A dynamic glucose monitoring system and a control method thereof

Abstract

The application provides a dynamic blood glucose monitoring system and a control method thereof, and relates to the field of test control. The method comprises the following steps: after the dynamic blood glucose monitoring system is woken up, a plurality of current values generated by a sensor in a predetermined period are obtained at a predetermined frequency; it is judged whether the initial current value generated by the sensor is zero; if yes, the initial current value is removed from the plurality of current values to obtain a current value sequence, and it is judged whether the current values in the current value sequence are sequentially increased and whether the number of current values in the current value sequence whose absolute value of the slope is not less than a preset absolute value of the slope is not less than a preset number; if yes, the dynamic blood glucose monitoring system is controlled to start blood glucose monitoring. The application can avoid the inconsistent situation of the time when the dynamic blood glucose monitoring system starts test caused by manual operation, thereby ensuring the accuracy of the measurement value of the dynamic blood glucose monitoring system, and avoiding the reuse of the implantable sensor without removing it from the body.

Description

Technical Field

[0001] This application relates to the field of test control, and in particular to a dynamic blood glucose monitoring system and its control method. Background Technology

[0002] The implanted sensor in a Continuous Glucose Monitoring System (CGMS) requires connection to an external Bluetooth device and manual operation after implantation before the system begins testing. This is inconvenient and not very intelligent. Furthermore, manual operation can cause inconsistencies in the start time of the sensor after implantation (e.g., starting immediately after implantation versus starting minutes or hours later; these differences can affect the algorithm), thus impacting the accuracy of the CGMS readings.

[0003] Furthermore, after the continuous glucose monitoring system automatically ends monitoring when it reaches its usage period, users may reset the transmitter using unconventional methods without removing the used sensor from their bodies, thus reusing the sensor. This can lead to inaccurate or abnormal test values, causing users to take incorrect remedial measures, such as taking medication at the wrong time or in the wrong dosage. In severe cases, it can even endanger the user's life.

[0004] Therefore, how to avoid inconsistencies in the start time of continuous glucose monitoring systems caused by manual operation, thereby ensuring the accuracy of the measurements, and at the same time, preventing the reuse of implantable sensors without removing them from the body, are technical problems that urgently need to be solved by those skilled in the art. Summary of the Invention

[0005] To address the aforementioned technical problems, this application provides a control method for a continuous glucose monitoring (CGM) system. This method avoids inconsistencies in the start time of the CGM system caused by manual operation, thereby ensuring the accuracy of the CGM measurements. Simultaneously, it prevents the implanted sensor from being reused without being removed from the body. This application also provides a CGM system with the same technical effects.

[0006] The first objective of this application is to provide a control method for a dynamic blood glucose monitoring system.

[0007] The aforementioned objective of this application is achieved through the following technical solution:

[0008] A control method for a dynamic blood glucose monitoring system, comprising:

[0009] Once the dynamic blood glucose monitoring system is activated, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency.

[0010] Determine whether the initial current value generated by the sensor is zero. If so, then: remove the initial current value from the plurality of current values ​​to obtain a current value sequence, and determine whether the current values ​​in the current value sequence increase sequentially, and whether the number of current values ​​in the current value sequence whose absolute slope value is not less than a preset absolute slope value is not less than a preset number. If so, then:

[0011] Control the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0012] Preferably, in the control method of the dynamic blood glucose monitoring system, after determining that the current values ​​in the current value sequence increase sequentially and that the number of times the absolute value of the slope of the current value sequence is not less than a preset absolute value of the slope is not less than a preset number, the method further includes:

[0013] Determine whether the slope values ​​of multiple consecutive current values ​​in the current value sequence are not equal. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0014] Preferably, in the control method of the dynamic blood glucose monitoring system, after determining that the slope values ​​of multiple consecutive current values ​​in the current value sequence are not equal, the method further includes:

[0015] Determine whether the proportion of current values ​​in the current value sequence that are located in a preset current value interval including the endpoints is not less than a preset proportion. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0016] Preferably, in the control method of the dynamic blood glucose monitoring system, after determining that the proportion of current values ​​in the current value sequence that are located within a preset current value interval including the endpoints is not less than a preset proportion, the method further includes:

[0017] The number of first differences in the current value sequence where the difference between adjacent current values ​​is not less than a preset lower limit, and the number of second differences in the current value sequence where the difference between adjacent current values ​​is not greater than a preset upper limit, are obtained.

[0018] Determine whether the number of the first difference is not less than the first preset threshold and whether the number of the second difference is not less than the second preset threshold. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0019] Preferably, the control method for the continuous glucose monitoring system further includes, after controlling the continuous glucose monitoring system to start glucose monitoring, the following:

[0020] If the total number of glucose concentration values ​​acquired by the dynamic blood glucose monitoring system exceeds a preset total, or if the total duration of current acquisition by the dynamic blood glucose monitoring system exceeds a preset duration, then the dynamic blood glucose monitoring system is controlled to stop blood glucose monitoring.

[0021] Preferably, in the control method of the dynamic blood glucose monitoring system, the preset slope absolute value and the preset quantity are determined by the following steps:

[0022] A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment.

[0023] Calculate the absolute value of the slope for each current value in each of the detected current value sequences to obtain multiple absolute slope value sequences;

[0024] From each of the slope absolute value sequences, the minimum value among the preset number of larger values ​​of the slope absolute value is selected to obtain a slope absolute value selection sequence containing multiple minimum values;

[0025] The minimum value in the sequence of absolute slope values ​​is selected as the preset absolute slope value.

[0026] The preset quantity is any value among 3, 4 or 5.

[0027] Preferably, in the control method of the dynamic blood glucose monitoring system, the preset current value range and the preset percentage are determined by the following steps:

[0028] A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment.

[0029] Obtain the minimum value in each of the detected current value sequences to form a lower limit sequence containing multiple minimum current values;

[0030] Obtain the maximum value in each of the detected current value sequences to form an upper limit sequence containing multiple maximum current values;

[0031] The minimum value in the lower limit sequence is used as the lower limit of the preset current value range, and the maximum value in the upper limit sequence is used as the upper limit of the preset current value range.

[0032] The preset percentage is any value between 0.7 and 1.

[0033] Preferably, in the control method of the dynamic blood glucose monitoring system, the preset lower limit of the difference and the preset upper limit of the difference are determined by the following steps:

[0034] A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment.

[0035] Calculate the absolute value of the difference between all adjacent current values ​​in each of the detected current value sequences to obtain multiple absolute difference value sequences;

[0036] From each of the absolute difference sequences, select the first minimum value among the larger values ​​of the first preset threshold absolute difference to obtain a first sequence containing multiple first minimum values;

[0037] From each of the absolute difference sequences, select the first maximum value among the smaller values ​​of the second preset threshold in the absolute difference to obtain a second sequence containing multiple first maximum values;

[0038] The minimum value in the first sequence is used as the preset lower limit of the difference, and the maximum value in the second sequence is used as the preset upper limit of the difference.

[0039] Preferably, in the control method of the dynamic blood glucose monitoring system, the first preset threshold is any value among 3, 4 and 5;

[0040] The second preset threshold is the number of current values ​​in the current value sequence minus 1.

[0041] The second objective of this application is to provide a dynamic blood glucose monitoring system.

[0042] The second objective of this application is achieved through the following technical solution:

[0043] A dynamic blood glucose monitoring system includes: a sensor and a data processing unit for receiving signals acquired by the sensor, wherein the data processing unit is used to execute instructions to implement any one of the control methods of the dynamic blood glucose monitoring system described above.

[0044] In the above technical solution, after the continuous glucose monitoring system is activated, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency. Since the sensor did not come into contact with glucose before implantation, its initial current value after starting operation is zero. If the sensor is not removed from the body after implantation, its initial current value will not be zero. Furthermore, by determining whether the initial current value generated by the sensor is zero, the continuous glucose monitoring system can be triggered to start blood glucose monitoring only when the initial current value is zero. This prevents patients from resetting the device through unconventional means without removing the sensor, thus avoiding the reuse of the implanted sensor. Furthermore, by removing the initial current value from the multiple current values ​​to obtain a current value sequence, and by determining whether the current values ​​in the current value sequence increase sequentially and whether the number of times the absolute value of the slope of the current value sequence is not less than a preset absolute value is not less than a preset number, it can be determined whether the sensor is operating normally. When these conditions are met, the continuous glucose monitoring system is automatically controlled to start blood glucose monitoring. This avoids inconsistencies in the start time of the continuous glucose monitoring system caused by manual operation, thereby ensuring the accuracy of the continuous glucose monitoring system's measurements. Attached Figure Description

[0045] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0046] Figure 1 This is a flowchart illustrating a control method for a dynamic blood glucose monitoring system provided in an embodiment of this application.

[0047] Figure 2 This is another flowchart illustrating a control method for a dynamic blood glucose monitoring system provided in this application embodiment;

[0048] Figure 3 This is a schematic diagram of the structure of a dynamic blood glucose monitoring system provided in the embodiments of this application. Detailed Implementation

[0049] To enable those skilled in the art to better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0050] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "a plurality of" or "several" means two or more, unless otherwise explicitly specified.

[0051] If a flowchart is used in this application, it is used to illustrate the operations performed by the system according to embodiments of this application. It should be understood that the preceding or following operations are not necessarily performed in exact order. Instead, the steps can be processed in reverse order or simultaneously. Furthermore, other operations can be added to these processes, or one or more steps can be removed from them.

[0052] It should also be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase “comprising one…” does not exclude the presence of other identical elements in the article or device that includes the aforementioned element.

[0053] Continuous glucose monitoring (CGM) is an innovative technological breakthrough in the field of blood glucose monitoring. It reflects blood glucose levels by continuously monitoring the glucose concentration in the subcutaneous intercellular fluid. CGM accurately and automatically records a patient's blood glucose levels and related events (medication, insulin, diet, exercise, and others). Through an external client, it downloads complete daily blood glucose charts, multi-day blood glucose charts, pre- and post-meal blood glucose charts, blood glucose charts for specific time periods, and statistical data reports. This provides comprehensive blood glucose information, revealing patterns of hyperglycemia, hypoglycemia, and blood glucose fluctuations that are often difficult to detect otherwise. It also helps understand the relationship between oral medications, insulin, diet, exercise, and blood glucose, providing valuable clinical evidence for developing and evaluating rational and individualized hypoglycemic treatment plans. Furthermore, it effectively aids in diabetes patient education, improving patient awareness and adherence to treatment.

[0054] The embodiments in this application are written in a progressive manner.

[0055] like Figure 1 As shown in the figure, this application provides a control method for a dynamic blood glucose monitoring system, including:

[0056] S101. After the dynamic blood glucose monitoring system is activated, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency.

[0057] In S101, the continuous glucose monitoring system may include a sensor and a transmitter. The sensor reacts with glucose in subcutaneous tissue fluid to generate an electric current. The transmitter provides an excitation voltage to the sensor and collects the current data generated by the sensor at regular intervals. The current data is processed to obtain the glucose value and then transmitted to an external client. The transmitter's internal circuitry may include a device wake-up circuit, an IV converter and voltage amplification circuit, an ADC acquisition circuit, and a Bluetooth MCU data processing, control, and Bluetooth data transmission circuit. Specifically, the device wake-up circuit can detect the device status to wake up the transmitter, enabling it to provide the excitation voltage to trigger the sensor to start operating. After being woken up, the transmitter begins monitoring the current value generated by the sensor. When glucose reacts with the sensor, an electric current is generated. This current passes through the IV converter and voltage amplification circuit, and then through the ADC acquisition circuit to transmit the collected voltage data to the Bluetooth MCU. The Bluetooth MCU calculates the corresponding current value. The predetermined period and predetermined frequency can be determined according to actual application requirements. For example, the predetermined period can be set to three minutes, and the predetermined frequency can be set to collect data once every 10 seconds. This application is not limited to these settings. It should be noted that the transmitter can also be designed for other types of circuits, and the sensor can be an existing blood glucose sensor, such as an electrochemical blood glucose sensor. In a dynamic blood glucose monitoring system, other types of functional modules can also be reasonably used to collect the current value generated by the sensor. This application does not limit this.

[0058] S102. Determine whether the initial current value generated by the sensor is zero. If so, proceed to S103.

[0059] In step S102, after the continuous glucose monitoring system is activated, it immediately begins acquiring the current value generated by the sensor, thus obtaining the initial current value. Before implantation, the sensor had not come into contact with glucose, so the initial current generated after the sensor started operating was zero. After implantation, if the sensor is not removed from the body, the initial current will not be zero. This step determines whether the initial current value generated by the sensor is zero. Only when the initial current value is zero can the continuous glucose monitoring system be triggered to start blood glucose monitoring. This prevents patients from resetting the device through unconventional means without removing the sensor, thus avoiding the reuse of the implanted sensor and preventing inaccurate or abnormal test values.

[0060] S103. Remove the initial current value from multiple current values ​​to obtain a current value sequence, and determine whether the current values ​​in the current value sequence increase sequentially and whether the number of current values ​​in the current value sequence whose slope absolute value is not less than the preset slope absolute value is not less than the preset number. If so, execute S104.

[0061] In S103, the initial current value is zero, and its magnitude differs significantly from other acquired current values, making subsequent comparison and judgment difficult. Therefore, the initial current value is first removed from the multiple current values ​​to obtain a current value sequence. After the sensor is implanted, the current value will increase at a certain slope during normal operation. By judging whether the current values ​​in the current value sequence increase sequentially, it can be determined whether the current value generated by the sensor is in an upward state. By judging whether the number of times the absolute value of the slope of the current value in the current value sequence is not less than the preset absolute value of the slope is not less than a preset number, it can be determined whether the slope of the current value meets the start-up requirements. The calculation method of the current value slope can be determined according to the actual application requirements. For example, it can be calculated using two points, that is, the slope calculated by the current current value and the next current value is used as the slope of the current point; it can also be calculated using three points, that is, the average of the two slopes calculated by the current current value and the next and last current values ​​is used as the slope of the current current value; it can also be calculated using other methods, and this application is not limited to these. The slope of the current value generated during normal operation after sensor implantation is related to the performance of the sensor itself. Therefore, the preset absolute value of the slope and the preset quantity can be obtained by conducting batch tests on sensors of the same type and batch. The preset absolute value of the slope can be calculated in the same way as the slope of the current value in this step during the statistical calculation process. The preset absolute value of the slope and the preset quantity can also be obtained directly through other methods, and this application is not limited to this.

[0062] S104. Control the continuous glucose monitoring system to start glucose monitoring.

[0063] In S104, when the current values ​​in the current value sequence increase sequentially, and the number of times the absolute value of the slope of the current value in the current value sequence is not less than the preset absolute value of the slope is not less than the preset number, the dynamic blood glucose monitoring system is automatically controlled to start blood glucose monitoring without the need for manual start-up. This avoids the inconsistency in the start-up time of the dynamic blood glucose monitoring system caused by manual operation, thereby ensuring the accuracy of the measurement values ​​of the dynamic blood glucose monitoring system.

[0064] Existing continuous glucose monitoring (CGM) systems require implanted sensors that connect to the transmitter via an external Bluetooth device after implantation, necessitating manual operation for the CGM system to begin testing. This is neither convenient nor intelligent. Furthermore, manual operation can lead to inconsistent start times for the implanted sensors, affecting the accuracy of the CGM readings. Additionally, after the CGM system automatically terminates monitoring at the end of its lifespan, users may attempt to reset the transmitter without removing the sensor, potentially leading to inaccurate or abnormal readings. This could result in incorrect remedial actions, such as incorrect medication timing or dosage, and in severe cases, even endanger the user's life.

[0065] In the above embodiments, after the continuous glucose monitoring system is activated, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency. Since the sensor did not come into contact with glucose before implantation, the initial current value generated after the sensor starts operating is zero. If the sensor is not removed from the body after implantation, the initial current value will not be zero. Furthermore, by determining whether the initial current value of the sensor is zero, the continuous glucose monitoring system can be triggered to start blood glucose monitoring only when the initial current value is zero. This prevents patients from resetting the device through unconventional means without removing the sensor, thus avoiding the reuse of the implanted sensor. Furthermore, by removing the initial current value from the multiple current values ​​to obtain a current value sequence, and by determining whether the current values ​​in the current value sequence increase sequentially and whether the number of times the absolute value of the slope of the current values ​​in the current value sequence is not less than a preset absolute value, it can be determined whether the sensor is operating normally. When the conditions are met, the continuous glucose monitoring system is automatically controlled to start blood glucose monitoring. This avoids inconsistencies in the start time of the continuous glucose monitoring system caused by manual operation, thereby ensuring the accuracy of the continuous glucose monitoring system's measurements.

[0066] In other embodiments of this application, the preset absolute value of the slope and the preset quantity can be determined by the following steps:

[0067] S201. Obtain a sequence of multiple detected current values ​​after removing the initial current value, obtained by multiple sensors performing current detection at a predetermined frequency within a predetermined period under a simulated detection environment.

[0068] In S201, multiple sensors of the same type and batch can be extracted according to the type of sensor used in the dynamic blood glucose monitoring system. Under a simulated testing environment, current testing is performed at the same predetermined period and frequency as in step S101 to obtain multiple detection current value sequences after removing the initial current value. The number of sensors can be determined according to actual testing needs. For example, the number of sensors can be 100. A certain amount of test data is used to ensure the reliability of the test.

[0069] S202. Calculate the absolute value of the slope of each current value in each detection current value sequence to obtain multiple absolute slope value sequences;

[0070] In S202, the method for calculating the slope of each current value in each detection current value sequence can be determined according to actual application requirements. For example, it can adopt the two-point calculation or three-point calculation method described above, which can be consistent with the method for calculating the slope of the current value in step S103. By calculating the absolute value of the slope of each current value in each detection current value sequence, a sequence of absolute slope values ​​corresponding to each detection current value sequence can be obtained.

[0071] S203. From each slope absolute value sequence, select the minimum value among a preset number of larger values ​​of slope absolute value to obtain a slope absolute value selection sequence containing multiple minimum values, wherein the preset number is any value among 3, 4 or 5.

[0072] In S203, specifically, for each slope absolute value sequence, the minimum value among a preset number of larger values ​​of slope absolute value can be selected, and then a slope absolute value selection sequence is formed based on all the selected minimum values.

[0073] S204. Select the minimum value in the sequence as the preset absolute slope value;

[0074] In S204, the minimum value in the sequence of absolute slope values ​​is selected as the preset absolute slope value.

[0075] The preset slope absolute value determined by the above steps can characterize the standard that the slope of the current value generated by the sensor meets the start-up condition, and can accurately reflect the performance of the sensor. By judging whether the number of current values ​​in the current value sequence whose slope absolute value is not less than the preset slope absolute value is not less than the preset number, it is possible to more accurately determine whether the sensor is operating normally. When the condition is met, the dynamic blood glucose monitoring system is automatically controlled to start blood glucose monitoring.

[0076] In a specific embodiment, 100 sensors can be randomly selected, and current detection can be performed in a simulated detection environment through a dynamic blood glucose monitoring system. After the dynamic blood glucose monitoring system is activated, the current value generated by one sensor is collected every 10 seconds. The current values ​​of all sensors in the first three minutes are recorded to obtain a sequence of 100 detection current values ​​after removing the initial current value.

[0077] Suppose that the sequence of detected current values ​​for sensor A out of 100 sensors is as follows: 22.6, 26.4, 28.5, 34.2, 42.3, 50.8, 58.6, 69.7, 85.2, 97.3, 82.4, 70.2, 63.4, 55.3, 49.5, 44.9, 40.8, 36.3, in nA. Using 10 seconds as one horizontal axis unit and 10 nA as one vertical axis unit, the line connecting each pair of adjacent current values ​​has a slope. The formula for calculating the absolute value of the slope is as follows:

[0078] |Slope|=|(Y2-Y1)| / 10

[0079] In the formula, Y2 represents the later current value among two adjacent current values, and Y1 represents the earlier current value among two adjacent current values.

[0080] The absolute value sequence of the slopes of adjacent current values ​​of sensor A (take one decimal place) is: 0.4, 0.2, 0.6, 0.8, 0.9, 0.8, 1.1, 1.6, 1.2, 1.5, 1.2, 0.7, 0.8, 0.6, 0.5, 0.4, 0.5.

[0081] For the absolute slope value sequence of sensor A, with a preset quantity of 3, the minimum value of 1.2 among the three larger absolute slope values ​​(i.e., 1.6, 1.5, 1.2) is selected. In other words, sensor A has at least three adjacent current values ​​with an absolute slope value ≥ 1.2.

[0082] Following the above process, a total of 100 minimum values ​​corresponding to the sensors that meet the requirements are obtained, forming a slope absolute value selection sequence containing 100 minimum values.

[0083] Finally, the minimum value of the absolute slope in the sequence is taken as the preset absolute slope value for this batch of sensors. It should be noted that the above specific embodiments are only examples. The current magnitudes of different sensor schemes are different, and the preset absolute slope value needs to be set according to the corresponding sensor scheme. The preset absolute slope value can also be obtained by other reasonable methods, and this application is not limited to this.

[0084] In other embodiments of this application, after determining that the current values ​​in the current value sequence increase sequentially and that the number of times the absolute value of the slope of the current value sequence is not less than a preset absolute value of the slope is not less than a preset number, the method further includes:

[0085] S301. Determine whether the slope values ​​of multiple consecutive current values ​​in the current value sequence are not equal. If so, execute the step of controlling the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0086] In step S301, under normal circumstances, the current value collected by the sensor should fluctuate to some extent, and correspondingly, the slope of the current values ​​in the current value sequence will also change to some extent. In this step, the calculation method for the slope of the current value can refer to step S103 above. The fluctuation state of the slope is evaluated by judging whether the slope values ​​of multiple consecutive current values ​​in the current value sequence are unequal. Multiple consecutive current values ​​can be set according to actual needs; for example, it can be 3, 5, or other consecutive values. This application does not impose any restrictions on this. In this step, when it is determined that the slope values ​​of multiple consecutive adjacent current values ​​in the current value sequence are equal, it can be determined that the slope has no change, that is, the change in the slope value of the current value does not meet the start-up requirements. When it is determined that the slope values ​​of multiple consecutive current values ​​in the current value sequence are unequal, it can be determined that the slope has a certain fluctuation, that is, the change in the slope value of the current value meets the start-up requirements, thereby triggering the continuous glucose monitoring system to start glucose monitoring. Based on the above judgment process, by adding the judgment condition of slope fluctuation, it is possible to more accurately assess whether the sensor is in a normal working state.

[0087] In other embodiments of this application, after determining that the slopes of multiple consecutive current values ​​in the current value sequence are not equal, the method further includes:

[0088] S401. Determine whether the proportion of current values ​​in the current value sequence that are located in the preset current value interval containing the endpoints is not less than the preset proportion. If so, execute the step of controlling the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0089] In S401, the preset current value range and preset percentage can be set according to actual application requirements. For example, they can be obtained through batch testing based on sensor type. The preset current value range serves as the upper and lower limits of the starting threshold for the current value generated by the sensor, used to verify whether the sensor is in normal working condition. Based on the above judgment process, by setting a judgment condition that the percentage of current values ​​in the current value sequence that fall within the preset current value range including the endpoints is not lower than the preset percentage, it is possible to more accurately assess whether the sensor is in normal working condition.

[0090] In other embodiments of this application, the preset current value range can be determined by the following steps:

[0091] S501. Obtain a sequence of multiple detected current values ​​after removing the initial current value, obtained by multiple sensors performing current detection at a predetermined frequency within a predetermined period under a simulated detection environment.

[0092] For details of the specific implementation of S501, please refer to the above-mentioned S201.

[0093] S502. Obtain the minimum value in each detection current value sequence to form a lower limit sequence containing multiple minimum current values;

[0094] S503. Obtain the maximum value in each detected current value sequence to form an upper limit sequence containing multiple maximum current values;

[0095] In S502 and S503, specifically, a lower limit sequence containing all minimum current values ​​and an upper limit sequence containing all maximum current values ​​can be constructed based on the minimum and maximum values ​​in each detected current value sequence. It should be noted that the execution order of S502 and S503 can be interchanged or executed simultaneously without affecting the implementation of this embodiment.

[0096] S504. The minimum value in the lower limit sequence is used as the lower limit of the preset current value range, and the maximum value in the upper limit sequence is used as the upper limit of the preset current value range;

[0097] In S504, the minimum value in the lower limit sequence is used to characterize the lower limit standard of the start-up threshold of the current value generated by this type of sensor; and the maximum value in the upper limit sequence is used to characterize the upper limit standard of the start-up threshold of the current value generated by this type of sensor.

[0098] The preset current value range determined by the above steps can characterize the upper and lower limits of the current value generated by the sensor to meet the start-up conditions, and can accurately reflect the performance of the sensor. By judging whether the proportion of the current values ​​in the current value sequence that are located in the preset current value range including the endpoints is not lower than the preset proportion, it can be more accurate to determine whether the sensor is operating normally. When the conditions are met, the dynamic blood glucose monitoring system is automatically controlled to start blood glucose monitoring.

[0099] In some embodiments, the preset percentage is any value between 0.7 and 1. That is, when the current value in the current value sequence that is not lower than the preset percentage is within the preset current value range, the current sensor is considered to be working normally, and then the dynamic blood glucose monitoring system is automatically controlled to start blood glucose monitoring.

[0100] In a specific embodiment, 100 sensors can be randomly selected, and current detection can be performed in a simulated detection environment through a dynamic blood glucose monitoring system. After the dynamic blood glucose monitoring system is activated, the current value generated by one sensor is collected every 10 seconds. The current values ​​of all sensors in the first three minutes are recorded to obtain a sequence of 100 detection current values ​​after removing the initial current value.

[0101] Suppose that the detection current value sequence of a certain sensor A out of 100 sensors is as follows: 22.6, 26.4, 28.5, 34.2, 42.3, 50.8, 58.6, 69.7, 85.2, 97.3, 82.4, 70.2, 63.4, 55.3, 49.5, 44.9, 40.8, 36.3, in nA.

[0102] As shown above, the minimum current value of the current value sequence of sensor A is 22.6 nA and the maximum current value is 97.3 nA. Similarly, based on the current value sequences of the 99 sensors in the same batch as sensor A, a total of 100 current value sequences can be obtained, which contain the maximum and minimum current values. This forms a lower limit sequence containing 100 minimum current values ​​and an upper limit sequence containing 100 maximum current values.

[0103] Finally, the minimum value of the lower limit sequence is taken as the lower limit of the preset current value range for this batch of sensors, and the maximum value of the upper limit sequence is taken as the upper limit of the preset current value range for this batch of sensors, thus obtaining the preset current value range. It should be noted that the current magnitudes of different sensor schemes are different, and the preset current value range needs to be set according to the corresponding sensor scheme. The preset current value range can also be obtained by other reasonable methods, and this application is not limited to these.

[0104] In other embodiments of this application, after determining that the proportion of current values ​​in the current value sequence that are located within a preset current value interval including the endpoints is not less than a preset proportion, the method further includes:

[0105] S601. Obtain the first number of current value differences in the current value sequence that are not less than a preset lower limit of difference, and the second number of current value differences in the current value sequence that are not greater than a preset upper limit of difference;

[0106] In S601, the preset lower limit and preset upper limit of the difference can be set according to actual application requirements. For example, they can be obtained statistically from batch tests based on sensor type. They serve as the upper and lower limit standards for the difference between adjacent current values ​​generated by the sensor to meet the start-up conditions, and are used to verify whether the sensor is in normal working condition. In some embodiments, for the convenience of numerical comparison, the difference between adjacent current values ​​can be taken as the absolute value before being compared with the preset lower limit or upper limit of the difference, which does not affect the implementation of this embodiment.

[0107] S602. Determine whether the number of first differences is not less than the first preset threshold and whether the number of second differences is not less than the second preset threshold. If so, execute the step of controlling the dynamic blood glucose monitoring system to start blood glucose monitoring.

[0108] In S602, the first preset threshold and the second preset threshold can be set according to actual application requirements. Based on the above judgment process, by setting the judgment conditions of whether the number of first differences is not less than the first preset threshold and whether the number of second differences is not less than the second preset threshold, it is possible to more accurately assess whether the sensor is in normal working condition.

[0109] In other embodiments of this application, the preset lower limit and preset upper limit of the difference are determined by the following steps:

[0110] S701. Obtain a sequence of multiple detected current values ​​after removing the initial current value, obtained by multiple sensors performing current detection at a predetermined frequency within a predetermined period under a simulated detection environment.

[0111] For details of the specific implementation of S701, please refer to S201 above.

[0112] S702. Calculate the absolute value of the difference between all adjacent current values ​​in each detection current value sequence to obtain multiple absolute value difference sequences;

[0113] In S702, by calculating the absolute value of the difference between all adjacent current values ​​in each detection current value sequence, a sequence of absolute difference values ​​corresponding to each detection current value sequence can be obtained.

[0114] S703. From each sequence of absolute difference values, select the first minimum value among the larger values ​​of the first preset threshold absolute difference values ​​to obtain a first sequence containing multiple first minimum values;

[0115] In S703, specifically, for each sequence of absolute difference values, the first minimum value among the larger values ​​of the first preset threshold absolute difference values ​​can be selected, and then a first sequence is formed based on all the selected first minimum values. The first sequence is used for the subsequent selection of the preset lower limit of difference.

[0116] S704. From each sequence of absolute difference values, select the first maximum value among the smaller values ​​of the second preset threshold absolute difference values ​​to obtain a second sequence containing multiple first maximum values;

[0117] In S704, specifically, for each sequence of absolute difference values, the first maximum value among the smaller values ​​of the second preset threshold absolute difference values ​​can be selected, and then a second sequence is formed based on all the selected first maximum values. The second sequence is used for the subsequent selection of the preset upper limit of difference.

[0118] It should be noted that the execution order of S703 and S704 can be interchanged or executed simultaneously, without affecting the implementation of this embodiment.

[0119] S705. Use the minimum value in the first sequence as the preset lower limit of the difference, and use the maximum value in the second sequence as the preset upper limit of the difference.

[0120] In S705, the minimum value in the first sequence is used as the preset lower limit of the difference, and the maximum value in the second sequence is used as the preset upper limit of the difference. The minimum value in the first sequence can be understood as the difference between adjacent current values ​​generated by each sensor meeting the lower limit standard of the start-up condition, and the maximum value in the second sequence can be understood as the difference between adjacent current values ​​generated by each sensor meeting the upper limit standard of the start-up condition.

[0121] The preset lower limit and preset upper limit of the difference determined by the above steps can characterize the upper and lower limit standards of the difference between adjacent current values ​​generated by the sensor to meet the start-up conditions, which can accurately reflect the performance of the sensor. By judging whether the number of the first difference is not less than the first preset threshold and whether the number of the second difference is not less than the second preset threshold, it can be more accurately determined whether the sensor is operating normally. When the conditions are met, the dynamic blood glucose monitoring system is automatically controlled to start blood glucose monitoring.

[0122] In some embodiments, the first preset threshold is any value among 3, 4 and 5; the second preset threshold is the number of current values ​​in the current value sequence minus 1. Accordingly, it can be understood that in the above S704, the maximum value of the absolute difference is selected from each absolute difference sequence to obtain a second sequence containing all the maximum values.

[0123] In a specific embodiment, 100 sensors can be randomly selected, and current detection can be performed in a simulated detection environment through a dynamic blood glucose monitoring system. After the dynamic blood glucose monitoring system is activated, the current value generated by one sensor is collected every 10 seconds. The current values ​​of all sensors in the first three minutes are recorded to obtain a sequence of 100 detection current values ​​after removing the initial current value.

[0124] Suppose that the detection current value sequence of a certain sensor A out of 100 sensors is as follows: 22.6, 26.4, 28.5, 34.2, 42.3, 50.8, 58.6, 69.7, 85.2, 97.3, 82.4, 70.2, 63.4, 55.3, 49.5, 44.9, 40.8, 36.3, in nA.

[0125] The absolute value of the difference between two adjacent current values ​​is equal to |Y2-Y1|, where Y2 represents the later current value and Y1 represents the earlier current value.

[0126] Accordingly, the absolute value sequence of the difference for sensor A is calculated as 3.8, 2.1, 5.7, 8.1, 8.5, 7.8, 11.1, 15.5, 12.1, 14.9, 12.2, 6.8, 8.1, 5.8, 4.6, 4.1, 4.5.

[0127] For the sequence of absolute differences of sensor A, when the first preset threshold is 3, the first minimum value of 12.2 among the three larger absolute differences (i.e., 15.5, 14.9, 12.2) is selected. That is, sensor A has at least three adjacent current values ​​with an absolute difference ≥ 12.2. When the second preset threshold is 17, the first maximum value of 15.5 among the 17 smaller absolute differences (i.e., 15.5, 14.9, 12.2, 12.1, 11.1, 8.5, 8.1, 8.1, 7.8, 6.8, 5.8, 5.7, 4.6, 4.5, 4.1, 3.8, 2.1) is selected. That is, the absolute difference of all adjacent current values ​​of sensor A is ≤ 15.5.

[0128] Following the above process, a total of 100 sensors are obtained, each corresponding to a first minimum value and a first maximum value that meet the requirements. These constitute a first sequence containing 100 first minimum values ​​and a second sequence containing 100 first maximum values, respectively.

[0129] Finally, the minimum value of the first sequence is taken as the preset lower limit of the difference for this batch of sensors, and the maximum value of the second sequence is taken as the preset upper limit of the difference for this batch of sensors. It should be noted that the above specific embodiments are only examples. The current magnitudes of different sensor schemes are different. The preset lower limit and preset upper limit of the difference need to be set according to the corresponding sensor scheme. The preset lower limit and preset upper limit of the difference can also be obtained by other reasonable methods, and this application is not limited to them.

[0130] like Figure 2 As shown, in another embodiment of this application, another control method for a dynamic blood glucose monitoring system is also provided, including:

[0131] S801. After the dynamic blood glucose monitoring system is woken up, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency.

[0132] S802. Determine if the initial current value generated by the sensor is zero. If so, execute S803.

[0133] S803. Remove the initial current value from multiple current values ​​to obtain a current value sequence, and determine whether the current values ​​in the current value sequence increase sequentially and whether the number of current values ​​in the current value sequence whose slope absolute value is not less than the preset slope absolute value is not less than the preset number. If so, execute S804.

[0134] For specific implementation details of S801 to S803, please refer to S101 to S103 above.

[0135] S804. Determine whether the slope values ​​of multiple consecutive current values ​​in the current value sequence are not equal. If so, execute S805.

[0136] For details on the implementation of S804, please refer to S301 above.

[0137] S805. Determine whether the proportion of current values ​​in the current value sequence that are located in the preset current value interval containing the endpoints is not less than the preset proportion. If so, execute S806.

[0138] For details on the implementation of S805, please refer to S401 above.

[0139] S806. Obtain the first number of current value differences in the current value sequence that are not less than a preset lower limit of difference, and the second number of current value differences in the current value sequence that are not greater than a preset upper limit of difference;

[0140] S807. Determine whether the number of first differences is not less than the first preset threshold and whether the number of second differences is not less than the second preset threshold. If so, execute S808.

[0141] For details on the implementation of S806 to S807, please refer to the above-mentioned S601 to S602.

[0142] S808. Controls the continuous glucose monitoring system to start glucose monitoring;

[0143] For details on the specific implementation of S808, please refer to S104 above.

[0144] S809. Determine whether the total number of glucose concentration values ​​acquired by the dynamic blood glucose monitoring system exceeds the preset total number, or determine whether the total duration of current acquisition by the dynamic blood glucose monitoring system exceeds the preset duration. If either of them is true, then execute S810.

[0145] In S809, after the continuous glucose monitoring system starts monitoring blood glucose, it determines whether the continuous glucose monitoring system has reached its service life by judging whether the total number of glucose concentration values ​​acquired by the system exceeds a preset total, or whether the total duration of current acquisition by the system exceeds a preset duration. The preset total and preset duration can be determined according to actual application needs. For example, the preset total can be 7200; when the total number of glucose concentration values ​​exceeds 7200, the continuous glucose monitoring system has reached its service life.

[0146] S810. Control the continuous glucose monitoring system to stop glucose monitoring.

[0147] In S810, when one of the judgment conditions in S809 is met, namely when the continuous glucose monitoring system reaches its service life, the continuous glucose monitoring system is automatically controlled to stop glucose monitoring without manual operation.

[0148] In this embodiment, by determining whether the initial current value generated by the sensor is zero, it avoids the user resetting the device and starting a second test without removing the sensor after the expiration of the usage period. Furthermore, based on the judgment process in S802 to S807, it can more accurately assess whether the sensor is in normal working condition. When the preset judgment conditions are met, the continuous glucose monitoring system can be automatically controlled to start blood glucose monitoring, thus avoiding inconsistencies in the start time of the continuous glucose monitoring system caused by manual operation, thereby ensuring the accuracy of the continuous glucose monitoring system's measurements. By determining whether the continuous glucose monitoring system has reached its usage period, it can automatically stop blood glucose monitoring after the usage period is reached, without requiring manual operation.

[0149] like Figure 3 As shown, in another embodiment of this application, a dynamic blood glucose monitoring system 10 is also provided, including: a sensor 11 and a data processing unit 12 for receiving signals collected by the sensor 11, wherein the data processing unit 12 is used to execute instructions to implement any one of the control methods of the dynamic blood glucose monitoring system described above.

[0150] The sensor 11 can be an existing blood glucose sensor, such as an electrochemical blood glucose sensor. The data processing unit 12 may include one or more processing cores. The data processing unit 12 can be at least one of an application-specific integrated circuit, a digital signal processor, a digital signal processing device, a programmable logic device, a field-programmable gate array, a central processing unit, a controller, a microcontroller, and a microprocessor. Understandably, for different devices, the electronic devices used to implement the functions of the data processing unit 12 may also be other types.

[0151] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A control method for a dynamic blood glucose monitoring system, characterized in that, include: Once the dynamic blood glucose monitoring system is activated, it immediately acquires multiple current values ​​generated by the sensor within a predetermined period at a predetermined frequency. Determine whether the initial current value generated by the sensor is zero. If so, then: remove the initial current value from the plurality of current values ​​to obtain a current value sequence, and determine whether the current values ​​in the current value sequence increase sequentially, and whether the number of current values ​​in the current value sequence whose absolute slope value is not less than a preset absolute slope value is not less than a preset number. If so, then: Control the dynamic blood glucose monitoring system to start blood glucose monitoring.

2. The method as described in claim 1, characterized in that, After determining that the current values ​​in the current value sequence increase sequentially, and that the number of times the absolute value of the slope of the current value sequence is not less than a preset absolute value is not less than a preset number, the process further includes: Determine whether the slope values ​​of multiple consecutive current values ​​in the current value sequence are not equal. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

3. The method as described in claim 2, characterized in that, After determining that the slopes of multiple consecutive current values ​​in the current value sequence are not equal, the process further includes: Determine whether the proportion of current values ​​in the current value sequence that are located in a preset current value interval including the endpoints is not less than a preset proportion. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

4. The method as described in claim 3, characterized in that, After determining that the proportion of current values ​​in the current value sequence that fall within a preset current value interval including the endpoints is not less than a preset proportion, the process further includes: The number of first differences in the current value sequence where the difference between adjacent current values ​​is not less than a preset lower limit, and the number of second differences in the current value sequence where the difference between adjacent current values ​​is not greater than a preset upper limit, are obtained. Determine whether the number of the first difference is not less than the first preset threshold and whether the number of the second difference is not less than the second preset threshold. If so, control the dynamic blood glucose monitoring system to start blood glucose monitoring.

5. The method according to any one of claims 1-4, characterized in that, After the control system for continuous glucose monitoring begins glucose monitoring, the method further includes: If the total number of glucose concentration values ​​acquired by the dynamic blood glucose monitoring system exceeds a preset total, or if the total duration of current acquisition by the dynamic blood glucose monitoring system exceeds a preset duration, then the dynamic blood glucose monitoring system is controlled to stop blood glucose monitoring.

6. The method as described in claim 1, characterized in that, The absolute value of the preset slope and the preset quantity are determined by the following steps: A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment. Calculate the absolute value of the slope for each current value in each of the detected current value sequences to obtain multiple absolute slope value sequences; From each of the slope absolute value sequences, the minimum value among the preset number of larger values ​​of the slope absolute value is selected to obtain a slope absolute value selection sequence containing multiple minimum values; The minimum value in the sequence of absolute slope values ​​is selected as the preset absolute slope value. The preset quantity is any value among 3, 4 or 5.

7. The method as described in claim 3, characterized in that, The preset current value range and the preset percentage are determined by the following steps: A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment. Obtain the minimum value in each of the detected current value sequences to form a lower limit sequence containing multiple minimum current values; Obtain the maximum value in each of the detected current value sequences to form an upper limit sequence containing multiple maximum current values; The minimum value in the lower limit sequence is used as the lower limit of the preset current value range, and the maximum value in the upper limit sequence is used as the upper limit of the preset current value range. The preset percentage is any value between 0.7 and 1.

8. The method as described in claim 4, characterized in that, The preset lower limit and the preset upper limit of the difference are determined by the following steps: A sequence of multiple detected current values, after removing the initial current value, is obtained by multiple sensors performing current detection at the predetermined frequency within the predetermined period under a simulated detection environment. Calculate the absolute value of the difference between all adjacent current values ​​in each of the detected current value sequences to obtain multiple absolute difference value sequences; From each of the absolute difference sequences, select the first minimum value among the larger values ​​of the first preset threshold absolute difference to obtain a first sequence containing multiple first minimum values; From each of the absolute difference sequences, select the first maximum value among the smaller values ​​of the second preset threshold in the absolute difference to obtain a second sequence containing multiple first maximum values; The minimum value in the first sequence is used as the preset lower limit of the difference, and the maximum value in the second sequence is used as the preset upper limit of the difference.

9. The method as described in claim 8, characterized in that, The first preset threshold is any value among 3, 4, and 5; The second preset threshold is the number of current values ​​in the current value sequence minus 1.

10. A dynamic blood glucose monitoring system, characterized in that, It includes: a sensor and a data processing unit for receiving signals acquired by the sensor, the data processing unit being used to execute instructions to implement the method as described in any one of claims 1 to 9.

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