransmitted data remains in the data storage unit 46 (YES), the process proceeds to the next step S105. On the other hand, when the control unit 47 determines that there is no untransmitted data remaining in the data storage unit 46 (NO), the process proceeds to step S105′.

[Step S105]
In step S105, the control unit 47 of the control device 40 causes the control device-side communication unit 41 to transmit the untransmitted data stored in the data storage unit 46 to the analysis device 50. At this time, if there is untransmitted data regarding the administration history stored in the data storage unit 46, the data regarding the administration history may be transmitted from the control device-side communication unit 41 to the analysis device 50. After the data transmission, the transmitted data may be left in the data storage unit 46 or may be deleted from the data storage unit 46. When the transmitted data is left in the data storage unit 46, the transmitted information is added to the transmitted data.

[Step S106]
In step S106, the analysis control unit 57 of the analysis device 50 saves the data transmitted from the control device 40 in the data storage unit 54. Then, it progresses to step S107.

[Step S105']
On the other hand, in step S105′, the control unit 47 of the control device 40 causes the control device-side communication unit 41 to transmit the notification of no untransmitted data to the analysis device 50.

[Step S106']
In step S106′, the analysis control unit 57 of the analysis device 50 causes the display unit 52 to perform a display notifying that the data has not been updated. Then, it progresses to step S107.

[Step S107]
In step S107, the analysis control unit 57 of the analysis device 50 causes the analysis device-side communication unit 51 to end communication with the control device 40, and thereafter ends a series of data acquisition processing.

<Analysis of blood glucose control information>
Next, a method of analyzing blood glucose control information will be described based on FIG. 4 and with reference to FIGS. 1 and 2.

[Step S201]
In step S201, the analysis control unit 57 of the analysis device 50 determines whether new data is additionally stored in the data storage unit 54 and the data in the data storage unit 54 has been updated. The analysis control unit 57 waits until it is determined that the data has been updated (YES), and proceeds to step S202 when it determines that the data has been updated (YES).

[Step S202]
In step S202, the data analysis unit 55 of the analysis device 50 groups the blood sugar control information in each range of the size of the external factor information managed by date and time. At this time, the data analysis unit 55 performs grouping on both the data originally stored in the data storage unit 54 and the newly added data as follows.

Here, FIG. 5 is a diagram illustrating grouping of blood sugar control information in the blood sugar control information analysis method according to the embodiment. As shown in this figure, the data analysis unit 55 divides the axis of the external factor information into groups each having a predetermined size range, and groups the blood glucose control information for which date and time is managed for each date (0:00 to 24:00). Associate with each group. It should be noted that the range of the size of each piece of external factor information is a range that is arbitrarily set for each type of external factor information by the operation from the operation unit 53.

For example, when the external factor information is the maximum body temperature [I], the maximum body temperature [I] within one day is used as the axis, and the maximum body temperature [I] is lower than 35.5° C. (group [No. 1]), 35. 5°C or higher and lower than 36.5°C (group [No. 2]), 36.5°C or higher and lower than 37.5°C (group [No. 3]), 37.5°C or higher and lower than 38.5°C (group [No. . 4]), and 38.5° C. or higher (group [No. 5]). Then, based on the measured data of the body temperature for each date stored in the data storage unit 54, the date having the highest body temperature [I] corresponding to each group is associated with each group. Thereby, the blood glucose control information associated with that date is associated with each group.

In the example of FIG. 5, the maximum body temperature [I] of the group [No. 1] is associated with dates for 5 days and blood glucose control information associated with these dates. In addition, the group [No. 2] is associated with dates for 13 days and blood glucose control information associated with these dates. In addition, a group [No. 1] having a maximum body temperature [I] of 36.5° C. or more and less than 37.5° C. [3] is associated with dates for 8 days and blood glucose control information associated with these dates. In addition, the maximum body temperature [I] was 37.5°C or higher and lower than 38.5°C in the group [No. 4] is associated with dates for three days and blood glucose control information associated with these dates. In addition, a group [No. 5] is associated with the date for one day and the blood glucose control information associated with this date.

When the external factor information is the average temperature [II] of the day, the average temperature [II] of the day is the axis, and the average temperature [II] is less than 10°C (group [No. 1]), 10°C or more. Below 20°C (Group [No. 2]), above 20°C and below 30°C (Group [No. 3]), above 30°C and below 40°C (Group [No. 4]), and above 40°C (Group [No. .5]). Then, based on the measured temperature data for each date stored in the data storage unit 54, the date having the average temperature [II] corresponding to each group is associated with each group. Thereby, the blood glucose control information associated with that date is associated with each group.

In the example of FIG. 5, the group [No. 1] is associated with dates for two days and blood glucose control information associated with these dates. In addition, the group [No. 2] is associated with dates for 22 days and blood glucose control information associated with these dates. In addition, the group [No. 3] is associated with dates for three days and blood glucose control information associated with these dates. In addition, the group [No. 4] is associated with the dates for two days and the blood glucose control information associated with these dates. In addition, the group [No. 5] is associated with the date for one day and the blood glucose control information associated with this date.

When the external factor information is the step count [III], the step count [III] is less than 5000 steps (group [No. 1]), 5000 steps or more and less than 8000 steps (group [No. 2]), 8000 steps or more and less than 11000 steps. (Group [No. 3]), 11000 steps or more and less than 14000 steps (Group [No. 4]), and 14000 steps or more (Group [No. 5]). Then, based on the measurement data of the step count [III] for each date stored in the data storage unit 54, the date having the step count [III] corresponding to each group is associated with each group. Thereby, the blood glucose control information associated with that date is associated with each group.

In the example of FIG. 5, a group [No. 1] is associated with dates for one day and blood glucose control information associated with these dates. In addition, a group [No. 2] is associated with dates for 14 days and blood glucose control information associated with these dates. In addition, a group [No. 3] is associated with the dates for seven days and the blood glucose control information associated with these dates. In addition, a group [No. 4] is associated with dates for 5 days and blood glucose control information associated with these dates. In addition, a group [No. [5] is associated with dates for three days and blood glucose control information associated with these dates.

[Step S203]
In step S203, the data analysis unit 55 of the analysis device 50 analyzes the blood glucose control information associated with each group for each external factor information using the method of AGP (Ambulatory Glucose Profile). FIG. 6 is a schematic diagram showing an example of blood glucose control information obtained by AGP analysis. As shown in this figure, by performing the AGP analysis of the blood glucose control information, the target range [T] of the blood glucose level (or glucose concentration in interstitial fluid) of the user who is the patient and the day of the median blood glucose level It is possible to grasp the middle fluctuation [Dm] and the daytime fluctuation of the blood sugar level distribution range. The target range [T] includes an upper limit and a lower limit. In the illustrated example, the target range [T]=80-160 (mg/dL), the intraday fluctuation of the median [Dm], the first distribution range [R1]=25th percentile-75th percentile range, and the second distribution Range [R2]=10th percentile-95th percentile range is shown.

Since the blood glucose control information for at least 2 days is required to carry out the AGP analysis, it is assumed that the AGP analysis is carried out only for a group in which the total number of days of the blood glucose control information is 2 days or more.

[Step S204]
In step S204, the data analysis unit 55 of the analysis device 50 calculates the setting information set for a predetermined distribution range for the result of the AGP analysis for each group of each external factor information. FIG. 7 is a diagram showing an example of the setting information obtained from the result of the AGP analysis of each group. As shown in this figure, the predetermined distribution range is a distribution range analyzed by the AGP method, and is, for example, the above-mentioned first distribution range [R1] or second distribution range [R2].

Further, the setting information for the predetermined distribution range includes, for example, the variation [A] of blood glucose control information in the first distribution range [R1] and the target range overtime [when the first distribution range [R1] exceeds the target range [T] B], the target range undertime [C] when the first distribution range [R1] is below the target range [T], the median value [D] of the first distribution range [R1], and the date associated with each group. Is the total number of days [E]. Among these, the data variation [A] in the first distribution range [R1] is the maximum value of the data variation in the first distribution range [R1]. Further, each of the target range over time [B] and the target range under time [C] is the total time during which the first distribution range [R1] is outside the target range [T]. Further, the median value [D] of the first distribution range [R1] may be the median value and average value of the entire first distribution range [R1].

[Step S205]
In step S205, the data analysis unit 55 of the analysis device 50 stores each data calculated by the data analysis unit 55 in the analysis result storage unit 56 as the analysis result.

In the above analysis process, when it is determined in step S201 that the data in the data storage unit 54 has been updated (YES), steps S202 and subsequent steps are performed. However, in step S201, the analysis control unit 57 of the analysis device 50 determines whether or not the operation of performing the data analysis on the operation unit 53 is performed, and when it is determined that the operation is performed (YES), The configuration may be such that the steps after step S202 are performed.

≪Display method of blood glucose control information analysis results≫
FIG. 8 is a flowchart showing a method of displaying an analysis result of blood glucose control information according to the embodiment. The method according to the embodiment described with reference to these drawings is realized by the CPU configuring the analysis device 50 executing the program recorded in each ROM or RAM. Hereinafter, the method for displaying the analysis result of the blood glucose control information according to the embodiment will be described with reference to FIGS. 1 and 2 in the order shown in the flowchart of FIG.

[Step S301]
In step S301, the analysis control unit 57 determines whether or not a display operation requesting display of the analysis result has been performed on the operation unit 53. The analysis control unit 57 waits until it is determined that the display operation has been performed (YES), and proceeds to step S302 when determining that the display operation has been performed (YES). Note that the display operation here includes an operation of requesting the display of the analysis result and an operation of designating a display format described below.

[Step S302]
In step S302, the analysis control unit 57 extracts the latest analysis result from the analysis result storage unit 56.

[Step S303]
In step S303, the analysis control unit 57 causes the display unit 52 to display the latest analysis result extracted from the analysis result storage unit 56. At this time, the analysis control unit 57 displays the analysis result in the format designated by the operation on the operation unit 53. Here, the designation of the display format by the operation of the operation unit 53 is the display format, the display item, the axis item, etc., and the analysis control unit 57 extracts from the analysis result storage unit 56 based on these designations. The latest analysis result is displayed on the display unit 52. The display example of the analysis result will be described below.

FIG. 9 is a radar chart (No. 1) showing the analysis result of blood glucose control information according to the embodiment. In the display of the analysis results shown in this figure, a radar chart is specified as the display format, setting information such as variation [A], overtime [B],... Is specified as the display items, and each external factor information is specified as the axis item. This is a display when a size range (groups [No. 1] to [No. 5]) is specified.

FIG. 10 is a radar chart (No. 2) showing the analysis result of blood glucose control information according to the embodiment. In the analysis result display shown in this figure, a radar chart is specified as the display format, external factor information such as maximum body temperature [I], average temperature [II], and step count [III] is specified as the display items, and axis items are specified as the axis items. This is a display when setting information such as variation [A], overtime [B],... Is designated.

FIG. 11 is a view (No. 1) showing a display example showing the analysis result of the blood sugar control information according to the embodiment as a line graph. FIG. 12 is a diagram (part 2) showing a display example in which the analysis result of the blood sugar control information according to the embodiment is shown by a line graph. In the display of the analysis results shown in these figures, a line graph is specified as the display format, setting information such as variation [A], overtime [B],... Is specified as the display items, and external factor information is specified as the axis items. This is a display when the size range (groups [No. 1] to [No. 5]) is designated.

<<Effect of Embodiment>>
According to the embodiment described above, for each size range (groups [No. 1] to [No. 5]) of external factor information such as maximum body temperature [I], average temperature [II], and step count [III]. The blood sugar control information is divided into groups and analyzed, and the analysis results are displayed. Therefore, for example, the higher the maximum body temperature [I] is, the more likely the blood glucose level is to fall outside (or below) the target range [T]. It is possible to easily understand how the value is affected. This makes it possible to adjust the insulin dose based on the degree of influence of the external factor information.

In the embodiment described above, the analysis system 1 includes the pump body 10, the blood glucose control information measurement device 20, the external factor information measurement device 30, the control device 40 of the pump body 10, and the analysis device 50. .. However, the blood sugar control information analysis system of the present invention need not include the pump body 10. Further, the control device 40 may also serve as the analysis device 50. In this case, a dedicated program for executing the function of the analysis device 50 is installed in the control device 40.

1... Blood glucose control information analysis system 20... Blood glucose control information measuring device 23... Data storage unit 24... Measuring unit 30... External factor information measuring device 30a... Thermometer (external factor information measuring device)
30b... Pedometer (external factor information measuring device)
50... Analysis device 52... Display unit 55... Data analysis unit

Claims (13)

Grouping the blood glucose control information according to the range of the size of the external factor information related to the user,
Analyzing the blood glucose control information for each of the groups. The external factor information and the blood glucose control information are date and time managed information,
The method of analyzing blood glucose control information according to claim 1, wherein in the step of grouping the blood glucose control information, the blood glucose control information is grouped by the range in units of dates. The blood sugar control according to claim 1 or 2, wherein in the step of analyzing the blood sugar control information, a daytime fluctuation of a median value of the blood sugar control information and a daytime fluctuation of a predetermined distribution range set in the blood sugar control information are calculated. Information analysis method. The method for analyzing blood glucose control information according to claim 3, wherein the information set for the daytime fluctuation of the predetermined distribution range is calculated. The information set for the daytime fluctuation of the predetermined distribution range includes the total time when the predetermined distribution range is out of the target range of the blood glucose control information, the variation of the predetermined distribution range, and the predetermined range. The method for analyzing blood glucose control information according to claim 4, wherein the method is at least one of the median values of the distribution range. The method for analyzing blood glucose control information according to claim 1, wherein the blood glucose control information is subcutaneous glucose concentration. A method of displaying an analysis result of blood sugar control information, which displays an analysis result obtained by the method of analyzing blood sugar control information according to any one of claims 1 to 6. The blood glucose control information analysis result display method according to claim 7, wherein the analysis result is displayed according to a designated display format, display item, and axis item of the display format. A blood glucose control information measuring device,
An external factor information measuring device for measuring external factor information related to a user,
An analyzer for analyzing the blood glucose control information obtained by the blood glucose control information measuring device using the measurement data obtained by the external factor information measuring device,
The analysis apparatus includes a data analysis unit that divides the blood glucose control information into groups according to the size range of the external factor information and analyzes the blood glucose control information for each group. The blood glucose control information measuring device includes a measurement unit that measures the blood glucose control information, and a data storage unit that stores the measured blood glucose control information in association with date and time information,
The external factor information measuring device includes a measuring unit that measures the external factor information, and a data storage unit that stores the measured external factor information in association with date and time information,
The blood sugar control information analysis system according to claim 9, wherein the analysis device divides the blood sugar control information into groups for each of the ranges in units of dates. The blood sugar control information analysis system according to claim 9 or 10, wherein the analysis device calculates a daytime fluctuation of a median value of the blood sugar control information and a daytime fluctuation of a predetermined distribution range set in the blood sugar control information. The blood sugar control information measuring device is a device for directly or indirectly measuring a blood sugar level, and the blood sugar control information analyzing system according to any one of claims 9 to 11. The blood glucose control information analysis system according to claim 9, wherein the analysis device includes a display unit that displays an analysis result of the data analysis unit.

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