Insulin infusion method, infusion system and sugar management system

Abstract

The invention provides an insulin infusion method, an infusion system and a sugar management system. The infusion method comprises the steps that a first electric signal generated by a first working electrode is obtained, and a second electric signal generated by a second working electrode is obtained; wherein the first working electrode and the second working electrode are configured to respectively measure the glucose concentration in the same user body; judging whether the glucose concentration measurement work of the infusion system is abnormal or not based on the first electric signal and the second electric signal; if the measurement work is abnormal, the infusion state of the infusion device is adjusted; wherein the infusion device is configured to be capable of infusing insulin into the body of a user. According to the insulin infusion method, the infusion system and the glucose management system provided by the invention, the measurement error of the measurement result of the glucose concentration can be judged, and when the measurement error exceeds a reasonable range, the abnormality of the measurement work of the infusion system can be found in time.

Description

Technical Field

[0001] The present specification relates to the technical field of insulin infusion, and in particular to an insulin infusion method, an infusion system and a sugar management system. Background Art

[0002] In recent years, insulin infusion technology represented by artificial pancreas has developed rapidly. The artificial pancreas (also known as closed-loop insulin infusion system) consists of three parts: continuous glucose monitoring system (CGM system), insulin pump and blood glucose controller. It can automatically infuse appropriate doses of insulin into the user's body according to the glucose concentration monitored by the CGM system, so that blood sugar is within the target control range, playing a strong and positive role in diabetes management.

[0003] In the construction of an artificial pancreas, it is very important that the CGM system can provide timely and accurate blood sugar concentration data. Incorrect blood sugar concentration data will cause the blood sugar controller to issue incorrect insulin infusion instructions, which will fail to achieve the effect of simulating the pancreas and even endanger the patient's life.

[0004] The working principle of the CGM system is very complicated, the production process is difficult, the yield rate of mass production is low, and not all commercialized CGM system products are reliable. On the one hand, the data accuracy and reliability of the CGM system worn by the user may not be high. On the other hand, the user's immune response, physical damage to the sensor and other reasons may cause the CGM system to decrease in accuracy or work abnormally. These factors have greatly affected the application and promotion of artificial pancreas products.

[0005] Therefore, it is necessary to provide an insulin infusion method that can determine the reliability of the blood glucose measurement results of the CGM system.

[0006] The content of the background technology section is only the information known to the inventor personally, and does not mean that the above information has entered the public domain before the application date of this disclosure, nor does it mean that it can become the prior art of the present disclosure. Summary of the invention

[0007] This manual provides an insulin infusion method, an infusion system, and a sugar management system, which can solve the problems existing in the related technologies.

[0008] In a first aspect, the present specification provides an insulin infusion method, which is applied to an insulin infusion system. The infusion method comprises:

[0009] Acquire a first electrical signal generated by the first working electrode, and acquire a second electrical signal generated by the second working electrode; wherein the first working electrode and the second working electrode are configured to respectively measure the glucose concentration in the body of the same user;

[0010] Based on the first electrical signal and the second electrical signal, determining whether the measurement of glucose concentration by the infusion system is abnormal;

[0011] If the measurement is abnormal, the infusion state of the infusion device is adjusted; wherein the infusion device is configured to be able to infuse insulin into the user's body.

[0012] In some embodiments, based on the first electrical signal and the second electrical signal, determining whether the measurement of glucose concentration by the infusion system is abnormal includes:

[0013] determining a first set of measurement values ​​for glucose concentration based on the first electrical signal, and determining a second set of measurement values ​​for glucose concentration based on the second electrical signal;

[0014] Based on the difference between the measured values ​​of the first measurement value group and the second measurement value group, it is determined whether the measurement operation is abnormal.

[0015] In some embodiments, judging whether the measurement operation is abnormal based on the difference between the measurement values ​​of the first measurement value group and the second measurement value group includes:

[0016] Calculate the first set of measurements and the second measurement set The difference degree value of

[0017] Compare the difference degree value with the preset difference threshold;

[0018] If the difference value is greater than the preset difference threshold, the measurement is judged to be abnormal.

[0019] In some embodiments, the difference degree value includes at least one of a paired absolute relative difference (PARD value), a mean absolute difference (MAD value), a mean absolute relative difference (MARD value), a root mean square error (RMSE value), a normalized root mean square error (NRMSE value), or a bias value (BIAS value);

[0020] Among them, the calculation formula of the paired absolute relative difference (PARD value) is:

[0021]

[0022] The calculation formula of mean absolute difference (MAD value) is:

[0023]

[0024] The calculation formula of the mean absolute relative difference (MARD value) is:

[0025]

[0026] The calculation formula of the root mean square error (RMSE value) is:

[0027]

[0028] The calculation formula for the standardized root mean square error (NRMSE value) is:

[0029] in express The average value of

[0030] The calculation formula of the deviation value (BIAS value) is:

[0031]

[0032] In some embodiments, adjusting the infusion state of the infusion device comprises:

[0033] Control the infusion device to stop infusing insulin.

[0034] In some embodiments, based on the first electrical signal and the second electrical signal, determining whether the measurement of glucose concentration by the infusion system is abnormal includes:

[0035] Acquire a signal difference between the first electrical signal and the second electrical signal;

[0036] Based on the signal difference, determine whether the measurement work is abnormal.

[0037] In some embodiments, based on the first electrical signal and the second electrical signal, determining whether the measurement of glucose concentration by the infusion system is abnormal includes:

[0038] Acquire a third electrical signal generated by the third working electrode; wherein the third working electrode is configured to measure the glucose concentration in the user's body separately with the first working electrode and the second working electrode;

[0039] Based on the first electrical signal, the second electrical signal and the third electrical signal, it is determined whether the measurement of glucose concentration by the infusion system is abnormal.

[0040] In a second aspect, the present specification provides an insulin infusion system, the infusion system comprising:

[0041] an infusion device configured to deliver insulin into a user;

[0042] a first working electrode configured to measure glucose concentration;

[0043] a second working electrode configured to measure glucose concentration; and

[0044] A sugar management system is connected in communication with the infusion device, the first working electrode, and the second working electrode, and includes:

[0045] at least one storage medium storing at least one instruction set for controlling the operation of the infusion system; and

[0046] at least one processor, in communication with at least one storage medium,

[0047] When the sugar management system is running, at least one processor reads at least one instruction set and executes the method provided in the first aspect according to the instructions of the at least one instruction set.

[0048] In some embodiments, the sugar management system includes a control system, the control system is in communication with the infusion device, and is configured to adjust the infusion state of the infusion device when an abnormality occurs in the measurement work; the control system includes a third processor;

[0049] The third processor is configured to determine whether the measurement of glucose concentration by the infusion system is abnormal based on the first electrical signal and the second electrical signal.

[0050] In some embodiments, the infusion system comprises:

[0051] a first sensor comprising a first processor and a first working electrode; and

[0052] a second sensor including a second processor and a second working electrode;

[0053] Among them, the first processor is electrically connected to the first working electrode and is configured to determine a first measurement value group of glucose concentration based on the first electrical signal; the second processor is electrically connected to the second working electrode and is configured to determine a second measurement value group of glucose concentration based on the second electrical signal.

[0054] In some embodiments, the infusion system includes a first CGM system and a second CGM system; the first CGM system includes a first transmitter and a first sensor, and the first transmitter is communicatively connected to the first processor and the third processor respectively; the second CGM system includes a second transmitter and a second sensor, and the second transmitter is communicatively connected to the second processor and the third processor respectively.

[0055] In some embodiments, the infusion system includes a third CGM system, the third CGM system includes a first transmitter, a first sensor, and a second sensor; the first transmitter is communicatively connected to the first processor, the second processor, and the third processor, respectively.

[0056] In some embodiments, the infusion system includes a third sensor; the third sensor includes a first processor, a first working electrode, and a second working electrode; wherein the first processor is electrically connected to the first working electrode and the second working electrode, and is configured to determine a first measurement value group of glucose concentration based on the first electrical signal, and to determine a second measurement value group of glucose concentration based on the second electrical signal.

[0057] In a third aspect, the present specification provides a sugar management system, comprising:

[0058] at least one storage medium storing at least one instruction set for controlling the operation of the infusion system; and

[0059] at least one processor, in communication with at least one storage medium,

[0060] When the sugar management system is running, at least one processor reads at least one instruction set and executes the method provided in the first aspect according to the instructions of the at least one instruction set.

[0061] It can be seen from the above technical solutions that the insulin infusion method, infusion system and sugar management system provided in this specification can judge the measurement error of the glucose concentration measurement result through at least two working electrodes, and promptly discover the abnormality of the measurement work of the infusion system when the measurement error exceeds a reasonable range, thereby reducing the risk of large deviations in the timing and dosage of insulin infusion, which is beneficial for the user's blood sugar to be maintained within a reasonable range, thereby reducing the risks to the user.

[0062] Other features of the insulin infusion method, infusion system, and sugar management system provided by this specification will be partially listed in the following description. Based on the description, the content introduced by the following figures and examples will be obvious to those of ordinary skill in the art. The creative aspects of the insulin infusion method, infusion system, and sugar management system provided by this specification can be fully explained by practicing or using the methods, devices, and combinations described in the following detailed examples. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] In order to more clearly illustrate the technical solutions in the embodiments of this specification, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this specification. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0064] Figure 1 It is a schematic diagram of the structure of a traditional closed-loop insulin infusion system;

[0065] Figure 2 It is a schematic structural diagram of a highly safe closed-loop insulin infusion system of the present invention;

[0066] Figure 3 The data of glucose concentration in human tissue fluid detected by two normally working CGMs in the same time period;

[0067] Figure 4 The data of glucose concentration in human tissue fluid detected by two abnormally working CGMs in the same time period;

[0068] Figure 5 A schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification;

[0069] Figure 6 A schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification;

[0070] Figure 7 A schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification;

[0071] Figure 8 A schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification;

[0072] Fig. 9 A schematic block diagram showing a partial circuit structure of an infusion system provided according to some embodiments of the present specification;

[0073] Fig.10 A schematic block diagram showing a partial circuit structure of an infusion system provided according to some embodiments of the present specification;

[0074] Fig.11 A schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification; and

[0075] Fig.12 A flow chart of an infusion method provided according to some embodiments of the present specification is shown. DETAILED DESCRIPTION

[0076] The following description provides specific application scenarios and requirements of this specification, with the purpose of enabling those skilled in the art to make and use the contents of this specification. Various local modifications to the disclosed embodiments will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of this specification. Therefore, this specification is not limited to the embodiments shown, but to the widest scope consistent with the claims.

[0077] The terms used herein are only used for the purpose of describing specific example embodiments and are not restrictive. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an" and "the" may also include plural forms. When used in this specification, the terms "include", "comprise" and / or "contain" mean that the associated features, integers, steps, operations, elements and / or components exist, but do not exclude the existence of one or more other features, integers, steps, operations, elements, components and / or groups or that other features, integers, steps, operations, elements, components and / or groups may be added in the system / method.

[0078] In view of the following description, these and other features of the present specification, as well as the operation and function of the related elements of the structure, and the economy of the combination and manufacture of the parts can be significantly improved. Reference is made to the accompanying drawings, all of which form a part of this specification. However, it should be clearly understood that the drawings are for illustration and description purposes only and are not intended to limit the scope of this specification. It should also be understood that the drawings are not drawn to scale.

[0079] The flowcharts used in this specification illustrate the operations implemented by the system according to some embodiments in this specification. It should be clearly understood that the operations of the flowcharts may not be implemented in sequence. On the contrary, the operations may be implemented in reverse order or simultaneously. In addition, one or more other operations may be added to the flowchart. One or more operations may be removed from the flowchart.

[0080] In this specification, "X includes at least one of A, B or C" means that X includes at least A, or X includes at least B, or X includes at least C. That is, X may include only any one of A, B, and C, or may include any combination of A, B, and C and other possible contents / elements at the same time. The any combination of A, B, and C may be A, B, C, AB, AC, BC, or ABC.

[0081] In this specification, unless explicitly stated otherwise, the association relationship between structures can be a direct association relationship or an indirect association relationship. For example, when describing "A is connected to B", unless it is explicitly stated that A is directly connected to B, it should be understood that A can be directly connected to B or indirectly connected to B; for another example, when describing "A is above B", unless it is explicitly stated that A is directly above B (AB is adjacent and A is above B), it should be understood that A can be directly above B or indirectly above B (AB is separated by other elements and A is above B). And so on.

[0082] In recent years, insulin infusion technology represented by artificial pancreas has developed rapidly. The artificial pancreas (also known as closed-loop insulin infusion system) consists of three parts: a continuous glucose monitoring (CGM) system, an insulin pump, and a blood glucose controller. It can automatically infuse appropriate doses of insulin into the user's body based on the glucose concentration monitored by the CGM system, so that blood sugar is within the target control range, playing a powerful and positive role in diabetes management.

[0083] In the construction of an artificial pancreas, it is very important that the CGM system can provide timely and accurate blood sugar concentration data. Incorrect blood sugar concentration data will cause the blood sugar controller to issue incorrect insulin infusion instructions, which will fail to achieve the effect of simulating the pancreas and even endanger the patient's life.

[0084] The working principle of the CGM system is very complicated, the production process is difficult, the yield rate of mass production is low, and not all commercialized CGM system products are reliable. On the one hand, the data accuracy and reliability of the CGM system worn by the user may not be high. On the other hand, the user's immune response, physical damage to the sensor and other reasons may cause the CGM system to decrease in accuracy or work abnormally. These factors have greatly affected the application and promotion of artificial pancreas products.

[0085] See also Figure 1 , the traditional artificial pancreas includes a CGM system 1', an insulin pump 2' and an intelligent terminal (smartphone) 3' equipped with an insulin control system. The CGM system 1' and the insulin pump 2' respectively transmit data to the insulin control system of the intelligent terminal 3' via Bluetooth to achieve communication between the devices, thereby helping to calculate the insulin dose required in the user's body. Based on the readings of the CGM system 1', the insulin control system automatically makes decisions about the insulin infusion dose and infusion time. Due to the lack of reference data, the system cannot determine whether the concentration data given by a single CGM system 1' is accurate. Once the glucose concentration data given by the CGM system 1' is abnormal, this will cause the system to issue an erroneous infusion instruction to the insulin pump.

[0086] The purpose of the present invention is to overcome the defects of the prior art and provide a highly safe closed-loop insulin infusion system. The infusion system may have at least two CGM systems. By evaluating the consistency of the glucose concentration data detected by all CGM systems within a specified time period, it is determined whether the CGM system is working normally and whether the glucose concentration data is valid, so as to calculate the dose and time of insulin infusion, which can effectively avoid incorrect insulin injection caused by CGM abnormalities and inaccurate detection data, and improve the safety of the closed-loop insulin infusion system.

[0087] The technical solution to achieve the above purpose may be: a highly secure closed-loop insulin infusion system comprises an insulin pump, an insulin control system and at least two CGM systems; the insulin control system obtains at least two sets of matching glucose concentration measurement values ​​from at least two CGM systems simultaneously worn by the same patient; the insulin control system evaluates the accuracy of the CGM system by calculating the paired absolute relative difference based on the obtained at least two sets of matching glucose concentration measurement values, and the paired absolute relative difference is defined as the PARD value; if the PARD value is greater than the PARD setting value in the insulin control system within the same time period, it is considered that the CGM system is working abnormally, and the credibility of the obtained glucose concentration measurement value data is low, and the insulin control system controls the insulin pump to stop working and stop infusing insulin; if the PARD value is less than or equal to the PARD setting value in the insulin control system within the same time period, it is considered that the CGM system is working normally, and the insulin control system calculates the dosage and time of insulin infusion based on the patient's current and historical glucose concentrations, living habits and the current paired absolute relative difference PARD value, and controls the insulin pump to start working to infuse insulin.

[0088] The above-mentioned high-safety closed-loop insulin infusion system, wherein each CGM system adopts an independently operated CGM system, or the at least two CGM systems are replaced by a single CGM product that simultaneously includes two or more biosensors that can independently detect glucose concentrations, or the at least two CGM systems are replaced by a single CGM product that includes a single biosensor provided with two or more working electrodes that can independently detect glucose concentrations.

[0089] The above-mentioned high-safety closed-loop insulin infusion system, wherein all CGM systems are worn on the same part or different parts of the same patient, and the different parts can be symmetrically or asymmetrically distributed on the patient's body.

[0090] In the above-mentioned high-safety closed-loop insulin infusion system, the calculation formula of the PARD value is:

[0091]

[0092] There are N pairs of glucose concentration measurements, each pair of glucose concentration measurements and Respectively from two matched CGM systems.

[0093] The above-mentioned high-safety closed-loop insulin infusion system, wherein N in the N pairs of glucose concentration measurement values ​​is greater than or equal to 5.

[0094] The above-mentioned high-safety closed-loop insulin infusion system, wherein the same time period is the time period from time 1 to time 2, wherein time 2 is the current time, time 1 is the time before time 2, and the time interval between time 1 and time 2 is greater than or equal to 5 minutes.

[0095] In the above-mentioned high-safety closed-loop insulin infusion system, the PARD setting value is 15.

[0096] The above-mentioned high-safety closed-loop insulin infusion system, wherein the insulin control system is installed in an intelligent terminal.

[0097] The high-security closed-loop insulin infusion system of the present invention has at least two CGM systems. By evaluating the consistency of glucose concentration data detected by all CGM systems within a specified time period, it is determined whether the CGM system is working normally and whether the concentration data is valid, so as to calculate the dosage and time of insulin infusion. This can effectively avoid incorrect insulin injection caused by CGM system abnormalities and inaccurate detection data, thereby improving the safety of the closed-loop insulin infusion system.

[0098] In order to enable those skilled in the art to better understand the technical solution of the present invention, the specific implementation methods thereof are described in detail below in conjunction with the accompanying drawings:

[0099] See also Figure 3 The study found that the glucose concentration values ​​of human tissue fluid detected by two normally functioning CGM systems worn on the same part of the human body (upper arm or abdomen) or the same part of the body symmetrically on both sides (left and right upper arms, or symmetrical parts of the abdomen) are highly consistent (see Figure 3 ). Instead, see Figure 4 If one of the two CGM systems is malfunctioning or cannot accurately measure the glucose concentration, the two sets of data detected by the two CGM systems will be quite different, and the concentration trends will be completely different (see Figure 4 ). Using this feature, we develop methods to improve the reliability of CGM systems in closed-loop systems, thereby enhancing the safety of artificial pancreas.

[0100] See also Figure 2 An embodiment of the present invention is a highly secure closed-loop insulin infusion system, comprising an insulin pump 3, an insulin control system and at least two CGM systems, the two CGM systems are CGM1 and CGM2, and the insulin control system is installed on an intelligent terminal 4, which can be a smart phone.

[0101] The insulin control system obtains at least two sets of matching glucose concentration measurement values ​​from at least two CGM systems worn by the same patient at the same time; the insulin control system evaluates the accuracy of the CGM system by calculating the paired absolute relative difference based on the obtained at least two sets of matching glucose concentration measurement values, and the paired absolute relative difference is defined as the PARD value; if the PARD value is greater than the set value in the same time period, it is considered that the CGM system is working abnormally, and the credibility of the obtained glucose concentration measurement value data is low, and the insulin control system controls the insulin pump 3 to stop working and stop infusing insulin; if the PARD value is less than or equal to the set value in the same time period, it is considered that the CGM system is working normally, and the insulin control system calculates the dose and time of insulin infusion based on the patient's current and historical glucose concentration, living habits, and the current paired absolute relative difference PARD value, and controls the insulin pump 3 to start working to infuse insulin. The same time period is the time period from time 1 to time 2, where time 2 is the current time, time 1 is the time before time 2, and the time interval between time 1 and time 2 is greater than or equal to 5 minutes.

[0102] Paired absolute relative difference (PARD) is an important indicator to measure the accuracy of CGM system. Its calculation formula is:

[0103]

[0104] There are N pairs of glucose concentration measurements, each pair of glucose concentration measurements and They are from two matching CGM systems respectively. And N is greater than or equal to 5. The PARD setting value in the insulin control system is 15. The two matching CGM systems are worn on the same part or different parts of the same patient, and the different parts can be symmetrically or asymmetrically distributed on the patient's body.

[0105] Example 1

[0106] See also Figure 3 ,The two CGM systems collected a glucose concentration data every 5 minutes, and the glucose concentration data detected by each CGM system was transmitted to the insulin control system. The insulin control system obtained two sets of matched glucose concentration data from CGM1 and CGM2 within 24 hours, a total of 288 pairs, see Table 1.

[0107] Table 1: Two groups of 288 pairs of blood glucose concentration values ​​obtained from CGM1 and CGM2 every 5 minutes for 24 consecutive hours (December 23, 2023)

[0108]

[0109]

[0110]

[0111]

[0112] According to the 288 pairs of data in Table 1, the paired absolute relative differences (PARD values) of the time periods were calculated according to the inverse of 1, 3, 6, 12, and 24 hours, respectively, as shown in Table 2.

[0113] Table 2: Paired absolute relative difference table

[0114] 1 hour 3 hours 6 hours 12 hours 24 hours PARD value 2.05 3.43 4.30 4.75 5.86

[0115] The PARD values ​​calculated based on the two sets of data in the five time periods are far lower than the set value of 15. It can be seen that the human glucose concentration values ​​detected by CGM1 and CGM2 in these five time periods are highly consistent, which can confirm that the CGM system is working properly and the glucose concentration data obtained is of guiding significance. The insulin control system can dynamically calculate the amount and time of insulin infusion based on the patient's current and historical glucose concentration values, living habits and current PARD values, and control the insulin pump to infuse insulin.

[0116] Example 2

[0117] See also Figure 4 ,The two CGM systems collected a glucose concentration data every 5 minutes, and the glucose concentration data detected by each CGM system were transmitted to the insulin control system. The insulin control system obtained two sets of matched glucose concentration data from CGM1 and CGM2 within 24 hours, a total of 288 pairs, see Table 3.

[0118] Table 3: Two groups of 288 pairs of blood glucose concentration data obtained from CGM1 and CGM2 every 5 minutes for 24 consecutive hours (2024-3-21)

[0119]

[0120]

[0121]

[0122]

[0123] According to the 288 pairs of data in Table 3, the paired absolute relative differences (PARD values) of the time periods were calculated within 1, 3, 6, 12, and 24 hours respectively, as shown in Table 4.

[0124] Table 4: Paired absolute relative difference table

[0125] 1 hour 3 hours 6 hours 12 hours 24 hours PARD value 23.9 11.8 8.0 6.4 8.5

[0126] Although the PARD values ​​in the last 3, 6, 12, and 24 hours were lower than the set value of 15, the PARD values ​​calculated by the two sets of data in the last hour were 23.9, which was higher than the set value of 15. It can be seen that the human glucose concentration values ​​detected by CGM1 and CGM2 in the last hour were quite different, which can be used to judge that at least one of the CGM systems is working abnormally, and the obtained glucose concentration data has no guiding significance. The insulin control system judges that the CGM system is working abnormally, prompting manual intervention or replacement of the CGM system. At this time, it stops sending insulin infusion instructions to the insulin pump until the PARD value returns to the normal range.

[0127] In the closed-loop insulin infusion system of the above embodiment, the two CGM systems are two independently operated CGM systems, which can be replaced by a single CGM product that includes two or more biosensors that can independently detect glucose concentration, or a single CGM product that includes a single biosensor with two or more working electrodes that can independently detect glucose concentration.

[0128] The high-safety closed-loop insulin infusion system of the present invention has at least two CGM systems. When in use, all CGM systems are worn on the same part of the human body (upper arm or abdomen), or on the same part of the human body that is symmetrical on both sides (left and right upper arms, or symmetrical parts of the abdomen). By calculating the paired absolute relative difference (PARD value) of at least two sets of matching glucose concentration data, it is confirmed that the CGM system is working abnormally when the PARD value is higher than the set value.

[0129] Only when at least two CGMs are working properly and giving relatively consistent glucose concentration data values, that is, when the PARD value is within the set range, will the insulin control system issue an infusion instruction to the insulin pump, otherwise it will stop infusing insulin, which greatly improves the safety and effectiveness of the closed-loop system. The smaller the PARD value within a specified time period, the higher the accuracy of the CGM system, and the more effective the glucose concentration data obtained from the CGM system, which can be used to calculate the dose and time of insulin infusion.

[0130] In summary, the highly secure closed-loop insulin infusion system of the present invention has at least two CGM systems. When the glucose concentration data of all CGM systems are basically consistent within a specified time period, that is, when the PARD value is within a specified range, it can be determined that each CGM system is working properly and the concentration data provided is reliable. The dosage and time of insulin infusion can be calculated based on this, which can effectively avoid incorrect insulin injections and improve the safety of the closed-loop insulin infusion system.

[0131] In view of this, the embodiments of this specification provide an insulin infusion method, an infusion system, and a sugar management system. The first working electrode and the second working electrode are configured to measure the glucose concentration in the body of the same user respectively. The first electrical signal can be obtained through the first working electrode, and the second electrical signal can be obtained through the second working electrode. Based on the first electrical signal and the second electrical signal, it is determined whether the measurement of glucose concentration by the infusion system is abnormal. If the measurement is abnormal, the infusion state of the infusion device is adjusted. For example, the infusion device is an insulin pump, and when the measurement of glucose concentration is abnormal, the insulin pump stops infusing insulin into the human body. Through at least two working electrodes, the sugar management system can judge the measurement error of the measurement result of glucose concentration, and promptly detect the abnormality of the measurement work of the infusion system when the measurement error exceeds a reasonable range, reduce the risk of large deviations in the timing and dosage of insulin infusion, and help the user's blood sugar to maintain within a reasonable range, thereby reducing the risk to the user.

[0132] Below, the technical solution of the infusion system embodiment of this specification will be described in detail with reference to the accompanying drawings.

[0133] Figure 5 FIG. 2 is a schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification. Figure 5 As shown, the insulin infusion system 001 includes an infusion device 100, a first working electrode 201, a second working electrode 202 and a sugar management system 300. The infusion device 100 is configured to be able to infuse insulin into the user's body. The infusion device 100 may include at least one of an insulin syringe, an insulin pen or an insulin pump.

[0134] In some embodiments, the infusion device 100 is an insulin pump. The insulin pump is provided with an electric micromotor, which can provide a variety of infusion modes such as square wave and double wave for insulin, and has high compatibility with application scenarios. The insulin pump may include a patch-type insulin pump and a pipeline-type insulin pump. The insulin source of the patch-type insulin pump can be attached to the site where insulin is injected. The insulin source of the pipeline-type insulin pump is at a certain distance from the site where insulin is injected, and insulin is delivered to the human body through a pipeline.

[0135] The first working electrode 201 is configured to measure glucose concentration. The second working electrode 202 is configured to measure glucose concentration. In some embodiments, the first working electrode 201 and the second working electrode 202 are integrated into a probe structure of a sensor, which can reduce the insertion site on the human body. In some embodiments, the first working electrode 201 and the second working electrode 202 are spaced apart to be inserted into different parts of the human body, which is conducive to improving the working independence of the first working electrode 201 and the second working electrode 202.

[0136] Figure 6 Schematic block diagram of the circuit structure of the infusion system provided according to some embodiments of the present specification is shown. Figure 6 As shown, the infusion system 001 includes a third working electrode 203, and the third working electrode 203 is configured to measure the glucose concentration. The first working electrode 201, the second working electrode 202 and the third working electrode 203 can have the same structure or different structures. The material of the first working electrode 201, the second working electrode 202 and the third working electrode 203 can include a platinum electrode or a carbon electrode.

[0137] The working modes of the first working electrode 201 and the second working electrode 202 are described in detail below.

[0138] Figure 7 FIG. 2 is a schematic block diagram showing a circuit structure of an infusion system provided according to some embodiments of the present specification. Figure 7 As shown, in some embodiments, the infusion system 001 includes a first CGM system 401 and a second CGM system 402 .

[0139] like Figure 7 As shown, the first CGM system 401 includes a first sensor 410, and the first sensor 410 includes a first processor 321, a first working electrode 201, a first reference electrode and a first auxiliary electrode (counter electrode). The first auxiliary electrode and the first working electrode 201 form a loop to allow the current of the first working electrode 201 to flow smoothly. The first reference electrode can be used as a potential reference for the first working electrode 201.

[0140] The first sensor 410 may have a probe structure, for example, the probe structure is in the form of a soft needle. The first working electrode 201 may be arranged on the probe structure, so that the first working electrode 201 can be inserted into the human body with the probe. For example, the first working electrode 201 is inserted into the subcutaneous depth of 5mm-8mm, at which time the first working electrode 201 can contact the glucose in the human tissue fluid.

[0141] In some embodiments, glucose oxidase may be disposed on the first working electrode 201. When the first working electrode 201 is inserted into human skin, the glucose oxidase disposed on the first working electrode 201 contacts glucose in the human body and undergoes a redox reaction. In other embodiments, metal nanoparticles that can undergo a redox reaction with glucose are disposed on the surface of the first working electrode 201.

[0142] When the first working electrode 201 comes into contact with glucose, a redox reaction can occur. Correspondingly, a first electrical signal can be generated on the first working electrode 201, and the intensity of the first electrical signal is associated with the glucose concentration in contact with the first working electrode 201. The first processor 321 is electrically connected to the first working electrode 201 and is configured to determine a first set of measured values of the glucose concentration based on the first electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3..., 288). That is to say, the first processor 321 can receive the first electrical signal and is capable of determining the glucose concentration in contact with the first working electrode 201 based on the first electrical signal. Further, the glucose in contact with the first working electrode 201 is the glucose in interstitial fluid, and the first processor 321 can convert the glucose concentration in interstitial fluid into a blood glucose concentration value. The first set of measured values may include multiple blood glucose concentration values measured in chronological order, and the generation interval time of the blood glucose concentration values may be between 1 min and 10 min.

[0143] Figure 8 FIG. shows a schematic block diagram of the circuit structure of an infusion system provided according to some embodiments of the present specification. As Figure 8 shown, in some embodiments, the infusion system 001 includes a receiver 500. The first CGM system 401 may include a first transmitter 4011, and the first transmitter 4011 is communicatively connected to the first processor 321 and the receiver 500 respectively. For example, the first transmitter 4011 is connected to the first processor 321 through a conductor such as a wire, and the first transmitter 4011 is connected to the receiver 500 through a wireless communication method such as WiFi, Zigbee, Bluetooth, Lora, NB-lot, or 4G. The first transmitter 4011 can send the first set of measured values calculated by the first processor 321 to the receiver 500.

[0144] Among them, the receiver 500 may include a mobile device, a tablet computer, a laptop computer, a built-in device of a motor vehicle, or the like, or any combination thereof. In some embodiments, the mobile device may include a smart home device, a smart mobile device, a virtual reality device, an augmented reality device, or the like, or any combination thereof. In some embodiments, the smart home device may include a smart TV, a desktop computer, etc., or any combination. In some embodiments, the smart mobile device may include a smart phone, a smart watch, a personal digital assistant, a gaming device, a navigation device, etc., or any combination thereof. In some embodiments, the virtual reality device or the augmented reality device may include a virtual reality helmet, virtual reality glasses, virtual reality patches, augmented reality helmets, augmented reality glasses, augmented reality patches, or the like, or any combination thereof. For example, the virtual reality device or the augmented reality device may include AR glasses, a head-mounted display, VR, etc. In some embodiments, the built-in device in the motor vehicle may include an in-vehicle computer, an in-vehicle TV, etc.

[0145] In some embodiments, the receiver 500 may be installed with one or more applications (APPs). The APP can provide the user with the ability and interface to interact with the outside world through the network. Among them, a target APP is installed on the receiver 500, and the target APP can provide the user with a display interface and a control interface related to the infusion method P100 of this specification. Further, the target APP can also display the first measurement value group and the second measurement value group.

[0146] In some embodiments, the receiver 500 can provide the user with a display interface and a control interface related to the infusion method P100 of this specification through a mini-program, and display the first measurement value group and the second measurement value group.

[0147] In some embodiments, the infusion system 001 includes a server. The server is communicatively connected to the receiver 500 or the transmitter (including the first transmitter 4011 and the second transmitter 4021). The receiver 500 or the transmitter can send the first measurement value group and the second measurement value group to the server, and the server analyzes or performs other further processing on the first measurement value group and the second measurement value group to determine whether the glucose concentration measurement work is abnormal.

[0148] Further, the server can send the judgment result of whether the glucose concentration measurement work is abnormal to the receiver 500. Through the server and the receiver 500, a remote monitoring system for determining whether the glucose concentration measurement work is abnormal can be formed. Even if the monitor is not beside the blood glucose test subject, the monitor can remotely view the judgment result of whether the glucose concentration measurement work is abnormal through the receiver 500.

[0149] Such as Figure 7 As shown, the second CGM system 402 includes a second sensor 420, and the second sensor 420 includes a second processor 322 and a second working electrode 202. Similar to the first sensor 410, the second sensor 420 may also include a second auxiliary electrode and a second reference electrode.

[0150] When the second working electrode 202 comes into contact with glucose, a redox reaction may occur. Accordingly, a second electrical signal may be generated on the second working electrode 202, and the intensity of the second electrical signal is associated with the glucose concentration contacted by the second working electrode 202. The second processor 322 is electrically connected to the second working electrode 202 and is configured to determine a second set of measured values of the glucose concentration based on the second electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3..., 288). That is to say, the second processor 322 can receive the second electrical signal and can determine the glucose concentration contacted by the second working electrode 202 based on the second electrical signal. Further, the glucose contacted by the second working electrode 202 is the glucose in the interstitial fluid, and the second processor 322 can convert the glucose concentration in the interstitial fluid into a blood glucose concentration value. The second set of measured values may include multiple blood glucose concentration values measured in chronological order, and the generation interval time of the blood glucose concentration values may be between 1 min and 10 min.

[0151] As Figure 8 shown, the second CGM system 402 may further include a second transmitter 4021, and the second transmitter 4021 is communicatively connected to the second processor 322 and the receiver 500 respectively. For example, the second transmitter 4021 is connected to the second processor 322 through a conductor such as a wire, and the second transmitter 4021 is connected to the receiver 500 through a wireless communication method such as WiFi, Zigbee, Bluetooth, Lora, NB-lot or 4G. The second transmitter 4021 may send the second set of measured values calculated by the second processor 322 to the receiver 500.

[0152] Fig. 9 The schematic block diagram of a partial circuit structure of an infusion system provided according to some embodiments of the present specification is shown. As Fig. 9 shown, in some other embodiments, the infusion system 001 includes a third CGM system 403, and the third CGM system 403 includes a first transmitter 4011, a first sensor 410 and a second sensor 420. The first sensor 410 includes a first processor 321 and a first working electrode 201. The second sensor 420 includes a second processor 322 and a second working electrode 202. The first processor 321 is electrically connected to the first working electrode 201 and is configured to determine a first set of measured values of the glucose concentration based on the first electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3 ……, 288). The second processor 322 is electrically connected to the second working electrode 202 and is configured to determine a second set of measured values of the glucose concentration based on the second electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3 ……, 288). The first transmitter 4011 is communicatively connected to the first processor 321, the second processor 322, and the receiver 500 respectively. The first transmitter 4011 can send the first set of measured values calculated by the first processor 321 to the receiver 500, and can also send the second set of measured values calculated by the second processor 322 to the receiver 500.

[0153] Fig.10 Fig. shows a schematic block diagram of a partial circuit structure of an infusion system provided according to some embodiments of the present specification. As Fig.10 shown, in some other embodiments, the infusion system 001 includes a fourth CGM system 404, and the fourth CGM system 404 includes a third sensor 430 and a first transmitter 4011. The third sensor 430 includes a first processor 321, a first working electrode 201, and a second working electrode 202; wherein, the first processor 321 is electrically connected to the first working electrode 201 and the second working electrode 202 and is configured to determine a first set of measured values of the glucose concentration based on the first electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3 ……, 288). The first processor 321 is further configured to determine a second set of measured values of the glucose concentration based on the second electrical signal (i.e., the aforementioned In Tables 1 and 3, i = 1, 2, 3 ……, 288). The first transmitter 4011 is communicatively connected to the first processor 321 and the receiver 500 respectively. The first transmitter 4011 can send the first set of measured values and the second set of measured values calculated by the first processor 321 to the receiver 500.

[0154] As Figure 5 shown, the sugar management system 300 is communicatively connected to the infusion device 100, the first working electrode 201, and the second working electrode 202. The first working electrode 201 and the second working electrode 202 can contact the human body to generate electrical signals corresponding to the glucose concentration in the human body. The sugar management system 300 can calculate the blood glucose concentration of the user according to the electrical signals generated by the first working electrode 201 and the second working electrode 202. When the blood glucose concentration in the human body is too low, the sugar management system 300 can calculate the infusion dose of insulin and control the infusion device 100 to infuse an appropriate amount of insulin into the human body.

[0155] The sugar management system 300 includes at least one storage medium 310 and at least one processor 320. In some embodiments, the sugar management system 300 is disposed in the receiver 500.

[0156] At least one storage medium 310 stores at least one instruction set for controlling the operation of the infusion system 001. The storage medium 310 may include one or more of a magnetic disk, a read-only storage medium, or a random access storage medium. The storage medium 310 may also include a non-volatile random access memory.

[0157] At least one processor 320 is communicatively connected to at least one storage medium 310. When the glucose management system 300 runs, at least one processor reads at least one instruction set and executes the following infusion method P100 according to the instructions of the at least one instruction set.

[0158] The processor 320 may be in the form of one or more processors 320. According to some embodiments of the present specification, the processor 320 may include one or more hardware processors, such as a microcontroller, a microprocessor, a reduced instruction set computer (RISC), an application-specific integrated circuit (ASIC), an application-specific instruction set processor (ASIP), a central processing unit (CPU), a microcontroller unit (MCU), a graphics processing unit (GPU), a physics processing unit (PPU), a microcontroller unit, a digital signal processor (DSP), a field programmable gate array (FPGA), an advanced RISC machine (ARM), a programmable logic device (PLD), any circuit or processor capable of performing one or more functions, etc., or any combination thereof.

[0159] As Figure 5 and Figure 7 shown, in some embodiments, in the glucose management system 300, at least one processor 320 may include a first processor 321, a second processor 322, and a third processor 3011. As Figure 5 and Fig.10 shown, in some other embodiments, at least one processor 320 may also include a first processor 321 and a third processor 3011. Fig.11 shows a schematic block diagram of the circuit structure of the infusion system provided according to some embodiments of the present specification. As Figure 5 and Fig.11 shown, at least one processor 320 may also include a first processor 321, a second processor 322, a third processor 3011, and a fourth processor 3012.

[0160] It should be noted that the sugar management system 300 in this specification may also include only one processor 320 or more than 4 processors 320. Therefore, the operations and / or method steps disclosed in this specification may be executed by one processor 320 or jointly executed by multiple processors 320. For example, if the processor 320 of the sugar management system 300 executes step A and step B in this specification, it should be understood that step A and step B may also be jointly or separately executed by two different processors 320.

[0161] In some embodiments, as Fig.11 shown, the sugar management system 300 includes a control system 301. The control system 301 includes a third processor 3011. The third processor 3011 is configured to: determine whether the measurement operation of the glucose concentration by the infusion system 001 is abnormal based on the first electrical signal and the second electrical signal.

[0162] In some embodiments, the third processor 3011 may be disposed in the receiver 500.

[0163] In some embodiments, as Fig.11 shown, the third processor 3011 may be communicatively connected to the first transmitter 4011 and the second transmitter 4021, and communicatively connected to the first working electrode 201 through the first transmitter 4011 and communicatively connected to the second working electrode 202 through the second transmitter 4021. The first transmitter 4011 may send the first measurement value group calculated by the first processor 321 to the third processor 3011. The second transmitter 4021 may send the second measurement value group calculated by the second processor 322 to the third processor 3011.

[0164] In other embodiments, as Fig. 9 shown, the third processor 3011 may be communicatively connected to the first transmitter 4011, and communicatively connected to the first working electrode 201 and the second working electrode 202 through the first transmitter 4011. The first transmitter 4011 may send the first measurement value group calculated by the first processor 321 to the third processor 3011, and may also send the second measurement value group calculated by the second processor 322 to the third processor 3011.

[0165] After obtaining the first measurement value group and the second measurement value group, the third processor 3011 may calculate the difference degree value between the first measurement value group and the second measurement value group, and determine whether the measurement operation of the glucose concentration is abnormal according to the difference degree value.

[0166] The control system 301 is communicatively connected to the infusion device 100. In some embodiments, as Figure 7As shown, the third processor 3011 is communicatively connected to the infusion device 100 and is configured to adjust the infusion state of the infusion device 100 when an abnormality occurs in the measurement operation. Further, the third processor 3011 may be disposed in the infusion device 100.

[0167] When the third processor 3011 determines that the measurement operation of the glucose concentration is abnormal, it can adjust the infusion state of the infusion device 100, thereby reducing the risk of incorrect insulin infusion. When the third processor 3011 determines that the measurement operation of the glucose concentration is normal and when the blood glucose concentration in the human body is low, the third processor 3011 can calculate the infusion dose of insulin and control the infusion device 100 to infuse an appropriate amount of insulin into the human body.

[0168] In some other embodiments, as Fig.11 shown, the control system 301 includes a fourth processor 3012. The fourth processor 3012 is communicatively connected to the third processor 3011 and the infusion device 100 and is configured to adjust the infusion state of the infusion device 100 when an abnormality occurs in the measurement operation. Further, the fourth processor 3012 may be disposed in the infusion device 100.

[0169] When the third processor 3011 determines that the measurement operation of the glucose concentration is abnormal, it can send an instruction to the fourth processor 3012. The fourth processor 3012 can adjust the infusion state of the infusion device 100, thereby reducing the risk of incorrect insulin infusion. When the third processor 3011 determines that the measurement operation of the glucose concentration is normal and when the blood glucose concentration in the human body is low, the fourth processor 3012 can calculate the infusion dose of insulin and control the infusion device 100 to infuse an appropriate amount of insulin into the human body.

[0170] The above is the schematic solution of the infusion system 001 in this specification and the schematic solution of the sugar management system 300. It should be noted that the schematic solution of the infusion system 001 and the schematic solution of the sugar management system 300 belong to the same concept as the technical solution of the following infusion method P100. The detailed contents in the schematic solution of the infusion system 001 and the schematic solution of the sugar management system 300 and the technical solution of the following infusion method P100 can be referred to each other.

[0171] The insulin infusion method P100 is applied to the insulin infusion system 001, and the infusion method P100 can be executed by the sugar management system 300. For the convenience of description, the execution subject of the infusion method P100 will be collectively referred to as the sugar management system 300 hereinafter. Fig.12 The flowchart of an infusion method provided according to some embodiments of this specification is shown. As Fig.12 shown, the infusion method P100 includes:

[0172] S100: Obtain the first electrical signal generated by the first working electrode 201 and obtain the second electrical signal generated by the second working electrode 202; wherein, the first working electrode 201 and the second working electrode 202 are configured to separately measure the glucose concentration in the body of the same user.

[0173] S200: Based on the first electrical signal and the second electrical signal, determine whether the measurement work of the infusion system 001 on the glucose concentration is abnormal.

[0174] S300: If the measurement work is abnormal, adjust the infusion state of the infusion device 100; wherein, the infusion device 100 is configured to be able to infuse insulin into the user's body.

[0175] In some embodiments, determining whether the measurement work of the infusion system 001 on the glucose concentration is abnormal based on the first electrical signal and the second electrical signal includes: obtaining the signal difference between the first electrical signal and the second electrical signal; based on the signal difference, determining whether the measurement work is abnormal.

[0176] For example, the sugar management system 300 can determine the potential difference between the first electrical signal and the second electrical signal, and compare the potential difference with a preset potential difference threshold. If the potential difference is less than or equal to the preset potential difference threshold, it is determined that the measurement work of the infusion system 001 on the glucose concentration is normal. If the potential difference is greater than the preset potential difference threshold, it is determined that the measurement work of the infusion system 001 on the glucose concentration is abnormal.

[0177] In other embodiments, determining whether the measurement work of the infusion system 001 on the glucose concentration is abnormal based on the first electrical signal and the second electrical signal includes: determining a first measurement value group of the glucose concentration based on the first electrical signal, and determining a second measurement value group of the glucose concentration based on the second electrical signal; based on the measurement value difference between the first measurement value group and the second measurement value group, determining whether the measurement work is abnormal.

[0178] For example, the sugar management system 300 can train a measurement value difference model with the first measurement value group and the second measurement value group obtained when the measurement work is normal. When it is necessary to determine whether the measurement work is abnormal, input the first measurement value group and the second measurement value group into the measurement value difference model, and use the measurement value difference model to determine whether the measurement work is abnormal.

[0179] In some embodiments, based on the first measurement value group and the second measurement value group to determine whether the measurement work is abnormal includes: calculating the difference degree value between the first measurement value group and the second measurement value group; comparing the size of the difference degree value and the preset difference threshold; if the difference degree value is greater than the preset difference threshold, determining that the measurement work is abnormal.

[0180] Further, the difference degree value includes at least one of a paired absolute relative difference (PARD value), a mean absolute difference (MAD value), a mean absolute relative difference (MARD value), a root mean square error (RMSE value), a normalized root mean square error (NRMSE value), or a bias value (BIAS value).

[0181] Among them, the calculation formula for the paired absolute relative difference (PARD value) is:

[0182]

[0183] The calculation formula for the mean absolute difference (MAD value) is:

[0184]

[0185] The calculation formula for the mean absolute relative difference (MARD value) is:

[0186]

[0187] The calculation formula for the root mean square error (RMSE value) is:

[0188]

[0189] The calculation formula for the normalized root mean square error (NRMSE value) is:

[0190] Where represents the average value of.

[0191] The calculation formula for the bias value (BIAS value) is:

[0192]

[0193] In some embodiments, adjusting the infusion state of the infusion device 100 includes: controlling the infusion device 100 to stop infusing insulin.

[0194] In other embodiments, adjusting the infusion state of the infusion device 100 includes: receiving measurement data obtained by fingertip blood sampling, and comparing the measurement values obtained in real time in the first measurement value group and the second measurement value group with the measurement data obtained by fingertip blood sampling. The group in the first measurement value group and the second measurement value group with higher consistency with the measurement data obtained by fingertip blood sampling is used as the basis for judging insulin injection.

[0195] That is, if the difference degree value is greater than a preset difference threshold, the sugar management system 300 determines that the measurement work is abnormal and issues an alarm. The user can collect blood from the fingertip, use a blood glucose meter and test strips to measure blood glucose, and input the measurement result into the sugar management system 300 for the sugar management system 300 to judge the first measurement value group and the second measurement value group which group of data is abnormal.

[0196] In some embodiments, based on the first electrical signal and the second electrical signal, determining whether the measurement work of the infusion system 001 on the glucose concentration is abnormal includes: obtaining a third electrical signal generated by the third working electrode 203; wherein, the third working electrode 203 is configured to separately measure the glucose concentration in the user's body with the first working electrode 201 and the second working electrode 202; based on the first electrical signal, the second electrical signal and the third electrical signal, determining whether the measurement work of the infusion system 001 on the glucose concentration is abnormal.

[0197] That is, in addition to the first working electrode 201 and the second working electrode 202, the infusion system 001 may further include other working electrodes. The more the number of working electrodes, the more conducive to accurately judging whether the measurement work is abnormal. The working mode of the third working electrode may refer to that of the first working electrode 201, which will not be elaborated here.

[0198] The sugar management system 300 pairwise judges the difference degree between the first electrical signal, the second electrical signal and the third electrical signal, so as to facilitate determining which electrical signal is abnormal. For example, the sugar management system 300 judges that the signal differences between the first electrical signal and the second electrical signal and the third electrical signal respectively are greater than the preset signal difference, and the signal difference between the second electrical signal and the third electrical signal is less than the preset signal difference, so as to determine that the first electrical signal is abnormal. At this time, the user can be reminded to replace the sensor or CGM system corresponding to the first working electrode.

[0199] The sugar management system 300 can also determine the third measurement value group based on the third electrical signal, pairwise judge the difference degree between the first measurement value group, the second measurement value group and the third measurement value group, so as to facilitate determining which group of measurement values is abnormal. For example, the sugar management system 300 judges that the difference degree values between the first measurement value group and the second measurement value group and the third measurement value group respectively are greater than the preset difference threshold, and the difference degree value between the second measurement value group and the third measurement value group is less than the preset difference threshold, so as to determine that the first measurement value group is abnormal. At this time, the user can be reminded to replace the sensor or CGM system corresponding to the first working electrode.

[0200] This specification further provides an infusion method, including: obtaining a first measurement value group and a second measurement value group of glucose concentration; the first measurement value group and the second measurement value group are respectively obtained by a sensor measuring the glucose concentration in the same user's body within the same time period; based on the measurement value difference between the first measurement value group and the second measurement value group, determining whether the measurement work is abnormal; if the measurement work is abnormal, adjusting the infusion state of the infusion device 100; wherein, the infusion device 100 is configured to be able to infuse insulin into the user's body.

[0201] On the other hand, this specification provides a method for determining whether the measurement work of glucose concentration is abnormal.

[0202] In some embodiments, the determination method includes: obtaining a first electrical signal generated by the first working electrode 201 and obtaining a second electrical signal generated by the second working electrode 202; wherein, the first working electrode 201 and the second working electrode 202 are configured to respectively measure the glucose concentration in the same user's body; based on the first electrical signal and the second electrical signal, determining whether the measurement work of the infusion system 001 for glucose concentration is abnormal. In other embodiments, the determination method includes: obtaining a first measurement value group and a second measurement value group of glucose concentration; the first measurement value group and the second measurement value group are respectively obtained by a sensor measuring the glucose concentration in the same user's body within the same time period; based on the measurement value difference between the first measurement value group and the second measurement value group, determining whether the measurement work is abnormal.

[0203] In summary, the infusion method P100 provided in this application can determine the measurement error of the glucose concentration measurement results through at least two working electrodes, and promptly detect the abnormality of the measurement work of the infusion system 001 when the measurement error exceeds the reasonable range, reducing the risk of large deviations in the insulin infusion timing and dose, which is beneficial to maintaining the user's blood sugar within a reasonable range, thereby reducing the risk to the user.

[0204] The specific embodiments of this specification are described above. Other embodiments are within the scope of the appended claims. In some cases, the actions or steps recited in the claims can be performed in a different order than in the embodiments and still achieve the desired results. Additionally, the processes depicted in the figures do not necessarily require a specific order or a continuous order to achieve the desired results. In certain embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0205] In summary, after reading this detailed disclosure, those skilled in the art will appreciate that the foregoing detailed disclosure may be presented by way of example only and is not necessarily limiting. Although not explicitly stated herein, those skilled in the art will understand that this specification is intended to encompass various reasonable changes, improvements, and modifications to the embodiments. These changes, improvements, and modifications are intended to be proposed by this specification and are within the spirit and scope of the exemplary embodiments of this specification.

[0206] In addition, certain terms in this specification have been used to describe the embodiments of this specification. For example, "one embodiment", "an embodiment", and / or "some embodiments" mean that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of this specification. Thus, it should be emphasized and understood that two or more references to "an embodiment" or "one embodiment" or "alternative embodiments" in various parts of this specification do not necessarily all refer to the same embodiment. Moreover, the particular features, structures, or characteristics may be appropriately combined in one or more embodiments of this specification.

[0207] It should be understood that in the foregoing description of the embodiments of this specification, for the purpose of helping to understand a feature, and for the purpose of simplifying this specification, this specification combines various features in a single embodiment, drawing, or its description. However, this does not mean that the combination of these features is necessary, and it is entirely possible for those skilled in the art, when reading this specification, to mark out some of the devices as separate embodiments for understanding. That is to say, the embodiments in this specification can also be understood as the integration of multiple sub - embodiments. And it also holds when the content of each sub - embodiment contains fewer features than all the features of a single foregoing disclosed embodiment.

[0208] Every patent, patent application, published patent application, and other materials cited in this disclosure, such as articles, books, specifications, publications, documents, literature, etc. (excluding any historical examination documents related thereto), are hereby incorporated by reference for all purposes relevant to this disclosure, such as in the specification and claims of this disclosure. However, if there are any inconsistencies or conflicts between the descriptions, definitions, and / or terms used in the above - mentioned materials and those used in this disclosure, the descriptions, definitions, and / or terms used in this disclosure shall prevail.

[0209] Finally, it should be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of this specification. Other modified embodiments are also within the scope of this specification. Therefore, the embodiments disclosed in this specification are merely examples and not limitations. Those skilled in the art can adopt alternative configurations based on the embodiments in this specification to implement the application in this specification. Therefore, the embodiments of this specification are not limited to the embodiments precisely described in the application.

Claims

1. An insulin infusion method, applied to an insulin infusion system, characterized in that: include: Acquire a first electrical signal generated by a first working electrode, and acquire a second electrical signal generated by a second working electrode; wherein the first working electrode and the second working electrode are configured to respectively measure the glucose concentration in the body of the same user; Based on the first electrical signal and the second electrical signal, determining whether the measurement of the glucose concentration by the infusion system is abnormal; If the measurement is abnormal, the infusion state of the infusion device is adjusted; wherein the infusion device is configured to be able to infuse insulin into the user's body.

2. The infusion method according to claim 1, characterized in that: The step of judging whether the measurement of the glucose concentration by the infusion system is abnormal based on the first electrical signal and the second electrical signal includes: determining a first set of measurement values ​​for the glucose concentration based on the first electrical signal, and determining a second set of measurement values ​​for the glucose concentration based on the second electrical signal; Based on the difference in the measured values ​​between the first measurement value group and the second measurement value group, it is determined whether the measuring operation is abnormal.

3. The infusion method according to claim 2, characterized in that: The determining whether the measurement operation is abnormal based on the difference between the measured values ​​of the first measurement value group and the second measurement value group includes: Calculate the first set of measurements and the second measurement value group The difference degree value of Comparing the difference degree value with a preset difference threshold; If the difference value is greater than the preset difference threshold, it is determined that the measurement operation is abnormal.

4. The infusion method according to claim 3, characterized in that: The difference degree value includes at least one of a paired absolute relative difference (PARD value), a mean absolute difference (MAD value), a mean absolute relative difference (MARD value), a root mean square error (RMSE value), a normalized root mean square error (NRMSE value), or a bias value (BIAS value); Wherein, the calculation formula of the paired absolute relative difference (PARD value) is: The calculation formula of the mean absolute difference (MAD value) is: The calculation formula of the mean absolute relative difference (MARD value) is: The calculation formula of the root mean square error (RMSE value) is: The calculation formula of the standardized root mean square error (NRMSE value) is: in express The average value of The calculation formula of the deviation value (BIAS value) is:

5. The infusion method according to claim 1, characterized in that: The adjusting the infusion state of the infusion device comprises: The infusion device is controlled to stop infusing insulin.

6. The infusion method according to claim 1, characterized in that: The step of judging whether the measurement of the glucose concentration by the infusion system is abnormal based on the first electrical signal and the second electrical signal includes: Acquire a signal difference between the first electrical signal and the second electrical signal; Based on the signal difference, it is determined whether the measurement operation is abnormal.

7. The infusion method according to claim 1, characterized in that: The step of judging whether the measurement of the glucose concentration by the infusion system is abnormal based on the first electrical signal and the second electrical signal includes: Acquiring a third electrical signal generated by a third working electrode; wherein the third working electrode is configured to measure the glucose concentration in the user's body separately with the first working electrode and the second working electrode; Based on the first electrical signal, the second electrical signal and the third electrical signal, it is determined whether the measurement of the glucose concentration by the infusion system is abnormal.

8. An insulin infusion system, characterized in that: include: an infusion device configured to deliver insulin into a user; a first working electrode configured to measure glucose concentration; a second working electrode configured to measure the glucose concentration; as well as A sugar management system, which is in communication with the infusion device, the first working electrode and the second working electrode, comprises: at least one storage medium storing at least one instruction set for controlling the operation of the infusion system; and at least one processor, in communication with the at least one storage medium, Wherein, when the sugar management system is running, the at least one processor reads the at least one instruction set and executes the method according to any one of claims 1 to 7 according to the instructions of the at least one instruction set.

9. The insulin infusion system according to claim 8, characterized in that: The sugar management system includes a control system, the control system is communicatively connected to the infusion device; the control system includes a third processor; The third processor is configured to determine whether the measurement of the glucose concentration by the infusion system is abnormal based on the first electrical signal and the second electrical signal.

10. The insulin infusion system according to claim 9, characterized in that: The infusion system comprises: a first sensor comprising a first processor and the first working electrode; and a second sensor comprising a second processor and the second working electrode; Among them, the first processor is electrically connected to the first working electrode and is configured to determine a first measurement value group of the glucose concentration based on the first electrical signal; the second processor is electrically connected to the second working electrode and is configured to determine a second measurement value group of the glucose concentration based on the second electrical signal.

11. The insulin infusion system according to claim 10, characterized in that: The infusion system includes a first CGM system and a second CGM system; the first CGM system includes a first transmitter and the first sensor, and the first transmitter is communicatively connected to the first processor and the third processor respectively; the second CGM system includes a second transmitter and the second sensor, and the second transmitter is communicatively connected to the second processor and the third processor respectively; or The infusion system includes a third CGM system, and the third CGM system includes a first transmitter, the first sensor, and the second sensor; the first transmitter is communicatively connected to the first processor, the second processor, and the third processor, respectively.

12. The insulin infusion system according to claim 8, characterized in that: The infusion system includes a third sensor; the third sensor includes a first processor, the first working electrode and the second working electrode; wherein the first processor is electrically connected to the first working electrode and the second working electrode, and is configured to determine a first measurement value group of the glucose concentration based on the first electrical signal, and to determine a second measurement value group of the glucose concentration based on the second electrical signal; or The infusion system comprises: a first sensor comprising a first processor and the first working electrode; and a second sensor comprising a second processor and the second working electrode; Among them, the first processor is electrically connected to the first working electrode and is configured to determine the first measurement value group based on the first electrical signal; the second processor is electrically connected to the second working electrode and is configured to determine the second measurement value group based on the second electrical signal.

13. A sugar management system, comprising: at least one storage medium storing at least one instruction set for controlling the operation of the infusion system; as well as at least one processor, in communication with the at least one storage medium, Wherein, when the sugar management system is running, the at least one processor reads the at least one instruction set and executes the method according to any one of claims 1 to 7 according to the instructions of the at least one instruction set.

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