A blood glucose measurement method based on hematocrit compensation and a blood glucose tester

Abstract

The present application provides a blood glucose measurement method and blood glucose meter based on hematocrit compensation, wherein the method comprises: obtaining an impedance value and a current value of the blood to be tested as detected by the blood glucose meter; determining a calibration current value and a hematocrit value based on the current value and the impedance value; and determining the blood glucose value of the blood to be tested based on the hematocrit value, the calibration current value, and a blood glucose test equation. The blood glucose test equation can be used to compensate for the hematocrit in the blood, reducing the impact of the hematocrit on the measurement results, thereby improving the measurement accuracy of the electrochemical test strip.

Description

Technical Field

[0001] The present application relates to the field of biosensor technology, and in particular to a blood glucose measurement method based on hematocrit compensation and a blood glucose tester. Background Art

[0002] Biosensors based on electrochemical principles have been widely used in POCT rapid diagnosis. This type of biosensor uses an insulating substrate (PET substrate) as a carrier, prints the biosensor electrode onto the insulating substrate, then adds an auxiliary enzyme solution to the reaction area of ​​the substrate, and then uses the electrochemical redox reaction between the enzyme and the target to generate current, and detects the target by the current strength. Such sensors have been widely used in auxiliary diagnosis and treatment of diabetes, such as blood glucose test strips and blood ketone test strips, and are also used in the diagnosis and treatment of gout and ketosis, such as uric acid test strips.

[0003] In particular, the test sample for blood glucose test strips is whole blood. The hematocrit in the blood of different people varies, and the main source of error in blood glucose testing is the hematocrit of the sample. Hematocrit (HCT) refers to the percentage of red blood cells in the whole blood volume. When blood contacts the reaction area of ​​the electrode, if the blood sample contains a large number of red blood cells, the effective contact area between the plasma and the electrode reaction area will decrease, and the generated electrochemical signal will decrease. If the blood sample contains a small number of red blood cells, the effective contact area between the plasma and the electrode reaction area will increase, and the generated electrochemical signal will increase.

[0004] Everyone's hematocrit is different. The normal hematocrit range for men is 42%-49%, the normal hematocrit range for women is 37%-43%, and the hematocrit range for newborns is 48%-68%. However, the hematocrit of some special patients, such as those with organ failure, anemia, and blood loss, is different from that of normal people. Taking blood sugar as an example, the national standard "GB / T 19634-2021 General Technical Conditions for Blood Glucose Monitoring Systems for Self-Testing in In Vitro Diagnostic Test Systems" requires that for blood sugar concentrations <5.55mmol / L, the allowable deviation is ±0.83mmol / L, and for blood sugar concentrations ≥5.55mmol / L, the allowable deviation is within ±15%. The hematocrit range of different populations is 20%-70%. Testing within such a wide range will cause a large deviation in the blood glucose results measured by electrochemical test strips, with the deviation reaching up to 40%-50%, which is much higher than the requirement of the national standard GB19634 / 2021 that the deviation should be within ±15%. Summary of the Invention

[0005] In view of this, the purpose of this application is to provide a blood glucose determination method and a blood glucose tester based on hematocrit compensation, which compensates the hematocrit in the blood through the blood glucose test equation, reduces the influence of hematocrit on the measurement results, and thus improves the measurement accuracy of the electrochemical test paper.

[0006] In a first aspect, an embodiment of the present application provides a blood glucose determination method based on hematocrit compensation, which is applied to a blood glucose tester, wherein the method includes: obtaining the impedance value and current value of the blood to be tested detected by the blood glucose tester; determining the calibration current value and hematocrit value according to the current value and impedance value, respectively; determining the blood glucose value of the blood to be tested according to the hematocrit value, the calibration current value and the blood glucose test equation.

[0007] Optionally, the calibration current value is determined by the following steps: determining the calibration current value according to the current value and a preset current calibration equation.

[0008] Optionally, the current calibration equation is determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations; measuring multiple sample current values ​​and multiple sample detection values ​​of the multiple blood samples; and determining the current calibration equation based on the multiple sample current values ​​and multiple sample detection values ​​of the multiple blood samples.

[0009] Optionally, the blood glucose test equation is determined by the following steps: obtaining multiple blood samples at multiple different blood glucose concentrations under multiple different hematocrit values ​​and actual hematocrit values ​​of the multiple blood samples; fitting multiple blood samples at multiple different blood glucose concentrations under multiple different hematocrit values ​​and actual hematocrit values ​​of the multiple blood samples to determine the blood glucose test equation, wherein the blood glucose test equation includes a first coefficient and a second coefficient, the first coefficient is determined according to a first correction equation, and the second coefficient is determined according to a second correction equation.

[0010] Optionally, the first correction equation is determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations, as well as actual hematocrit values ​​of the multiple blood samples; and performing fitting based on the hematocrit values ​​of the multiple blood samples, the blood glucose values ​​of the multiple blood samples, and the actual hematocrit values ​​of the multiple blood samples to determine the first correction equation.

[0011] Optionally, the second correction equation is determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations, as well as actual hematocrit values ​​of the multiple blood samples; and determining the second correction equation by fitting the hematocrit values ​​of the multiple blood samples, the blood glucose values ​​of the multiple blood samples, and the actual hematocrit values ​​of the multiple blood samples.

[0012] Optionally, the constant blood glucose test equation is: y=Cx+D; wherein y is the blood glucose value of the blood to be tested, C is the first coefficient, D is the second coefficient, and x is the calibration current value.

[0013] Alternatively, the first coefficient is determined by the following equation: C = A1H 2 +B1H+C1; where C is the first coefficient, H is the hematocrit value of the blood to be tested, A1 is the first sub-coefficient, B1 is the second sub-coefficient, and C1 is the third sub-coefficient.

[0014] Alternatively, the second coefficient is determined by the following equation: D = A2H 2 +B2H+C2; where D is the second coefficient, H is the hematocrit value of the blood to be tested, A2 is the fourth sub-coefficient, B2 is the fifth sub-coefficient, and C2 is the sixth sub-coefficient.

[0015] In a second aspect, an embodiment of the present application further provides a blood glucose tester, which includes: a processor, a memory, and a bus, wherein the memory stores machine-readable instructions executable by the processor. When the electronic device is running, the processor communicates with the memory through the bus, and the processor executes the machine-readable instructions to perform the steps of any of the above methods.

[0016] The blood glucose determination method and blood glucose meter based on hematocrit compensation provided in the embodiments of the present application compensate for the hematocrit in the blood through the blood glucose test equation, thereby reducing the influence of the hematocrit on the measurement results, thereby improving the measurement accuracy of the electrochemical test paper.

[0017] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 A schematic diagram of a blood glucose tester provided in an embodiment of the present application;

[0020] Figure 2 This is a flow chart of blood glucose measurement based on hematocrit compensation provided in an embodiment of the present application. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application for which protection is claimed, but merely represents the selected embodiments of the present application. Based on the embodiments of the present application, each other embodiment obtained by those skilled in the art without making creative work falls within the scope of protection of the present application.

[0022] First, the application scenarios to which this application is applicable are introduced. This application can be applied in the field of biosensor technology.

[0023] Research has found that electrochemical biosensors have been widely used in POCT rapid diagnosis. This type of biosensor uses an insulating substrate (PET substrate) as a carrier, and the biosensor electrode is printed on the insulating substrate. Then, an auxiliary enzyme solution is added to the reaction area of ​​the substrate. The electrochemical redox reaction between the enzyme and the target is used to generate an electric current, and the target is detected by the current strength. Such sensors have been widely used in the auxiliary diagnosis and treatment of diabetes, such as blood glucose test strips and blood ketone test strips. They are also used in the diagnosis and treatment of gout and ketosis, such as uric acid test strips.

[0024] In particular, the test sample of blood glucose test strips is whole blood. The hematocrit in the blood of different people is different. The main source of error in blood glucose testing is the hematocrit of the sample. Hematocrit (HCT) refers to the percentage of red blood cells in the whole blood volume. When the blood contacts the reaction area in the electrode, if there are many red blood cells in the blood sample, the effective contact area between the plasma and the electrode reaction area will be reduced, and the generated electrochemical signal (for example, current signal, impedance signal, etc.) will be reduced; if there are few red blood cells in the blood sample, the effective contact area between the plasma and the electrode reaction area will increase, and the generated electrochemical signal will increase.

[0025] Everyone's hematocrit varies. Normal male hematocrit ranges from 42% to 49%, normal female hematocrit ranges from 37% to 43%, and newborn hematocrit ranges from 48% to 68%. However, some special patients, such as those with organ failure, anemia, or blood loss, may have hematocrit levels that differ from normal. Taking blood glucose as an example, the national standard "GB-T 19634-2021 General Technical Requirements for Blood Glucose Monitoring Systems for Self-Testing in In Vitro Diagnostic Test Systems" stipulates an accuracy tolerance of ±0.83 mmol / L for blood glucose concentrations <5.55 mmol / L and ±15% for blood glucose concentrations ≥5.55. Hematocrit varies from 20% to 70% across different populations. Testing within such a wide range can lead to significant deviations in blood glucose results measured by electrochemical test strips, potentially exceeding the reference value by 40% to 50%, severely impacting the accuracy of blood glucose test results and even causing the error of blood glucose meters to significantly exceed the nationally specified tolerances.

[0026] Based on this, the embodiments of the present application provide a blood glucose determination method and a blood glucose tester based on hematocrit compensation, which compensates for the hematocrit in the blood through the blood glucose test equation, reduces the impact of the hematocrit on the measurement results, and thus improves the measurement accuracy of the electrochemical test paper.

[0027] See also Figure 2 , Figure 2 This is a flow chart of a blood glucose determination method based on hematocrit compensation provided in an embodiment of the present application. Figure 2 As shown in , the blood glucose determination method based on hematocrit compensation provided in the embodiment of the present application includes:

[0028] S101. Obtain the impedance value and current value of the blood to be tested detected by the blood glucose tester.

[0029] As an example, see Figure 1 , Figure 1 This is a schematic diagram of a blood glucose tester provided in an embodiment of the present application. Figure 1 As shown in , the blood glucose tester provided in the embodiment of the present application includes: a measurement working electrode 3, a sample measurement counter electrode 4, an impedance measurement working electrode 2, an impedance measurement counter electrode 5, a PET substrate 1, an insulating layer 6, an enzyme layer 7, a siphon guide groove 8 and a logo film strip 9.

[0030] The impedance measurement working electrode 2 and the impedance measurement counter electrode 5 constitute an impedance measurement electrode, and the measurement working electrode 3 and the sample measurement counter electrode 4 constitute a measurement working electrode.

[0031] Specifically, during measurement, electrochemical parameters of the sample detection electrode and the impedance detection electrode can be measured by applying voltage or current.

[0032] Among them, the specific steps of the blood glucose tester to test current and impedance include: applying different AC frequencies and voltages in different directions; generating AC impedance values ​​and current values ​​on the electrochemical test paper; the instrument collects the AC impedance signal generated on the test paper, and then calculates the hematocrit value of the sample.

[0033] S102: Determine a calibration current value and a hematocrit value according to the current value and the impedance value.

[0034] The calibration current value may be determined by the following steps: determining the calibration current value according to the current value and a current calibration equation.

[0035] Specifically, the current calibration equation can be determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations; measuring multiple sample current values ​​and multiple sample detection values ​​of the multiple blood samples; and determining the current calibration equation based on the multiple sample current values ​​and multiple sample detection values ​​of the multiple blood samples.

[0036] For example, blood samples with different hematocrit values ​​of 20%, 30%, 45%, 50%, 60%, and 70% can be configured. For each hematocrit value, blood samples with blood glucose concentrations of 2.8 mmol / L, 6.1 mmol / L, 15.3 mmol / L, and 29.2 mmol / L can be configured.

[0037] As an example, the original current value of the sample can be collected by applying voltages in different ways.

[0038] There are several options for applying voltage, including applying a forward voltage first and then a reverse voltage. The optimal approach is to first apply a fixed reverse voltage, then reapply the forward voltage after a period of time, and then the reverse voltage. The voltage application times can be 2 seconds, 1 second, and 2 seconds, respectively. By applying forward and reverse voltages, currents at different hematocrit levels can be more accurately captured.

[0039] As an example, there are multiple options for current calibration, including linear fitting and polynomial fitting. Preferably, the current calibration selects linear equation fitting, i.e., I 校准 =aI 原始 +b, where I 校准 Indicates the calibrated current, I 原始 represents the collected current value, and a and b are correlation coefficients.

[0040] As an example, this application provides a variety of current data under experimental conditions. Table 1 below shows the average values ​​of original current tests for different hematocrit and blood glucose values, and Table 2 below shows the average values ​​of calibrated current tests for different hematocrit and blood glucose values.

[0041] Table 1:

[0042] Target HCT Actual HCT 2.8mmo / L 6.1mmo / L 15.3mmo / L 29.2mmo / L 20％ 20.40％ 1.50 2.52 5.21 8.41 30％ 31.30％ 1.38 2.32 4.67 7.75 45％ 45.60％ 1.24 1.90 3.53 5.76 50％ 49.20％ 1.23 1.93 3.49 5.78 60％ 60.00％ 1.20 1.88 3.21 4.85 70％ 70.00％ 1.12 1.53 2.51 4.00

[0043] Table 2:

[0044] Target HCT Actual HCT 2.8mmo / L 6.1mmo / L 15.3mmo / L 29.2mmo / L 20％ 20.40％ 2.54 4.93 11.21 18.72 30％ 31.30％ 2.27 4.47 9.96 17.16 45％ 45.60％ 1.94 3.47 7.30 12.51 50％ 49.20％ 1.90 3.54 7.19 12.55 60％ 60.00％ 1.84 3.43 6.55 10.39 70％ 70.00％ 1.66 2.62 4.90 8.39

[0045] As an example, by fitting the data in Table 1 and Table 2, the calibration equation can be determined as: 校准 =2.34I 原始 +0.97.

[0046] Among them, the hematocrit value can be determined based on the impedance value.

[0047] Specifically, the steps of determining the hematocrit value based on the impedance value are well known to those skilled in the art and will not be described in detail here.

[0048] S103 , determining the blood glucose value of the blood to be tested according to the hematocrit value, the calibration current value, and a blood glucose test equation.

[0049] The blood glucose test equation can be determined by the following steps: obtaining multiple blood samples at multiple different blood glucose concentrations under multiple different hematocrit values ​​and the actual hematocrit values ​​of the multiple blood samples; fitting the multiple blood samples at multiple different blood glucose concentrations under multiple different hematocrit values ​​and the actual hematocrit values ​​of the multiple blood samples to determine the blood glucose test equation.

[0050] The blood glucose test equation includes a first coefficient and a second coefficient, the first coefficient is determined according to a first correction equation, and the second coefficient is determined according to a second correction equation.

[0051] As an example, using an experimental approach to determine the blood glucose test equation, using current values ​​collected at different blood glucose concentrations as the horizontal axis and different blood glucose values ​​as the vertical axis, a linear equation for blood glucose at different hematocrit levels can be fitted using a linear equation. Table 3 below shows the linear equations and their fitting coefficients under different conditions.

[0052] Table 3:

[0053] Target HCT Actual HCT Linear equations Linear coefficient constant term Fitting coefficient R2 20％ 20.4％ y=1.6419x-1.8867 1.6419 -1.8867 0.9982 30％ 31.3％ y=1.7941x-1.9204 1.7941 -1.9204 0.9985 45％ 45.6％ y=2.5484x-2.9019 2.5484 -2.9019 0.9991 50％ 49.2％ y=2.5155x-2.54 2.5155 -2.54 0.9993 60％ 60.0％ y=3.11x-3.3257 3.11 -3.3257 0.999 70％ 70.0％ y=3.9962x-4.3148 3.9962 -4.3148 0.9998

[0054] Specifically, the step of fitting multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations and the actual hematocrit values ​​of the multiple blood samples includes: determining multiple fitting equations based on the hematocrit values ​​of the multiple blood samples, the blood glucose values ​​of the multiple blood samples, and the blood glucose values ​​of the multiple blood samples; calculating fitting coefficients of the multiple fitting equations, and if the multiple fitting coefficients of the multiple fitting equations are all greater than a preset fitting correlation number, determining that the fitting of the blood glucose test equation is completed.

[0055] Specifically, the constant blood sugar test equation is:

[0056] y=Cx+D;

[0057] Wherein, y is the blood glucose value of the blood to be measured, C is the first coefficient, D is the second coefficient, and x is the calibration current value.

[0058] Specifically, the first correction equation can be determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations, as well as actual hematocrit values ​​of the multiple blood samples; performing fitting based on the hematocrit values ​​of the multiple blood samples, the blood glucose values ​​of the multiple blood samples, and the actual hematocrit values ​​of the multiple blood samples, to determine the first correction equation.

[0059] Among them, the hematocrit value is used as the horizontal coordinate, and the linear coefficient in the corresponding equation is used as the vertical coordinate. Multiple fitting is performed. You can choose linear fitting of the linear equation or one-variable quadratic equation for fitting.

[0060] As an example, the first coefficient can be determined by the following equation:

[0061] C=A1H 2 +B1H+C1;

[0062] Wherein, C is the first coefficient, H is the hematocrit value of the blood to be tested, A1 is the first sub-coefficient, B1 is the second sub-coefficient, and C1 is the third sub-coefficient.

[0063] Specifically, the second correction equation can be determined by the following steps: obtaining multiple blood samples at multiple different hematocrit values ​​and multiple different blood glucose concentrations, as well as actual hematocrit values ​​of the multiple blood samples; and performing fitting based on the hematocrit values ​​of the multiple blood samples, the blood glucose values ​​of the multiple blood samples, and the actual hematocrit values ​​of the multiple blood samples to determine the second correction equation.

[0064] Specifically, the hematocrit value can be used as the horizontal coordinate and the constant term in the corresponding equation can be used as the vertical coordinate to perform multiple fittings. A linear fitting of a linear equation or a quadratic equation can be selected for fitting.

[0065] Specifically, the second coefficient can be determined by the following equation:

[0066] D=A2H 2 +B2H+C2;

[0067] Wherein, D is the second coefficient, H is the hematocrit value of the blood to be tested, A2 is the fourth sub-coefficient, B2 is the fifth sub-coefficient, and C2 is the sixth sub-coefficient.

[0068] For example, after fitting the data of the above-mentioned multiple blood samples, C=6.8271H2-1.4251H+1.6547 can be obtained, and the fitting coefficient R2 of the first calibration equation for calculating the above coefficients is 0.9921; after fitting the data of the above-mentioned multiple blood samples, D=-9.4241H2+3.3243H-2.5523 can be obtained, and the fitting coefficient R2 of the first calibration equation for calculating the above coefficients is 0.8908.

[0069] From the above example, it can be seen that when C = 6.8271H2-1.4251H+1.6547 and D = -9.4241H2+3.3243H-2.5523, the blood glucose test equation is y = (6.8271H2-1.4251H+1.6547)x+-9.4241H2+3.3243H-2.5523.

[0070] Based on the above blood glucose test equation, the blood glucose test results in Table 4 below can be calculated.

[0071] Table 4:

[0072] Hematocrit 2.8mmol / L 6.1mmol / L 15.3mmol / L 29.2mmol / L 20.4％ 2.38 6.18 15.86 28.66 31.3％ 2.51 6.26 16.43 29.76 45.6％ 2.46 6.05 14.89 27.33 49.2％ 2.34 6.36 15.74 29.50 60.0％ 2.47 6.59 16.16 29.94 70.0％ 2.73 6.09 15.12 28.87

[0073] Optionally, the deviation of the blood glucose measurement results for different hematocrit values ​​can be tested, and the current value in Table 1 can be substituted to obtain the deviation between the test value and the reference value. The national standard "GB-T19634-2021 General Technical Conditions for Blood Glucose Monitoring Systems for Self-Testing in In Vitro Diagnostic Test Systems" requires that when the blood glucose concentration is less than 5.55mmol / L, the deviation between the measurement result and the reference value shall not exceed ±0.83mmol / L, and when the concentration is ≥5.55mmol / L, the deviation between the measurement result and the reference value shall not exceed ±15%. According to the measurement results in Table 5, it can be seen that the accuracy meets the national standard requirements, indicating that the hematocrit compensation method of the test paper can effectively reduce the influence of hematocrit on the measurement results.

[0074] Table 5:

[0075]

[0076]

[0077] Specifically, in order to better evaluate the hematocrit correction effect of the electrochemical test paper of the present invention, extreme hematocrits were selected for testing, and samples with a hematocrit of 20% and 70% were selected, and the blood glucose concentrations were configured to be 3mmol / L, 10mmol / L, 15mmol / L, 20mmol / L and 25mmol / L, respectively. Each sample was tested 10 times and the average value was taken to calculate the deviation from the reference value. As shown in Table 6 below, when red blood cell compensation was not performed, the average value of the test results and the reference value exceeded the accuracy acceptance range in the national standard "GB-T19634-2021 General Technical Conditions for Blood Glucose Monitoring Systems for Self-Testing in In Vitro Diagnostic Test Systems".

[0078] As an example, as shown in Table 7 below, when the hematocrit of the blood sample is compensated, the average value of the test results and the reference value both meet the accuracy acceptance range in the national standard "GB / T 19634-2021 General Technical Conditions for Self-Testing Blood Glucose Monitoring Systems for In Vitro Diagnostic Test Systems".

[0079] Table 6:

[0080] Target blood sugar level 3mmol / L 10mmol / L 15mmol / L 20mmol / L 25mmol / L Reference value 2.85 9.79 15.12 19.5 25.4 20% HCT 3.8 12.8 19.3 26.52 32.1 70% HCT 1.8 7.1 9.8 12.6 19.8 20% deviation 0.95％ 30.7％ 27.6％ 36.0％ 26.4％ 70% deviation -1.05％ -27.5％ -35.2％ -35.4％ -22.0％

[0081] As an example, as shown in Table 7 below, Table 7 is a comparison table of deviations between test results and reference values ​​when hematocrit compensation is performed.

[0082] Table 7:

[0083] Target blood sugar level 3mmol / L 10mmol / L 15mmol / L 20mmol / L 25mmol / L Reference value 2.85 9.79 15.12 19.5 25.4 20% HCT 3.1 9.2 15.8 18.4 26.4 70% HCT 2.5 10.3 15.2 19.2 26.9 20% deviation 0.25 -6.0％ 4.5％ -5.6％ 3.9％ 70% deviation -0.35 5.2％ 0.5％ -1.5％ 5.9％

[0084] The blood glucose determination method and blood glucose meter based on hematocrit compensation provided in the embodiments of the present application compensate for the hematocrit in the blood through the blood glucose test equation, thereby reducing the influence of the hematocrit on the measurement results, thereby improving the measurement accuracy of the electrochemical test paper.

[0085] In the several embodiments provided in this application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. The device embodiments described above are merely schematic. For example, the division of the units is merely a logical function division. There may be other division methods in actual implementation. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed may be through some communication interface, indirect coupling or communication connection of devices or units, which may be electrical, mechanical or other forms.

[0086] The units described as separate components may or may not be physically separate, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed across multiple network units. Some or all of these units may be selected to achieve the purpose of this embodiment according to actual needs.

[0087] In addition, each functional unit in each embodiment of the present application may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0088] If the functions are implemented in the form of software functional units and sold or used as independent products, they can be stored in a non-volatile computer-readable storage medium that is executable by a processor. Based on this understanding, the technical solution of the present application, or the part that contributes to the prior art, or the part of the technical solution, can be embodied in the form of a software product. The computer software product is stored in a storage medium and includes several instructions for enabling a computer device (which can be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the method described in each embodiment of the present application. The aforementioned storage medium includes various media that can store program codes, such as a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk or an optical disk.

[0089] Finally, it should be noted that the above-described embodiments are only specific implementation methods of the present application, which are used to illustrate the technical solutions of the present application, rather than to limit them. The scope of protection of the present application is not limited thereto. Although the present application has been described in detail with reference to the above-mentioned embodiments, those skilled in the art should understand that any person skilled in the art can modify or easily conceive of changes to the technical solutions described in the above-mentioned embodiments within the technical scope disclosed in the present application, or perform equivalent replacements for some of the technical features thereof. These modifications, changes, or replacements do not deviate from the spirit and scope of the technical solutions of the embodiments of the present application, and should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. A blood glucose determination method based on hematocrit compensation, characterized in that: Used in blood glucose testers, The method comprises: Obtaining the impedance value and current value of the blood to be tested detected by the blood glucose tester; determining a calibration current value and a hematocrit value according to the current value and the impedance value; determining the blood glucose value of the blood to be tested according to the hematocrit value, the calibration current value and a blood glucose test equation; Determine the blood glucose test equation using the following steps: obtaining a plurality of blood samples at a plurality of different blood glucose concentrations at a plurality of different hematocrit values ​​and actual hematocrit values ​​of the plurality of blood samples; Fitting a plurality of blood samples at a plurality of different hematocrit values ​​and a plurality of different blood glucose concentrations and the actual hematocrit values ​​of the plurality of blood samples to determine the blood glucose test equation, Wherein, the blood glucose test equation includes a first coefficient and a second coefficient, the first coefficient is determined according to a first correction equation, and the second coefficient is determined according to a second correction equation; The first correction equation is determined by the following steps: obtaining a plurality of blood samples at a plurality of different blood glucose concentrations at a plurality of different hematocrit values ​​and actual hematocrit values ​​of the plurality of blood samples; Determining a first correction equation by fitting the hematocrit values ​​of the plurality of blood samples, the blood glucose values ​​of the plurality of blood samples, and the actual hematocrit values ​​of the plurality of blood samples; The second correction equation is determined by the following steps: obtaining a plurality of blood samples at a plurality of different blood glucose concentrations at a plurality of different hematocrit values ​​and actual hematocrit values ​​of the plurality of blood samples; performing fitting based on the hematocrit values ​​of the plurality of blood samples, the blood glucose values ​​of the plurality of blood samples, and the actual hematocrit values ​​of the plurality of blood samples to determine a second correction equation; The blood sugar test equation is: ； Wherein, y is the blood glucose value of the blood to be measured, C is the first coefficient, D is the second coefficient, and x is the calibration current value.

2. The method according to claim 1, characterized in that Determine the calibration current value by following these steps: A calibration current value is determined according to the current value and a preset current calibration equation.

3. The method according to claim 2, characterized in that The current calibration equation is determined by the following steps: obtaining a plurality of blood samples at a plurality of different hematocrit values ​​and a plurality of different blood glucose concentrations; measuring a plurality of sample current values ​​and a plurality of sample detection values ​​of the plurality of blood samples; A current calibration equation is determined based on a plurality of sample current values ​​and a plurality of sample detection values ​​of a plurality of blood samples.

4. The method according to claim 1, wherein The first coefficient is determined by the following equation: ； Among them, C is the first coefficient, H is the hematocrit value of the blood to be tested, is the first sub-coefficient, is the second sub-coefficient, is the third sub-coefficient.

5. The method according to claim 1, characterized in that The second coefficient is determined by the following equation: ； Where D is the second coefficient, H is the hematocrit value of the blood to be tested, is the fourth sub-coefficient, is the fifth sub-coefficient, is the sixth sub-coefficient.

6. A blood glucose tester, characterized in that: The blood glucose tester includes: a processor, a memory and a bus, the memory stores machine-readable instructions executable by the processor, and when the electronic device is running, the processor and the memory communicate through the bus, and the processor executes the machine-readable instructions to perform the steps of any one of the methods described in claims 1 to 5.

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