Calibration method and system of continuous blood glucose sensor, storage medium and equipment

Abstract

The invention provides a calibration method and system for a continuous blood glucose sensor, and relates to the technical field of sensor calibration, the method comprises the following steps: carrying out multi-factor attenuation parameter calibration on the same batch of sensors before leaving factory, and obtaining factory calibration parameters of the sensors, and acquiring temperature and humidity historical data corresponding to a transportation and storage environment from delivery to use by a user, performing compensation calculation on a current signal measured by the sensor in real time after the sensor is implanted into the body based on the delivery calibration parameter and the temperature and humidity historical data, and outputting a calibrated blood glucose value. According to the method, through multi-factor coupling compensation and full-life-cycle simulation calibration before delivery, the problem that in the prior art, the calibration factor of a continuous blood glucose sensor is single is solved, the blood glucose monitoring accuracy of the continuous blood glucose sensor is effectively improved, a user does not need to conduct secondary calibration before use or during use, and the user experience is improved. And finally realizing calibration-free in an implantation use stage.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of sensor calibration, in particular to a calibration method and system for continuous glucose sensors, a storage medium and equipment. BACKGROUND

[0002] With the continuous progress of technology, dynamic glucose monitoring technology has become an important means in the field of diabetes monitoring. Dynamic glucose monitoring systems continuously detect glucose concentration in tissue fluid, providing detailed blood glucose change data for diabetes patients, which helps better manage blood glucose levels. However, in practical application, dynamic glucose monitoring technology still has some problems to be solved in the accuracy and stability of blood glucose monitoring.

[0003] The accuracy and stability of dynamic glucose monitoring systems are influenced by a variety of factors. Among them, the performance degradation of the sensor is a key problem. The sensor will be affected by various factors such as temperature and humidity changes, storage time, use time, etc. during production, sterilization, storage and long-term use, resulting in gradual decline in performance.

[0004] At present, most dynamic glucose meters will be calibrated before leaving the factory, but the existing calibration technology considers relatively limited degradation factors, usually covering only a few aspects such as temperature and use time, and does not adequately consider the comprehensive impact of other important degradation factors such as production sterilization and long-term storage. This limited factor calibration method cannot fully reflect the performance changes of the sensor in the actual use environment, thereby limiting the accuracy and stability of dynamic glucose monitoring. SUMMARY

[0005] In view of the deficiencies of the prior art, the purpose of the present application is to provide a calibration method and system for continuous glucose sensors, a storage medium and equipment, aiming to solve the above-mentioned problems recorded in the prior art.

[0006] The first aspect of the present application provides a calibration method for continuous glucose sensors, the method comprising: calibrating the multi-factor degradation parameters of the same batch of sensors before leaving the factory to obtain the factory calibration parameters of the sensors; obtaining the temperature and humidity history data of the transportation and storage environment of the sensor from the factory to the user before use; Based on the factory calibration parameters and the temperature and humidity history data, the current signal measured by the sensor after implantation in the body is compensated and calculated, and the calibrated blood glucose value is output.

[0007] According to an aspect of the above technical solution, the multi-factor attenuation parameter calibration of the same batch of sensors before leaving the factory includes any one or any combination of current-sugar concentration model establishment, use period attenuation calibration, sterilization attenuation calibration, storage attenuation calibration, and temperature response calibration in the use process.

[0008] According to an aspect of the above technical solution, the current-sugar concentration model establishment includes: Full inspection testing is performed on all sensors of the same batch, and current data of a plurality of the sensors in different concentrations of glucose solution is collected; According to the current data and the sugar concentration, an initial current-sugar concentration model is established, and an optimization algorithm is used for parameter fitting to obtain a current-sugar concentration model.

[0009] According to an aspect of the above technical solution, the collection of the current data of a plurality of the sensors in different concentrations of glucose solution includes: The current signal of each sensor is collected in sequence according to a preset time to obtain current data; According to the current data, the average value and the standard deviation of the current signal are calculated; According to the average value and the standard deviation, the current data is subjected to data screening to obtain target current data, and the average value of the target current data is calculated as the current output value of the sensor.

[0010] According to an aspect of the above technical solution, the use period attenuation calibration includes: Sampling is performed on the sensors among all sensors of the same batch, simulation testing of a complete use period is performed on the sensors determined by sampling, and a total sugar catalytic amount-performance attenuation relationship is established accordingly.

[0011] According to an aspect of the above technical solution, the sampling of the sensors among all sensors of the same batch, the simulation testing of a complete use period on the sensors determined by sampling, and the establishment of a total sugar catalytic amount-performance attenuation relationship accordingly include: Random sampling is performed on all sensors of the same batch according to a preset proportion, and the sensors are grouped and immersed in a glucose solution with a fixed concentration, keeping the concentration constant; Current response data of the sensors are obtained, the current response data are subjected to normalization processing, and the total sugar catalytic amount is calculated; The total sugar catalytic amount-performance attenuation data of all tested sensors are averaged to obtain a performance attenuation average curve and perform fitting.

[0012] According to an aspect of the above technical solution, the expression for obtaining the current response data of the sensors, subjecting the current response data to normalization processing, and calculating the total sugar catalytic amount is: ; In the formula, is a total sugar catalytic amount, is a concentration of a glucose solution corresponding to a test environment of a sensor, p is a permeation ratio of an outer membrane of a continuous blood glucose sensor.

[0013] According to an aspect of the above technical solution, the sterilization attenuation calibration comprises: respectively performing key concentration tests on the sensor before and after sterilization, and calculating an attenuation ratio caused by sterilization.

[0014] According to an aspect of the above technical solution, the respectively performing key concentration tests on the sensor before and after sterilization, and calculating an attenuation ratio caused by sterilization comprises: immersing the sensor before sterilization in a glucose solution of a fixed concentration to perform a key concentration test, and obtaining an attenuation amount of the sensor before sterilization; immersing the sensor after sterilization in a glucose solution of a fixed concentration to perform a key concentration test, and obtaining an attenuation amount of the sensor after sterilization; based on the attenuation amounts of the sensor before and after sterilization, calculating an attenuation ratio caused by sterilization of the sensor.

[0015] According to an aspect of the above technical solution, the storage attenuation calibration comprises: grouping a plurality of the sensors after sterilization, storing the plurality of groups of sensors under different temperature and humidity conditions, regularly testing the plurality of groups of sensors, and correspondingly establishing a temperature and humidity-time-attenuation model.

[0016] According to an aspect of the above technical solution, the grouping a plurality of the sensors after sterilization, storing the plurality of groups of sensors under different temperature and humidity conditions, regularly testing the plurality of groups of sensors, and correspondingly establishing a temperature and humidity-time-attenuation model comprises: sampling and grouping a plurality of the sensors after sterilization, storing the plurality of groups of sensors under different temperature and humidity combination conditions, regularly taking out the stored sensors to perform key concentration tests, and obtaining an optimal current response; based on the optimal current response, calculating a storage attenuation ratio of the sensor; based on the optimal current response and the storage attenuation ratio, establishing a temperature and humidity-time-attenuation model, and performing parameter fitting using an optimization algorithm.

[0017] According to an aspect of the above technical solution, the temperature response calibration during use comprises: The sensor sampling is performed in the same batch of sensors, the sampled sensors are tested at different temperatures, and a temperature response change rate model is established.

[0018] According to an aspect of the above technical solution, the sensor sampling is performed in the same batch of sensors, the sampled sensors are tested at different temperatures, and a temperature response change rate model is established, including: The sensors in the same batch are randomly sampled according to a preset proportion, and the sampled sensors are respectively immersed in glucose solutions at different temperatures to obtain corresponding current responses; According to the current responses corresponding to different temperature environments, a temperature response change rate model is established.

[0019] According to an aspect of the above technical solution, based on the factory calibration parameters and the temperature and humidity historical data, the current signal measured by the sensor after being implanted in the body is compensated and calculated, and the calibrated blood glucose value is output, including: Based on the factory calibration parameters and the temperature and humidity historical data, the total attenuation of the sensor after being factory-calibrated is calculated; According to the total attenuation, the current signal measured by the sensor after being implanted in the body is compensated and calculated, and the calibrated blood glucose value is output.

[0020] According to an aspect of the above technical solution, based on the factory calibration parameters and the temperature and humidity historical data, the total attenuation of the sensor after being factory-calibrated is calculated, including: The temperature and humidity historical data and time data corresponding to the transportation and storage environment are imported into a temperature and humidity-time-attenuation model, and the storage attenuation of the sensor is calculated; According to the storage attenuation and the sterilization attenuation, the total attenuation of the sensor after being factory-calibrated is calculated.

[0021] According to an aspect of the above technical solution, according to the total attenuation, the current signal measured by the sensor after being implanted in the body is compensated and calculated, and the calibrated blood glucose value is output, including: According to the total attenuation, the current signal measured by the sensor after being implanted in the body is compensated and calculated, and the calibrated blood glucose value is output, including: The current signal after filtering and denoising is temperature-compensated; According to the current signal after temperature compensation, the initial blood glucose value corresponding to the sensor is calculated; Based on the cumulative working load of the sensor, the initial blood glucose value is attenuated and corrected, and the final blood glucose value is output.

[0022] The second aspect of the present application provides a calibration system for a continuous blood glucose sensor, which is applied to the method in the above technical solution, and the system comprises: A parameter calibration module is configured to calibrate multi-factor attenuation parameters of sensors in the same batch before leaving the factory, and obtain factory calibration parameters of the sensors. A data acquisition module is configured to acquire historical temperature and humidity data of the sensors corresponding to the storage environment during transportation from leaving the factory to being used by a user. A calibration execution module is configured to compensate and calculate the current signal measured by the sensor in real time after being implanted in the body based on the factory calibration parameters and the historical temperature and humidity data, and output the calibrated blood glucose value.

[0023] A third aspect of the present application provides a readable storage medium having computer instructions stored thereon, the instructions being executed by a processor to implement the steps of the method in the above technical solutions.

[0024] A fourth aspect of the present application provides an electronic device including a storage, a processor, and a computer program stored on the storage and executable on the processor, the processor executing the program to implement the steps of the method in the above technical solutions.

[0025] Compared with the prior art, the calibration method, system, storage medium and device of the continuous blood glucose sensor have the following beneficial effects: The method calibrates multi-factor attenuation parameters of sensors in the same batch before leaving the factory, obtains factory calibration parameters of the sensors, acquires historical temperature and humidity data of the sensors corresponding to the storage environment during transportation from leaving the factory to being used by a user, compensates and calculates the current signal measured by the sensor in real time after being implanted in the body based on the factory calibration parameters and the historical temperature and humidity data, and outputs the calibrated blood glucose value. The method compensates and calibrates multi-factors and simulates and calibrates the whole life cycle before leaving the factory, solves the problem of single calibration factor of the continuous blood glucose sensor in the prior art, effectively improves the blood glucose monitoring accuracy of the continuous blood glucose sensor, does not require secondary calibration by the user before or during use, and finally realizes calibration-free during the implantation and use stages. BRIEF DESCRIPTION OF DRAWINGS

[0026] The above and / or additional aspects and advantages of the present application will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings, in which: Figure 1 A flowchart of the calibration method of the continuous blood glucose sensor according to the embodiments of the present application is shown. Figure 2 A structure block diagram of the calibration system of the continuous blood glucose sensor according to the embodiments of the present application is shown. DETAILED DESCRIPTION

[0027] In order to make the objects, features and advantages of the present application more clear, the detailed description of the specific embodiments of the present application is given below with reference to the accompanying drawings. The drawings show several embodiments of the present application. However, the present application can be realized in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided for more clearly and fully conveying the disclosure of the present application.

[0028] It should be noted that when an element is referred to as being "fixed" to another element, it can be directly on the other element or there can be intervening elements. When an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements can be present. The terms "vertical", "horizontal", "left", "right", and the like as used herein are for purposes of illustration only.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0030] Embodiment one Please refer to Figure 1 The first embodiment of the present application provides a calibration method for continuous blood glucose sensor, which comprises steps S10-S30: Step S10, multi-factor attenuation parameter calibration before factory leaving is performed on sensors of the same batch to obtain factory leaving calibration parameters of the sensors.

[0031] It should be noted that the sensor is a continuous blood glucose sensor for blood glucose monitoring of diabetes patients. When the method shown in the embodiment calibrates the sensor, the sensors of the same batch are used. This is because the sensors of the same batch have the same production conditions and high consistency in basic performance indicators such as initial sensitivity and noise level. During the test process, the interference caused by individual differences of the sensors can be effectively reduced, so that the test results are more comparable, and the effectiveness and accuracy of the calibration method can be conveniently and accurately evaluated.

[0032] In the embodiment, the above-mentioned test is performed on all sensors of the batch with a sampling rate of 100%, and the test is a normal test in the production process of the sensor. The test after this step will not affect the use performance of the sensor.

[0033] The multi-factor attenuation parameter calibration of the sensors in the same batch before factory shipment includes any one or any combination of the following: current-sugar concentration model establishment, usage period attenuation calibration, sterilization attenuation calibration, storage attenuation calibration, and temperature response calibration during use.

[0034] In a preferred embodiment, the multi-factor attenuation parameter calibration of the sensors in the factory shipment stage includes the above five parameter calibrations, and in other feasible embodiments, only one or several of them can be used for the factory shipment stage calibration.

[0035] In the step of multi-factor attenuation parameter calibration of the sensors in the same batch in the factory shipment stage, the step of current-sugar concentration model establishment includes: performing full inspection tests on all sensors in the same batch to collect current data of the sensors in different concentrations of glucose solution; establishing a current-sugar concentration initial model according to the current data and the sugar concentration, and performing parameter fitting using an optimization algorithm to obtain a current-sugar concentration model.

[0036] In the step of collecting current data of the sensors in different concentrations of glucose solution, it includes: collecting current signals of each sensor in a preset time to obtain current data; calculating the average value and the standard deviation of the current signals according to the current data; performing data screening on the current data according to the average value and the standard deviation to obtain target current data, and calculating the average value of the target current data as the current output value of the sensor.

[0037] More specifically, in the factory calibration stage of the sensor, when each sensor is tested, for example, the sensor collects current data every 10s for 3min, a total of 18 current data are obtained, and then a current screening algorithm is used to process the 18 current data, and output a current output value of 3min. An average current value is calculated and output through the above preprocessing to reflect the current value of the sensor corresponding to three minutes. By selecting the data between one standard deviation above and below the average value, the interference of occasional abnormal data can be effectively avoided, and the outliers of the data are removed.

[0038] In the step of processing the 18 current data using the current screening algorithm, it specifically includes: calculating the average value of the 18 current data, expressed as: ; In the formula, is the average value of the 18 current data, The first of 18 current data points within three minutes i Current data; The standard deviation of the current data is calculated using the following expression: ; In the formula, The standard deviation of 18 current data points within three minutes ， The first of 18 current data points within three minutes i Current data, The average value of 18 current data points; And, filtering [( , The current data within the specified range is used to calculate the average value as the three-minute current output value. The expression is: ; In the formula, The current output value is selected within a three-minute range. For the selected range of the first m Current data, M To select the number of current data points within the range, m and M The range is all within 【1，18】 Inside.

[0039] In this embodiment, after the current data is collected and processed, current-concentration data pairs will be generated.

[0040] Specifically, the multiple sensors to be tested were grouped, with each group containing an equal number of sensors. Each sensor in each group was then sequentially immersed in glucose solutions of different concentrations, such as 2 mmol / L, 5 mmol / L, 10 mmol / L, 15 mmol / L, and 20 mmol / L. Each concentration was tested for one hour. All sensors at each concentration were then analyzed. Take the average value to obtain the current value corresponding to that concentration.

[0041] It should be noted that the glucose test concentration in the method shown in this embodiment is selected and set between 2 mmol / L and 20 mmol / L, covering three important physiological states of hypoglycemia, normal blood glucose and hyperglycemia, and meeting the conventional requirements of blood glucose meter performance testing, and has a certain scientific nature. The specific test concentration can be selected as 2 mmol / L, 5 mmol / L, 10 mmol / L, 15 mmol / L, 20 mmol / L, etc. These concentration points are evenly distributed in the entire test range, which can better evaluate the linearity, accuracy and precision of the sensor in the entire range, and can be adjusted appropriately in other feasible embodiments.

[0042] Among them, 2 mmol / L can be used to test the detection ability of the sensor in the low blood glucose range, 5 mmol / L is close to the normal fasting blood glucose value, 10 mmol / L is at the medium concentration level, and 15 mmol / L and 20 mmol / L can be used to evaluate the performance of the high blood glucose segment.

[0043] In this embodiment, the current-concentration data pair is specifically represented as: ; In the formula, is the current-concentration data pair generated by the sensor numbered n , is the first concentration tested by the sensor numbered n , m is the first concentration tested by the sensor numbered , n is the average value of the current output value corresponding to the first concentration tested by the sensor numbered m .

[0044] In this embodiment, after generating the current-concentration data pair, a current-sugar concentration model is also established, and the expression of the current-sugar concentration model is: ; In the formula, is the output current value after three-minute aggregation after outlier rejection and mean value processing, representing the output of the sensor in a stable state, S is the glucose concentration, are both model parameters to be fitted of the current-sugar concentration initial model.

[0045] In addition, in this embodiment, the current-concentration data collected on the same day is also used to fit the model parameters of the current-sugar concentration model by using an optimization algorithm, for example, the gradient descent method is used to fit the model parameters of the current-sugar concentration model to obtain the optimal model parameter value corresponding to the current-sugar concentration model, which specifically includes: fitting the model parameters to be fitted Initialization processing is performed respectively, and after initialization, the initial values are set respectively , and the range is

-100, 100

[0046] The model parameters are updated using the gradient descent algorithm, and the corresponding update rule is ; ; ; In the formula, is the learning rate of the gradient descent algorithm, is the corresponding initialization parameter, is the model parameter after iterative update, is the three-minute output current value.

[0047] Then, it is also judged whether the change of the residual sum of squares in the update iteration process is lower than the preset threshold value, if it is lower than the threshold value, the group of model parameters is taken as the optimal parameter of the current-sugar concentration model, if it is higher than or equal to the threshold value, the partial derivative is solved again, and the gradient descent is performed again to update the model parameters, and the update is based on the parameters after iterative update .

[0048] In the formula, ; In the formula, m is the total number of current-sugar concentration data, is the glucose concentration corresponding to the i th current-sugar concentration data, is the current output value corresponding to the i th current-sugar concentration data.

[0049] More specifically, the threshold value for the residual sum of squares is a set value, for example, 0.01 in the present embodiment, and can be set to other values according to experience. When the residual sum of squares of the model parameters of the current-sugar concentration model after iteration is less than the threshold value, the model parameters of the current-sugar concentration model at this time can be used as the optimal parameters of the current-sugar concentration model, and when the residual sum of squares of the model parameters of the current-sugar concentration model after iteration is greater than or equal to the threshold value, the set of model parameters is continued to be used to return to solving the partial derivative to repeat the subsequent steps until the residual sum of squares of the model parameters of the current-sugar concentration model is less than the threshold value.

[0050] Finally, the corrected nonlinear model is obtained.

[0051] Specifically, the optimal parameters are substituted into the initial model of the current-sugar concentration model, and the current response value under the test concentration (2 mmol / L, 5 mmol / L, 10 mmol / L, 15 mmol / L, and 20 mmol / L set above) is calculated, and the expression is: ; In the formula, is the optimal parameter obtained, and S is the glucose concentration, i.e., the test concentration 2 mmol / L, 5 mmol / L, 10 mmol / L, 15 mmol / L, and 20 mmol / L set above; and is substituted into the formula with each test concentration to obtain the current response value S corresponding to each test concentration , and the current response value is the ideal response value, and when the model is used subsequently, the optimal parameters and the glucose concentration S are substituted to obtain the ideal optimal current value.

[0052] In addition, since the current value at the key concentration in actual measurement will have a certain deviation from the ideal value of the model, in order to eliminate the deviation, the key concentration S and the optimal parameters are substituted into the above fitted model to obtain the ideal optimal current value , and the key concentration finally obtained and the ideal optimal current value are set as S key1 , I best1}… S keyn, I bestn wherein, S key is the key concentration, I best is the optimal current value.

[0053] In summary, the current response parameters under each key concentration are calibrated, and the current-sugar concentration model is established accordingly.

[0054] Next, the service life attenuation of the sensor will also be calibrated in the factory calibration stage in this embodiment.

[0055] The service life attenuation calibration step comprises: Sampling the sensors in all sensors of the same batch, performing complete service life simulation tests on the sampled sensors, and establishing a total sugar catalytic amount-performance attenuation relationship.

[0056] Among them, the sampling of sensors in all sensors of the same batch, the complete service life simulation test of the sampled sensors, and the establishment of the total sugar catalytic amount-performance attenuation relationship comprise: Randomly sampling all sensors of the same batch according to a preset proportion, and grouping the sensors into a fixed concentration of glucose solution, keeping the concentration constant; Obtaining the current response data of the sensor, normalizing the current response data, and calculating the total sugar catalytic amount; Average the total sugar catalytic amount-performance attenuation data of all tested sensors to obtain the performance attenuation average curve and perform fitting.

[0057] Among them, the expression for calculating the total sugar catalytic amount is: ; In the formula, is the total sugar catalytic amount, is the concentration of the glucose solution corresponding to the test environment of the sensor, p is the outer membrane permeation ratio of the continuous glucose sensor.

[0058] Specifically, in this embodiment, when performing complete service life simulation tests on the plurality of sensors to be tested, the plurality of sensors are evenly grouped, and each group of sensors is immersed in a fixed concentration glucose solution, i.e. one sensor is placed in one test cup, the concentration needs to be calibrated and kept constant at regular intervals, and the sensor does not need to change the test concentration during this period.

[0059] It should be noted that during the determination process, the standard glucose concentration test instrument needs to be used regularly to determine the concentration of the glucose solution in the test cup, and deionized water or glucose is added according to the concentration and volume change of the test solution to keep the concentration of the glucose solution constant during the test process.

[0060] During the use cycle simulation test of the sensor, a sequence of three-minute current output values of each sensor corresponding to the total test time length of the test glucose solution concentration is obtained, that is, The corresponding sequence. Among them, one sensor is fixed in one concentration solution for 15 days to obtain 7200 three-minute current output values.

[0061] Then, the test data of each sensor in 15 days is filtered, that is, the above 7200 three-minute current output values are filtered, and the filtering method includes using a zero-phase filtering method, such as a traditional zero-phase filter, Kalman filtering, etc. Taking the traditional zero-phase filter as an example, it specifically includes: Set the filter coefficient; wherein the filter coefficient is determined by the specific length, cutoff frequency, and amplitude response of the filter; Perform the first round of convolution operation, including packing the above 7200 three-minute current output values in a data packet, and performing convolution based on the above filter coefficient, the expression is: ; In the formula, is the data packet corresponding to the 7200 three-minute current output values, is the filter coefficient; Perform the first round of inversion, including obtaining the data from the first round of convolution operation ; Perform the second round of convolution, including obtaining the data from the first round of inversion and the filter coefficient again, to obtain the data after the second convolution processing, that is, the filtered current response value; Perform the second round of inversion, including obtaining the data from the second round of convolution operation from back to front inversion; this is because the data points obtained from the first round of inversion are arranged in reverse order after the second round of inversion, and the time sequence is restored, so as to make the signal delay by inverting the inversion processing caused by the second round of convolution operation, offset the signal advance after the first inversion, and restore the normal data signal. The normal data is

[0062] In this embodiment, after acquiring and filtering the current data, the process also includes processing the performance degradation data. Specifically, this includes: The maximum current response of each sensor after filtering was calculated. The current data of each sensor was then normalized to the maximum value. The normalized data represents the performance degradation data of the sensor over a 15-day testing period. The expression is: ; In the formula, max is the function for maximizing the current signal, which aims to capture the maximum value of the current signal. The maximum value.

[0063] Then, a total sugar catalysis versus performance degradation graph was plotted for each sensor; where total sugar catalysis is defined as the specific amount of glucose co-catalyzed by a single sensor during the test time, expressed as: ; In the formula, This represents the total catalytic activity of sugars. The concentration of the glucose solution in the test environment corresponding to the sensor. p This represents the permeation rate of the outer membrane of a continuous glucose sensor.

[0064] It should be noted that the above parameters are the design parameters of the sensor. These parameters are related to factors such as the membrane material, lipophilicity, membrane pore size and porosity, and membrane thickness used in the sensor fabrication process. They are usually determined during the sensor research and development and fabrication process.

[0065] In this embodiment, after processing the performance degradation data, the method further includes fitting a performance degradation curve. Specifically, this includes: The total sugar catalytic activity of each sensor involved in the periodic decay calibration simulation test ( - Performance degradation The average performance degradation curve of the current batch of sensors is obtained by averaging the results. The total sugar catalytic capacity of the sensor was fitted to the performance degradation curve to obtain the total sugar catalytic capacity ( ) as the independent variable, sensor performance degradation data over 15 days ( Let be a function of the dependent variable; where the fitting method can be linear fitting using the least squares method, polynomial fitting, rational function fitting, power function fitting, etc.; taking linear fitting using the least squares method as an example, it specifically includes: Total sugar catalytic amount As an independent variable x Performance degradation data As dependent variable y ; Calculate the slope of the fitted functionk , the expression is: ; In the formula, k is the slope of the fitting function, x is the total sugar catalytic amount data of all extracted sensors, y is the performance attenuation data of all sensors, is the average value of the total sugar catalytic amount of all sensors, is the average value of the performance attenuation data of all sensors; The intercept of the fitting function is calculated b , the expression is: ; In the formula, b is the intercept of the fitting function; In this process, the slope k and the intercept b of the fitting function are calculated, which are used as parameters of the performance attenuation of the sensor under long-time operation.

[0066] Therefore, the attenuation calibration during the use cycle of the sensor is completed.

[0067] Next, the attenuation of the enzyme catalytic capacity under sterilization conditions will also be calibrated in this embodiment.

[0068] The sterilization attenuation calibration step includes: The key concentration test is performed on the sensor before and after sterilization, and the attenuation ratio caused by sterilization is calculated.

[0069] The key concentration test is performed on the sensor before and after sterilization, and the attenuation ratio caused by sterilization is calculated. The sensor before sterilization is immersed in a glucose solution with a fixed concentration for key concentration test to obtain the attenuation amount of the sensor before sterilization; The sensor after sterilization is immersed in a glucose solution with a fixed concentration for key concentration test to obtain the attenuation amount of the sensor after sterilization; Based on the attenuation amounts of the sensor before and after sterilization, the attenuation ratio caused by sterilization of the sensor is calculated.

[0070] Specifically, the remaining sensors of the same batch after the use cycle attenuation calibration simulation test are sterilized, and after sampling, the calibration of the current response parameters at each key concentration is repeated to obtain the optimal current response of the key concentration such as 2mmol / L 5mmol / L 10mmol / L 15mmol / L 20mmol / L after sterilization. I out Based on the optimal current responseI out The ideal optimal current response is obtained by calibrating the current response parameters at each of the above key concentrations.

[0071] It should be noted that the reason for recalibration is that sterilization can damage the outer membrane material of the sensor and the glucose oxidase on the sensor, causing changes in the current response performance of the sensor before and after sterilization. In the normal production process, reopening a sterilized and packaged sensor would destroy the sensor's sterile environment, making it impossible to repackage and sell it. Therefore, it is necessary to sample the product and recalibrate its current response.

[0072] Then, the sterilization attenuation value is calculated, which involves averaging the optimal current response at the corresponding test glucose concentration, the optimal current response at the sensor's critical concentration before sterilization, and the optimal current response at the sensor's critical concentration after sterilization. The ratio of the optimal current response after sterilization to the optimal current response before sterilization is then calculated; this ratio is the sterilization attenuation value. The expression for averaging the above ratio is as follows: ; In the formula, This is the sterilization attenuation value. Before sterilization i The average optimal current response at each key concentration For the first time after sterilization i The average optimal current response at each key concentration N This represents the total number of optimal current responses.

[0073] in, N This indicates the total number of data points, for example, 5 data points each from 6 sensors. ， but N =6*5=30.

[0074] The above completes the calibration of the enzyme catalytic capacity decay under sterilization conditions.

[0075] Next, in this embodiment, the attenuation of enzyme catalytic ability under different temperature and humidity storage conditions will be calibrated.

[0076] The storage attenuation calibration step includes: The sterilized sensors are grouped together, and the groups of sensors are stored under different temperature and humidity conditions. The groups of sensors are tested periodically, and a temperature-humidity-time-degradation model is established accordingly.

[0077] The process of grouping the sterilized sensors into groups, storing the groups of sensors under different temperature and humidity conditions, periodically testing the groups of sensors, and establishing a corresponding temperature-humidity-time-degradation model includes: The sterilized sensors are sampled and grouped, and the groups of sensors are stored under different temperature and humidity combination conditions. The stored sensors are periodically taken out for key concentration testing, and the optimal current response is obtained; According to the optimal current response, the storage decay ratio of the sensor is calculated; According to the optimal current response and the storage decay ratio, a temperature and humidity-time-decay model is established, and an optimization algorithm is used for parameter fitting.

[0078] Specifically, the sterilized sensors are sampled and grouped, and the temperature and humidity of different groups are different, such as 25 groups, which are divided into 5 groups according to temperature 20℃, 30℃, 40℃, 45℃, 50℃, and 5 groups according to humidity 10%, 30%, 50%, 70%, 90%, respectively. The temperature and humidity are combined into a group of temperature and humidity storage environment, i.e. C5 1 *C5 1 =5*5=25 groups; Then the stored sensors are periodically taken out, and each sensor is tested for key concentration, such as 2mmol / L, 5mmol / L, 10mmol / L, 15mmol / L, 20mmol / L, to obtain the direct current response of the sensor under the key concentration , and the corresponding optimal current response is obtained; After each test, the optimal current response of each corresponding sensor is averaged according to the number of test groups, and the optimal current response is taken as a ratio, i.e. the decay of enzyme catalytic ability of the sensor under a certain storage condition after a certain storage time. The corresponding expression is: ; In the formula, is the decay value ratio of all sensors in the j group temperature and humidity storage environment, is the optimal current response of the sensor after sterilization without storage, is the optimal current response of the sensor after sterilization and storage, N is the number of test data; The data is arranged as temperature-humidity-time-decay data pairs, and the data pair expression is:

[0079] ; In the formula, is the temperature-humidity-storage time-decay data pair corresponding to the n group sensor, is the temperature-humidity-storage time-decay data pair corresponding to the ntemperature parameter of the group, the first n humidity parameter of the group, the first n storage time of the group, the first n sensor attenuation ratio of the group; Then, a storage attenuation model is established, and a target function is established to express the relationship between temperature, humidity, storage time and temperature; the target function can be a polynomial function, a power function, an exponential function, etc.; the target function is expressed as, for example: ; In the formula, k 1, b 1, b 2, b 3, c are model parameters, temp , h , time temperature, humidity and storage time, respectively; The above model parameters k 1, b 1, b 2, b 3, c are initialized, respectively represented by k 1 ’ , b 1 ’ , b 2 ’ , b 3 ’ , c’ and the initial values are set, the initial value range is between

-100, 100

[0080] The above, that is, the calibration of the enzyme catalytic capacity decay under different temperature and humidity storage conditions is completed.

[0081] Next, the temperature response in the use process will also be calibrated in this embodiment.

[0082] The steps of the temperature response calibration in the use process include: Sensors from the same batch are sampled and tested at different temperatures to establish a temperature response rate model.

[0083] The step of sampling sensors from the same batch, testing the sampled sensors at different temperatures, and establishing a temperature response rate of change model includes: All sensors in the same batch are randomly sampled according to a preset ratio, and multiple selected sensors are immersed in glucose solutions at different temperatures to obtain the corresponding current responses. Based on the current response corresponding to different temperature environments, a temperature response change rate model is established accordingly.

[0084] Specifically, this includes sampling sensors from the same batch of sterilized sensors and immersing them in a glucose solution of a fixed concentration, such as 5 mmol / L or 15 mmol / L, or other concentrations; and adjusting the temperature, testing for 1 hour after each temperature stabilizes to obtain... Then, the optimal current response at the corresponding temperature is obtained by using the current response parameters calibrated at each of the above key concentrations.

[0085] The test temperature can be adjusted sequentially within the range of 31℃-40℃. This is because the temperature range not only covers the human body's baseline temperature of 37℃, but also includes the normal temperature fluctuation range. For example, in a cold environment, the temperature of the human body's extremities can drop to 31℃, while after exercise or fever, the local temperature of the human body can reach 40℃.

[0086] The sampled sensors were placed in glucose solutions of the same concentration (e.g., 5 mmol / L, 15 mmol / L, or other glucose concentrations) for measurement. During the test, the temperature of the glucose solution in which the sensors were immersed was adjusted multiple times in sequence, and the sensors did not need to be removed from the glucose solution during the adjustment. After each temperature adjustment, the temperature was allowed to stabilize for a period of time, and the current response of the sensors at the current temperature was acquired (i.e., the current response of all sensors tested in parallel). The average value), and the method for obtaining the current response are as follows: The current data from each sensor measured at each temperature is averaged. For example, if a sensor is tested at 32°C for one hour with a data measurement period of 3 minutes, the 20 data points obtained during that hour at 32°C are averaged to obtain the sensor's current response at 32°C. The same processing method is used for other test temperatures. Furthermore, the averaged three-minute current output value is used as the basis for the calculation. Then, by combining the current response parameters calibrated at each key concentration, the optimal current response at the corresponding temperature can be obtained.

[0087] Then set the reference temperature, for example, 37℃, divide the optimal current response of each sensor at other temperatures by the optimal current response of the sensor at the reference temperature to obtain the percentage change; Then calculate the average temperature response percentage change, the expression is: ; In the formula, n is the total amount of data, i is the data number, is the final temperature response percentage change, is the optimal temperature response percentage change under the first i data, is the temperature of the first i data, is the reference temperature, n is the number of current responses.

[0088] The above, that is, the calibration of the temperature response in use is completed, that is, the factory calibration of the continuous blood glucose sensor is completed.

[0089] Step S20, obtain the temperature and humidity history data corresponding to the transportation and storage environment of the sensor from factory to user use.

[0090] In this embodiment, the temperature and humidity history data corresponding to the transportation and storage environment of the sensor from factory to user use is obtained, specifically, temperature sensors, humidity sensors, or combined sensors of temperature sensors and humidity sensors are arranged in the transportation packaging of the sensor, the temperature data and humidity data in the packaging are collected and recorded by the sensors regularly, and the time data is correspondingly output, the output data format is determined, for example, the data sequence of {time, temperature, humidity}.

[0091] Step S30, based on the factory calibration parameters and the temperature and humidity history data, compensating calculation is performed on the current signal measured by the sensor in real time after being implanted in the body, and the calibrated blood glucose value is output.

[0092] In this embodiment, based on the factory calibration parameters and the temperature and humidity history data, compensating calculation is performed on the current signal measured by the sensor in real time after being implanted in the body, and the calibrated blood glucose value is output, including: Based on the factory calibration parameters and the temperature and humidity history data, the total attenuation of the sensor after factory is calculated; According to the total attenuation, compensating calculation is performed on the current signal measured by the sensor in real time after being implanted in the body, and the calibrated blood glucose value is output.

[0093] Among them, based on the factory calibration parameters and the temperature and humidity history data, the total attenuation of the sensor after factory is calculated, including: Import historical temperature and humidity data and time data corresponding to the transportation and storage environment into the temperature-humidity-time-degradation model to calculate the storage degradation of the sensor. Based on the storage attenuation and sterilization attenuation, calculate the total attenuation of the sensor after it leaves the factory.

[0094] In addition, based on the total attenuation, the current signal measured in real time by the sensor after implantation is compensated and calculated, and the calibrated blood glucose value is output, including: Based on the total attenuation, the current signal measured by the sensor after implantation is filtered and denoised. Temperature compensation is performed on the filtered and denoised current signal; The initial blood glucose value corresponding to the sensor is calculated based on the temperature-compensated current signal. Based on the cumulative workload of the sensor, the initial blood glucose value is attenuated and corrected, and the final blood glucose value is output.

[0095] Specifically, in this embodiment, temperature, humidity, and time data during transportation are input into the storage degradation model, i.e., the optimized model calibrated at the factory, to calculate the performance degradation of the sensor before use and after storage. The specific calculation is as follows: Obtain the {time, temperature, humidity} sequence for the transportation calibration phase, for example, set as { h 1 , temp 1 , tv 1} ， { h 2 ， temp 2 , tv 2} ， … ， { h s , temp s , tv s Let the cumulative storage time of the sensor from its manufacture to each recording be} tv ( tv For cumulative time, such as tv 1. When storing for 10 days, record the temperature and humidity again after a 10-day interval. tv 2 means storage for 20 days, and so on. temp This refers to the temperature data stored by the sensor from the time it leaves the factory until it is used by the user. h This refers to the humidity data stored by the sensor from the time it leaves the factory until it is used by the user. The total amount of data is [number missing]. s (To represent data from a single sensor). Calculate the average storage temperature, average storage humidity, and cumulative storage time, and substitute them into the formula: ; In the formula, is the average temperature during storage, is the average humidity during storage, time is the cumulative storage time.

[0096] The total attenuation of the sensor at the factory is calculated, including: The sterilization attenuation at the factory and the storage attenuation in the implantation measurement stage of the factory calibration measurement are obtained, and the total attenuation at the factory is calculated, and the expression is: ; The current-sugar concentration model parameters are adjusted, including obtaining the optimal parameters of the sensor in the factory calibration, adjusting the current-sugar concentration model calculation formula, and the expression is: ; The correction parameter for adjusting the current-sugar concentration model calculation formula is 、 .

[0097] The corrected current-sugar concentration model calculation formula is updated as: .

[0098] After the continuous blood glucose sensor is implanted subcutaneously in the user, the glucose in the tissue fluid is continuously catalyzed by the glucose oxidase on the sensor, and an oxidation-reduction reaction is carried out, and the sensor captures the current signal for processing.

[0099] The current signal collected in this embodiment can be denoised by FIR, IIR, adaptive filtering and other filtering methods. Taking the FIR filtering method as an example, the filtering method specifically includes: The filtering coefficient is set B2 ( n ); wherein the filtering coefficient is determined according to the specific length, cutoff frequency, amplitude response, etc. of the filter; The real-time measurement data , that is, the current signal, is convolved with the filtering coefficient, and the expression is: ; The sensor runtime, the actual environment temperature during sensor use, and the factory calibration data are combined, including temperature compensation during use, attenuation compensation data during use, and calibration parameters. The data calibrated in stage two are used to model the current response parameters of the long-time running sensor in real time. Specifically, it includes: The temperature response data measured by the factory calibration is used for temperature compensation to eliminate the current change caused by the use environment temperature, and the expression is: ; In the formula, is the signal compensated by the ambient temperature, is the ambient temperature when the sensor is used, is the reference temperature, is the average temperature response change percentage.

[0100] The preliminary interstitial fluid glucose concentration value is calculated by the expression: ; Solving the above formula, the value of is obtained, wherein is the preliminary interstitial fluid glucose concentration value measured by the sensor, which can be understood as S in the corrected current-glucose concentration model calculation formula, and are both correction parameters of the current-glucose concentration model in the implantation measurement stage.

[0101] The preliminary interstitial fluid glucose concentration value is integrated to calculate the total glucose catalytic amount of the current sensor, and the performance attenuation ratio of the current sensor is calculated according to the attenuation parameters fitted in the factory calibration stage k , b , and the expression is: ; In the formula, is the performance attenuation ratio of the sensor in use.

[0102] The preliminary interstitial fluid glucose concentration value is corrected to eliminate the influence of sensor performance attenuation during long-term implantation and use, and the expression is: ; In the formula, is the corrected blood glucose data.

[0103] In summary, the continuous blood glucose sensor using the method shown in the embodiment is more accurate in measuring blood glucose values during use.

[0104] Compared with the prior art, the calibration method of the continuous blood glucose sensor using the embodiment has the beneficial effects that: The method shown in the embodiment calibrates multi-factor attenuation parameters of sensors of the same batch before factory shipment to obtain factory calibration parameters of the sensors, obtains temperature and humidity history data corresponding to a transportation and storage environment of the sensors from factory shipment to user use, compensates and calculates a current signal measured by the sensors in real time after implantation in the body based on the factory calibration parameters and the temperature and humidity history data, and outputs a calibrated blood glucose value. The method calibrates multi-factor coupling compensation and simulates and calibrates the whole life cycle before factory shipment, solves the problem of single calibration factor of a continuous blood glucose sensor in the prior art, effectively improves the blood glucose monitoring accuracy of the continuous blood glucose sensor, and does not require secondary calibration by the user before or during use, thereby finally realizing calibration-free use in the implantation stage.

[0105] Embodiment Two Please refer to Figure 2 The second embodiment of the present application provides a calibration system of a continuous blood glucose sensor, which is applied to the method in the above embodiments. The system comprises: A calibration module 10 is configured to calibrate multi-factor attenuation parameters of sensors of the same batch before factory shipment to obtain factory calibration parameters of the sensors. An acquisition module 20 is configured to acquire temperature and humidity history data corresponding to a transportation and storage environment of the sensors from factory shipment to user use. A calibration module 30 is configured to compensate and calculate a current signal measured by the sensors in real time after implantation in the body based on the factory calibration parameters and the temperature and humidity history data, and output a calibrated blood glucose value.

[0106] Compared with the prior art, the calibration system of the continuous blood glucose sensor has the following beneficial effects: The system calibrates multi-factor attenuation parameters of sensors of the same batch before factory shipment to obtain factory calibration parameters of the sensors, acquires temperature and humidity history data corresponding to a transportation and storage environment of the sensors from factory shipment to user use, compensates and calculates a current signal measured by the sensors in real time after implantation in the body based on the factory calibration parameters and the temperature and humidity history data, and outputs a calibrated blood glucose value. The system calibrates multi-factor coupling compensation and simulates and calibrates the whole life cycle before factory shipment, solves the problem of single calibration factor of a continuous blood glucose sensor in the prior art, effectively improves the blood glucose monitoring accuracy of the continuous blood glucose sensor, and does not require secondary calibration by the user before or during use, thereby finally realizing calibration-free use in the implantation stage.

[0107] Embodiment Three The third embodiment of the present application provides a readable storage medium, which stores computer instructions. The instructions are executed by a processor to realize the steps of the method in any of the above embodiments.

[0108] Embodiment Four A fourth embodiment of the present application provides an electronic device comprising a storage, a processor, and a computer program stored on the storage and executable on the processor, the processor implementing the steps of the method of any of the above embodiments when executing the program.

[0109] In the description of the specification, the description of the terms "one embodiment", "some embodiments", "an example", "a specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the specification, the illustrative description of the above terms does not necessarily mean the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0110] The above embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it cannot be understood as the limitation of the patent scope of the present application. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A calibration method for a continuous glucose sensor, characterized in that, The method includes: Before leaving the factory, perform multi-factor attenuation parameter calibration on the same batch of sensors to obtain the sensor's factory calibration parameters; Acquire historical temperature and humidity data of the sensor from the time it leaves the factory until it is used by the user during transportation and storage. Based on the factory calibration parameters and the historical temperature and humidity data, the current signal measured in real time by the sensor after implantation is compensated and calculated, and the calibrated blood glucose value is output.

2. The calibration method for a continuous glucose sensor according to claim 1, characterized in that, Before leaving the factory, perform multi-factor attenuation parameter calibration on the same batch of sensors, including any one or more of the following: current-sugar concentration model establishment, usage cycle attenuation calibration, sterilization attenuation calibration, storage attenuation calibration, and temperature response calibration during use.

3. The calibration method for a continuous glucose sensor according to claim 2, characterized in that, The current-sugar concentration model was established, including: All sensors in the same batch were subjected to full inspection and testing, and current data of multiple sensors in glucose solutions of different concentrations were collected. Based on the current data and sugar concentration, an initial current-sugar concentration model was established, and an optimization algorithm was used to fit the parameters to obtain the current-sugar concentration model.

4. The calibration method for a continuous glucose sensor according to claim 3, characterized in that, The acquisition of current data from multiple sensors in glucose solutions of different concentrations includes: Current signals are collected from each sensor sequentially at preset time intervals to obtain current data; Based on the current data, calculate the average value and standard deviation of the current signal; The current data is filtered based on the average value and the standard deviation to obtain target current data. The average value of the target current data is then calculated as the current output value of the sensor.

5. The calibration method for a continuous glucose sensor according to claim 2, characterized in that, The usage cycle attenuation calibration includes: Sensors were sampled from all sensors in the same batch, and the selected sensors were subjected to a full-cycle simulation test to establish the relationship between total sugar catalytic amount and performance degradation.

6. The calibration method for a continuous glucose sensor according to claim 5, characterized in that, The process involves sampling sensors from all sensors in the same batch, conducting simulated tests on the sampled sensors throughout their entire lifespan, and establishing a corresponding relationship between total sugar catalytic capacity and performance degradation. This includes: All sensors in the same batch are randomly sampled according to a preset ratio, and the sensors are grouped and immersed in a glucose solution of a fixed concentration to maintain a constant concentration. Acquire the current response data of the sensor, normalize the current response data, and calculate the total sugar catalytic amount; The total sugar catalytic capacity-performance degradation data of all tested sensors were averaged to obtain an average performance degradation curve, which was then fitted.

7. The calibration method for a continuous glucose sensor according to claim 6, characterized in that, The expression for calculating the total sugar catalytic amount is as follows: The current response data of the sensor is acquired, the current response data is normalized, and the total sugar catalytic amount is calculated. ； In the formula, This represents the total catalytic activity of sugars. The concentration of the glucose solution in the test environment corresponds to the sensor. p This represents the permeation ratio of the outer membrane of a continuous glucose sensor.

8. The calibration method for a continuous glucose sensor according to claim 2, characterized in that, The sterilization attenuation calibration includes: Key concentration tests were performed on the sensors before and after sterilization to calculate the attenuation rate caused by sterilization.

9. The calibration method for a continuous glucose sensor according to claim 8, characterized in that, The process of performing key concentration tests on the sensors before and after sterilization, and calculating the attenuation ratio caused by sterilization, includes: Before sterilization, the sensor was immersed in a glucose solution of a fixed concentration for key concentration testing to obtain the attenuation of the sensor before sterilization. The sterilized sensor was immersed in a glucose solution of a fixed concentration for key concentration testing to obtain the attenuation of the sensor after sterilization. Based on the attenuation of the sensor before and after sterilization, the attenuation ratio caused by sterilization of the sensor is calculated.

10. The calibration method for a continuous glucose sensor according to claim 2, characterized in that, The storage decay calibration includes: The sterilized sensors are grouped together, and the groups of sensors are stored under different temperature and humidity conditions. The groups of sensors are tested periodically, and a temperature-humidity-time-degradation model is established accordingly.

11. The calibration method for a continuous glucose sensor according to claim 10, characterized in that, The process of grouping the sterilized sensors into groups, storing the groups of sensors under different temperature and humidity conditions, periodically testing the groups of sensors, and establishing corresponding temperature-humidity-time-degradation models includes: After sterilization, multiple sensors are sampled and grouped, and multiple groups of sensors are stored under different temperature and humidity combinations. The stored sensors are periodically taken out for key concentration tests to obtain the optimal current response. Based on the optimal current response, calculate the storage decay ratio of the sensor; Based on the optimal current response and the storage decay ratio, a temperature-humidity-time-decay model is established, and an optimization algorithm is used to fit the parameters.

12. The calibration method for a continuous glucose sensor according to claim 2, characterized in that, The temperature response calibration during use includes: Sensors from the same batch are sampled and tested at different temperatures to establish a temperature response rate model.

13. The calibration method for a continuous glucose sensor according to claim 12, characterized in that, The process of sampling sensors from the same batch, testing the sampled sensors at different temperatures, and establishing a temperature response rate of change model includes: All sensors in the same batch are randomly sampled according to a preset ratio, and multiple selected sensors are immersed in glucose solutions at different temperatures to obtain the corresponding current responses. Based on the current response corresponding to different temperature environments, a temperature response change rate model is established accordingly.

14. The calibration method for a continuous glucose sensor according to any one of claims 1-13, characterized in that, Based on the factory calibration parameters and the historical temperature and humidity data, the current signal measured in real time by the sensor after implantation is compensated and calculated, and the calibrated blood glucose value is output, including: Based on the factory calibration parameters and the historical temperature and humidity data, the total attenuation of the sensor after it leaves the factory is calculated; The total attenuation is used to compensate for the current signal measured in real time by the sensor after implantation, and the calibrated blood glucose value is output.

15. The calibration method for a continuous glucose sensor according to claim 14, characterized in that, Based on the factory calibration parameters and the historical temperature and humidity data, the total attenuation of the sensor after leaving the factory is calculated, including: Import historical temperature and humidity data and time data corresponding to the transportation and storage environment into the temperature-humidity-time-degradation model to calculate the storage degradation of the sensor. Based on the storage attenuation and sterilization attenuation, calculate the total attenuation of the sensor after it leaves the factory.

16. The calibration method for a continuous glucose sensor according to claim 14 or 15, characterized in that, The total attenuation is used to compensate for the current signal measured in real time by the sensor after implantation, and the calibrated blood glucose value is output, including: Based on the total attenuation, the current signal measured by the sensor after implantation is filtered and denoised. Temperature compensation is performed on the filtered and denoised current signal; The initial blood glucose value corresponding to the sensor is calculated based on the temperature-compensated current signal. Based on the cumulative workload of the sensor, the initial blood glucose value is attenuated and corrected, and the final blood glucose value is output.

17. A calibration system for a continuous glucose sensor, characterized in that, The system, applicable to the method of any one of claims 1-16, comprises: The parameter calibration module is used to calibrate the multi-factor attenuation parameters of sensors in the same batch before they leave the factory, and to obtain the factory calibration parameters of the sensors. The data acquisition module is used to acquire historical temperature and humidity data of the sensor from the time it leaves the factory until it is used by the user during transportation and storage. The calibration execution module is used to perform compensation calculations on the current signal measured in real time by the sensor after implantation, based on the factory calibration parameters and the historical temperature and humidity data, and output the calibrated blood glucose value.

18. A readable storage medium having computer instructions stored thereon, characterized in that, When executed by the processor, this instruction implements the steps of the method as described in any one of claims 1-16.

19. An electronic device comprising a storage device, a processor, and a computer program stored in the storage device and executable on the processor, characterized in that, When the processor executes the program, it implements the steps of the method as described in any one of claims 1-16.

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