Method for correcting sensitivity for blood glucose measurement

A multi-stage sensitivity calibration method for continuous glucose monitoring systems addresses sensor sensitivity changes, enhancing accuracy and reliability in blood glucose measurements.

JP2024178943APending Publication Date: 2024-12-25I SENS INC
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Patent Information

Application Number
JP2024095579
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-06-13
Filing Date
2024-06-13
Publication Date
2024-12-25

AI Technical Summary

Technical Problem

Existing continuous glucose monitoring systems face challenges in maintaining accuracy due to changes in sensor sensitivity caused by biological reactions, leading to inaccurate blood glucose measurements.

Method used

A multi-stage sensitivity calibration method involving offset value determination, comparison with preset sensor sensitivity, reliability assessment, and adjustment based on sensitivity differences and blood sugar level ranges to ensure accurate sensitivity adjustments.

Benefits of technology

The method enhances the accuracy of blood glucose measurements by calibrating sensitivity through multiple stages, improving the reliability and precision of continuous glucose monitoring systems.

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Abstract

To provide a technique to correct sensitivity for acquiring accurate sensitivity.SOLUTION: A method for correcting sensitivity for blood glucose measurement includes the steps of: acquiring an offset value for determining sensitivity; determining first sensitivity from a sensing value and a reference blood glucose value on the basis of the offset value; determining second sensitivity from the first sensitivity and sensitivity set by a sensor beforehand; determining third sensitivity by adjusting the second sensitivity with a degree of reliability of the first sensitivity based on a difference between the first sensitivity and previous sensitivity as a reference; determining fourth sensitivity from the third sensitivity according to whether or not a blood glucose value acquired from the offset value and the third sensitivity belongs to a fixed range; and determining the fourth sensitivity as the sensitivity.SELECTED DRAWING: Figure 6
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Description

[Technical field]

[0001] The present embodiment relates to a technique for calibrating sensitivity for blood glucose measurement, and more particularly, to a technique for calibrating sensitivity that includes multiple steps for adjusting the sensitivity. [Background technology]

[0002] With the recent development of medical technology, various medical devices that are attached to the user's body have been developed and sold. The medical devices that are attached to the user's body are attached to the skin of patients with chronic diseases and can be conveniently used to monitor biological information and provide treatment.

[0003] For example, chronic diseases such as diabetes require continuous management, and medical devices that are attached to the skin to measure blood glucose can be used to monitor the blood glucose of diabetic patients. Diabetes is characterized by having almost no subjective symptoms in the early stages, but as the disease progresses, specific symptoms such as excessive drinking, excessive eating, frequent urination, weight loss, general fatigue, skin pruritus, and prolonged wounds on the hands and feet that do not heal appear. As diabetes progresses further, complications such as vision impairment, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms and neuralgia, and gangrene appear. In order to diagnose and manage diabetes so that it does not progress to complications, systematic blood glucose measurement and treatment must be performed in parallel.

[0004] For people with diabetes, and those who have not yet developed diabetes but have higher than normal levels of sugar in their blood, many medical device manufacturers offer a wide variety of blood glucose meters that can measure blood glucose.

[0005] There are two types of blood glucose measuring devices: one in which the user takes a blood sample from the fingertip and measures the blood glucose level one time, and one in which the device is attached to the user's abdomen, arm, etc. and measures the blood glucose level continuously.

[0006] Diabetic patients generally go back and forth between hyperglycemic and hypoglycemic states, but emergency situations occur in the hypoglycemic state, and if the hypoglycemic state continues for a long time without sugar supply, they may lose consciousness. Therefore, rapid detection of hypoglycemic states is very important for diabetic patients, but blood glucose measuring devices that measure blood glucose intermittently have limitations in accurately detecting hypoglycemic states.

[0007] Recently, to overcome these limitations, a Continuous Glucose Monitoring System (CGMS) has been developed and is being used, which is inserted into the human body to measure blood glucose levels at intervals of several minutes. The Continuous Glucose Monitoring System is able to continuously measure blood glucose levels by inserting a needle-shaped transcutaneous sensor into areas such as the abdomen and arm where pain is relatively low, in order to minimize the user's pain and refusal to take blood.

[0008] The continuous blood glucose monitoring system includes a sensor transmitter that is inserted into the user's skin to measure blood glucose inside the body and transmit the measured blood glucose value, and a terminal that outputs the transmitted blood glucose value.

[0009] Here, since blood glucose is measured while the sensor transmitter is attached to the body and part of the sensor of the sensor transmitter is inserted into the human body, there is a possibility that the sensor inserted into the human body will be recognized as a foreign body. In other words, a biological reaction to the sensor, such as hydration, may occur. As a result, the sensitivity (slope) may change when the sensor is first inserted. This may reduce the accuracy of the sensor and make it difficult to maintain its expiration date. The changed slope may reduce the accuracy of the continuous blood glucose measurement system by obtaining (or calculating) a blood glucose value that is too high or too low for the measured biological signal. In the past, in order to compensate for such changes in sensitivity (slope), a method was developed that uses a simple sensitivity obtained by dividing the reference blood glucose value input by the user (blood glucose monitoring system (BGMS)) by the current value of the sensor and a preset offset value, or a method that determines the sensitivity through regression analysis of the reference blood glucose value and the corresponding current value. However, such a method may have the problem of providing inaccurate sensitivity and offset values ​​because it cannot sensitively respond to abnormal blood glucose levels or abnormal sensor operation. Summary of the Invention [Problem to be solved by the invention]

[0010] In this context, one object of the present embodiment is to provide a technique for calibrating sensitivity to obtain accurate sensitivity.

[0011] In this context, another object of the present embodiment is to provide a technique for providing calibrated sensitivity by adjusting the sensitivity through multiple stages to improve the accuracy of the sensitivity. [Means for solving the problem]

[0012] In order to achieve the above-mentioned object, one embodiment may provide a method for calibrating sensitivity for blood glucose measurement, including a step of obtaining an offset value for determining sensitivity; a step of determining a first sensitivity from a sensed value and a reference blood glucose value based on the offset value; a step of determining a second sensitivity from the first sensitivity and a sensitivity preset by a sensor; a step of determining a third sensitivity by adjusting the second sensitivity based on a reliability of the first sensitivity based on a difference between the first sensitivity and a previous sensitivity; a step of determining a fourth sensitivity from the third sensitivity depending on whether the blood glucose value obtained from the offset value and the third sensitivity falls within a certain range; and a step of determining the fourth sensitivity as the sensitivity.

[0013] Another embodiment may provide a method for calibrating sensitivity for blood glucose measurement, including a step of acquiring an offset value; a step of determining sensitivity from a sensing value and a reference blood glucose value based on the offset value; and a step of adjusting the sensitivity by at least one of a first method of adjusting the sensitivity based on a sensitivity preset by a sensor, a second method of adjusting the sensitivity based on a difference between the sensitivity and a previous sensitivity, and a third method of adjusting the sensitivity depending on whether the sensing value reflecting the offset value and the blood glucose value acquired from the sensitivity fall within a certain range. Effect of the Invention

[0014] As described above, according to this embodiment, the sensitivity can be calibrated to obtain an accurate sensitivity.

[0015] According to the present embodiment, the accuracy of the sensitivity can be improved by adjusting the sensitivity through a plurality of stages. [Brief description of the drawings]

[0016] [Figure 1] 1 is a diagram for illustrating a blood glucose measurement system according to an embodiment; [Diagram 2]1 is a diagram illustrating an applicator for attaching a sensor transmitter to a human body according to an embodiment; [Diagram 3] 1 is a diagram illustrating a process of attaching a sensor transmitter to a human body using an applicator according to an embodiment. [Figure 4] FIG. 2 is a configuration diagram of a sensor transmitter according to an embodiment. [Diagram 5] FIG. 2 is a configuration diagram of a terminal according to an embodiment. [Figure 6] 10 is a flowchart illustrating a method for calibrating sensitivity according to an embodiment. [Figure 7] 11 is a diagram illustrating an example of adjusting sensitivity based on coding information of a sensor according to an embodiment; [Figure 8] 13 is a diagram illustrating an example of adjusting sensitivity based on a difference from a previous sensitivity according to an embodiment; [Figure 9] FIG. 13 is an example diagram illustrating how sensitivity is adjusted based on a certain range formed by a reference blood glucose value and a previous blood glucose value obtained from a previous sensitivity according to an embodiment. [Figure 10] FIG. 13 is an example diagram illustrating how sensitivity is adjusted based on a certain range formed by a reference blood glucose value and a previous blood glucose value obtained from a previous sensitivity according to an embodiment. [Figure 11] FIG. 13 is an example diagram illustrating how sensitivity is adjusted based on a certain range formed by a reference blood glucose value and a previous blood glucose value obtained from a previous sensitivity according to an embodiment. [Figure 12] 10 is a flowchart illustrating a method for calibrating sensitivity according to another embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] In describing the present invention, detailed descriptions of related publicly known functions will be omitted if they are considered to be obvious to a person skilled in the art and may unnecessarily obscure the gist of the present invention.

[0018] The terms used in this application are merely used to describe certain embodiments and are not intended to limit the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this application, terms such as "include" or "have" are intended to specify the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and should be understood not to preclude the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0019] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the description with reference to the accompanying drawings, the same or corresponding components will be given the same drawing numbers, and duplicate descriptions thereof will be omitted.

[0020] FIG. 1 is a diagram for explaining a blood glucose measuring system according to one embodiment.

[0021] Referring to FIG. 1, a blood glucose measuring system (10, hereinafter referred to as the “system”) according to one embodiment may include a sensor transmitter 100 and a terminal 200.

[0022] The sensor transmitter 100 is attached to the human body B, and when the sensor transmitter 100 is attached to the human body B, one end of the sensor of the sensor transmitter 100 is inserted into the skin to periodically extract body fluids from the human body to measure blood glucose.

[0023] The terminal 200 can receive a biosignal including blood glucose information from the sensor transmitter 100, generate blood glucose information from the biosignal, and output the blood glucose information to a user. The terminal 200 can include various devices such as a smartphone, a mobile phone, a tablet PC, a desktop, a laptop, etc., but is not limited thereto, and can include a device having a communication interface capable of communicating with the sensor transmitter 100 and in which a program or application can be installed.

[0024] The sensor transmitter 100 may transmit a measured biosignal to the terminal 200 at a request of the terminal 200 or periodically at set times. For data communication between the sensor transmitter 100 and the terminal 200, the sensor transmitter 100 and the terminal 200 may be connected to each other by a wire such as a USB cable or may be connected wirelessly by infrared communication, NFC communication, Bluetooth (registered trademark), etc.

[0025] FIG. 2 is a diagram illustrating an applicator for attaching a sensor transmitter to a human body according to one embodiment, and FIG. 3 is a diagram illustrating a process of attaching a sensor transmitter to a human body using an applicator according to one embodiment.

[0026] 2 and 3, an applicator 300 according to an embodiment includes a sensor transmitter 100 therein, and is operated by a user to discharge the sensor transmitter 100 to the outside and attach it to a specific body part of the user. The applicator 300 is formed in a shape with one side open, and the sensor transmitter 100 is installed on the applicator 300 through the open side of the applicator 300.

[0027] When attaching the sensor transmitter 100 to a part of the body using the applicator 300, the applicator 300 may include a needle (not shown) formed to surround one end of the sensor, a first elastic member (not shown) for pushing both the needle and one end of the sensor into the skin, and a second elastic member (not shown) for pulling out only the needle. With such a configuration of the applicator 300, the needle and one end of the sensor may be simultaneously inserted into the skin by releasing the compression of the first elastic member (not shown) arranged in a compressed state inside the applicator 300. When one end of the sensor is inserted into the skin, only the needle is pulled out by releasing the compression of the compressed second elastic member (not shown). A user can attach the sensor transmitter 100 to the skin safely and easily using the applicator 300.

[0028] Looking in detail at the process of attaching the applicator 300 to the human body B, with the protective cap (not shown) removed, the open side of the applicator 300 is brought into close contact with the skin S of a specific part of the human body B. When the applicator 300 is operated with the applicator 300 in close contact with the skin S of the human body B in this manner, the sensor transmitter 100 can be discharged from the applicator 300 and attached to the skin S. Here, one end of the sensor 101 is disposed at the bottom of the sensor transmitter 100 so as to be exposed from the sensor transmitter 100, and one end of the sensor 101 can be partially inserted into the skin S through a needle provided in the applicator 300. Therefore, the sensor transmitter 100 can be attached to the skin S with one end of the sensor 101 inserted into the skin S.

[0029] Here, an adhesive tape may be provided on the surface of the sensor transmitter 100 that contacts the human body B so that the sensor transmitter 100 can be fixedly attached to the skin S of the human body B. Therefore, when the applicator 300 is separated from the skin S of the human body B, the sensor transmitter 100 may be fixedly attached to the skin S of the human body B by the adhesive tape.

[0030] Thereafter, when power is applied to the sensor transmitter 100, the sensor transmitter 100 communicates with the terminal and can transmit a biological signal including blood glucose information to the terminal. The sensor transmitter 100 can generate various biological information in addition to blood glucose information, but in the following, the measurement of blood glucose information will be described as an example of biological information.

[0031] FIG. 4 is a configuration diagram of a sensor transmitter according to an embodiment.

[0032] Referring to FIG. 4, a sensor transmitter 100 according to an embodiment may include a sensor module 110, a sensor communication unit 120, a sensor control unit 130, and a sensor storage unit 140.

[0033] The sensor module 110 may include at least one sensor that is inserted into the human body to sense a bio-quantity. The at least one sensor may measure a bio-quantity and generate a bio-signal. The bio-signal may be an analog signal and may include a current value.

[0034] The sensor communication unit 120 may exchange data or information with the terminal. For example, the sensor communication unit 120 may transmit a biosignal received from the sensor module 110 or data stored in the sensor storage unit 140 to the terminal.

[0035] The sensor control unit 130 may control the overall configuration of the sensor transmitter 100, including the sensor module 110, the sensor storage unit 140, and the sensor communication unit 120. For example, the sensor control unit 130 may receive a control signal from a terminal and control the configuration of the sensor transmitter 100 accordingly. The sensor control unit 130 may also process a biosignal. For example, the sensor control unit 130 may convert the biosignal into an analog or digital form and perform processing to remove noise as necessary.

[0036] Data or information may be stored in the sensor storage unit 140. For example, data on a bioquantity measured by the sensor module 110, such as a current value of a biosignal, or data received from a terminal, such as a command value of a control signal, may be stored in the sensor storage unit 140.

[0037] FIG. 5 is a diagram illustrating a configuration of a terminal according to an embodiment.

[0038] Referring to FIG. 5, a terminal 200 according to an embodiment may include an output unit 210, a communication unit 220, a control unit 230, and a storage unit 240.

[0039] The output unit 210 can output the bioinformation included in the biosignal, such as blood glucose information, so that the user can check it. For example, the output unit 210 can display the blood glucose information as a numerical value or even a graph processed from the numerical value.

[0040] The communication unit 220 can communicate with the sensor communication unit of the sensor transmitter to exchange data or information. For example, the communication unit 220 can receive a biosignal including information on a bioquantity measured by the sensor transmitter (biometric information). Here, the communication unit 220 can receive a biosignal that has been primarily processed by the sensor transmitter. Alternatively, the communication unit 220 can transmit a control signal for controlling the sensor transmitter to the sensor transmitter.

[0041] Data or information may be stored in the storage unit 240. For example, data received from a sensor transmitter, such as biological information, may be stored in the storage unit 240. Here, the biological information may include blood glucose information and may be in the form of a current value. Alternatively, the storage unit 240 may store data input by a user or environment setting data for setting the operating environment of the terminal.

[0042] The control unit 230 may include at least one processor that executes a program for calibrating sensitivity for blood glucose measurement and at least one memory that stores the program. The memory and processor included in the control unit 230 may be integrated into one chip or may be physically separated.

[0043] The memory may be implemented as a non-volatile memory device such as a read only memory (ROM), a programmable ROM (PROM), an erasable programmable ROM (EPROM), an electrically erasable programmable ROM (EEPROM), and a flash memory, or a volatile memory device such as a random access memory (RAM) to store various programs, data, and / or information.

[0044] Meanwhile, the control unit 230 can generate a blood glucose value, which is blood glucose information digitized from the biological information. To this end, the control unit 230 can obtain biological information in the form of a current value from a sensor transmitter and pre-process and / or process the current value of the biological information. The control unit 230 can first obtain sensitivity and generate a blood glucose value according to the sensitivity.

[0045] The control unit 230 can determine the sensitivity based on the current value and an externally input reference blood glucose value, and the sensitivity can be determined by the following mathematical formula 1. Here, C means the current value at the time when the sensitivity is determined based on the reference blood glucose value, i.e., at the time when the sensitivity is calibrated, and BGr is the reference blood glucose value, which is a blood glucose value obtained from a blood glucose monitoring system (BGMS), and does not necessarily have to be obtained at the time when the sensitivity is calibrated.

[0046]

number

[0047] After the sensitivity is obtained as described above, the control unit 230 can generate a blood glucose value corresponding to the current value by multiplying the current value by the sensitivity. The control unit 230 can provide the new blood glucose value to the user through the output unit 210. For example, the control unit 230 can obtain the sensitivity according to the mathematical formula 1 using a first current value obtained at a first time point and one reference blood glucose value, and obtain a new blood glucose value using this sensitivity until the time point at which the next sensitivity calibration is performed (the second time point). Then, the control unit 230 can calibrate the sensitivity again at the second time point. The control unit 230 can obtain the sensitivity according to the mathematical formula 1 using a second current value obtained at a second time point and another reference blood glucose value, and obtain a new blood glucose value corresponding thereto.

[0048] Meanwhile, such sensitivity may vary depending on various environmental variables. For example, a change in current value caused by hydration occurring when the sensor is inserted into a living body, or a negative intercept phenomenon in which a decrease in current value continues, may be a factor that changes the sensitivity. If the sensor transmitter transmits a current value that is lower than the original current value to the terminal 200 due to the negative intercept phenomenon, the control unit 230 of the terminal 200 can obtain the sensitivity from a current value smaller than the original current value according to Equation 1. The sensitivity obtained in this way may be very large. If the control unit 230 obtains a blood glucose value with an excessively large sensitivity, the blood glucose value will be high even for a small current value, and the control unit 230 may generate an inaccurate blood glucose value.

[0049] In order to correct such errors, the control unit 230 can obtain an offset value and reflect the offset value in obtaining the sensitivity. The control unit 230 can obtain the offset value in various ways without limitation, and the offset value can be fixed or variable. The control unit 230 can determine the sensitivity reflecting the offset value according to the following Equation 2. Here, Voff can be a value preset by a user as the offset value, or a value that can be varied according to an algorithm of the storage unit 240.

[0050]

number

[0051] In the above example, the decrease in the current value due to the negative intercept phenomenon is offset by the offset value, and the small denominator becomes large, so that the sensitivity can be changed to an appropriate level that is not excessive. However, the control unit 230 of the terminal 200 according to an embodiment does not immediately use the sensitivity reflecting the offset value to obtain the blood glucose level, but adjusts the sensitivity and then finally uses the adjusted sensitivity to obtain the blood glucose level. Hereinafter, a method for calibrating the sensitivity through multiple steps in which the control unit 230 of the terminal 200 adjusts the sensitivity will be described.

[0052] FIG. 6 is a flowchart showing a method for calibrating sensitivity according to one embodiment, FIG. 7 is an example diagram showing adjusting sensitivity based on coding information of a sensor according to one embodiment, FIG. 8 is an example diagram showing adjusting sensitivity based on a difference from a previous sensitivity according to one embodiment, and FIGS. 9 to 11 are example diagrams showing adjusting sensitivity based on a certain range formed by a reference blood glucose value and a previous blood glucose value obtained from the previous sensitivity according to one embodiment.

[0053] 6, a method of calibrating sensitivity in a terminal constituting a blood glucose measurement system according to an embodiment can be illustrated. Hereinafter, the sensitivity calibration is described as being performed in the terminal, but is not limited thereto, and may be performed in a sensor transmitter or a host (e.g., a server) connected to the terminal via a wired / wireless network depending on the configuration. The control unit of the terminal can first determine the sensitivity required to generate a blood glucose value from a current value, and finally generate a blood glucose value by applying the current value to the determined sensitivity.

[0054] To this end, the control unit of the terminal may first obtain an offset value for determining the sensitivity (step S601). The offset value may be a value that compensates for a change in the sensitivity due to a decrease in the current value.

[0055] Then, the control unit can determine the sensitivity from the current value reflecting the offset value and the reference blood glucose value according to Equation 2 (step S603). The sensitivity determined here is not the final sensitivity, but may be the sensitivity reflecting only the offset value before the adjustment step. Hereinafter, for convenience of explanation, such sensitivity will be named "first sensitivity". Also, the current value is a type of value measured by a sensor included in the sensor module, and may be named a sensing value.

[0056] First, an adjustment to the first sensitivity may be performed. The control unit of the terminal may determine a second sensitivity from the first sensitivity and the sensitivity preset by the sensor (step S605). The sensitivity preset by the sensor may be a sensitivity preset for any one sensor, or a sensitivity preset for any one group (lot) which is a collection of a plurality of sensors. The sensitivity for a group of sensors may be understood as a specific sensitivity that represents an entire group rather than a single sensor. Hereinafter, for convenience of explanation, the sensitivity preset by the sensor may be referred to as "sensor sensitivity".

[0057] Here, the sensor sensitivity may include an ideal sensitivity expected from a sensor or a group of sensors under ideal conditions. For example, the sensor sensitivity may be understood as the sensitivity that a sensor or a group of sensors should have under ideal conditions such as a laboratory environment. Alternatively, the sensor sensitivity may be understood as a sensitivity that is preset in a factory when a sensor or a group of sensors is manufactured. Although the sensor sensitivity needs to be coded for initialization when the terminal is used, the sensor sensitivity may be included in the coding information during the coding process and input and / or stored in the terminal.

[0058] 7, an example of determining a second sensitivity from a first sensitivity and a sensor sensitivity can be illustrated. The terminal control unit can reflect the sensor sensitivity to adjust the first sensitivity and determine the second sensitivity based on the result. However, the terminal control unit can reflect the sensor sensitivity differently in some cases.

[0059] First, the control unit may compare the first sensitivity with the sensor sensitivity. If the first sensitivity is greater than the sensor sensitivity, the control unit may determine the sensor sensitivity as the second sensitivity. For example, in this drawing, if the first sensitivity S1 is 25 at the first calibration point P1 and the sensor sensitivity Ss, which is the sensitivity according to the coding information, is 20, the control unit may determine the second sensitivity S2 as 20. Hereinafter, units will be omitted for convenience of explanation. The control unit may more reliably determine the sensor sensitivity Ss as the second sensitivity S2.

[0060] Otherwise, that is, if the first sensitivity is smaller than the sensor sensitivity, the control unit may process the sensor sensitivity and determine the processed sensor sensitivity as the second sensitivity. For example, in this drawing, if the first sensitivity S1 is 5 at the second calibration point P2 and the sensor sensitivity Ss, which is the sensitivity according to the coding information of the sensor, is 20, the control unit may process the sensor sensitivity Ss to obtain a value corresponding to 1 / 3 of the sensor sensitivity Ss and determine 20 / 3 (≒6.7), which is a value corresponding to 1 / 3 of the sensor sensitivity Ss, as the second sensitivity S2. The control unit may more reliably determine the processed value of the sensor sensitivity Ss as the second sensitivity S2.

[0061] If the first sensitivity is the same as the sensor sensitivity, the control unit may determine the first sensitivity as the second sensitivity.

[0062] Returning to FIG. 6 again, an adjustment to the second sensitivity may be performed. The control unit of the device may determine the third sensitivity by adjusting the second sensitivity based on the reliability of the first sensitivity based on the difference between the first sensitivity and a previously determined sensitivity (step S607). Here, the previously determined sensitivity may refer to the final sensitivity at a previous point in time, and the previous point in time may refer to a specific point in time in the past prior to the current point in time at which the sensitivity is to be calibrated. The control unit of the device may have obtained the blood glucose level according to the previously determined sensitivity at a previous point in time as well. Hereinafter, for convenience of explanation, this may be referred to as the "previous sensitivity."

[0063] Specifically, if the first sensitivity is higher or lower than the previous sensitivity consecutively - at least twice - the control unit of the terminal can trust the first sensitivity and determine that the reliability of the first sensitivity is high. Then, the control unit can obtain a combined sensitivity reflecting the first sensitivity and the second sensitivity, and determine this combined sensitivity as the third sensitivity. The control unit can obtain the combined sensitivity by averaging the first sensitivity and the second sensitivity.

[0064] 8, an example of determining the third sensitivity by adjusting the second sensitivity may be illustrated. For example, in this figure, if the first sensitivity S1 is 30 and the previous sensitivity Sp is 25 at the first calibration time point P1, and the first sensitivity S1 is 32 and the previous sensitivity Sp is 27 at the second calibration time point P2, the first sensitivity S1 has a higher value than the previous sensitivity Sp at two consecutive calibration times, so the control unit can determine that the reliability of the first sensitivity S1 having 29 is high at the third calibration time point P3. Then, at the third calibration time point P3, the control unit can obtain a combined sensitivity from the first sensitivity S1 29 and the second sensitivity S2 25. The control unit can obtain 27 (=(29+25) / 2), which is the average value of the first sensitivity S1 29 and the second sensitivity S2 25, as the combined sensitivity. The control unit can determine the combined sensitivity 27 as the third sensitivity S3.

[0065] In this way, when the first sensitivity is successively higher or lower, the first sensitivity may be deemed appropriate, and it is preferable that the first sensitivity is more favorably reflected than the second sensitivity, unlike step S605.

[0066] Returning to Fig. 6 again, adjustment of the third sensitivity may be performed. The control unit of the terminal may obtain a blood glucose value from the offset value and the third sensitivity, and may determine a fourth sensitivity from the third sensitivity depending on whether the obtained blood glucose value falls within a certain range (step S609). If the obtained blood glucose value falls within the certain range, the control unit may regard the third sensitivity as appropriate and determine the third sensitivity as the fourth sensitivity as it is. Otherwise, the control unit may regard the third sensitivity as inappropriate, obtain an adjusted sensitivity instead of the third sensitivity, and determine the adjusted sensitivity as the fourth sensitivity.

[0067] Here, the certain range may be specified by the previous blood glucose value and the reference blood glucose value. The control unit can acquire the previous blood glucose value from the current current value, the previous sensitivity, and the previously acquired offset value - the previous offset value. The control unit can also acquire the reference blood glucose value - the reference blood glucose value used to determine the first sensitivity in step S601 - from outside. The control unit can determine whether the blood glucose value acquired from the current current value, the current offset value, and the third sensitivity is within the range defined by the previous blood glucose value and the reference blood glucose value.

[0068] 9, an example of determining the fourth sensitivity from the third sensitivity depending on whether the blood glucose level obtained from the third sensitivity falls within a certain range can be shown. In one example, it can be assumed that the control unit determines the fourth sensitivity at a first calibration point P1. First, the control unit can identify a certain range and determine the validity of the third sensitivity.

[0069] If the current value C at the first calibration point P1 is 7, the previous sensitivity Sp is 20, and the previous offset value Voff_p is 0, then the previous blood glucose level BGp can be 140 (=(7-0)×20). Here, the previous sensitivity Sp and the previous offset value Voff_p can be the sensitivity and offset value before the sensitivity calibration is performed at the first calibration point P1. If the reference blood glucose level BGr is 200 at the first calibration point P1, the blood glucose level range for which the blood glucose level according to the third sensitivity is valid, i.e., a certain range determined by the previous blood glucose level and the reference blood glucose level, can be 140~200.

[0070] And, since the current value C at the first calibration point in time P1 is 7, the offset value Voff at the first calibration point in time P1 is 0, and the third sensitivity S3 is 30, the control unit can obtain a blood glucose level (BG) of 210 (=(7-0)×30) from these. Since the blood glucose level (BG) is 210, which falls outside the certain range of 140 to 200, the control unit considers the third sensitivity S3 to be invalid and can obtain an adjustment sensitivity to determine the fourth sensitivity.

[0071] The control unit can obtain the adjustment sensitivity through the following mathematical formula 3 using the current value (at the current time), the offset value (at the current time), the previous blood glucose value, and the reference blood glucose value.

[0072]

number

[0073] According to this example, the current value C at the first calibration point P1 is 7, the offset value Voff at the first calibration point P1 is 0, the previous blood glucose value BGp is ​​140, and the reference blood glucose value BGr is 200, so the adjustment sensitivity Sa can be 24.29. The control unit can determine the adjustment sensitivity Sa as the fourth sensitivity. The control unit can determine 24.29 as the fourth sensitivity.

[0074] 10, another example of determining the fourth sensitivity from the third sensitivity depending on whether the blood glucose level obtained from the third sensitivity falls within a certain range can be shown. In another example, it can be assumed that the control unit determines the fourth sensitivity at the second calibration point P2. First, the control unit can identify a certain range and determine the validity of the third sensitivity.

[0075] If the current value C at the second calibration point P2 is 5, the previous sensitivity Sp is 30, and the previous offset value Voff_p is 1, then the previous blood glucose level BGp may be 120 (=(5-1)×30). Here, the previous sensitivity Sp and the previous offset value Voff_p may be the sensitivity and offset value before the sensitivity calibration is performed at the second calibration point P2. If the reference blood glucose level BGr is 140 at the second calibration point P2, then the blood glucose level range for which the blood glucose level according to the third sensitivity is valid, i.e., a certain range determined by the previous blood glucose level and the reference blood glucose level, may be 120~140.

[0076] And, since the current value C at the second calibration point P2 is 5, the offset value Voff at the second calibration point P2 is 0.5, and the third sensitivity S3 is 28, the control unit can obtain the blood glucose level (BG) of 126 (=(5-0.5)×28) from these. Since the blood glucose level (BG) is 126, which is within a certain range of 120 to 140, the control unit can determine the third sensitivity S3 as valid and determine it as the fourth sensitivity. Therefore, in this example, the fourth sensitivity can be 28.

[0077] 11, another example of determining the fourth sensitivity from the third sensitivity depending on whether the blood glucose level obtained from the third sensitivity falls within a certain range can be shown. In this example, it can be assumed that the control unit determines the fourth sensitivity at the third calibration point P3. First, the control unit can identify a certain range and determine the validity of the third sensitivity.

[0078] If the current value C at the third calibration point P3 is 12, the previous sensitivity Sp is 25, and the previous offset value Voff_p is 0.5, then the previous blood glucose value BGp may be 287.5 (=(12-0.5)×25). Here, the previous sensitivity Sp and the previous offset value Voff_p may be the sensitivity and offset value before the sensitivity calibration is performed at the third calibration point P3. If the reference blood glucose value BGr is 200 at the third calibration point P3, then the blood glucose value range for which the blood glucose value according to the third sensitivity is valid, i.e., a certain range determined by the previous blood glucose value and the reference blood glucose value, may be 200 to 287.5.

[0079] And, since the current value C at the third calibration point P3 is 12, the offset value Voff at the third calibration point P3 is 0.3, and the third sensitivity S3 is 15, the control unit can obtain the blood glucose level (BG) of 175.5 (=(12-0.3)×15) from these. Since the blood glucose level (BG) is 175.5, which falls outside the certain range of 200 to 287.5, the control unit considers the third sensitivity S3 to be invalid and can obtain the adjustment sensitivity to determine the fourth sensitivity.

[0080] The control unit can obtain the adjustment sensitivity through the current value (at the current time), the offset value (at the current time), the previous blood glucose value, and the reference blood glucose value through the above-mentioned mathematical formula 3. According to this example, the current value C at the third calibration point in time P3 is 12, the offset value Voff at the third calibration point in time P3 is 0.3, the previous blood glucose value BGp is ​​287.5, and the reference blood glucose value BGr is 200, so the adjustment sensitivity Sa can be 20.33. The control unit can determine 20.33 as the fourth sensitivity.

[0081] FIG. 12 is a flowchart showing a method for calibrating sensitivity according to another embodiment.

[0082] 12, a method for calibrating sensitivity in a terminal constituting a blood glucose measuring system according to another embodiment can be illustrated. First, a control unit of the terminal can obtain an offset value for determining sensitivity (step S1201).

[0083] In addition, the control unit may determine a first sensitivity based on the sensed value (or current value) reflecting the acquired offset value and the reference blood glucose level (operation S1203).

[0084] The control unit can adjust the sensitivity by at least one of the following methods (step S1205): a first method of adjusting the first sensitivity based on the sensor sensitivity--a sensitivity preset by the sensor, a second method of adjusting the first sensitivity based on a difference between the first sensitivity and a previous sensitivity, and a third method of adjusting the first sensitivity depending on whether the blood glucose level obtained from the first sensitivity falls within a certain range determined by the previous blood glucose level and the reference blood glucose level. Also, the control unit can adjust the sensitivity by sequentially performing the first to third methods one by one, or can adjust the sensitivity by selectively performing only one of the methods.

[0085] Here, the first to third methods are the same as the first embodiment, but there may be some differences. The control unit can calibrate the sensitivity by using the first method alone. Then, in the same manner as the first embodiment, the control unit can adjust the first sensitivity according to the sensor sensitivity to determine the final sensitivity.

[0086] Also, the control unit can calibrate the sensitivity by using the second method alone. If the second method is not used in succession to the first method, the sensitivity adjusted according to the sensor sensitivity may not exist in the second method. In this case, the control unit can determine the first sensitivity as the final sensitivity if the first sensitivity is continuously higher or lower than the previous sensitivity.

[0087] Also, the control unit can calibrate the sensitivity by using the third method alone. Then, in the same manner as the first embodiment, the control unit can determine the first sensitivity as the final sensitivity depending on whether the blood glucose value obtained from the first sensitivity falls within a certain range determined by the previous blood glucose value and the reference blood glucose value, or can obtain an adjusted sensitivity according to the mathematical formula 3 and determine it as the final sensitivity.

[0088] When the control unit determines the first sensitivity adjusted by at least one of the first to third methods as the final sensitivity, the control unit may end the sensitivity calibration procedure. The control unit may generate a blood glucose level based on the final sensitivity, the offset value, and the sensing value (current value).

[0089] Aspects of the subject matter described herein may be described in the context of computer-executable instructions, such as program modules, being executed by a computer. Generally, program modules include routines, programs, objects, components, data structures, etc., that perform particular tasks or perform particular abstract data types.

[0090] Alternatively or additionally, the functionality described herein may be performed, at least in part, by one or more hardware logic components. By way of non-limiting example, exemplary types of hardware logic components that may be used include field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), application-specific standard products (ASSPs), system-on-a-chip systems (SOCs), complex programmable logic devices (CPLDs), and the like.

[0091] Meanwhile, the disclosed embodiments may be embodied in the form of a recording medium storing a program and / or instructions executable by a computer. The instructions may be stored in the form of program code, and when executed by a processor, may generate program modules to perform the operations of the disclosed embodiments. The recording medium may be embodied in a computer-readable recording medium.

[0092] The computer-readable recording medium includes all kinds of recording media in which instructions that can be decoded by a computer are stored, such as read only memory (ROM), random access memory (RAM), magnetic tape, magnetic disk, flash memory, optical data storage device, etc.

[0093] Although one embodiment of the present invention has been described above, a person having ordinary knowledge in the relevant technical field may modify and change the present invention in various ways by adding, changing or deleting components without departing from the concept of the present invention described in the claims, and this can also be said to be within the scope of the claims of the present invention.

Claims

1. obtaining an offset value for determining sensitivity; determining a first sensitivity from the sensed value and the reference blood glucose value based on the offset value; determining a second sensitivity from the first sensitivity and a sensitivity preset by a sensor; determining a third sensitivity by adjusting the second sensitivity based on a reliability of the first sensitivity based on a difference between the first sensitivity and a previous sensitivity; determining a fourth sensitivity from the third sensitivity according to whether the offset value and the blood glucose value obtained from the third sensitivity belong to a certain range; and A method of calibrating sensitivity for blood glucose measurement, comprising the step of determining said fourth sensitivity as said sensitivity.

2. The step of determining the second sensitivity includes:

2. The method of claim 1, further comprising the step of determining the sensitivity preset by the sensor as the second sensitivity when the first sensitivity is greater than the sensitivity preset by the sensor.

3. The step of determining the second sensitivity includes:

2. The method of claim 1, further comprising: if the first sensitivity is smaller than the sensitivity preset by the sensor, processing the sensitivity preset by the sensor; and determining the processed sensitivity as the second sensitivity.

4. The sensitivity preset by the sensor is:

2. The method of calibrating sensitivity for blood glucose measurements according to claim 1, comprising a preset ideal sensitivity for a sensor or group of sensors.

5. determining a third sensitivity by adjusting the second sensitivity based on the reliability of the first sensitivity, 2. The method of claim 1, further comprising the steps of: determining that the reliability of the first sensitivity is high if the difference occurs continuously; obtaining a combined sensitivity from the first sensitivity and the second sensitivity; and determining the combined sensitivity as the third sensitivity.

6. The step of acquiring the binding sensitivity includes:

6. The method of calibrating sensitivity for blood glucose measurement according to claim 5, further comprising averaging the first sensitivity and the second sensitivity.

7. The certain range is 2. The method of calibrating sensitivity for blood glucose measurements according to claim 1, wherein the sensitivity is specified by a previous blood glucose value obtained from a previously obtained offset value and the reference blood glucose value.

8. The step of determining the fourth sensitivity from the third sensitivity includes:

8. The method of claim 7, further comprising determining the third sensitivity as the fourth sensitivity if the acquired blood glucose value is within the certain range.

9. The step of determining the fourth sensitivity from the third sensitivity includes: if the acquired blood glucose value is outside the certain range, acquiring an adjustment sensitivity from the sensing value reflecting the offset value, the previous blood glucose value, and the reference blood glucose value; and 8. The method of calibrating sensitivity for blood glucose measurements according to claim 7, further comprising determining the adjusted sensitivity as the fourth sensitivity.

10. The step of obtaining the adjustment sensitivity includes:

10. The method of calibrating sensitivity for blood glucose measurement according to claim 9, wherein an average value of the previous blood glucose value and the reference blood glucose value is used to obtain the adjusted sensitivity.

11. obtaining an offset value; determining sensitivity from the sensing value reflecting the offset value and a reference blood glucose value; and A method for calibrating sensitivity for blood glucose measurement, comprising the steps of: adjusting the sensitivity by at least one of a first method of adjusting the sensitivity based on a sensitivity preset by a sensor; a second method of adjusting the sensitivity based on a difference between the sensitivity and a previous sensitivity; and a third method of adjusting the sensitivity depending on whether a sensing value reflecting the offset value and a blood glucose value obtained from the sensitivity fall within a certain range.

12. The step of adjusting the sensitivity by at least one of the first to third methods includes:

12. The method for calibrating sensitivity for blood glucose measurement according to claim 11, wherein the sensitivity is adjusted by sequentially applying the first to third methods.