Blood glucose measuring method and blood glucose tester based on hematocrit compensation

Abstract

The invention provides a blood glucose measuring method based on hematocrit compensation and a blood glucose test.The method comprises the steps that the impedance value and the current value, detected by the blood glucose tester, of to-be-measured blood are obtained; determining a calibration current value and a hematocrit value according to the current value and the impedance value; according to the hematocrit value, the calibration current value and a blood glucose test equation, the blood glucose value of the blood to be tested is determined. The hematocrit in blood can be compensated through a blood glucose test equation, and the influence of the hematocrit on a measurement result is reduced, so that the measurement accuracy of the electrochemical test paper is improved.

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 strength of the current. Such sensors have been widely used in auxiliary diagnosis and treatment of diabetes, such as blood glucose test strips, blood ketone test strips, etc., 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 of the blood glucose test strip 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 more red blood cells in the blood sample, the effective contact area between the plasma and the electrode reaction area will decrease, and the generated electrochemical signal will decrease; if there are fewer 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.

[0004] Everyone's hematocrit is different. The normal hematocrit range for normal men is 42%-49%, the normal hematocrit range for normal women is 37%-43%, and the hematocrit range for newborns is 48%-68%. However, for some special patients, such as those with organ failure, anemia, and blood loss, the hematocrit 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 when the blood sugar concentration is less than 5.55mmol / L, the allowable deviation is ±0.83mmol / L, and when the blood sugar concentration is ≥5.55mmol / L, the allowable deviation is within ±15%. The hematocrit range of different populations is 20%-70%. Testing in such a wide range will cause large deviations in the blood sugar results measured by electrochemical test strips, with deviations as high as 40%-50%, which is much higher than the requirement in the national standard GB19634 / 2021 that the deviation should be within ±15%. Summary of the invention

[0005] In view of this, the purpose of the present 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 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, 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 blood glucose concentrations at multiple different hematocrit values; 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 blood glucose concentrations at multiple different hematocrit values ​​and actual hematocrit values ​​of the multiple blood samples; and determining the first 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.

[0011] Optionally, the second correction equation is determined by the following steps: obtaining multiple blood samples at multiple different blood glucose concentrations at multiple different hematocrit values ​​and 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 sugar test equation is: y=Cx+D; wherein y is the blood sugar 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] Optionally, the first coefficient is determined by the following equation: C = A 1 H 2 +B 1 H+C 1 ; Where C is the first coefficient, H is the hematocrit value of the blood to be tested, A 1 is the first sub-coefficient, B 1 is the second sub-coefficient, C 1 is the third sub-coefficient.

[0014] Optionally, the second coefficient is determined by the following equation: D = A 2 H 2 +B 2 H+C 2 ; Where D is the second coefficient, H is the hematocrit value of the blood to be tested, A 2 is the fourth sub-coefficient, B 2 is the fifth sub-coefficient, C 2 is the sixth sub-coefficient.

[0015] In the second aspect, an embodiment of the present application also 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, and 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 tester 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, reduce the influence of the hematocrit on the measurement results, and thus improve 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 specifically cited below and described in detail with reference to the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. 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 related drawings can be obtained based on these drawings without paying creative work.

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

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

[0021] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme 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 usually 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 claimed for protection, 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 belongs to the scope of protection of the present application.

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

[0023] Research has found that 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 strength of the current. Such sensors have been widely used in auxiliary diagnosis and treatment of diabetes, such as blood glucose test strips, blood ketone test strips, etc. It is also used in the diagnosis and treatment of gout and ketosis, such as uric acid test strips.

[0024] In particular, the test sample of the blood glucose test strip 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 more red blood cells in the blood sample, the effective contact area between the plasma and the electrode reaction area will decrease, and the generated electrochemical signal (for example, current signal, impedance signal, etc.) will decrease; if there are fewer 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 is different. The normal hematocrit of men ranges from 42% to 49%, the normal hematocrit of women ranges from 37% to 43%, and the hematocrit of newborns ranges from 48% to 68%. However, for some special patients, such as those with organ failure, anemia, and blood loss, the hematocrit is different from that of normal people. Taking blood sugar as an example, the national standard "19634GB-T 19634-2021 General Technical Conditions for Self-testing Blood Glucose Monitoring Systems for In Vitro Diagnostic Test Systems" requires that the accuracy of blood sugar concentrations <5.55mmol / L is allowed to be within ±0.83mmol / L, and blood sugar concentrations ≥5.55 are allowed to be within ±15%. The hematocrit range of different populations is 20%-70%, and testing in such a wide range will cause a large deviation in the blood sugar results measured by electrochemical test strips, which can exceed the reference value by 40%-50%, seriously affecting the accuracy of blood sugar test results, and even causing the error of the blood sugar tester to seriously exceed the allowable deviation range specified by the state.

[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 influence 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 measurement 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 comprises:

[0028] S101, obtaining 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 Schematic diagram of a blood glucose tester provided in an embodiment of the present application. Figure 1 As shown in the figure, 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 the measurement, electrochemical parameters such as the sample detection electrode and the impedance detection electrode can be measured by applying a 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 blood glucose concentrations at multiple different hematocrit values; 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] As an example, blood samples with different hematocrit values ​​can be configured, which can be 20%, 30%, 45%, 50%, 60% and 70%. Under each hematocrit value, blood samples with blood glucose concentrations of 2.8mmol / L, 6.1mmol / L, 15.3mmol / L and 29.2mmol / L can be configured respectively.

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

[0038] There are many options for applying voltage, which can be applying a forward voltage first and then applying a reverse voltage. The best option is to first apply a fixed voltage in the reverse direction, then apply a forward voltage after a period of time, and then apply a reverse voltage. The voltage application time can be 2s, 1s, and 2s, respectively. By applying forward and reverse voltages, the current under different hematocrits can be collected more accurately.

[0039] As an example, there are multiple options for current calibration, and a linear fit or a multi-equation fit can be selected. Preferably, the current calibration selects a linear equation fit, i.e., I 校准 =aI 原始 +b, where I 校准 Represents the calibrated current, I 原始 It represents the collected current value, and a and b are the correlation coefficients.

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

[0049] Among them, 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 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.

[0050] The blood sugar 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, taking the blood sugar test equation determined by experiment as an example, the current value collected at different blood sugar concentrations is used as the horizontal coordinate, and the different blood sugar values ​​are used as the vertical coordinate. According to the one-variable linear equation, the blood sugar linear equation under different hematocrits can be obtained by fitting. The following Table 3 gives the one-variable 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 a plurality of blood samples at a plurality of different blood glucose concentrations at a plurality of different hematocrit values ​​and the actual hematocrit values ​​of the plurality of blood samples comprises: determining a plurality of fitting equations according to the hematocrit values ​​of the plurality of blood samples, the blood glucose values ​​of the plurality of blood samples and the blood glucose values ​​of the plurality of blood samples; calculating the fitting coefficients of the plurality of fitting equations, and if the plurality of fitting coefficients of the plurality of fitting equations are all greater than a preset fitting correlation number, it is determined 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 tested, 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 blood glucose concentrations at multiple different hematocrit values ​​and actual hematocrit values ​​of the multiple blood samples; fitting according to 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 coefficient of the first-order term in the corresponding equation is used as the vertical coordinate. Multiple fittings can be performed. Either a linear equation linear fitting or a quadratic equation can be selected for fitting.

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

[0061] C=A 1 H 2 +B 1 H+C 1 ;

[0062] Among them, C is the first coefficient, H is the hematocrit value of the blood to be tested, and A 1 is the first sub-coefficient, B 1 is the second sub-coefficient, C 1 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 blood glucose concentrations at multiple different hematocrit values ​​and actual hematocrit values ​​of the multiple blood samples; and performing fitting according to 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, multiple fittings can be performed with the hematocrit value as the horizontal coordinate and the constant term in the corresponding equation as the vertical coordinate. 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=A 2 H 2 +B 2 H+C 2 ;

[0067] Where D is the second coefficient, H is the hematocrit value of the blood to be tested, and A 2 is the fourth sub-coefficient, B 2 is the fifth sub-coefficient, C 2 is the sixth sub-coefficient.

[0068] Illustratively, after data fitting of the above-mentioned multiple blood samples, C=6.8271H2-1.4251H+1.6547 can be obtained, and the fitting coefficient of the first calibration equation calculated by calculating the above coefficients is R2=0.9921; after data fitting of the above-mentioned multiple blood samples, D=-9.4241H2+3.3243H-2.5523 can be obtained, and the fitting coefficient of the first calibration equation calculated by calculating the above coefficients is R2=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 sugar test equation, the blood sugar 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 impact 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 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, and the deviation from the reference value was calculated. As shown in Table 6 below, when red blood cell compensation is not performed, the average value of the test results and the reference value both exceed 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 result and the reference value are both within the accuracy acceptance range of 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 tester 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, reduce the influence of the hematocrit on the measurement results, and thus improve the measurement accuracy of the electrochemical test paper.

[0085] In the several embodiments provided in the present 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 only a logical function division. There may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some communication interfaces, and the indirect coupling or communication connection of devices or units can be electrical, mechanical or other forms.

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

[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 can essentially be embodied in the form of a software product, or in other words, the part that contributes to the prior art or the part of the technical solution. The computer software product is stored in a storage medium, including several instructions for a computer device (which can be a personal computer, a server, or a network device, etc.) to perform 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 protection scope of the present application is not limited thereto. Although the present application is described in detail with reference to the above-mentioned embodiments, ordinary technicians in the field should understand that any technician familiar with the technical field can still modify the technical solutions recorded in the above-mentioned embodiments within the technical scope disclosed in the present application, or can easily think of changes, or make equivalent replacements for some of the technical features therein; and these modifications, changes or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application, and should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. A blood glucose determination method based on hematocrit compensation, characterized in that: Used in blood glucose testers, Wherein, 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; The blood glucose value of the blood to be tested is determined according to the hematocrit value, the calibration current value and the blood glucose test equation.

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 blood glucose concentrations at a plurality of different hematocrit values; measuring a plurality of sample current values ​​and a plurality of sample detection 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, characterized in that Determine the blood glucose test equation by following these 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 ​​for the plurality of blood samples; Fitting a plurality of blood samples at a plurality of different blood glucose concentrations at a plurality of different hematocrit values ​​and the actual hematocrit values ​​of the plurality of blood samples to determine the blood glucose test equation, The blood sugar 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.

5. The method according to claim 4, characterized in that 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 ​​for the plurality of blood samples; A first correction equation is determined 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.

6. The method according to claim 5, characterized in that 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 ​​for the plurality of blood samples; A second correction equation is determined by 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.

7. The method according to claim 4, characterized in that The constant blood sugar 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.

8. The method according to claim 5, characterized in that The first coefficient is determined by the following equation: C=A1H 2 +B1H+C1; Among them, 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.

9. The method according to claim 6, characterized in that The second coefficient is determined by the following equation: D=A2H 2 +B2H+C2; 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.

10. A blood glucose tester, characterized in that: The blood glucose tester comprises: a processor, a memory and a bus, wherein the memory stores machine-readable instructions executable by the processor, and when the electronic device is running, the processor communicates with the memory via the bus, and the processor executes the machine-readable instructions to perform the steps of any method as described in claims 1 to 9.

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