Calibration method and calibration system for analyte sensing components

Abstract

The present disclosure relates to a calibration method and calibration system for an analyte sensor component, wherein the method comprises: using different barcodes to bind the analyte sensor component; simulating the performance test of the analyte sensor component in the use scenario, obtaining the calibration information of the analyte sensor component, and associating the calibration information with the barcode corresponding to the analyte sensor; storing the barcode information in a local device and printing the barcode; before using the analyte sensor component, scanning and identifying the barcode and obtaining the calibration information according to the barcode; and generating a compensation model based on the calibration information, and calibrating the sensing data of the analyte sensor component through the compensation model. The system comprises a strapping device, a testing device, an identification device, and a calibration device. According to the present disclosure, a method and system can be provided for effectively calibrating the sensor component before use by using an in vitro calibration method and providing the user with a better user experience.

Description

[0001] This application is a divisional application of a patent application with an application date of September 24, 2021, application number 2021111233310, and invention name “Method and system for calibrating sensor data of analyte sensor components”. Technical Field

[0002] The present disclosure generally relates to a calibration method and system, and more particularly to a calibration method and system for an analyte sensor 10 assembly. Background Art

[0003] Diabetes is a common disease worldwide. According to statistics from the International Diabetes Federation, the number of patients worldwide in 2017 was approximately 425 million, and it is expected to reach 629.15 million by 2045. For diabetic patients, monitoring blood sugar is an essential thing every day. The most commonly used blood sugar testing device is the blood glucose meter, but it can only detect the patient's blood sugar value at a single time point, and cannot continuously monitor blood sugar levels, which has great limitations. In addition, fingertip blood sugar collection often causes 20% physical and even psychological harm to diabetic patients. Therefore, implantable continuous glucose monitors (CGMs) came into being. The rapid development of continuous glucose monitors (CGMs) has brought advantages such as comfort, flexibility and convenience to diabetes monitoring.

[0004] If the blood sugar measurement data is inaccurate, it will bring extremely high risks to patients in medication decisions.

[0005] Therefore, as an implantable sensor, the performance requirements of the continuous blood glucose monitor need to be comparable or even higher than those of traditional sampling and testing. In recent years, with the continuous advancement of biosensor technology, the continuous blood glucose monitor has become increasingly mature in biocompatibility and biofilm technology, especially in terms of performance, which has been close to meeting the requirements that are comparable or even higher than those of traditional sampling and testing. Due to the differences in manufacturing processes and sensor data processing methods, in order to ensure the performance of the sensor of the continuous blood glucose monitor, that is, the accuracy of the monitored blood glucose data, most of the current prior art 30 adopts a method of multiple finger-sampling calibration before implanting the sensor of the continuous blood glucose monitor into the patient's body, which still lacks comfort, convenience, and a better user experience for patients. Summary of the invention

[0006] The present invention is completed in view of the above-mentioned state of the prior art, and its purpose is to provide a method and system for calibrating the sensing data of an analyte sensor component, which is a method and system for calibrating the sensing data of an analyte sensor component using a barcode before using the analyte sensor component. It can solve the problem of the fingertip blood sampling calibration method in the prior art that lacks comfort, convenience and better user experience for patients.

[0007] A first aspect of the present disclosure provides a method for calibrating sensor data of an analyte sensor component, which is a method for calibrating the sensor data of the analyte sensor component using a barcode before using the analyte sensor component, comprising: preparing a plurality of the analyte sensor components, and binding each of the analyte sensor components using the barcode; performing a functional test on each of the analyte sensor components to obtain sensor data of each of the analyte sensor components, and determining calibration information based on a comparison between the sensor data of the analyte sensor component and a preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor; before using the analyte sensor component, identifying the barcode and obtaining the calibration information based on the barcode; and calibrating the sensor data of the analyte sensor component based on the calibration information.

[0008] In this case, this method can solve the problem of the fingertip blood sampling calibration method in the prior art lacking comfort, convenience and better user experience for patients.

[0009] According to the method involved in the present disclosure, optionally, the sensing data is a concentration change curve, which is obtained by performing functional tests on each of the analyte sensing components using a variety of different analyte concentrations and obtaining the concentration change curve of each of the analyte sensing components. In this case, the concentration data of the analyte can be more intuitively presented in the form of a curve, thereby making it easier to analyze the change in analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0010] According to the method involved in the present disclosure, optionally, the information of the barcode is stored in a server, and the analyte sensor component can be packaged, and the information of the barcode can be downloaded from the server and displayed on the package. In this case, the information of the barcode can be stored in the server after being associated with the sensor data, and can be pre-processed in the server, and the barcode with the associated information or data can be downloaded and printed before leaving the factory and displayed on the package, thereby forming pre-factory and post-factory information tracking of the analyte sensor component.

[0011] According to the method involved in the present disclosure, optionally, the sensing data includes at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate. In this case, when the analyte sensing component needs to be calibrated, the calibration algorithm or model can judge the performance of the analyte sensing component according to the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0012] According to the method involved in the present disclosure, optionally, the analyte sensor assembly can be bound by using the batch and the position of the tooling as the information of the barcode. In this case, the pre-factory information of the analyte sensor assembly can be tracked by using the barcode.

[0013] According to the method involved in the present disclosure, optionally, a compensation model is generated based on the calibration information, and the sensor data of the analyte sensor component can be calibrated by the compensation model. In this case, by using the pre-factory sensor data obtained by the barcode and thereby obtaining the calibration information, the analyte sensor component can be calibrated using a preset compensation model before the analyte sensor component is used, i.e., in vitro calibration after leaving the factory, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method and obtaining a better user experience.

[0014] According to the method involved in the present disclosure, optionally, a terminal device with a display function is used to match the analyte sensor component, and the calibrated sensor data can be displayed on the terminal device. In this case, when the analyte sensor component is used, the terminal device with a display function can better and more intuitively display the sensor data of the analyte sensor component to the patient or other person who needs to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0015] According to the method involved in the present disclosure, optionally, the calibration information includes at least one of a calibration behavior, a calibration factor and a calibration coefficient. In this case, the calibration behavior can determine whether the sensor data needs to be calibrated and pass the determination result to the next calibration process. The calibration factor can make the calibration information more complete, for example, it can be a simulation factor, a test time period, a test method, etc. of the pre-factory test equipment. The calibration coefficient can enable the calibration information to obtain a corresponding compensation coefficient when generating a compensation model, that is, the degree of compensation or a mathematical method, etc.

[0016] A second aspect of the present disclosure provides a system for calibrating sensor data of an analyte sensor component, which is a system for calibrating the sensor data of the analyte sensor component using a barcode before using the analyte sensor component, and may include: a binding device, which can use the barcode to bind each of a plurality of the analyte sensor components; a testing device, which can perform a functional test on each of the analyte sensor components to obtain the sensor data of each of the analyte sensor components, and can determine calibration information based on a comparison of the sensor data of the analyte sensor component with a preset parameter range, and can associate the calibration information with the barcode corresponding to the analyte sensor; an identification device, which can identify the barcode before using the analyte sensor component and obtain the calibration information based on the barcode; a calibration device, which can calibrate the sensor data of the analyte sensor component based on the calibration information.

[0017] In this case, the system solves the problem of the fingertip blood sampling calibration method in the prior art lacking comfort, convenience and better user experience for patients.

[0018] According to the calibration system involved in the present disclosure, optionally, the calibration system also includes a communication device for information transmission and a user display device for display. In this case, the binding device, the test device, and the identification device in the system can communicate data through the communication device, such as obtaining barcode information, barcode binding information, sensor data, information associated with the barcode and the sensor data, calibration information of the analyte sensor component based on the sensor data, etc. The user display device can better and more intuitively display the sensor data of the analyte sensor component to the patient or other person who needs to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0019] According to the calibration system involved in the present disclosure, optionally, a server for data storage is further included, and the server can communicate data with the binding device, the test device, and the identification device through the communication device. In this case, the binding device, the test device, and the identification device in the system can transmit data to each other and be processed and stored by the server, thereby achieving data intercommunication and information tracking.

[0020] According to the calibration system involved in the present disclosure, optionally, the sensor data is a concentration change curve, which is obtained by performing functional tests on each of the analyte sensor components using a plurality of different analyte concentrations, thereby obtaining the concentration change curve of each of the analyte sensor components. In this case, the concentration change curve can more conveniently analyze and calibrate the sensor data, and can also be more intuitively presented to personnel who need to obtain the sensor data.

[0021] According to the calibration system involved in the present disclosure, optionally, the information of the barcode is stored in the server, and the analyte sensor component can be packaged, the information of the barcode is downloaded from the server, and the barcode can be displayed on the package. In this case, the information of the barcode can be stored in the server after being associated with the sensor data, and can be pre-processed in the server, and the barcode with the associated information or data can be downloaded and printed before leaving the factory and displayed on the package, thereby forming pre-factory and post-factory information tracking of the analyte sensor component.

[0022] According to the calibration system involved in the present disclosure, optionally, the sensing data includes at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate. In this case, when the analyte sensing component needs to be calibrated, the calibration algorithm or model can judge the performance of the analyte sensing component according to the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0023] According to the calibration system involved in the present disclosure, optionally, the analyte sensor assembly is bound by using the batch and the position of the tooling as the information of the barcode. In this case, the pre-factory information of the analyte sensor assembly can be tracked by using the barcode.

[0024] According to the calibration system involved in the present disclosure, optionally, a compensation model is generated based on the calibration information, and the sensor data of the analyte sensor component can be calibrated by the compensation model. In this case, by using the pre-factory sensor data obtained by the barcode and thereby obtaining the calibration information, the analyte sensor component can be calibrated using a preset compensation model before the analyte sensor component is used, i.e., in vitro calibration after leaving the factory, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method and obtaining a better user experience.

[0025] According to the calibration system involved in the present disclosure, optionally, a terminal device with a display function is used to match the analyte sensor component, and the calibrated sensor data can be displayed on the terminal device. In this case, when the analyte sensor component is used, the terminal device with a display function can better and more intuitively display the sensor data of the analyte sensor component to the patient or other person who needs to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0026] According to the calibration system involved in the present disclosure, optionally, the calibration information includes at least one of a calibration behavior, a calibration factor and a calibration coefficient. In this case, the calibration behavior can determine whether the sensor data needs to be calibrated and pass the determination result to the next calibration process. The calibration factor can make the calibration information more complete, for example, it can be the simulation factor, test time period, test method, etc. of the pre-factory test equipment. The calibration coefficient can enable the calibration information to obtain the corresponding compensation coefficient when generating the compensation model, that is, the degree of compensation or mathematical method, etc.

[0027] According to the calibration system involved in the present disclosure, optionally, the compensation model includes at least one of probability analysis, fuzzy logic, and decision function. In this case, the compensation model can calibrate the sensor data accordingly in the manner of probability analysis, fuzzy logic, decision function, etc. according to different requirements.

[0028] According to the calibration system involved in the present disclosure, optionally, the compensation model may also include a display model, and the display model may include at least one of parameter compensation correction, curve curvature compensation correction, and image compensation correction. In this case, after the sensor data of the analyte sensor component is calibrated, the display model in the compensation model can display compensation correction information including parameter compensation correction, curve curvature compensation correction, image compensation correction, etc., so as to more intuitively present the compensation calibration information to the personnel who need to obtain the sensor data and calibration information.

[0029] A third aspect of the present disclosure provides an analyte sensing assembly, which may have a chemical substance that reacts with glucose and generates sensing data. In this case, the analyte sensing assembly can form a complete calibration system with each device in the above system.

[0030] According to the analyte sensing assembly involved in the present disclosure, optionally, the analyte sensing assembly includes a sensing unit for detecting the concentration of the analyte and generating sensing data, and a communication unit for transmitting the sensing data. In this case, the sensing unit can obtain the sensing data required by the above-mentioned system or method and transmit it to each device in the system or method through the communication unit.

[0031] According to the analyte sensing assembly involved in the present disclosure, optionally, the sensing data is sent to a terminal device for processing and / or displaying the sensing data through the communication unit. In this case, when the analyte sensing assembly is used, the sensing unit can obtain real-time sensing data in the human body and obtain calibrated sensing data according to the calibration system, and intuitively display the calibrated sensing data in the terminal device with a display function through the communication unit.

[0032] According to the analyte sensing assembly involved in the present disclosure, optionally, the sensing data is processed by the terminal device to generate a concentration change curve over time. In this case, the sensing data can be intuitively displayed in the terminal device with a display function.

[0033] According to the present disclosure, a method and system for calibrating the sensing data of an analyte sensing component can be provided. The method and system are used to calibrate the sensing data of an analyte sensing component using a barcode before using the analyte sensing component. The method and system can solve the problem of the fingertip blood sampling calibration method in the prior art that lacks comfort, convenience and better user experience for patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The present invention is a flowchart of a method for calibrating sensing data of an analyte sensing component.

[0035] Figure 2The present invention relates to a block diagram of a calibration system for calibrating sensing data of an analyte sensing assembly.

[0036] Figure 3 It is a schematic diagram of an application scenario of an analyte sensing component involved in the present disclosure.

[0037] Figure 4 It is a schematic diagram of a method for calibrating sensing data of an analyte sensing component and / or a calibration result of a calibration system involved in the present disclosure.

[0038] Figure 5 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing component and / or a calibration system using a compensation model of probability analysis involved in the present disclosure.

[0039] Figure 6 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing component and / or a calibration system using a compensation model of fuzzy logic according to the present disclosure.

[0040] Figure 7 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing component and / or a calibration system using a compensation model of a decision function involved in the present disclosure.

[0041] Figure 8 It is a schematic diagram of a method for calibrating sensing data of an analyte sensing component and / or a calibration result of a calibration system displayed in a terminal device according to the present disclosure. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] It should be noted that the terms "first", "second", "third" and "fourth" in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish different objects rather than to describe a specific order. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units that are not listed, or may optionally include other steps or units that are inherent to these processes, methods, products or devices. In the following description, the same symbols are given to the same components, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the ratio of the sizes of the components to each other or the shapes of the components may be different from the actual ones.

[0044] The present disclosure provides a method and system for calibrating the sensing data of an analyte sensing component, which is a method and system for calibrating the sensing data of an analyte sensing component using a barcode before using the analyte sensing component, and can solve the problem that the fingertip blood sampling calibration method in the prior art lacks comfort, convenience and better user experience for patients. The following is a detailed description in conjunction with the accompanying drawings.

[0045] Figure 1 The flowchart shows a method for calibrating sensing data of an analyte sensing assembly according to the present disclosure.

[0046] like Figure 1 As shown, the first aspect of the present disclosure provides a method for calibrating sensing data of an analyte sensing component, which is a method for calibrating the sensing data of the analyte sensing component using a barcode before using the analyte sensing component, comprising:

[0047] Step S001, preparing a plurality of analyte sensing components, and binding each analyte sensing component with a different barcode;

[0048] Step S002, performing a functional test on each analyte sensing component to obtain sensing data of each analyte sensing component;

[0049] Step S003, determining calibration information based on the comparison between the sensing data of the analyte sensing component and the preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor;

[0050] Step S004, before using the analyte sensing component, identifying the barcode and obtaining calibration information according to the barcode;

[0051] Step S005: calibrate the sensing data of the analyte sensing component based on the calibration information.

[0052] In this case, this method can solve the problem of the fingertip blood sampling calibration method in the prior art lacking comfort, convenience and better user experience for patients.

[0053] In some examples, the preset parameter range may refer to preset analyte concentration data, change rate, sensitivity, or sensitivity change rate, etc.

[0054] In some examples, the analyte concentration may refer to the glucose concentration of the interstitial fluid in the human body. In other examples, the analyte concentration may refer to the concentration of lactic acid, vitamin C, uric acid, urea, glutamic acid, or transaminase.

[0055] In some examples, the barcode used in step S001 may be a one-dimensional barcode or a two-dimensional barcode. In some examples, the one-dimensional barcode may include EAN-13 code, UPC-A code, Code-128 code, Code-39 code, EAN / UCC-128 code or ITF-14 code, etc., and the two-dimensional barcode may include PDF417, Data Matrix, Maxi Code, QR Code, Code 49, Code16K, Code one, Veri code barcode, CP barcode, Coda block F barcode, Tianzi code, Ultra code barcode or Aztec barcode, etc. In some examples, the barcode used in step S001 may be other scannable barcodes. Thus, the corresponding barcode type may be used to perform step S001 according to the production and post-shipment requirements, which provides convenience for the binding of the barcode.

[0056] In some examples, the barcode binding in step S001 can be the binding of the barcode with the corresponding batch and tooling information that can be used as an ID identification mark before the analyte sensor component is produced, that is, step S001 can be completed before the analyte sensor component is produced. In other examples, step S001 can be completed before the analyte sensor component is produced and is to be tested. Therefore, the analyte sensor component that has undergone the binding step S001 can be identified and tracked in subsequent steps.

[0057] In some examples, in step S002, a functional test device may be used to perform a functional test on the analyte sensor component, wherein the functional test refers to a performance test of the simulated analyte sensor component in a usage scenario, thereby obtaining sensing data of the analyte sensor component to analyze its performance.

[0058] In some examples, step S003 can be completed in the test device in the aforementioned step S002. In other examples, step S003 can also be performed on the server after obtaining the sensor data after the test device tests the analyte sensor component. Therefore, completing step S003 in the test device can reduce the processing load of the server, and completing step S003 in the server can reduce the calculation processing of the test device.

[0059] In some examples, step S004 may be to use a terminal device with a barcode recognition function to scan and identify the barcode to obtain the sensing data and calibration information of the analyte sensor component. Thus, the user can obtain the calibration information through the terminal device before using the analyte sensor component and use the terminal device to calibrate the sensing data of the analyte sensor component after use based on the calibration information.

[0060] In some examples, step S005 may be completed in the terminal device in step S004, so that the user can use the terminal device to calibrate the sensing data of the analyte sensing component after use based on the calibration information.

[0061] In some examples, steps S001 to S005 in the method can solve the problem of the fingertip blood sampling calibration method in the prior art lacking comfort, convenience and better user experience for patients.

[0062] In some examples, the sensing data may be a concentration change curve, which may be obtained by performing functional tests on each analyte sensing component using a plurality of different analyte concentrations and obtaining a concentration change curve for each analyte sensing component. In this case, the analyte concentration data may be more intuitively presented in the form of a curve, thereby making it easier to analyze the change in analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0063] In some examples, the sensor data may also be a line or graph of concentration changes.

[0064] In some examples, the multiple different analysis concentrations can be the concentrations of pure analyte solutions or non-pure analyte solutions. In this case, using a pure concentration analyte solution to test the analyte sensing component can reflect the true performance parameters of the analyte sensing component, and using a non-pure concentration analyte solution to test the analyte sensing component can reflect the performance parameters of the analyte sensing component close to actual use.

[0065] In some examples, the barcode information can be stored in a server, and the analyte sensor assembly can be packaged, and the barcode information can be downloaded from the server and displayed on the package. In this case, the barcode information can be stored in the server after being associated with the sensor data, and can be pre-processed in the server, and the barcode with the associated information or data can be downloaded and printed before leaving the factory and displayed on the package, thereby forming pre-factory and post-factory information tracking of the analyte sensor assembly.

[0066] In some examples, the barcode information may be temporarily stored in a local device, such as the test device involved in step S002 above, and then uploaded to the server after the test is completed, or the barcode information may be directly read and printed from the test device.

[0067] In some examples, the packaging can be manual packaging or packaging machine packaging. For example, using a packaging machine to pack can quickly and efficiently complete the packaging task, and the packaging machine is connected to the server to conveniently and quickly download and print barcodes to complete the packaging.

[0068] In some examples, the sensing data may include at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate. In this case, when the analyte sensing component needs to be calibrated, the calibration algorithm or model can judge the performance of the analyte sensing component according to the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0069] In some examples, the analyte concentration may refer to data generated by the conversion of chemical energy between the analyte and the sensor in the analyte sensing assembly into electrical energy. In some examples, the analyte concentration may be specific single analyte concentration data or multi-component analyte concentration data.

[0070] In some examples, the analyte concentration change rate may refer to a change rate or change amount of the analyte concentration data itself, or may refer to a slope or change rate of a curve generated based on the analyte concentration.

[0071] In some examples, the analyte detection time may refer to the time from when the sensor of the analyte sensing component contacts the analyte solution or the interstitial fluid in the human body to generate an electrical signal and is acquired by the analyte sensing component to when the sensor separates from the analyte solution or the interstitial fluid in the human body or stops reacting.

[0072] In some examples, sensor sensitivity may refer to the lower limit of the sensor's response to the analyte of the analyte sensing assembly.

[0073] In some examples, the sensitivity change rate may refer to the rate of change of the lower limit of the sensor-analyte response of the analyte sensing assembly.

[0074] In some examples, the analyte sensing component can be bound by using the location of the batch and the tooling as the information of the barcode. In this case, the tracking of the pre-factory information of the analyte sensing component can be completed by using the barcode.

[0075] In other examples, the server may randomly generate a unique serial number as barcode information and bind it to each analyte sensing component that needs to be bound.

[0076] In some examples, a compensation model can be generated based on the calibration information, and the sensor data of the analyte sensor component can be calibrated by the compensation model. In this case, by using the pre-factory sensor data obtained by the barcode and thereby obtaining the calibration information, the analyte sensor component can be calibrated by using the preset compensation model before the analyte sensor component is used, i.e., in vitro calibration after leaving the factory, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method and obtaining a better user experience.

[0077] In some examples, the compensation model may be preset in the terminal device and multiple corresponding compensation models may be selected based on the calibration information. Specifically, for example, if the sensor data tested is larger than the preset parameter range, the compensation model may select negative compensation; otherwise, the compensation model may select positive compensation. Thus, the user can obtain more accurate analyte concentration data when using the analyte sensor component.

[0078] In some examples, a terminal device with a display function can be used to match the analyte sensor component, and the calibrated sensor data can be displayed on the terminal device. In this case, during the use of the analyte sensor component, the terminal device with a display function can better and more intuitively display the sensor data of the analyte sensor component to the patient or other person who needs to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0079] In some examples, the terminal device may be a specific analyte concentration analyzer with scanning and display functions. In other examples, the terminal device may be a mobile phone, tablet, or personal computer with analyte concentration analysis function. Thus, it is convenient for the user to analyze the analyte concentration using the analyte sensor component.

[0080] In some examples, the calibration information may include at least one of a calibration behavior, a calibration factor, and a calibration coefficient. In some examples, the calibration behavior may determine whether the sensor data needs to be calibrated and pass the determination result to the next calibration process. The calibration factor may make the calibration information more complete. For example, the calibration factor may be a simulation factor of the pre-factory test equipment, a test time period, a test method, etc. The calibration coefficient may enable the calibration information to obtain a corresponding compensation coefficient when generating a compensation model, that is, the degree of compensation or a mathematical method, etc. In this case, the calibration accuracy can be improved by setting a variety of calibration information.

[0081] Figure 2 is a block diagram showing a calibration system for calibrating sensing data of an analyte sensing assembly according to the present disclosure; Figure 4 is a schematic diagram showing a method for calibrating sensing data of an analyte sensing assembly and / or a calibration result of a calibration system involved in the present disclosure; Figure 5 is a schematic diagram showing a method for calibrating sensing data of an analyte sensing component and / or a calibration result of a calibration system using a compensation model of probability analysis according to the present disclosure; Figure 6 is a schematic diagram showing a method for calibrating sensing data of an analyte sensing component and / or a calibration result of a calibration system using a compensation model of fuzzy logic according to the present disclosure; Figure 7 It is a schematic diagram showing a calibration result of a method for calibrating sensing data of an analyte sensing component and / or a calibration system using a compensation model of a decision function according to the present disclosure.

[0082] like Figure 2 As shown, the second aspect of the present disclosure provides a calibration system 10 for calibrating the sensing data of an analyte sensing component, which is a calibration system 10 for calibrating the sensing data of an analyte sensing component by using a barcode before using the analyte sensing component.

[0083] In some examples, the calibration system 10 may include a binding device 11 , a testing device 12 , an identification device 131 , and a calibration device 132 .

[0084] In some examples, the binding device 11 can use different barcodes to bind each of the multiple analyte sensing components. In some examples, the testing device 12 can perform functional tests on each analyte sensing component to obtain the sensing data of each analyte sensing component, and can determine the calibration information based on the comparison of the sensing data of the analyte sensing component with the preset parameter range, and can associate the calibration information with the barcode corresponding to the analyte sensor. In some examples, the identification device 131 can identify the barcode before using the analyte sensing component and obtain the calibration information based on the barcode. In some examples, the calibration device 132 can calibrate the sensing data of the analyte sensing component based on the calibration information.

[0085] In this case, calibration information can be obtained before using the analysis sensor component, and then the sensor data of the analyte sensor component can be calibrated based on the above calibration information, which can solve the shortcomings of the fingertip blood collection method in the prior art, such as improving the convenience of blood sugar collection for patients, providing users with a better experience, and also overcoming the problems of lack of comfort for patients in the prior art.

[0086] In some examples, the binding device 11 may be an information binding device 11 in the server 15. In other examples, the binding device 11 may be independent of the server 15 and communicate with the server 15, thereby facilitating remote planning of the factory workshop. In other examples, the binding device 11 may be integrated with the testing device 12, thereby facilitating the binding of information and barcodes after the analyte sensing component is produced and before being tested, thereby reducing the binding steps in other production processes.

[0087] In some examples, functional testing of the analyte sensing component in the testing device 12 may include, but is not limited to: performance testing based on simulated analyte concentrations, sensitivity testing of the analyte sensing component, testing of the electrical performance of the analyte sensing component (including but not limited to circuit continuity, resistance, capacitance, inductance, etc.), etc.

[0088] In some examples, the identification device 131 may be a barcode scanner or a barcode scanner, etc., such as a scanning identification device 131. In other examples, the identification device 131 may be a mobile device with a scanning identification function, such as a mobile phone, a tablet, a personal computer, etc.

[0089] In some examples, the identification device 131 and the calibration device 132 may be integrated into the terminal device 13. Thus, it is convenient for the user to use the analyte sensing component.

[0090] In some examples, the calibration system 10 may also include a communication device 14 for information transmission and a user display device for display (not shown). In this case, the binding device 11, the test device 12, and the identification device 131 in the calibration system 10 can communicate data through the communication device 14, such as obtaining barcode information, barcode binding information, sensor data, information associated with the barcode and the sensor data, calibration information of the analyte sensor component based on the sensor data, etc. The user display device can better and more intuitively display the sensor data of the analyte sensor component to the patient or other person who needs to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0091] In some examples, the communication device 14 can communicate with the binding device 11 and the testing device 12 via the field bus 16. In some examples, the communication device 14 can communicate with the identification device 131 and the calibration device 132 via the cloud, a local area network or the Internet.

[0092] In some examples, the user display device, the identification device 131, and the calibration device 132 may be integrated into the terminal device 13. Thus, it is convenient for the user to use the analyte sensing component.

[0093] In some examples, the calibration system 10 may further include a server 15 for data storage, and the server 15 may communicate data with the binding device 11, the test device 12, the identification device 131, and the calibration device 132 through the communication device 14. In this case, the binding device 11, the test device 12, and the identification device 131 in the system 10 can transmit data to each other and be processed and stored by the server 15, thereby achieving data intercommunication and information tracking.

[0094] In some examples, the server 15 may not be provided. In other words, in the calibration system 10 , the binding device 11 , the testing device 12 , the identification device 131 , and the calibration device 132 communicate data through the communication device 14 and complete data processing.

[0095] In some examples, the sensing data may be a concentration change curve, which is obtained by performing functional tests on each analyte sensing component using a variety of different analyte concentrations to obtain the concentration change curve of each analyte sensing component. In this case, by observing the concentration change curve, it is more convenient to analyze and calibrate the sensing data, and it is also more intuitive to the person who needs to obtain the sensing data. Therefore, it is easier to analyze the change in analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0096] In some examples, the sensor data may also be a line or graph of concentration changes.

[0097] In some examples, the multiple different analysis concentrations can be the concentrations of pure analyte solutions or non-pure analyte solutions. In this case, using a pure concentration analyte solution to test the analyte sensing component can reflect the true performance parameters of the analyte sensing component, and using a non-pure concentration analyte solution to test the analyte sensing component can reflect the performance parameters of the analyte sensing component close to actual use.

[0098] In some examples, the barcode information can be stored in the server 15, and the analyte sensing component can be packaged, the barcode information can be downloaded from the server 15, and the barcode can be displayed on the package. In this case, the barcode information can be stored in the server 15 after being associated with the sensor data, and can be pre-processed in the server 15, and the barcode with the associated information or data can be downloaded and printed before leaving the factory and displayed on the package, thereby forming pre-factory and post-factory information tracking of the analyte sensing component.

[0099] In some examples, the barcode information may be temporarily stored in a local device, such as the test device 12, and then uploaded to the server 15 after the test is completed, or the barcode information may be directly read and printed from the test device.

[0100] In some examples, the packaging can be manual packaging or packaging machine packaging. For example, using a packaging machine to pack can quickly and efficiently complete the packaging task, and the packaging machine is connected to the server 15 to conveniently and quickly download and print barcodes to complete the packaging.

[0101] In some examples, the sensing data may include at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate. In this case, when the analyte sensing component needs to be calibrated, the calibration algorithm or model can judge the performance of the analyte sensing component according to the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0102] In some examples, the analyte concentration may refer to data generated by the conversion of chemical energy between the analyte and the sensor in the analyte sensing assembly into electrical energy, which may be specific single analyte concentration data or multi-component analyte concentration data.

[0103] In some examples, the analyte concentration change rate may refer to a change rate or change amount of the analyte concentration data itself, or may refer to a slope or change rate of a curve generated based on the analyte concentration.

[0104] In some examples, the analyte detection time may refer to the time from when the sensor of the analyte sensing component contacts the analyte solution or the interstitial fluid in the human body to generate an electrical signal and is acquired by the analyte sensing component to when the sensor separates from the analyte solution or the interstitial fluid in the human body or stops reacting.

[0105] In some examples, sensor sensitivity may refer to the lower limit of the sensor's response to the analyte of the analyte sensing assembly.

[0106] In some examples, the sensitivity change rate may refer to the rate of change of the lower limit of the sensor-analyte response of the analyte sensing assembly.

[0107] In some examples, the analyte sensing component can be bound by using the location of the batch and the tooling as the information of the barcode. In this case, the tracking of the pre-factory information of the analyte sensing component can be completed by using the barcode.

[0108] In other examples, the server 15 may randomly generate a unique serial number as barcode information and bind it to each analyte sensing component that needs to be bound.

[0109] In some examples, a compensation model can be generated based on the calibration information, and the sensor data of the analyte sensor component can be calibrated by the compensation model. In this case, by using the pre-factory sensor data obtained by the barcode and thereby obtaining the calibration information, the analyte sensor component can be calibrated by using the preset compensation model before the analyte sensor component is used, i.e., in vitro calibration after leaving the factory, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method and obtaining a better user experience.

[0110] In some examples, the compensation model may be preset in the calibration device 132 and multiple corresponding compensation models may be selected based on the calibration information. Specifically, for example, if the sensor data of the test is larger than the preset parameter range, the compensation model may select negative compensation; otherwise, the compensation model may select positive compensation. Thus, the user can obtain more accurate analyte concentration data when using the analyte sensor component.

[0111] In some examples, a terminal device 13 with a display function can be used to match the analyte sensor component, and the calibrated sensor data can be displayed on the terminal device 13. In this case, when the analyte sensor component is used, the terminal device 13 with a display function can better and more intuitively display the sensor data of the analyte sensor component to the patient or other people who need to obtain accurate analyte sensor data, that is, it is more convenient to obtain information.

[0112] In some examples, the identification device 131 and the calibration device 132 may be specific analyte concentration analyzers with scanning and display functions. In other examples, the identification device 131 and the calibration device 132 may be mobile phones, tablets, personal computers, etc. with analyte concentration analysis functions. Thus, it is convenient for users to use the analyte sensor assembly to analyze the analyte concentration.

[0113] In some examples, the calibration information may include at least one of a calibration behavior, a calibration factor, and a calibration coefficient. In this case, the calibration behavior can determine whether the sensor data needs to be calibrated and pass the determination result to the next step of calibration processing. The calibration factor can make the calibration information more complete. For example, it can be the simulation factor, test time period, test method, etc. of the pre-factory test equipment. The calibration coefficient can enable the calibration information to obtain the corresponding compensation coefficient when generating the compensation model, that is, the degree of compensation or mathematical method, etc. For example: Figure 4 As shown, if the sensor data before calibration is generally smaller than the preset parameter range, that is, as shown by curve 1 before calibration, it can be judged based on the calibration behavior that positive compensation needs to be added, and the result after calibration can be shown as curve 3 after calibration; otherwise, curve 2 before calibration can be referred to, and negative compensation can be judged based on the calibration behavior, and the result after calibration can be shown as curve 3 after calibration.

[0114] In some examples, the compensation model may include at least one of probability analysis, fuzzy logic, and decision function. In this case, the compensation model can calibrate the sensor data in a manner of probability analysis, fuzzy logic, decision function, etc. according to different requirements.

[0115] like Figure 5 As shown, in the compensation model of probability analysis, for the sensor data of the same analyte sensor component: curve c is the curve of normal sensor data or the curve of sensor data after calibration, and curves a and b are the sensor data curves that need to be calibrated, wherein, in the test, the sensor data of curves a and b are randomly distributed on both sides of curve c with curve c as the center, then curves a and b need to be fitted to be close to curve c through mathematical algorithms, that is, after the analyte sensor is used, although the actual sensor data may be a or b, it is still displayed as curve c after compensation calibration.

[0116] like Figure 6 As shown, in the fuzzy logic compensation model, for the sensor data of the same analyte sensor component: curve f is the curve of normal sensor data or the curve of calibrated sensor data, and curves d and e are the sensor data curves that need to be calibrated. In the test, the sensor data of curves d and e completely match or overlap with the sensor data of part of the detection time period of curve f, and the other time periods do not match. Then, the fuzzy logic compensation model is used to perform compensation calibration on curves d and e, that is, the parts of curves d and e that match curve f are retained through the fuzzy algorithm, and the rest are compensated accordingly.

[0117] like Figure 7As shown, in the compensation model of the decision function, for the sensor data of the same analyte sensor component: curve k is the curve of normal sensor data or the curve of calibrated sensor data, and curves h and g are the sensor data curves that need to be calibrated. In the test, if the sensor data of curves h and g can correspond to curve k only in a certain detection time period x (x=x2-x1) but do not completely match, the decision function model is used to compensate and calibrate curves h and g, that is, the abnormal data outside the detection time period x is not calculated and only the sensor data of the detection time period x is compensated.

[0118] In some examples, the compensation model may also include a display model, and the display model may include at least one of parameter compensation correction, curve curvature compensation correction, and image compensation correction. In this case, after the sensor data of the analyte sensor component is calibrated, the display model in the compensation model can display compensation correction information including parameter compensation correction, curve curvature compensation correction, image compensation correction, etc., so as to more intuitively present the compensation calibration information to personnel who need to obtain sensor data and calibration information.

[0119] Figure 3 is a schematic diagram showing an application scenario of an analyte sensing component involved in the present disclosure; Figure 8 It is a schematic diagram showing a method for calibrating sensing data of an analyte sensing component and / or a calibration result of a calibration system displayed in a terminal device according to the present disclosure.

[0120] like Figure 3 As shown, the third aspect of the present disclosure provides an analyte sensing component 02, which may have a chemical substance that reacts with glucose, and is an analyte sensing component 02 applied to the above method or calibration system. In this case, the analyte sensing component 02 can form a complete calibration system with each device in the above system.

[0121] In some examples, the analyte sensing assembly 02 may include a sensing unit for detecting the concentration of the analyte and generating sensing data, and a communication unit for transmitting the sensing data. In this case, the sensing unit can obtain the sensing data required by the calibration system or method and transmit it to each device in the calibration system or method through the communication unit.

[0122] In some examples, preferably, the analyte sensing component can be used for detecting and analyzing the glucose concentration in the human body.

[0123] In some examples, the sensing data can be sent to a terminal device 13 for processing and / or displaying the sensing data via a communication unit. In this case, when using the analyte sensing component 02, the sensing unit can obtain real-time sensing data in the human body and obtain calibrated sensing data according to the calibration system, and intuitively display the calibrated sensing data in the terminal device 13 with a display function via the communication unit.

[0124] In some examples, the sensing data can be processed by the terminal device 13 to generate a concentration change curve over time. In this case, the sensing data can be intuitively displayed in the terminal device 13 with a display function.

[0125] According to the present disclosure, a method and system for calibrating the sensing data of an analyte sensing component can be provided. The method and system are used to calibrate the sensing data of an analyte sensing component using a barcode before using the analyte sensing component, which can solve the problem of the fingertip blood sampling calibration method in the prior art that lacks comfort, convenience and better user experience for patients.

[0126] Although the present invention is specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the above description does not limit the present invention in any form. Those skilled in the art can modify and change the present invention as needed without departing from the essential spirit and scope of the present invention, and these modifications and changes all fall within the scope of the present invention.

Claims

1. A method for calibrating an analyte sensor component, which is a method for calibrating the analyte sensor component using a barcode before using the analyte sensor component, characterized in that: The method comprises: preparing a plurality of the analyte sensor components, and binding each of the analyte sensor components with the barcode; performing a functional test on each of the analyte sensor components, wherein the functional test is a performance test simulating a use scenario, obtaining sensor data of each of the analyte sensor components, and determining calibration information based on a comparison between the sensor data of the analyte sensor component and a preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor; storing the information of the barcode in a local device and printing the barcode; before using the analyte sensor component, scanning and identifying the barcode and obtaining the calibration information based on the barcode; and generating a compensation model based on the calibration information, and calibrating the sensor data of the analyte sensor component through the compensation model.

2. The method according to claim 1, characterized in that The sensing data is a concentration variation curve, which is obtained by performing functional tests on each of the analyte sensing components using a variety of different analyte concentrations and obtaining the concentration variation curve of each of the analyte sensing components.

3. The method according to claim 1, characterized in that The sensing data includes at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate.

4. The method according to claim 1, characterized in that: The analyte sensing component is bound by using the batch and tooling location as the barcode information.

5. The method according to claim 1, characterized in that The local device is a device for performing the functional test.

6. The method according to claim 1, characterized in that The compensation model is preset in the terminal device and a plurality of corresponding compensation models can be selected based on the calibration information.

7. A calibration system for an analyte sensor assembly, which is a system for calibrating the sensing data of the analyte sensor assembly using a barcode before using the analyte sensor assembly, characterized in that: Include: a binding device that uses the barcode to bind each of the plurality of analyte sensing components; A testing device, which performs a performance test on each of the analyte sensor components in a simulated usage scenario, obtains sensor data of each of the analyte sensor components, determines calibration information based on a comparison of the sensor data of the analyte sensor components with a preset parameter range, and associates the calibration information with a barcode corresponding to the analyte sensor; The information of the barcode is stored in the testing device, and the information of the barcode is read and printed after the analyte sensing component test is completed; an identification device, which scans and identifies the barcode and obtains the calibration information according to the barcode before using the analyte sensing component; A calibration device generates a compensation model based on the calibration information and calibrates the sensing data of the analyte sensing component by using the compensation model.

8. The calibration system according to claim 7, characterized in that The calibration system further comprises a communication device for information transmission and a user display device for display.

9. The calibration system according to claim 8, characterized in that It also includes a server, which performs data communication with the binding device, the testing device and the identification device through the communication device.

10. The calibration system according to claim 7, characterized in that: The sensing data is a concentration variation curve. A plurality of different analyte concentrations are used to perform functional tests on each of the analyte sensing components to obtain a concentration variation curve of each of the analyte sensing components.

11. The calibration system according to claim 7, characterized in that: The sensing data includes at least one of analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate.

12. The calibration system according to claim 7, characterized in that The analyte sensing component is bound by using the batch and tooling location as the barcode information.

13. The calibration system according to claim 9, characterized in that The binding device is an information binding device in the server.

14. The calibration system according to claim 7, characterized in that The compensation model is preset in the terminal device and a plurality of corresponding compensation models can be selected based on the calibration information.

15. The calibration system according to claim 7, characterized in that The compensation model includes at least one of probability analysis, fuzzy logic, and decision function.

16. The calibration system according to claim 7, characterized in that The compensation model also includes a display model, and the display model includes at least one of a parameter compensation correction, a curve curvature compensation correction, and an image compensation correction.

17. An analyte sensing component calibrated using the method of any one of claims 1 to 6, characterized in that: The analyte sensing component has chemicals that react with glucose and generate sensing data.

18. The analyte sensing assembly according to claim 17, characterized in that The analyte sensing component includes a sensing unit for detecting the concentration of the analyte and generating the sensing data, and a communication unit for transmitting the sensing data.

19. The analyte sensing assembly according to claim 18, characterized in that The sensing data is sent through the communication unit to a terminal device for processing and / or displaying the sensing data.

20. The analyte sensing assembly according to claim 19, characterized in that The sensing data is processed by the terminal device to generate a concentration change curve that changes over time.

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