JP2014195539A - Blood glucose level measuring device, and blood glucose level recording analysis system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood glucose level measuring device for recording a blood glucose level measurement value to a nonvolatile memory in association with measurement date and time to determine whether or not the measurement date and measurement time are correct on the basis of the recording.SOLUTION: A blood glucose level measuring device 10 includes: a housing; a display 12; an attaching portion 13 for attaching a biosensor 15; and an operation button. Inside the housing, the blood glucose level measuring device 10 includes: a measuring unit 17; a built-in clock 18; a nonvolatile memory 19; a calculation unit 20; a calculation value display unit 21; and an interface 22. The interface 22 can be connected to an external computer 24 via a cable 23. In the blood glucose level measuring device 10, a measurement number, measurement date, measurement time, and a blood glucose level are associated with each other to be recorded on the nonvolatile memory 19.

Description

  The present invention relates to a blood glucose level measuring device that measures a blood glucose level (glucose concentration in blood), and a blood glucose level record analysis system that analyzes a record of the measured blood glucose level and uses it for diagnosis.

  In recent years, diabetes, which is one of lifestyle-related diseases, is increasing, and it is said that there are millions of patients in Japan. There are diet therapy, exercise therapy, pharmacotherapy, insulin therapy, etc. as a therapy for such diabetic patients. In any case, daily blood glucose management is important, and daily blood glucose measurement at home is indispensable. Absent. For such blood glucose level measurement, portable blood glucose level measuring instruments capable of measuring blood glucose level with a small amount of blood are commercially available and widely used.

  A conventional blood glucose level measuring device 30 shown in FIG. 10 includes a housing 31, a display 32, an attachment portion 33, and operation buttons 34. A biosensor 35 for measuring a blood glucose level is attached to the attachment portion 33. When measuring the blood glucose level, the blood glucose level of the blood introduced into the reaction unit 36 of the biosensor 35 is measured by a measurement unit (not shown) inside the housing 31 and displayed on the display 32.

  However, even if the patient uses the blood glucose level measuring device 30 to measure the blood glucose level, it is difficult to grasp whether the blood glucose level is increasing or decreasing. Furthermore, even if the measured blood glucose level rises or falls, the patient may not be able to accurately recognize how it is related to his / her lifestyle, food consumption, and the passage of time.

  Conventionally, the blood glucose level is recorded in a nonvolatile memory (not shown) in the blood glucose level measuring device 30 in association with the measurement date and the measurement time in the format shown in FIG. Recent non-volatile memories have a large capacity and can store thousands of blood glucose levels.

  In order to grasp whether the blood glucose level is increasing or decreasing, it is effective to graph the recorded blood glucose level. For example, in the blood glucose level measuring device disclosed in Patent Document 1 (Japanese Patent Application Laid-Open No. 2012-247338), for example, a time series graph of blood glucose levels for the past 30 days or a frequency graph of blood glucose levels for the past 30 days is displayed on the display. The patient can use the graph displayed on the display of the blood glucose meter for self-diagnosis.

  In the blood glucose level measuring device disclosed in Patent Document 2 (Japanese Patent Application Laid-Open No. 2010-82210), the blood glucose level measuring device is connected to an external computer, and the blood glucose level recorded in the blood glucose level measuring device is transferred to the external computer. For example, a time series graph of blood glucose levels for the past 15 weeks is displayed. Such an external computer is usually installed in a hospital, and a doctor connects a blood glucose measuring device brought by the patient to the external computer to display a graph and use it for diagnosis.

JP 2012-247338 A JP 2010-82210 A

  It is very useful for patients and doctors to grasp the blood glucose level change trend by using the past blood glucose level as a time series graph. However, the premise is that the measurement date and measurement time recorded in association with the blood glucose level must be accurate. If the measurement date and measurement time recorded in association with the blood glucose level are incorrect, the time series graph will be inaccurate. Such an inaccurate time series graph may not make a correct diagnosis.

  The blood glucose level measuring device uses a battery as a power source. The battery can be used for about half a year under normal use. When the battery is depleted and the power supply voltage drops below the limit, the clock in the blood glucose level measuring instrument stops operating, and the date and time return to the initial value (for example, January 1, 2000, 0:00). . Even if the battery is not exhausted, the same is true after the battery replacement. When a new battery is installed and the power supply voltage returns to the specified value, the date and time measurement starts from the initial value. Since the date and time are not correct as they are, it is necessary to set the date and time to correct values after battery replacement.

  If the setting of the date and time after battery replacement is correct, the measurement date and time recorded in association with the blood glucose level are correct, and the time series graph based on the measurement date and time is correct, so that it can be used for diagnosis. However, since the person who sets the date and time after battery replacement is a patient, the setting of the date and time is not always correct. In some cases, the date and time are not set after battery replacement (in this case, the date and time are measured from the initial value), or the incorrect date and time may be set.

  In the conventional blood glucose level measuring device, even if the set date and time are incorrect, there is no warning display. Therefore, even if the measurement date and time of the blood glucose level are incorrect, there is a possibility that an incorrect time series graph is displayed assuming that it is correct, and an incorrect diagnosis is made based on the incorrect time series graph.

  Moreover, in the conventional blood glucose level measuring device, even if it is noticed that the measurement date and measurement time are incorrect, there is no clue to determine when the measurement date and measurement time are incorrect. For this reason, the past blood glucose level records recorded in the blood glucose level measuring device cannot be used for diagnosis even if there are some correct records.

  The purpose of the blood glucose level measuring device and the blood glucose level recording / analysis system of the present invention is to (1) provide a warning to the user if the date and time settings of the blood glucose level measuring device are incorrect; Even if the date and time are set incorrectly, the blood glucose level record recorded in the blood glucose level measuring device can be used to the maximum for diagnosis.

In order to solve the above problems, the present invention has the following configuration.
[1] The blood glucose level measuring device of the present invention includes at least a housing, a display, a mounting portion for attaching a biosensor, and an operation button. The blood glucose level measuring device of the present invention includes at least a measurement unit, a built-in clock, a nonvolatile memory, a calculation unit, a calculation value display unit, and an interface in the housing. In the blood glucose level measuring device of the present invention, at least the measurement number, measurement date, measurement time, and blood glucose level are associated and recorded in the nonvolatile memory. In the blood glucose level measuring device of the present invention, an interface and an external computer can be connected.
[2] In the blood glucose level recording / analysis system of the present invention, the correctness / incorrectness of the measurement date and time is determined based on the recorded measurement number, measurement date, measurement time, and blood glucose level recorded in association with each other. A determination unit, a warning unit that displays correct / incorrect determination, and a graph creation unit are provided.
The determination unit (a) determines that there is an error in the measurement date and measurement time if there is a record in which the measurement date or measurement time is reversed despite the increase in the measurement number.
(B) When there is a record that the blood glucose level has not been measured for a long time, which is inconsistent with the measurement interval, it is determined that the measurement date and measurement time are incorrect.
The determination unit determines that the measurement date and the measurement time are correct when it is not determined as an error in (a) and (b).
[3] In the blood sugar level recording / analysis system of the present invention, when the measurement date and time are determined to be incorrect by the procedure of [2], the warning unit creates and displays a warning.
[4] In the blood sugar level recording / analysis system of the present invention, when the measurement date and time are determined to be correct by the procedure of [2], the graph creation unit creates and displays a predetermined graph.

  The blood glucose level measuring device and the blood glucose level recording / analyzing system of the present invention can (1) provide a warning for a wrong date and time of the blood glucose level measuring device. (2) Even if the date and time are incorrect, the past blood glucose level recorded in the blood glucose level measuring device can be utilized for diagnosis to the maximum extent.

Example of blood glucose level measuring instrument of the present invention Example of block diagram of blood glucose level measuring instrument of the present invention and blood glucose level record analyzing system of the present invention Example of recording of measurement number, measurement date, measurement time, blood glucose level of blood glucose level measuring instrument of the present invention An example of a trend graph 1A obtained by the blood sugar level record analysis system of the present invention An example of the trend graph 2 obtained by the blood sugar level record analysis system of the present invention An example of a histogram obtained by the blood sugar level record analysis system of the present invention An example of a day-of-week unit graph obtained by the blood sugar level record analysis system of the present invention An example of a time unit graph obtained by the blood sugar level record analysis system of the present invention An example of a trend graph 1B obtained by the blood sugar level record analysis system of the present invention An example of a conventional blood glucose level measuring instrument An example of recording the measurement date, measurement time, and blood glucose level of a conventional blood glucose level measuring instrument

  FIG. 1 shows an example of a blood glucose level measuring device 10 of the present invention. The blood glucose level measuring device 10 of the present invention includes a housing 11, a display 12, a mounting portion 13, and operation buttons 14. A biosensor 15 for measuring a blood glucose level is attached to the attachment portion 13. When measuring the blood glucose level, the blood glucose level of the blood introduced into the reaction unit 16 of the biosensor 15 is measured by a measurement unit (not shown) inside the housing 11 and displayed on the display 12.

  FIG. 2 shows a block diagram of an example of the blood glucose level measuring device 10 of the present invention. The blood glucose level of the blood introduced into the reaction unit 16 of the biosensor 15 is measured by the measurement unit 17 inside the housing 11. The measured blood glucose level is recorded in the nonvolatile memory 19 in association with the measurement date and the measurement time with the built-in clock 18 as a reference. The blood sugar level, the measurement date, and the measurement time recorded in the nonvolatile memory 19 are displayed on the display 12 via the calculation unit 20 and the calculation value display unit 21. What is displayed on the display 12 is, for example, the measurement date, measurement time, and blood glucose level. An interface 22 is attached to the nonvolatile memory 19 and can be connected to an external computer 24 via a cable 23 as necessary.

  In the blood glucose level measuring device 10 of the present invention, the measurement number, measurement date, measurement time, and blood glucose level are recorded in association with each other in the format of FIG. The first column is the measurement number, the second column is the measurement date, the third column is the measurement time, and the fourth column is the blood glucose level. Since the recording of FIG. 3 is recorded in the non-volatile memory 19 for each measurement, it does not disappear or change even if the battery is replaced. The blood glucose level measuring device 10 of the present invention is characterized in that “measurement numbers” (first row in FIG. 3) that are not found in the conventional blood glucose level measuring device 30 are recorded. “Measurement number” is given as 1, 2, 3, 4, 5, 6,... In the order in which the blood glucose level is measured by the blood glucose level measuring device 10. The “measurement number” will not disappear, be reset, used twice, missed out, or swapped.

  In blood glucose measurement over a long period of time, if the date and time settings return to the initial value or become incorrect due to battery consumption or battery replacement, the incorrect measurement date and time are associated with the blood glucose level. To be recorded. However, it is not known from which point the measurement date and measurement time are incorrect. Therefore, if the measurement date and measurement time are incorrect, the measurement date (second column) and measurement time (third column) portions of the record in FIG. 3 cannot be used.

  However, since the measurement number (first column) in the record of FIG. 3 is not affected by the internal clock of the blood glucose meter, the measurement date (second column) and measurement time (third column) are incorrect. Even always correct. Therefore, it can be determined to some extent whether the measurement date and the measurement time are correct based on the measurement number. In addition, the blood sugar level recorded by using the measurement number is statistically analyzed, and the change tendency of the blood sugar level can be known, though not completely. This is a feature of the blood glucose level measuring device 10 and the blood glucose level recording / analysis system of the present invention.

  If the measurement date and time are set incorrectly on a conventional blood glucose meter, all records will be used for diagnosis even if it seems that there is a record of the correct measurement date and time. It becomes impossible. However, in the blood glucose level measuring device of the present invention, even if the measurement date and time are set incorrectly, the recording is not complete but can be used for diagnosis. The measurement of blood glucose level is not only troublesome and expensive, but also painful. Therefore, it is a great advantage for patients that past blood glucose level recording is incomplete and can be used for diagnosis.

  The blood glucose level recording / analysis system of the present invention is included in the external computer 24 and includes at least a determination unit, a warning unit, and a graph creation unit. In the blood glucose level recording / analysis system of the present invention, the measurement number, the measurement date, the measurement time, and the blood glucose level recorded in the non-volatile memory 19 of the blood glucose level measuring device 10 of the present invention are transmitted via the cable 23 to an external computer. 24 can be read and graphed. The patient brings the blood glucose level measuring device 10 in which the measurement number, the measurement date, the measurement time, and the blood glucose level are recorded, to the hospital. The doctor connects the blood glucose level measuring device 10 to the external computer 24 with the cable 23, creates various graphs related to the blood glucose level, and uses them for diagnosis. It is also possible for the patient to create a graph by connecting the blood glucose level measuring device 10 to the external computer 24 with the cable 23 at home and use it for self-diagnosis.

  Hereinafter, a procedure for performing statistical analysis of blood glucose level recording using the blood glucose level recording analysis system of the present invention will be described.

1. When the blood glucose level record is read, the determination part (in the external computer 24) of the blood glucose level record analysis system first checks the following (a) and (b), and the recorded measurement date Also, the correctness of the measurement time is determined.
(A) If the measurement date and measurement time are sequentially updated as the measurement number increases, the measurement date and measurement time are likely to be correct. If there is a record in which the measurement date and measurement time are reversed and are out of date despite the increase in the measurement number, the measurement date and measurement time are likely to be incorrect. The date and measurement time are determined to be incorrect.
(B) Even if blood glucose level is measured every day or every few days, according to the measurement date, there is a record that it has not been measured for a long time (for example, one month). Since there is a high possibility that the date and measurement time are incorrect, it is determined that the measurement date and measurement time are incorrect. The determination unit determines that the measurement date and the measurement time are correct when it is not determined as an error in (a) and (b).

  2. The read blood glucose level records are listed in the graph creation unit (in the external computer 24) of the blood glucose level recording analysis system. At this time, the records are arranged with reference to the measurement number (first row) as shown in FIG. Since the measurement date (second column) and measurement time (third column) may be incorrect, the records are not sorted based on the measurement date and measurement time. The completed list is displayed on the display of the external computer 24 as needed.

  3. When it is determined that the recorded measurement date and measurement time are correct according to the procedures 1 (a) and 1 (b), the graph creation unit of the blood sugar level recording / analysis system of the present invention performs the following ( The graphs 1) to (5) are created and displayed on the display of the external computer 24 as necessary. These graphs are useful for diagnosis. Each graph and the list of FIG. 3 can be simultaneously displayed on the display of the external computer 24.

(1) Trend graph 1A (FIG. 4)
The trend graph 1A is a line graph with the horizontal axis as the measurement date and time and the vertical axis as the blood glucose level. All measured blood glucose levels are displayed as dots, and adjacent points are connected by a straight line. For example, an average line (illustrated) by the least square method or an average value (illustrated) for all periods can be displayed. A long-term blood glucose level change tendency can be grasped from the trend graph 1A. It is also possible to grasp blood sugar level variations from the distribution of points. The trend graph 1A is the most basic graph.

(2) Trend graph 2 (Fig. 5)
The trend graph 2 is a distribution graph in which the horizontal axis represents the measurement date and the vertical axis represents the maximum and minimum blood glucose levels for each day. The maximum and minimum blood glucose levels for each day are displayed as dots. It is possible to grasp the long-term change tendency of the average value of blood sugar level and the daily fluctuation of blood sugar level.

(3) Histogram (Fig. 6)
The histogram is a histogram in which the horizontal axis is a blood glucose level and the vertical axis is the number of appearances. The blood glucose level on the horizontal axis is divided, for example, every 25 mg / dl. The number of appearances is represented by a bar graph. The distribution of blood glucose level within the measurement period can be intuitively grasped.

(4) Day-of-week graph (Figure 7)
The day unit graph is a distribution graph in which the horizontal axis is Sunday to Saturday and the vertical axis is blood glucose level. Display all measured blood glucose levels as dots. The average value (illustrated) for each day of the week can also be displayed with a short horizontal line. By using the day-of-week graph, for example, the difference in blood glucose level between weekdays and holidays can be grasped.

(5) Time unit graph (Figure 8)
The time unit graph is a distribution graph in which the horizontal axis represents measurement time (0:00 to 24:00) and the vertical axis represents blood glucose level. Display all measured blood glucose levels as dots. By connecting the points measured on the same day with a polygonal line, it is possible to grasp the daily fluctuation of the blood glucose level. An average value of all blood glucose levels (for example, 131.6 mg / dl in FIG. 8) can also be shown.

  4). When it is determined that the measurement date and the measurement time recorded by the procedures 1 (a) and 1 (b) are incorrect, the blood glucose level recording / analysis system The graph creation unit creates a trend graph 1B (FIG. 9) and a histogram (FIG. 6) and displays them on the display of the external computer 24 as necessary. The trend graph 2 (FIG. 5), the day unit graph (FIG. 7), and the time unit graph (FIG. 8) are not displayed, and a warning is created and displayed by the warning unit of the blood sugar level recording analysis system.

(1) Trend graph 1B (FIG. 9)
The trend graph 1B is a line graph with the horizontal axis as the measurement number instead of the date and measurement time and the vertical axis as the blood glucose level. All blood glucose levels measured are displayed as dots, and adjacent points are connected with a straight line. For example, an average line (illustrated) by the least square method can be displayed, or an average value (illustrated) for all periods can be displayed. Although the measurement date and measurement time cannot be grasped, the measurement order based on the measurement number is correct, so that a long-term blood glucose level change tendency can be roughly grasped. The variation in blood glucose level can also be grasped from the distribution of points. In this case, a warning created by the warning unit of the blood glucose level recording / analysis system is displayed on the display of the external computer 24 simultaneously with the graph. The warning is, for example, “There is a record that the measurement date and time of blood glucose measurement are incorrect. Therefore, a graph is displayed with the horizontal axis as the measurement number”. By this warning, the user can know that the measurement date and measurement time setting of the blood glucose level measuring device is incorrect. When the graph is printed, a warning is printed with it.

(2) Histogram (Fig. 6)
“Histogram” is a histogram in which the horizontal axis is a blood glucose level and the vertical axis is the number of appearances. The blood glucose level on the horizontal axis is divided, for example, every 25 mg / dl. The number of appearances is represented by a bar graph. Since the histogram is irrelevant to the measurement date and measurement time, a correct graph can be obtained even if the measurement date and measurement time are incorrect. Therefore, no warning is displayed when the histogram is displayed. The distribution of blood glucose levels within the measurement period can be intuitively grasped by the histogram.

  (3) The trend graph 2 (FIG. 5), the day unit graph (FIG. 7), and the time unit graph (FIG. 8) cannot display a correct graph even if the measurement number is used. Only warnings generated by the warning unit of the blood sugar level record analysis system are displayed. The warning is, for example, “There is a record that the measurement date and time of blood glucose measurement are incorrect. The graph cannot be displayed”. By this warning, the user can know that the measurement date and measurement time setting of the blood glucose level measuring device is incorrect. The graph cannot be printed.

  The blood glucose level measuring device and the blood glucose level recording / analysis system according to the present invention are: (1) warning the blood glucose level measuring device when the date and time are set incorrectly; Even if the time is incorrect, the blood glucose level record recorded in the blood glucose level measuring device can be utilized to the maximum for diagnosis. Measuring blood glucose is not only laborious and expensive, but is also painful, and it is a great advantage for patients that past blood glucose recordings can be used for diagnosis although they are incomplete.

DESCRIPTION OF SYMBOLS 10 Blood glucose level measuring device 11 Housing 12 Display 13 Attachment part 14 Operation button 15 Biosensor 16 Reaction part 17 Measurement part 18 Built-in clock 19 Non-volatile memory 20 Calculation part 21 Calculation value display part 22 Interface 23 Cable 24 External computer 30 Blood glucose level measurement Device 31 housing 32 display 33 mounting part 34 operation button 35 biosensor 36 reaction part

Claims (4)

At least a housing, a display, a mounting portion for attaching a biosensor, and an operation button,
The enclosure includes at least a measurement unit, a built-in clock, a nonvolatile memory, a calculation unit, a calculation value display unit, and an interface.
At least a measurement number, a measurement date, a measurement time, and a blood glucose level are associated and recorded in the nonvolatile memory,
A blood glucose level measuring device capable of connecting the interface and an external computer. A determination unit that performs correct / incorrect determination of the measurement date and measurement time based on the recorded measurement number, measurement date, measurement time, and blood glucose level recorded in association with each other, a warning unit that displays the correct / incorrect determination, and a graph With a creation section,
The determination unit (a) determines that the measurement date and measurement time are incorrect if there is a record in which the measurement date or measurement time is reversed despite the increase in the measurement number,
(B) When there is a record that the blood glucose level has not been measured for a long time, which contradicts the measurement interval, it is determined that the measurement date and measurement time are incorrect,
A blood sugar level record analysis system that determines that the measurement date and measurement time are correct when it is not determined as an error in (a) and (b).   The blood sugar level record analysis system according to claim 2, wherein when the measurement date and time are determined to be incorrect by the procedure of claim 2, the warning unit creates and displays a warning.   The blood sugar level record analysis system according to claim 2, wherein when the measurement date and time are determined to be correct according to the procedure of claim 2, the graph creation unit creates and displays a predetermined graph.

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