Compensation method and equipment for continuous blood glucose monitoring device

Abstract

The invention discloses a compensation method and equipment for a continuous blood glucose monitoring device, belongs to the technical field of CGM early signal attenuation compensation, and is used for solving the technical problem that accurate blood glucose data cannot be obtained in the early stage of using a CGM by a user due to the fact that an early signal attenuation phenomenon affects the stability and accuracy of the CGM of the continuous blood glucose monitoring device. The method comprises the following steps: continuously acquiring a real-time blood glucose value of a user; determining a user type and a blood sugar trend type according to the real-time blood sugar value; wherein the user types at least comprise a first user type and a second user type; judging whether a compensation starting condition is met or not based on the real-time blood glucose value, if yes, starting a compensation algorithm, determining a compensation formula based on the real-time blood glucose value, the blood glucose trend type and the user type, and obtaining a compensated blood glucose value based on the real-time blood glucose value and the compensation formula until a compensation stopping condition is met.

Description

[0001] This application claims priority based on an invention patent application filed with the China Patent Office on September 27, 2024, with application number 202411361229.8 and invention name “A compensation method and device for a continuous blood glucose monitoring device”. This application cites the full text of the above-mentioned Chinese patent application. Technical Field

[0002] The present invention relates to the technical field of CGM early signal attenuation compensation, and in particular to a compensation method and device for a continuous blood glucose monitoring device. Background Art

[0003] A continuous glucose monitor (CGM) is a sterile, small and soft glucose monitoring sensor implanted under the user's skin, which can continuously monitor the glucose concentration in the blood between the user's subcutaneous tissues. It transmits real-time blood glucose readings to a mobile phone via Bluetooth, showing the user's blood glucose level fluctuations, providing important diagnosis and treatment basis for users and doctors.

[0004] When CGM is implanted under the user's skin, trauma to the skin and / or tissue may cause varying degrees of rejection, allergic reaction or wound infection, which will cause certain changes in the environment in which the CGM is located. CGM is greatly affected by environmental changes. Common influencing factors include temperature, detected blood glucose concentration, etc. Environmental changes often cause CGM detection signals to attenuate, and pseudo-hypoglycemia may occur where the glucose concentration measured by CGM is lower than the actual glucose concentration. This phenomenon usually occurs in the early stages of a user's use of CGM, generally lasts for a few days, and then gradually disappears. This phenomenon is called Early Signal Attenuation (ESA).

[0005] When the ESA phenomenon occurs, the working current of CGM will fluctuate, causing the blood sugar value output by CGM to fluctuate as well. However, the actual blood sugar value of the human body has not changed. Therefore, there will be a large deviation between the estimated blood sugar value and the actual blood sugar value of the human body. It can be seen that the ESA phenomenon has a great negative impact on the stability and accuracy of CGM. Users cannot obtain accurate blood sugar data in the early stage of using CGM, and cannot make timely and accurate judgments on blood sugar levels. Therefore, it is urgent to suppress and compensate for the ESA phenomenon to reduce the occurrence rate of the ESA phenomenon and improve the accuracy of CGM sensor monitoring blood sugar. Summary of the invention

[0006] The embodiments of the present invention provide a compensation method and device for a continuous blood glucose monitoring device, which are used to solve the following technical problems: the early signal attenuation phenomenon affects the stability and accuracy of the continuous blood glucose monitoring device CGM, resulting in the user being unable to obtain accurate blood glucose data in the early stage of using the CGM.

[0007] The embodiment of the present invention adopts the following technical solution:

[0008] In one aspect, an embodiment of the present invention provides a compensation method for a continuous blood glucose monitoring device, the method comprising: continuously acquiring a user's real-time blood glucose value;

[0009] Determining a user type and a blood sugar trend type according to the real-time blood sugar value; wherein the user type includes at least a first user type and a second user type;

[0010] Based on the real-time blood glucose value, determine whether the compensation start condition is met, and if so, start the compensation algorithm, determine the compensation formula based on the real-time blood glucose value, the blood glucose trend type and the user type, and obtain the compensated blood glucose value based on the real-time blood glucose value and the compensation formula until the compensation stop condition is met.

[0011] In a feasible implementation manner, the compensation formula includes a first compensation coefficient and a second compensation coefficient;

[0012] Determine a first compensation coefficient according to the concentration interval of the real-time blood glucose value and the blood glucose trend type; substitute the first compensation coefficient into the initial formula to obtain an intermediate formula;

[0013] A second compensation coefficient is determined based on the initial compensation value obtained from the intermediate formula, and the second compensation coefficient is substituted into the intermediate formula to obtain the compensation formula.

[0014] In a feasible implementation, when the initial compensation value obtained based on the intermediate formula is less than or equal to a first set threshold, the second compensation coefficient is determined according to the concentration range in which the initial compensation value is located; when the initial compensation value is not lower than the first set threshold, the intermediate formula is used as the compensation formula.

[0015] In a feasible implementation manner, the compensation formula is: Among them, GLU ESA is the blood glucose value after compensation, α is the first compensation coefficient and is a non-positive number, β is the second compensation coefficient and is a non-negative number, I w is the operating current of the continuous blood glucose monitoring device, K s In vivo sensitivity of continuous glucose monitoring devices, Real-time blood sugar value.

[0016] In a feasible implementation, if the decreasing speed of the real-time blood glucose value is lower than the first speed threshold and higher than the second speed threshold, the blood glucose trend type is a slow decrease;

[0017] If the decreasing speed of the real-time blood glucose value is lower than the second speed threshold, the blood glucose trend type is a rapid decrease; wherein the first speed threshold and the second speed threshold are both negative numbers.

[0018] In a feasible implementation, within a preset compensation time after the continuous blood glucose monitoring device is implanted in the human body, if the highest value of the real-time blood glucose value never exceeds the second set threshold, the user type is the first user type; if the highest value of the real-time blood glucose value exceeds the second set threshold, the user type is the second user type.

[0019] In a feasible implementation, the compensation start condition for the first user type is: the real-time blood glucose value is lower than the first start threshold, and the blood glucose trend type is a slow decline or a rapid decline; the compensation start condition for the second user type is: the real-time blood glucose value is lower than the second start threshold, and the blood glucose trend type is a slow decline or a rapid decline; the first start threshold is greater than the second start threshold.

[0020] In a feasible implementation manner, the compensation stop condition is:

[0021] The continuous blood glucose monitoring device is implanted in the human body for a preset compensation time; or

[0022] The real-time blood glucose value exceeds a third set threshold; or,

[0023] When the lowest value of the real-time blood glucose value is greater than or equal to the fourth set threshold, compensation for the continuous blood glucose monitoring device of the first user type is stopped; when the lowest value of the real-time blood glucose value is greater than or equal to the fifth set threshold, compensation for the continuous blood glucose monitoring device of the second user type is stopped; wherein the fourth set threshold is greater than the fifth set threshold.

[0024] In a feasible implementation manner, when the current user type is the first user type,

[0025] If the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α=0.1×GLU-0.55; wherein GLU is the real-time blood glucose value;

[0026] If the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is a slow decline or a fast decline, the first compensation coefficient α is: α=0.1×GLU-0.5; wherein the minimum value of the first threshold interval is greater than the maximum value of the second threshold interval;

[0027] When the current user type is the second user type,

[0028] If the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α=0.05×GLU-0.29;

[0029] If the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is slow decline or rapid decline, the first compensation coefficient α is: α=0.05×GLU-0.25; wherein the minimum value of the third threshold interval is greater than the maximum value of the fourth threshold interval.

[0030] On the other hand, an embodiment of the present invention also provides an ESA compensation device for a CGM sensor, the device comprising: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions that can be executed by the at least one processor so that the at least one processor can execute the compensation method for a continuous blood glucose monitoring device.

[0031] Compared with the prior art, the compensation method and device for a continuous blood glucose monitoring device provided by the embodiment of the present invention have the following beneficial effects:

[0032] The present invention continuously obtains the user's real-time blood glucose value through the continuous blood glucose monitoring device CGM, and divides the user type and blood glucose trend type according to the actual blood glucose value, and then determines the compensation start condition. After determining that the user has the ESA phenomenon, different compensation formulas are generated for users of different types and different blood glucose trend types based on the real-time blood glucose value, and the blood glucose data output by the CGM is corrected and compensated by the compensation formula to obtain more accurate blood glucose data. And the compensation operation is stopped in time after the compensation stop condition is met to avoid unnecessary ESA compensation. Through the above settings, the method provided by the present invention can obtain more accurate data that is closer to the actual blood glucose value, and reduce the impact of the ESA phenomenon on the accuracy of CGM. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the prior art descriptions. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. In the drawings:

[0034] Figure 1 A flow chart of a compensation method for a continuous blood glucose monitoring device provided by an embodiment of the present invention;

[0035] Figure 2 A specific flow chart of a compensation method for a continuous blood glucose monitoring device provided by an embodiment of the present invention;

[0036] Figure 3 A schematic diagram of the structure of a compensation device for a continuous blood glucose monitoring device provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0037] In order to enable those skilled in the art to better understand the technical solutions in the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of this specification, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0038] The embodiment of the present invention provides a compensation method for a continuous blood glucose monitoring device, such as Figure 1 As shown, the compensation method for a continuous blood glucose monitoring device specifically includes steps S101-S105:

[0039] S101. Continuously obtain the user's real-time blood sugar value.

[0040] Specifically, under normal circumstances, the working current of CGM is linearly proportional to the glucose concentration of the human body, and the conversion coefficient between the two is defined as the in vivo sensitivity. The basic principle formula of CGM is: Among them, GLU is the glucose concentration of the human body, that is, the blood sugar value; I w is the operating current of CGM, K s is the in vivo sensitivity of CGM.

[0041] In CGM, K s It is usually set as a constant based on the measurement and experience on the production line. w By analyzing the changes in blood sugar levels, we can estimate the corresponding changes in human blood sugar.

[0042] Since ESA phenomenon occurs more often in the first few days when users start wearing CGM, the real-time blood glucose value of the user is continuously obtained through CGM after the user starts wearing CGM. The real-time blood glucose value is calculated according to the above basic principle formula. When ESA phenomenon occurs, the real-time blood glucose value does not represent the user's actual blood glucose value.

[0043] S102. Determine a user type and a blood sugar trend type according to the real-time blood sugar value; wherein the user type includes at least a first user type and a second user type.

[0044] Specifically, within the preset compensation time after the CGM is implanted in the human body, if the highest value of the real-time blood glucose value never exceeds the second set threshold, the user type is the first user type; if the highest value of the real-time blood glucose value exceeds the second set threshold, the user type is the second user type.

[0045] As a feasible implementation method, during the preset compensation time from the beginning of implantation of CGM in the user's body, the real-time blood glucose value is continuously calculated according to the basic principle formula of CGM. And the highest and lowest historical blood glucose values ​​before the current moment are obtained. If the highest value does not exceed the set threshold (i.e., the second set threshold) all the time, it is considered that the blood glucose volatility of the user is small and is determined as the first user type; if the highest value exceeds the set threshold (i.e., the second set threshold), it is considered that the blood glucose volatility of the user is large and is determined as the second user type.

[0046] The preset compensation time has a value range of 2 to 4 days, preferably 3 days. The second set threshold has a value range of [8 mmol / L, 11 mmol / L], preferably 9 mmol / L.

[0047] In one embodiment, within 3 days (i.e., the preset compensation time) when the user uses CGM, the ESA compensation algorithm will count the highest and lowest real-time blood glucose values ​​calculated according to the basic principle formula of CGM in real time. Assuming that the current moment is moment t (t≤3 days), then count the highest and lowest real-time blood glucose values ​​of the user in the time period of 0 to t. If the highest value is 8mmol / L, which does not exceed the second set threshold of 9mmol / L, it is determined that the blood glucose volatility of the user in the time period of 0 to t is small, and is set as a Class A user (i.e., the first user type).

[0048] If at time t+1, the real-time blood sugar value reaches 9.5mmol / L, then the highest blood sugar value in the time period from 0 to t+1 is 9.5mmol / L, which exceeds the second set threshold of 9mmol / L, indicating that the user's blood sugar fluctuates greatly in the time period from 0 to t+1. At this time, the user becomes a Class B user (i.e., the second user type).

[0049] Based on the above embodiments, it can be seen that the user type of the user within the preset compensation time is not fixed, but changes according to the continuous change of the real-time blood glucose value. The user type may be the first one in the last second, and may become the second one in the next second. Therefore, during the compensation process, it is necessary to monitor the user type change of the user at all times, so as to adopt different compensation formula adjustment methods.

[0050] Furthermore, within the preset compensation time, the real-time blood glucose value is monitored to calculate the real-time decreasing trend and decreasing speed of blood glucose. If the decreasing speed of the real-time blood glucose value is lower than the first speed threshold and higher than the second speed threshold, the blood glucose trend type is a slow decrease. If the decreasing speed of the real-time blood glucose value is lower than the second speed threshold, the blood glucose trend type is a fast decrease; wherein the first speed threshold and the second speed threshold are both negative numbers.

[0051] As a feasible implementation, the ESA compensation algorithm continuously calculates the trend of the blood glucose value estimated by the CGM basic principle formula to determine whether the estimated blood glucose value is decreasing slowly or rapidly during each observation window. The blood glucose trend can be calculated by linear regression or numerical difference.

[0052] The observation window period ranges from 10 minutes to 15 minutes, preferably 12 minutes. The first speed threshold ranges from [-0.04mmol / (L·min), -0.02mmol / (L·min)], preferably -0.03mmol / (L·min). The second speed threshold ranges from [-0.07mmol / (L·min), -0.04mmol / (L·min)], preferably -0.06mmol / (L·min).

[0053] In one embodiment, the observation window period is set to 12 minutes, and the rate of decline of the real-time blood glucose value is calculated every 12 minutes starting from the 0th moment. If the rate of decline of blood glucose in the current observation window period is lower than the first rate threshold -0.03mmol / (L·min) and higher than the second rate threshold -0.06mmol / (L·min), the blood glucose trend type in the current observation window period is determined to be a slow decline. If the rate of decline of blood glucose in the current observation window period is lower than the second rate threshold -0.06mmol / (L·min), the blood glucose trend type in the current observation window period is determined to be a rapid decline. If the rate of decline of blood glucose is greater than the first rate threshold -0.03mmol / (L·min), the current rate of decline of blood glucose is considered to be within the normal fluctuation range and is not considered to be an abnormal decline.

[0054] It should be noted that the numerical values ​​used in the above embodiments are all examples and are not used to limit the actual usage values ​​of this solution. The actual usage data can be flexibly set according to actual conditions or expert experience.

[0055] The present invention continuously monitors the real-time blood glucose value in the first few days when the user uses CGM, and performs a series of data analysis on the acquired real-time blood glucose value to determine the user type and blood glucose trend type, so as to subsequently adopt different compensation coefficient adjustment rules according to the user type and blood glucose trend type to adapt to the individual differences of users and make the compensated blood glucose value closer to the actual blood glucose value of different users.

[0056] S103: Based on the real-time blood glucose value, determine whether the compensation start condition is met, and if so, start the compensation algorithm.

[0057] Specifically, the compensation start condition for the first user type is: the real-time blood glucose value is lower than the first start threshold, and the blood glucose trend type is slow decline or fast decline; the compensation start condition for the second user type is: the real-time blood glucose value is lower than the second start threshold, and the blood glucose trend type is slow decline or fast decline. The first start threshold is greater than the second start threshold.

[0058] As a feasible implementation method, if the current user is the first user type at the current moment, that is, the blood sugar fluctuation is small, then if the real-time blood sugar value estimated by the CGM basic principle formula is lower than the first start threshold, and the blood sugar trend type is slow decline or fast decline, then the ESA compensation algorithm is started. If the current user is the second user type at the current moment, that is, the blood sugar fluctuation is large, then if the real-time blood sugar value estimated by the CGM basic principle formula is lower than the second start threshold, and the blood sugar trend type is slow decline or fast decline, then the ESA compensation algorithm is started. Since the blood sugar fluctuation of the second user type is large, a lower blood sugar value for the first type of user may be a normal value for the second type of user, so the second type of user needs to set a lower start threshold to adapt to the characteristics of this type of user, so the second start threshold is set to be less than the first start threshold.

[0059] The first activation threshold value ranges from [3.5mmol / L, 5mmol / L], preferably 4.4mmol / L. The second activation threshold value ranges from [2mmol / L, 3.5mmol / L), preferably 3.0mmol / L.

[0060] In one embodiment, when the real-time blood glucose level of a class A user is lower than the first start threshold of 4.4 mmol / L and is decreasing slowly or rapidly, the ESA compensation algorithm is started to perform blood glucose compensation on the class A user. When the real-time blood glucose level of a class B user is lower than the second start threshold of 3.0 mmol / L and is decreasing slowly or rapidly, the ESA compensation algorithm is started to perform blood glucose compensation on the class B user.

[0061] It should be noted that the startup threshold values ​​listed in the above embodiments are all examples and are not used to limit the actual startup threshold values ​​of this solution. The actual usage data can be flexibly set according to the actual situation or expert experience.

[0062] The present invention specifies compensation start conditions for different user types and different blood sugar drop trends according to the physical signs of ESA phenomenon that may occur in different types of users. ESA compensation will only be started when the user's real-time blood sugar value is lower than a certain value and the drop rate is also lower than a certain value. This avoids the situation where erroneous compensation is performed when the CGM does not show ESA phenomenon, and ensures the accuracy of data in the early stage of user use of CGM.

[0063] S104. Determine a compensation formula based on the real-time blood glucose value, blood glucose trend type and user type.

[0064] Specifically, firstly, the present invention defines the ESA compensation formula according to the basic principle formula of CGM: Among them, GLU ESA is the blood glucose value after compensation, I w is the operating current of the continuous blood glucose monitoring device, K s In vivo sensitivity of continuous glucose monitoring devices, This is the basic principle formula of CGM, which represents the real-time blood glucose value estimated by CGM. α is the first compensation coefficient and is a non-positive number used to reduce K s To improve the estimated blood sugar level; β is the second compensation coefficient and is a non-negative number, which is used to make up for the limitation that α alone is not enough to improve the blood sugar level to the expected range in some scenarios.

[0065] Further, according to the concentration interval of the real-time blood glucose value and the blood glucose trend type, the first compensation coefficient α is determined, and then the first compensation coefficient α is substituted into the initial formula to obtain the intermediate formula. In the initial formula, α and β are both 0. At this time, the initial formula is equivalent to After determining the value of the first compensation coefficient α, the intermediate formula obtained is equivalent to

[0066] Furthermore, the second compensation coefficient β is determined by the initial compensation value obtained by the intermediate formula, and then the second compensation coefficient β is substituted into the intermediate formula to obtain the final compensation formula. After the value of the second compensation coefficient β is determined, the compensation formula obtained is the final complete compensation formula:

[0067]

[0068] As a feasible implementation, when the initial compensation value obtained based on the intermediate formula is less than or equal to the first set threshold, the second compensation coefficient is determined according to the concentration range of the initial compensation value; when the initial compensation value is not less than or equal to the first set threshold, the intermediate formula is used as the final compensation formula. The value range of the first set threshold is [1.7mmol / L, 3.5mmol / L], preferably 3.5mmol / L.

[0069] Specifically, when the current user type is the first user type, if the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α = 0.1 × GLU-0.55; where GLU is the real-time blood glucose value. If the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is a slow decline or a rapid decline, the first compensation coefficient α is: α = 0.1 × GLU-0.5; where the minimum value of the first threshold interval is greater than the maximum value of the second threshold interval.

[0070] Then, the calculated first compensation coefficient α is substituted into the user-defined ESA compensation formula to calculate the initial compensation value at this time. If the initial compensation value is less than or equal to the first set threshold, the second compensation coefficient β is adjusted according to the interval where the initial compensation value is located.

[0071] Among them, the first threshold interval is preferably [3.5mmol / L, 4.4mmol / L], and the second threshold interval is preferably less than 3.5mmol / L.

[0072] In one embodiment, for a first user type with smaller blood sugar fluctuation, the adjustment strategy of the first compensation coefficient α is shown in Table 1.

[0073] Table 1

[0074]

[0075] After calculating the first compensation coefficient α according to the adjustment strategy in Table 1, substitute it into the self-defined ESA compensation formula to calculate the initial compensation value.

[0076] In a further embodiment, if the initial compensation value is less than or equal to the first set threshold value of 3.5 mmol / L, the adjustment strategy of the second compensation coefficient β is as shown in Table 2.

[0077] Table 2

[0078]

[0079] The adjustment range of the first compensation coefficient α is limited to between -0.25 and 0, and the adjustment range of the second compensation coefficient β is limited to between 0 and 2.5. Thus, the adjustment of the ESA compensation coefficient adapted to the first type of users with small blood sugar fluctuations is completed.

[0080] Further, when the current user type is the second user type, if the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α = 0.05 × GLU-0.29. If the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is a slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is a slow decline or a rapid decline, the first compensation coefficient α is: α = 0.05 × GLU-0.25; wherein the minimum value of the third threshold interval is greater than the maximum value of the fourth threshold interval.

[0081] Then, the calculated first compensation coefficient α is substituted into the user-defined ESA compensation formula to calculate the initial compensation value at this time. If the initial compensation value is less than or equal to the first set threshold, the second compensation coefficient β is adjusted according to the interval where the initial compensation value is located.

[0082] Among them, the third threshold interval is preferably [2.2mmol / L, 3.0mmol / L], and the second threshold interval is preferably [1.7mmol / L, 2.2mmol / L].

[0083] In one embodiment, for the second user type with large blood sugar fluctuations, the adjustment strategy of the first compensation coefficient α is shown in Table 3.

[0084] Table 3

[0085]

[0086] After calculating the first compensation coefficient α according to the adjustment strategy in Table 1, substitute it into the self-defined ESA compensation formula to calculate the initial compensation value.

[0087] In a further embodiment, if the initial compensation value is less than or equal to the first set threshold value of 3.5 mmol / L, the adjustment strategy of the second compensation coefficient β is as shown in Table 4.

[0088] Table 4

[0089] Initial compensation value β regulation strategy Less than 2.2mmol / L β increases by 0.8 In the range of [2.2mmol / L, 3.0mmol / L] β increases by 0.5 In the range of [3.0mmol / L, 3.5mmol / L] β increases by 0.2 Other ranges No adjustment

[0090] The adjustment range of the first compensation coefficient α is limited to between -0.25 and 0, and the adjustment range of the second compensation coefficient β is limited to between 0 and 2.5. Thus, the adjustment of the ESA compensation coefficient adapted to the second type of users with large blood sugar fluctuations is completed.

[0091] The present invention is based on the basic principle of the continuous blood glucose monitoring device CGM, and customizes the ESA compensation algorithm and the ESA compensation formula. According to the user's real-time blood glucose value, the two compensation coefficients in the ESA compensation formula corresponding to different user types are adjusted in turn to compensate for the deviation blood glucose value output by the CGM, thereby outputting data that is more accurate and closer to the actual blood glucose value that adapts to the individual differences of users.

[0092] S105: Obtaining a compensated blood glucose value based on the real-time blood glucose value and the compensation formula until a compensation stop condition is met.

[0093] Specifically, the adjusted compensation coefficient obtained in the previous step is substituted into the ESA compensation formula to continuously compensate the real-time blood glucose value obtained by the CGM.

[0094] Furthermore, the compensation stop condition of the ESA compensation algorithm is:

[0095] (1) The duration of implantation of the continuous blood glucose monitoring device in the human body reaches the preset compensation time;

[0096] (2) the real-time blood glucose value exceeds a third set threshold;

[0097] (3) When the lowest value of the real-time blood glucose value is greater than or equal to the fourth set threshold, the compensation for the continuous blood glucose monitoring device of the first user type is stopped; when the lowest value of the real-time blood glucose value is greater than or equal to the fifth set threshold, the compensation for the continuous blood glucose monitoring device of the second user type is stopped; wherein the fourth set threshold is greater than the fifth set threshold.

[0098] As a feasible implementation method, since the ESA phenomenon occurs more frequently in the first few days when users start wearing the CGM device, the ESA compensation algorithm will take effect in the first few days of using the CGM device. After the preset compensation time, ESA compensation will no longer be performed.

[0099] During the preset compensation time, if the real-time blood glucose value calculated by the CGM basic principle formula during the ESA compensation process exceeds the third set threshold, the ESA compensation is stopped and the compensation coefficients α and β are reset to 0.

[0100] During the preset compensation time, if the minimum real-time blood glucose value of the first type of user within a certain set time period is not lower than the fourth set threshold value during the ESA compensation process, it is considered that the user will no longer experience the ESA phenomenon, and ESA compensation will not be performed subsequently. When the minimum real-time blood glucose value of the second type of user within a certain set time period is not lower than the fifth set threshold value, it is considered that the user will no longer experience the ESA phenomenon, and ESA compensation will not be performed subsequently. Compared with the first type of users, because the blood glucose volatility of the second type of users is greater, the setting of the blood glucose historical minimum value for the second type of users is lower than that for the first type of users. Therefore, the fifth set threshold value is set to be less than the fourth set threshold value.

[0101] The range of the third preset threshold is: [4mmol / L, 6mmol / L], preferably 5mmol / L. The range of the fourth preset threshold is: [3.5mmol / L, 4mmol / L), preferably 3.9mmol / L. The range of the fifth preset threshold is: [2.5mmol / L, 3.5mmol / L), preferably 3mmol / L. The range of the set time is 15 hours to 36 hours.

[0102] In one embodiment, after the user wears the CGM device for a preset compensation time of 3 days, ESA compensation is no longer performed.

[0103] Alternatively, within 3 days, if the real-time blood glucose value during the ESA compensation process exceeds the third set threshold of 5mmol / L, the ESA compensation is stopped, and the compensation coefficients α and β are reset to 0.

[0104] Alternatively, within 3 days, if during the ESA compensation process, the minimum real-time blood glucose value of the first category of users is not lower than the fourth set threshold value of 3.9mmol / L within the set time of 15 hours, it is considered that the user will no longer experience ESA phenomenon, and ESA compensation is stopped. If the minimum real-time blood glucose value of the second category of users is not lower than the fifth set threshold value of 3.0mmol / L within the set time of 15 hours, it is considered that the user will no longer experience ESA phenomenon, and ESA compensation is stopped.

[0105] It should be noted that each specific value listed in the above embodiment can be flexibly adjusted within a certain range, for example, 15 hours can be adjusted to 36 hours, and the threshold value can also be adjusted to other values, as long as the size relationship between the various threshold values ​​is satisfied. Therefore, the values ​​in the above embodiment are not used to limit the present solution, but are only exemplary descriptions for the purpose of describing the present solution clearly.

[0106] The present invention stipulates a variety of detailed compensation stop conditions according to the real-time blood glucose value obtained by CGM to avoid unnecessary compensation operations when ESA compensation is not needed, thereby ensuring the accuracy of the output blood glucose value in many aspects.

[0107] It should be noted that the entire solution of the present invention is an iterative process. Figure 2 Take this as an example to explain in detail.

[0108] Figure 2 A specific flow chart of a compensation method for a continuous blood glucose monitoring device provided by an embodiment of the present invention is as follows: Figure 2 As shown, firstly, the real-time blood glucose value of the user at the current moment is obtained through CGM, and then the user type and blood glucose trend type are determined according to the real-time blood glucose value. Further, it is determined whether the compensation start condition is met at the current moment according to the user type and blood glucose trend type. If not, it is continued to determine whether the compensation stop condition is met. If it is met, it is determined that the user will no longer produce ESA phenomenon and the algorithm is terminated directly; if not, the real-time blood glucose value at the next moment is continued to be obtained, and ESA compensation is not started temporarily. If the start condition is met, the ESA compensation algorithm is started, and the first compensation coefficient α is determined according to the real-time blood glucose value, blood glucose trend type and user type, and then the second compensation coefficient β is determined according to the initial compensation value and user type, so as to obtain the compensation formula. Further, the compensated blood glucose value is obtained through the compensation formula. Finally, it is determined whether the compensation stop condition is met at present according to parameters such as the real-time blood glucose value and the CGM usage time. If it is met, the ESA compensation is stopped. If the compensation stop condition is not met, the real-time blood glucose value at the next moment is continued to be obtained, and the above process is iterated and cycled.

[0109] The present invention continuously obtains the user's real-time blood glucose value through the continuous blood glucose monitoring device CGM, and divides the user type and blood glucose trend type according to the actual blood glucose value, and then determines the compensation start condition. After determining that the user has the ESA phenomenon, different compensation formulas are generated for users of different types and different blood glucose trend types based on the real-time blood glucose value, and the blood glucose data output by the CGM is corrected and compensated by the compensation formula to obtain more accurate blood glucose data. The present invention also provides detailed compensation start conditions and compensation stop conditions, which can ensure that no interference is performed when ESA compensation is not required, avoiding unnecessary ESA compensation. The method provided by the present invention can obtain data that is more accurate and closer to the actual blood glucose value, and is suitable for users with different degrees of blood glucose fluctuations, and will not be generalized. The impact of the ESA phenomenon on the stability and accuracy of CGM is greatly reduced.

[0110] In addition, the embodiment of the present invention also provides a compensation device for a continuous blood glucose monitoring device, such as Figure 3 As shown, the compensation device for the continuous blood glucose monitoring device specifically includes:

[0111] at least one processor; and a memory in communication with the at least one processor; wherein,

[0112] The memory stores instructions executable by at least one processor to enable the at least one processor to perform:

[0113] Continuously obtain the user's real-time blood sugar value;

[0114] Determining a user type and a blood sugar trend type according to the real-time blood sugar value; wherein the user type includes at least a first user type and a second user type;

[0115] Based on the real-time blood glucose value, determine whether the compensation start condition is met, and if so, start the compensation algorithm, determine the compensation formula based on the real-time blood glucose value, the blood glucose trend type and the user type, and obtain the compensated blood glucose value based on the real-time blood glucose value and the compensation formula until the compensation stop condition is met.

[0116] Each embodiment of the present invention is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the device, equipment, and non-volatile computer storage medium embodiments, since they are basically similar to the method embodiments, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiments.

[0117] The above describes specific embodiments of the present invention. In addition, the processes depicted in the accompanying drawings do not necessarily require the specific order or sequential order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0118] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the embodiments of the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the embodiments of the present invention should be included in the protection scope of the present invention.

Claims

1. A compensation method for a continuous blood glucose monitoring device, characterized in that: The method comprises: Continuously obtain the user's real-time blood sugar value; Determining a user type and a blood sugar trend type according to the real-time blood sugar value; wherein the user type includes at least a first user type and a second user type; Based on the real-time blood glucose value, determine whether the compensation start condition is met, and if so, start the compensation algorithm, determine the compensation formula based on the real-time blood glucose value, the blood glucose trend type and the user type, and obtain the compensated blood glucose value based on the real-time blood glucose value and the compensation formula until the compensation stop condition is met.

2. A compensation method for a continuous blood glucose monitoring device according to claim 1, characterized in that: The compensation formula includes a first compensation coefficient and a second compensation coefficient; Determine a first compensation coefficient according to the concentration interval of the real-time blood glucose value and the blood glucose trend type; substitute the first compensation coefficient into the initial formula to obtain an intermediate formula; A second compensation coefficient is determined based on the initial compensation value obtained from the intermediate formula, and the second compensation coefficient is substituted into the intermediate formula to obtain the compensation formula.

3. A compensation method for a continuous blood glucose monitoring device according to claim 2, characterized in that: When the initial compensation value obtained based on the intermediate formula is less than or equal to the first set threshold, the second compensation coefficient is determined according to the concentration range in which the initial compensation value is located; when the initial compensation value is not lower than the first set threshold, the intermediate formula is used as the compensation formula.

4. A compensation method for a continuous blood glucose monitoring device according to claim 1, characterized in that: The compensation formula is: Among them, GLU ESA is the blood glucose value after compensation, α is the first compensation coefficient and is a non-positive number, β is the second compensation coefficient and is a non-negative number, I w is the operating current of the continuous blood glucose monitoring device, K s In vivo sensitivity of continuous glucose monitoring devices, Real-time blood sugar value.

5. A compensation method for a continuous blood glucose monitoring device according to claim 1, characterized in that: If the falling speed of the real-time blood glucose value is lower than the first speed threshold and higher than the second speed threshold, the blood glucose trend type is a slow decline; If the decreasing speed of the real-time blood glucose value is lower than the second speed threshold, the blood glucose trend type is a rapid decrease; wherein the first speed threshold and the second speed threshold are both negative numbers.

6. A compensation method for a continuous blood glucose monitoring device according to claim 1, characterized in that: Within the preset compensation time after the continuous blood glucose monitoring device is implanted in the human body, if the highest value of the real-time blood glucose value never exceeds the second set threshold, the user type is the first user type; If the highest value of the real-time blood glucose level exceeds the second set threshold, the user type is the second user type.

7. A compensation method for a continuous blood glucose monitoring device according to claim 6, characterized in that: The compensation start conditions for the first user type are: the real-time blood glucose value is lower than the first start threshold, and the blood glucose trend type is a slow decline or a rapid decline; the compensation start conditions for the second user type are: the real-time blood glucose value is lower than the second start threshold, and the blood glucose trend type is a slow decline or a rapid decline; the first start threshold is greater than the second start threshold.

8. A compensation method for a continuous blood glucose monitoring device according to claim 6, characterized in that: The compensation stop condition is: The continuous blood glucose monitoring device is implanted in the human body for a preset compensation time; or The real-time blood glucose value exceeds a third set threshold; or, When the lowest value of the real-time blood glucose value is greater than or equal to the fourth set threshold, compensation for the continuous blood glucose monitoring device of the first user type is stopped; when the lowest value of the real-time blood glucose value is greater than or equal to the fifth set threshold, compensation for the continuous blood glucose monitoring device of the second user type is stopped; wherein the fourth set threshold is greater than the fifth set threshold.

9. A compensation method for a continuous blood glucose monitoring device according to claim 6, characterized in that: When the current user type is the first user type, If the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α=0.1×GLU-0.55; wherein GLU is the real-time blood glucose value; If the real-time blood glucose value is within the first threshold interval and the blood glucose trend type is a slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is a slow decline or a fast decline, the first compensation coefficient α is: α=0.1×GLU-0.5; wherein the minimum value of the first threshold interval is greater than the maximum value of the second threshold interval; When the current user type is the second user type, If the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is a rapid decline, the first compensation coefficient α is: α=0.05×GLU-0.29; If the real-time blood glucose value is within the third threshold interval and the blood glucose trend type is slow decline, or the real-time blood glucose value is within the second threshold interval and the blood glucose trend type is slow decline or rapid decline, the first compensation coefficient α is: α=0.05×GLU-0.25; wherein the minimum value of the third threshold interval is greater than the maximum value of the fourth threshold interval.

10. A compensation device for a continuous blood glucose monitoring device, characterized in that: The device comprises: at least one processor; and, a memory communicatively connected to the at least one processor; wherein, The memory stores instructions that can be executed by the at least one processor, so that the at least one processor can execute the compensation method for a continuous blood glucose monitoring device according to any one of claims 1-9.

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