Method and System for Calibrating the Concentration Change Curve of an Analyte Sensing Assembly

Abstract

The present disclosure relates to a method and system for calibrating a concentration change curve of an analyte sensing assembly. The method includes: binding each analyte sensing assembly using a barcode; performing performance tests on each analyte sensing assembly to obtain the concentration change curve of each analyte sensing assembly, determining calibration information based on the comparison between the concentration change curve of the analyte sensing assembly and a preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor; before using the analyte sensing assembly, scanning and identifying the barcode and obtaining the calibration information according to the barcode; and calibrating the concentration change curve of the analyte sensing assembly based on the calibration information. The system includes a strapping device, a testing device, an identifying device, and a calibrating device. According to the present disclosure, it is possible to provide a method and system that can effectively calibrate before using the sensing assembly by an in vitro calibration method and provide a better user experience for users.

Description

[0001] This application is a divisional application of the patent application with the application date of September 24, 2021, application number 2021111233310, and invention title "Method and System for Calibrating Sensing Data of Analyte Sensing Assembly". Technical Field

[0002] The present disclosure generally relates to a calibration method and system, and particularly to a method and system for calibrating the concentration change curve of an analyte sensing assembly. Background Art

[0003] Diabetes is a common global disease. For diabetic patients, monitoring blood glucose is an essential thing every day. The currently commonly used blood glucose testing device is a blood glucose meter, but it can only detect the blood glucose value of a patient at a single time point and cannot continuously monitor the blood glucose level, which has great limitations. In addition, fingertip blood glucose collection often brings physical and even psychological harm to diabetic patients. Therefore, implantable continuous glucose monitors (CGMs) have emerged. The rapid development of continuous glucose monitors (CGMs) has brought advantages such as comfort, flexibility, and convenience to the monitoring of diabetes.

[0004] If the measurement data of blood glucose is inaccurate, it will bring extremely high risks to the patient's medication decision-making. Therefore, as an implantable sensor, continuous glucose monitors require even higher performance requirements compared to traditional sampling detection. In recent years, with the continuous progress of biosensing technology, continuous glucose monitors have become increasingly mature in biocompatibility and biofilm technology, especially in terms of performance, which has nearly met the requirements of being equivalent to or even higher than traditional sampling detection. Due to different manufacturing processes and sensing data processing methods, in order to ensure the performance of the sensors of continuous glucose monitors, that is, the monitored blood glucose data is accurate, most of the current existing technologies adopt the method of multiple fingerstick blood sampling calibrations before implanting the sensors of continuous glucose meters into the patient's body, which still lacks comfort, convenience, and a better user experience for patients. Summary of the Invention

[0005] 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 sensing assembly, which is a method and system for calibrating the sensing data of an analyte sensing assembly using a barcode before using the analyte sensing assembly, and can solve the problems that the fingerstick blood sampling calibration method in the prior art lacks comfort, convenience, and a better user experience for patients.

[0006] The first aspect of the present disclosure provides a method for calibrating sensing data of an analyte sensing assembly, which is a method for calibrating the sensing data of the analyte sensing assembly using a barcode before using the analyte sensing assembly, and includes: preparing a plurality of the analyte sensing assemblies, and binding each of the analyte sensing assemblies using the barcode; performing a function test on each of the analyte sensing assemblies, obtaining the sensing data of each of the analyte sensing assemblies, determining calibration information based on a comparison between the sensing data of the analyte sensing assembly and a preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor; before using the analyte sensing assembly, identifying the barcode and obtaining the calibration information according to the barcode; and calibrating the sensing data of the analyte sensing assembly based on the calibration information.

[0007] In this case, this method can solve the problems in the prior art that the fingertip blood sampling calibration method lacks comfort, convenience, and better user experience for patients.

[0008] According to the method involved in the present disclosure, optionally, the sensing data is a concentration change curve, which is obtained by performing a function test on each of the analyte sensing assemblies using a variety of different analyte concentrations and obtaining the concentration change curve of each of the analyte sensing assemblies. In this case, the concentration data of the analyte can be presented more intuitively in the form of a curve, and thus it is more convenient to analyze the change in the analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0009] According to the method involved in the present disclosure, optionally, the information of the barcode is stored in a server. Additionally, the analyte sensing assemblies can be packaged, and the information of the barcode can be downloaded from the server and displayed on the package. In this case, after the information of the barcode is associated with the sensing data, it can be stored in the server and preprocessed in the server. Before leaving the factory, a barcode with associated information or data can be downloaded and printed and displayed on the package, thereby enabling tracking of the pre-factory and post-factory information of the analyte sensing assembly.

[0010] 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 assembly needs to be calibrated, the calibration algorithm or model can determine the performance of the analyte sensing assembly based on the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0011] According to the method involved in the present disclosure, optionally, the analyte sensing component 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 sensing component can be traced by using the barcode.

[0012] According to the method involved in the present disclosure, optionally, a compensation model is generated based on the calibration information, and the sensing data of the analyte sensing component can be calibrated by the compensation model. In this case, the pre-factory sensing data obtained by using the barcode and the calibration information obtained therefrom can be used to calibrate the analyte sensing component with a preset compensation model before the analyte sensing component is used, that is, 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.

[0013] According to the method involved in the present disclosure, optionally, a terminal device with a display function is used to match with the analyte sensing component, and the calibrated sensing data can be displayed on the terminal device. In this case, when the analyte sensing component is used, the terminal device with a display function can display the sensing data of the analyte sensing component to the patient or other people who need to obtain accurate sensing data of the analyte sensing component better and more intuitively, that is, it is more convenient to obtain information.

[0014] According to the method involved in the present disclosure, optionally, the calibration information includes at least one of calibration behavior, calibration factor, and calibration coefficient. In this case, the calibration behavior can judge whether the sensing data needs to be calibrated and transfer the judgment result to the next calibration process. The calibration factor can make the calibration information more perfect. For example, it can be the simulation factors of the pre-factory test equipment, the test time period, the test method, etc. The calibration coefficient can obtain the corresponding compensation coefficient when the calibration information generates a compensation model, that is, the degree of compensation or the mathematical method, etc.

[0015] The second aspect of the present disclosure provides a system for calibrating the sensing data of an analyte sensing component, which is a system for calibrating the sensing data of the analyte sensing component by using a barcode before using the analyte sensing component. It may include: a binding device, which can bind each of the multiple analyte sensing components by using the barcode; a testing device, which can perform a function test on each of the analyte sensing components, obtain the sensing data of each of the analyte sensing components, determine the calibration information according to the comparison between the sensing data of the analyte sensing component and 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 and obtain the calibration information according to the barcode before using the analyte sensing component; a calibration device, which can calibrate the sensing data of the analyte sensing component based on the calibration information.

[0016] In this case, the calibration system solves the problems in the prior art that the fingertip blood sampling calibration method lacks comfort, convenience and better user experience for patients.

[0017] According to the calibration system involved in the present disclosure, optionally, the calibration system further includes a communication device for information transmission and a user display device for display. In this case, the binding device, the testing device, and the identification device in the system can perform data communication through the communication device, such as obtaining barcode information, barcode binding information, sensing data, information associated with the barcode and the sensing data, calibration information of the analyte sensing component based on the sensing data, etc. The user display device can display to the patient or other people who need to obtain the sensing data of the accurate analyte sensing component better and more intuitively, that is, it is more convenient to obtain information.

[0018] According to the calibration system involved in the present disclosure, optionally, it further includes a server for data storage, and the server can perform data communication with the binding device, the testing device, and the identification device through the communication device. In this case, the binding device, the testing device, and the identification device in the system can transmit data to each other and be processed and stored by the server, thereby realizing data intercommunication and information tracking.

[0019] According to the calibration system 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, so as to obtain the concentration change curves of each of the analyte sensing components. In this case, the concentration change curve can facilitate the analysis and calibration of the sensing data, and can also be more intuitively presented to the personnel who need to obtain the sensing data.

[0020] According to the calibration system involved in the present disclosure, optionally, the information of the barcode is stored in the server, and the analyte sensing component can be packaged, the information of the barcode can be downloaded from the server and the barcode can be displayed on the package. In this case, after the information of the barcode is associated with the sensing data, it can be stored in the server and can be preprocessed in the server. Before leaving the factory, the barcode with associated information or data can be downloaded and printed and displayed on the package, thereby enabling the tracking of the information before and after the factory of the analyte sensing component.

[0021] 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 determine the performance of the analyte sensing component based on the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate, and perform corresponding analysis and calibration.

[0022] According to the calibration system involved in the present disclosure, optionally, the analyte sensing component is bound by using the position of the batch and the tooling as the information of the barcode. In this case, the pre-factory information tracking of the analyte sensing component can be completed by using the barcode.

[0023] According to the calibration system involved in the present disclosure, optionally, a compensation model is generated based on the calibration information, and the sensing data of the analyte sensing component can be calibrated by the compensation model. In this case, the pre-factory sensing data obtained by using the barcode and the calibration information obtained therefrom can be used to calibrate the analyte sensing component with a preset compensation model before the analyte sensing component is used, that is, 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.

[0024] According to the calibration system involved in the present disclosure, optionally, a terminal device with a display function is used to match with the analyte sensing component, and the calibrated sensing data can be displayed on the terminal device. In this case, when the analyte sensing component is used, the terminal device with a display function can display to patients or others who need to obtain accurate sensing data of the analyte sensing component better and more intuitively, that is, it is more convenient to obtain information.

[0025] According to the calibration system involved in the present disclosure, optionally, the calibration information includes at least one of calibration behavior, calibration factor, and calibration coefficient. In this case, the calibration behavior can judge whether the sensing data needs to be calibrated and transfer the judgment result to the next calibration process. The calibration factor can make the calibration information more perfect. For example, it can be the simulation factors of the pre-factory test equipment, test time period, test method, etc. The calibration coefficient can obtain the corresponding compensation coefficient when the calibration information generates the compensation model, that is, the degree of compensation or mathematical method, etc.

[0026] 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 sensing data in corresponding ways such as probability analysis, fuzzy logic, and decision function according to different requirements.

[0027] According to the calibration system involved in the present disclosure, optionally, the compensation model may further 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 calibrating the sensing data of the analyte sensing component, the display model in the compensation model can display compensation correction information including parameter compensation correction, curve curvature compensation correction, image compensation correction, etc., and more intuitively present the compensation calibration information to those who need to obtain the sensing data and calibration information.

[0028] The third aspect of the present disclosure provides an analyte sensing component, which can have a chemical substance that reacts with glucose and generates sensing data. In this case, the analyte sensing component can form a complete calibration system with each device in the above system.

[0029] According to the analyte sensing component involved in the present disclosure, optionally, the analyte sensing component includes a sensing unit for detecting the concentration of the analyte to be analyzed 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 system or method and transmit it to each device in the system or method through the communication unit.

[0030] According to the analyte sensing component 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 using the analyte sensing component, the sensing unit can obtain real-time sensing data in the human body and display the calibrated sensing data intuitively in a terminal device with a display function according to the calibration system through this communication unit.

[0031] According to the analyte sensing component involved in the present disclosure, optionally, a concentration change curve over time is generated after the sensing data is processed by the terminal device. In this case, the sensing data can be intuitively displayed in a terminal device with a display function.

[0032] According to the present disclosure, a method and a system for calibrating the sensing data of an analyte sensing component can be provided, which are a method and a system for calibrating the sensing data of an analyte sensing component using a barcode before using the analyte sensing component, and can solve the problems of lack of comfort, convenience, and better user experience for patients in the existing fingertip blood sampling calibration method. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a flowchart of a method for calibrating the sensing data of an analyte sensing component involved in the present disclosure.

[0034] Figure 2It is a block diagram of a calibration system for calibrating sensing data of an analyte sensing assembly related to the present disclosure.

[0035] Figure 3 It is a schematic diagram of an application scenario of an analyte sensing assembly related to the present disclosure.

[0036] Figure 4 It is a schematic diagram of a method for calibrating sensing data of an analyte sensing assembly and / or a calibration result of a calibration system related to the present disclosure.

[0037] Figure 5 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing assembly and / or a calibration system using a compensation model of probability analysis related to the present disclosure.

[0038] Figure 6 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing assembly and / or a calibration system using a compensation model of fuzzy logic related to the present disclosure.

[0039] Figure 7 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing assembly and / or a calibration system using a compensation model of a decision function related to the present disclosure.

[0040] Figure 8 It is a schematic diagram of a calibration result of a method for calibrating sensing data of an analyte sensing assembly and / or a calibration system displayed in a terminal device related to the present disclosure. Detailed implementation manners

[0041] Next, the technical solutions in the embodiments of the present disclosure will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only a part of the embodiments of the present disclosure, rather than all the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present disclosure.

[0042] It should be noted that in the description of the present disclosure, the claims, and the above-mentioned drawings, the terms "first", "second", "third", "fourth", etc. are used to distinguish different objects, rather than to describe a specific order. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. 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 further include steps or units not listed, or may optionally further include other steps or units inherent to these processes, methods, products, or devices. In the following description, the same reference numerals are given to the same components, and repeated descriptions are omitted. Additionally, the drawings are only schematic diagrams, and the proportional relationship of the sizes between components or the shapes of components may be different from the actual ones.

[0043] The present disclosure provides a method and a system for calibrating the sensing data of an analyte sensing assembly, which are used to calibrate the sensing data of the analyte sensing assembly using a barcode before using the analyte sensing assembly, and can solve the problems of lack of comfort, convenience, and better user experience for patients in the prior art's fingertip blood sampling calibration method. The following will be described in detail with reference to the accompanying drawings.

[0044] Figure 1 It is a flowchart showing a method for calibrating the sensing data of an analyte sensing assembly according to the present disclosure.

[0045] As Figure 1 shown, in the first aspect of the present disclosure, a method for calibrating the sensing data of an analyte sensing assembly is provided, which is a method for calibrating the sensing data of the analyte sensing assembly using a barcode before using the analyte sensing assembly, and includes:

[0046] Step S001, prepare a plurality of analyte sensing assemblies, and bind each analyte sensing assembly with a different barcode;

[0047] Step S002, perform a function test on each analyte sensing assembly to obtain the sensing data of each analyte sensing assembly;

[0048] Step S003, determine calibration information according to the comparison between the sensing data of the analyte sensing assembly and a preset parameter range, and associate the calibration information with the barcode corresponding to the analyte sensor;

[0049] Step S004, before using the analyte sensing assembly, identify the barcode and obtain the calibration information according to the barcode;

[0050] Step S005, calibrate the sensing data of the analyte sensing assembly based on the calibration information.

[0051] In this case, this method can solve the problems of the fingertip blood sampling calibration method in the prior art, which lacks comfort, convenience, and a better user experience for patients.

[0052] In some examples, the preset parameter range may refer to preset analyte concentration data, rate of change, sensitivity, or rate of change of sensitivity, etc.

[0053] In some examples, the analyte concentration may refer to the glucose concentration in interstitial fluid in the human body. In other examples, the analyte concentration may refer to the concentrations of lactic acid, vitamin C, uric acid, urea, glutamic acid, or transaminase, etc.

[0054] 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, Tian character 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 can be used for step S001 according to the production and post-factory requirements, providing convenience for the binding of the barcode.

[0055] In some examples, the barcode binding in step S001 may be the binding of the corresponding batch and tooling information, etc., which can be used as ID identification marks, with the barcode before the production of the analyte sensing component, that is, step S001 can be completed before the production of the analyte sensing component. In other examples, step S001 may be completed before the analyte sensing component is produced and waiting for testing. Thus, the analyte sensing component after the binding step S001 can be identified and traced in subsequent steps.

[0056] In some examples, a functional test device can be used in step S002 to perform a functional test on the analyte sensing component, where the functional test refers to a performance test that simulates the analyte sensing component in the usage scenario. Thus, the sensing data of the analyte sensing component can be obtained to analyze its performance.

[0057] In some examples, step S003 can be completed in the testing device in the foregoing step S002. In other examples, step S003 can also be performed in the server after obtaining the sensing data of the analyte sensing component tested by the testing device. Thus, completing step S003 in the testing device can reduce the processing load of the server, and completing S003 in the server can reduce the computing processing of the testing device.

[0058] In some examples, step S004 can be to use a terminal device with barcode recognition function to scan and recognize the barcode to obtain the sensing data and calibration information of the analyte sensing component. Thus, the user can obtain the calibration information through the terminal device before using the analyte sensing component and use the terminal device to calibrate the sensing data of the analyte sensing component after use based on the calibration information.

[0059] In some examples, step S005 can be completed in the terminal device in step S004. Thus, the user can use the terminal device to calibrate the sensing data of the analyte sensing component after use based on the calibration information.

[0060] In some examples, through steps S001 to S005 in this method, the problems of lack of comfort, convenience and better user experience for patients in the prior art's fingertip blood sampling calibration method can be solved.

[0061] In some examples, the sensing data can be a concentration change curve, which can be obtained by performing functional tests on each analyte sensing component using a variety of different analyte concentrations and obtaining the concentration change curves of each analyte sensing component. In this case, the concentration data of the analyte can be presented more intuitively in the form of a curve, and thus it is more convenient to analyze the change of the analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0062] In some examples, the sensing data can also be a broken line or a graph of concentration change.

[0063] In some examples, the variety of different analysis concentrations can be the concentration of a pure analyte solution or the concentration in a non-pure analyte solution. In this case, using the pure concentration analyte solution to test the analyte sensing component can reflect the true performance parameters of the analyte sensing component, and using the 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.

[0064] In some examples, the information of the barcode can be stored in a server. Additionally, the analyte sensing component can be packaged, and the information of the barcode can be downloaded from the server and displayed on the package. In this case, after the information of the barcode is associated with the sensing data, it can be stored in the server and pre-processed in the server. Before leaving the factory, a barcode with associated information or data can be downloaded and printed and displayed on the package, thereby enabling pre-factory and post-factory information tracking of the analyte sensing component.

[0065] In some examples, the information of the barcode can be temporarily stored in a local device, such as the testing device involved in the above step S002. Thus, after the test is completed, it can be uploaded to the server, or the barcode information can be directly read and printed from the testing device.

[0066] In some examples, the packaging can be one of manual packaging or packaging by a packaging machine. For example, using a packaging machine for packaging can quickly and efficiently complete the packaging task, and connecting the packaging machine to the server can facilitate and quickly download and print the barcode to complete the packaging.

[0067] In some examples, the sensing data can 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 based on the analyte concentration, analyte concentration change rate, analyte detection time, sensor sensitivity, and sensitivity change rate and perform corresponding analysis and calibration.

[0068] In some examples, the analyte concentration can refer to the data generated when chemical energy in the analyte is converted into electrical energy by the sensor in the analyte sensing component. In some examples, the analyte concentration can be the concentration data of a specific single analyte or the concentration data of multi-component analytes.

[0069] In some examples, the analyte concentration change rate can refer to the change rate or change amount of the analyte concentration data itself, or can refer to the slope or change rate of the curve generated based on the analyte concentration.

[0070] In some examples, the analyte detection time can refer to the time from when the sensor of the analyte sensing component comes into contact with the analyte solution or interstitial fluid in the human body to generate an electrical signal and is acquired by the analyte sensing component until the separation or cessation of the reaction between the sensor and the analyte solution or interstitial fluid in the human body.

[0071] In some examples, the sensor sensitivity can refer to the lower limit of the reaction between the sensor of the analyte sensing component and the analyte.

[0072] In some examples, the sensitivity change rate may refer to the change rate of the sensor of the analyte sensing component with respect to the lower limit of the reaction with the analyte.

[0073] In some examples, the analyte sensing component can be bound by using the position of the batch and the tooling as the information of the barcode. In this case, the pre-factory information of the analyte sensing component can be traced by using the barcode.

[0074] In some other examples, the server can randomly generate a unique serial number as the barcode information and bind it to each analyte sensing component that needs to be bound.

[0075] In some examples, a compensation model can be generated based on the calibration information, and the sensing data of the analyte sensing component can be calibrated by the compensation model. In this case, by using the pre-factory sensing data obtained through the barcode and thus obtaining the calibration information, the analyte sensing component can be calibrated by using the preset compensation model before use, that is, 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.

[0076] In some examples, the compensation model can be preset in the terminal device and multiple corresponding compensation models can be selected based on the calibration information. Specifically, for example, if the tested sensing data is larger than the preset parameter range, the negative compensation can be selected for the compensation model; on the contrary, the positive compensation can be selected for the compensation model. Thus, the user can obtain more accurate analyte concentration data when using the analyte sensing component.

[0077] In some examples, a terminal device with a display function can be used to match with the analyte sensing component, and the calibrated sensing data can be displayed on the terminal device. In this case, during the use of the analyte sensing component, the terminal device with a display function can display better and more intuitively to the patient or other people who need to obtain the sensing data of the accurate analyte sensing component, that is, it is more convenient to obtain information.

[0078] In some examples, the terminal device can be a specific analyte concentration analyzer with a scanning function and a display function. In some other examples, the terminal device can be a mobile phone, a tablet or a personal computer with an analyte concentration analysis function, etc. Thus, it can facilitate the user to use the analyte sensing component to analyze the analyte concentration.

[0079] In some examples, the calibration information may include at least one of calibration behavior, calibration factor, and calibration coefficient. In some examples, the calibration behavior can determine whether the sensed 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, the calibration factor can be the simulation factors of the pre-factory test equipment, the test time period, the test method, etc. The calibration coefficient can obtain the corresponding compensation coefficient when generating the compensation model for the calibration information, that is, the degree of compensation or the mathematical method, etc. In this case, setting multiple calibration information can improve the calibration accuracy.

[0080] Figure 2 is a block diagram showing a calibration system for calibrating the sensed data of a calibration analyte sensing assembly according to the present disclosure; Figure 4 is a schematic diagram showing the calibration result of a method for calibrating the sensed data of a calibration analyte sensing assembly and / or a calibration system according to the present disclosure; Figure 5 is a schematic diagram showing the calibration result of a method for calibrating the sensed data of a calibration analyte sensing assembly and / or a calibration system using a compensation model of probability analysis; Figure 6 is a schematic diagram showing the calibration result of a method for calibrating the sensed data of a calibration analyte sensing assembly and / or a calibration system using a compensation model of fuzzy logic; Figure 7 is a schematic diagram showing the calibration result of a method for calibrating the sensed data of a calibration analyte sensing assembly and / or a calibration system using a compensation model of decision function.

[0081] As Figure 2 shown, a second aspect of the present disclosure provides a calibration system 10 for calibrating the sensed data of a calibration analyte sensing assembly, which is a calibration system 10 for calibrating the sensed data of the calibration analyte sensing assembly using a bar code before using the calibration analyte sensing assembly.

[0082] 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.

[0083] In some examples, the binding device 11 can bind each of a plurality of calibration analyte sensing assemblies using different bar codes. In some examples, the testing device 12 can perform a functional test on each calibration analyte sensing assembly, obtain the sensed data of each calibration analyte sensing assembly, and can determine the calibration information according to the comparison between the sensed data of the calibration analyte sensing assembly and the preset parameter range. At the same time, the calibration information can be associated with the bar code corresponding to the calibration analyte sensor. In some examples, the identification device 131 can identify the bar code and obtain the calibration information according to the bar code before using the calibration analyte sensing assembly. In some examples, the calibration device 132 can calibrate the sensed data of the calibration analyte sensing assembly based on the calibration information.

[0084] In this case, calibration information can be obtained before using the analyte sensing component, and then the sensing data of the analyte sensing component can be calibrated based on the above calibration information, which can solve the deficiencies existing in the finger-pricking blood sampling method in the prior art. For example, it can improve the convenience of collecting the blood glucose of patients, provide a better experience for users, and at the same time overcome the problems such as the lack of comfort of patients in the prior art.

[0085] In some examples, the binding device 11 can be the information binding device 11 in the server 15. In other examples, the binding device 11 can be independent of the server 15 and communicate with the server 15, whereby the remote planning of the factory workshop can be facilitated. In other examples, the binding device 11 can be integrated with the testing device 12, whereby the binding of information and barcodes can be facilitated before the analyte sensing component is completed and to be tested, reducing the binding steps in other production processes.

[0086] In some examples, the functional testing of the analyte sensing component in the testing device 12 can include but is not limited to: performance testing based on the simulated analyte concentration, sensitivity testing of the analyte sensing component, testing of the electrical properties of the analyte sensing component (including but not limited to circuit on / off, resistance, capacitance, inductance, etc.).

[0087] In some examples, the identification device 131 can be a scanning and identification device 131 such as a barcode scanner or a barcode reader. In other examples, the identification device 131 can be a mobile device with scanning and identification functions, such as a mobile phone, a tablet computer, a personal computer, etc.

[0088] In some examples, the identification device 131 and the calibration device 132 can be integrated into the terminal device 13 as a whole. Thereby, it can facilitate the user to use the analyte sensing component.

[0089] In some examples, the calibration system 10 can further include a communication device 14 for information transmission and a user display device (not shown) for display. In this case, the binding device 11, the testing device 12, and the identification device 131 in the calibration system 10 can perform data communication through the communication device 14, such as obtaining barcode information, barcode binding information, sensing data, information related to the association between the barcode and the sensing data, calibration information of the analyte sensing component based on the sensing data, etc. The user display device can display better and more intuitively to patients or others who need to obtain the accurate sensing data of the analyte sensing component, that is, it is more convenient to obtain information.

[0090] In some examples, the communication device 14 can be connected and communicate with the binding device 11 and the testing device 12 through the fieldbus 16. In some examples, the communication device 14 can be connected to the identification device 131 and the calibration device 132 through the cloud, local area network or Internet for information exchange.

[0091] In some examples, the user display device, the identification device 131, and the calibration device 132 can be integrated into the terminal device 13 as a whole. Thus, it is convenient for users to use the analyte sensing component.

[0092] In some examples, the calibration system 10 may further include a server 15 for data storage. The server 15 can communicate with the binding device 11, the testing device 12, the identification device 131, and the calibration device 132 through the communication device 14. In this case, the binding device 11, the testing device 12, and the identification device 131 in the system 10 can transfer data to each other and be processed and stored by the server 15, thereby realizing data intercommunication and information tracking.

[0093] 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 through the communication device 14 and complete data processing.

[0094] In some examples, the sensing data can be a concentration change curve, which is obtained by functionally testing each analyte sensing component with a variety of different analyte concentrations, so as to obtain the concentration change curve of each analyte sensing component. In this case, it is more convenient to analyze and calibrate the sensing data by observing the concentration change curve, and it is also more intuitive to present to the personnel who need to obtain the sensing data. Thus, it is more convenient to analyze the change of analyte concentration by analyzing the slope or curvature of the concentration change curve.

[0095] In some examples, the sensing data can also be a broken line or graph of concentration change.

[0096] In some examples, the various different analysis concentrations can be the concentrations of pure analyte solutions or non-pure analyte solutions. In this case, using pure-concentration analyte solutions to test the analyte sensing components can reflect the true performance parameters of the analyte sensing components, and using non-pure-concentration analyte solutions to test the analyte sensing components can reflect the performance parameters of the analyte sensing components close to actual use.

[0097] In some examples, the information of the barcode can be stored in the server 15, and the analyte sensing component can be packaged, the information of the barcode can be downloaded from the server 15 and the barcode can be displayed on the package. In this case, after the information of the barcode is associated with the sensing data, it can be stored in the server 15, and can be pre-processed in the server 15. Before leaving the factory, the barcode with associated information or data can be downloaded and printed and displayed on the package, thereby enabling the tracking of the pre-factory and post-factory information of the analyte sensing component.

[0098] In some examples, the information of the barcode can be temporarily stored in a local device, such as the test device 12. Thus, after the test is completed, it can be uploaded to the server 15, or the barcode information can be directly read and printed from the test device.

[0099] In some examples, the package can be one of manual packaging or packaging by a packaging machine. For example, using a packaging machine for packaging can quickly and efficiently complete the packaging task, and connecting the packaging machine to the server 15 can facilitate and quickly download and print the barcode to complete the packaging.

[0100] In some examples, the sensing data can 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.

[0101] In some examples, the analyte concentration can refer to the data generated when the chemical energy of the analyte is converted into electrical energy by the sensor in the analyte sensing component. It can be the concentration data of a specific single analyte, or the concentration data of a multi-component analyte.

[0102] In some examples, the analyte concentration change rate can refer to the change rate or change amount of the analyte concentration data itself, or can refer to the slope or change rate of the curve generated based on the analyte concentration.

[0103] In some examples, the analyte detection time can refer to the time from when the sensor of the analyte sensing component contacts the analyte solution or interstitial fluid in the human body to generate an electrical signal and is acquired by the analyte sensing component until the separation or stop of the reaction between the sensor and the analyte solution or interstitial fluid in the human body.

[0104] In some examples, the sensor sensitivity can refer to the lower limit of the reaction between the sensor of the analyte sensing component and the analyte.

[0105] In some examples, the sensitivity change rate may refer to the change rate of the sensor of the analyte sensing component with respect to the lower limit of the reaction with the analyte.

[0106] In some examples, the analyte sensing component can be bound by using the position of the batch and the tooling as the information of the barcode. In this case, the pre-factory information of the analyte sensing component can be tracked by using the barcode.

[0107] In some other examples, the server 15 can randomly generate a unique serial number as the barcode information and bind it to each analyte sensing component that needs to be bound.

[0108] In some examples, a compensation model can be generated based on the calibration information, and the sensing data of the analyte sensing component can be calibrated by the compensation model. In this case, by using the pre-factory sensing data obtained through the barcode and thus obtaining the calibration information, the analyte sensing component can be calibrated by using the preset compensation model before use, that is, 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.

[0109] In some examples, the compensation model can be preset in the calibration device 132 and multiple corresponding compensation models can be selected based on the calibration information. Specifically, for example, if the tested sensing data is larger than the preset parameter range, the negative compensation model can be selected; conversely, the positive compensation model can be selected. Thus, users can obtain more accurate analyte concentration data when using the analyte sensing component.

[0110] In some examples, the terminal device 13 with a display function can be used to match with the analyte sensing component, and the calibrated sensing data can be displayed on the terminal device 13. In this case, when the analyte sensing component is in use, the terminal device 13 with a display function can display better and more intuitively for patients or others who need to obtain the sensing data of the accurate analyte sensing component, that is, it is more convenient to obtain information.

[0111] In some examples, the identification device 131 and the calibration device 132 can be a specific analyte concentration analyzer with scanning and display functions. In some other examples, the identification device 131 and the calibration device 132 can be a mobile phone, a tablet computer, a personal computer, etc. with an analyte concentration analysis function. Thus, it is convenient for users to use the analyte sensing component to analyze the analyte concentration.

[0112] In some examples, the calibration information may include at least one of calibration behavior, calibration factor, and calibration coefficient. In this case, the calibration behavior can determine whether the sensed data needs to be calibrated and transfer the determination result to the next calibration process. The calibration factor can make the calibration information more complete. For example, it can include simulation factors of pre-factory test equipment, test time periods, test methods, etc. The calibration coefficient can obtain corresponding compensation coefficients when generating a compensation model for the calibration information, that is, the degree of compensation or mathematical method, etc. For example: As Figure 4 shown, if the sensed data before calibration is generally less than the preset parameter range, that is, as shown by curve 1 before calibration, according to the calibration behavior, it can be determined that positive compensation is needed, and the result after calibration can be as shown by curve 3 after calibration; conversely, referring to curve 2 before calibration, according to the calibration behavior, it can be determined that negative compensation is needed, and the result after calibration can be as shown by curve 3 after calibration.

[0113] 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 sensed data in corresponding ways such as probability analysis, fuzzy logic, and decision function according to different requirements.

[0114] As Figure 5 shown, in the compensation model of probability analysis, for the sensed data of the same analyte sensing component: curve c is the curve of normal sensed data or the curve of sensed data after calibration, and curves a and b are the curves of sensed data that need to be calibrated. Among them, in the test, the sensed data of curves a and b is randomly distributed on both sides of curve c with curve c as the center. Then, curves a and b need to be fitted close to curve c through a mathematical algorithm. That is, after the analyte sensor is used, although the actual sensed data may be a or b, it is still shown as curve c after compensation calibration.

[0115] As Figure 6 shown, in the compensation model of fuzzy logic, for the sensed data of the same analyte sensing component: curve f is the curve of normal sensed data or the curve of sensed data after calibration, and curves d and e are the curves of sensed data that need to be calibrated. Among them, in the test, the sensed data of curves d and e is completely matched or coincident with the sensed data of curve f in some detection time periods, and does not match in the remaining time periods. Then, the compensation model of fuzzy logic is used to compensate and calibrate curves d and e. That is, the parts of curves d and e that match curve f are retained through a fuzzy algorithm, and the rest are given corresponding compensation.

[0116] As Figure 7As shown, in the compensation model of the decision function, for the sensing data of the same analyte sensing component: Curve k is the curve of normal sensing data or the curve of calibrated sensing data, and curves h and g are the curves of sensing data that need to be calibrated. Among them, in the test, if the sensing data of curves h and g can only correspond to curve k but not completely match in a certain detection time period x (x = x2 - x1), the decision function model is selected to perform compensation calibration on curves h and g. That is, the abnormal data outside the detection time period x is not calculated, and only the sensing data in the detection time period x is compensated.

[0117] In some examples, the compensation model may further 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 calibrating the sensing data of the analyte sensing component, the display model in the compensation model can display compensation correction information including parameter compensation correction, curve curvature compensation correction, image compensation correction, etc., and more intuitively present the compensation calibration information to the personnel who need to obtain the sensing data and calibration information.

[0118] Figure 3 is a schematic diagram showing an application scenario of an analyte sensing component involved in the present disclosure; Figure 8 is a schematic diagram showing the display of the calibration result of a method for calibrating the sensing data of an analyte sensing component and / or a calibration system in a terminal device.

[0119] As Figure 3 shown, the third aspect of the present disclosure provides an analyte sensing component 02. The analyte sensing component 02 may have a chemical substance that reacts with glucose and is the 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.

[0120] In some examples, the analyte sensing component 02 may include a sensing unit for detecting the concentration of the analyte to be analyzed 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 calibration system or method and transmit it to each device in the calibration system or method through the communication unit.

[0121] In some examples, preferably, the analyte sensing component can be used for the detection and analysis of glucose concentration in the human body.

[0122] In some examples, the sensing data can be sent to the terminal device 13 for processing and / or displaying the sensing data through the 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 display it intuitively in the terminal device 13 with a display function through the communication unit.

[0123] 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.

[0124] 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 calibration system are used to calibrate the sensing data of the analyte sensing component using a barcode before using the analyte sensing component, and can solve the problems of lack of comfort, convenience and better user experience for patients in the prior art's fingertip blood sampling calibration method.

[0125] Although the present disclosure has been specifically described above in combination with the accompanying drawings and examples, it can be understood that the above description does not limit the present disclosure in any form. Those skilled in the art can make deformations and changes to the present disclosure according to needs without departing from the essence and scope of the present disclosure, and these deformations and changes all fall within the scope of the present disclosure.

Claims

1. A method for calibrating the concentration change curve of an analyte sensing assembly, which is a method for calibrating the concentration change curve of the analyte sensing assembly using a barcode before using the analyte sensing assembly, characterized in that, Including: preparing a plurality of the analyte sensing components, and binding each of the analyte sensing components using the barcode; performing a functional test on each of the analyte sensing components to obtain a concentration change curve of each of the analyte sensing components, and determining calibration information based on a comparison between the concentration change curve of the analyte sensing component and a preset parameter range, and associating the calibration information with the barcode corresponding to the analyte sensor, wherein the functional test is a performance test simulating the analyte sensing component in a usage scenario; before using the analyte sensing component, scanning the barcode to identify and obtaining the calibration information according to the barcode; and calibrating the concentration change curve of the analyte sensing component based on the calibration information.

2. The method according to claim 1, wherein the concentration change curve is obtained by performing the test on each of the analyte sensing components using a plurality of different analyte concentrations.

3. The method according to claim 1, wherein the concentration change curve 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, wherein the information of the barcode is stored in a server, and the analyte sensing component is packaged, downloading the information of the barcode from the server and displaying the barcode on the package.

5. The method according to claim 4, wherein the server randomly generates a unique serial number, and the unique serial number is used as the information of the barcode and is bound to each analyte sensing component to be bound.

6. The method according to claim 1, wherein a compensation model is generated based on the calibration information, and the concentration change curve of the analyte sensing component is calibrated by the compensation model.

7. The method according to claim 6, wherein the compensation model is preset in a terminal device and there are a plurality of compensation models available for selection corresponding to the calibration information.

8. A calibration system for calibrating the concentration change curve of an analyte sensing component, which is a system for calibrating the concentration change curve of the analyte sensing component using a barcode before using the analyte sensing component, characterized in that, Including: a binding device that binds a plurality of the analyte sensing components using the barcode; a testing device that performs a functional test on each of the analyte sensing components to obtain a concentration change curve of each of the analyte sensing components, and determines calibration information based on a comparison between the concentration change curve of the analyte sensing component and a preset parameter range, and associates the calibration information with the barcode corresponding to the analyte sensor, wherein the functional test is a performance test simulating the analyte sensing component in a usage scenario; an identifying device that scans the barcode to identify and obtains the calibration information according to the barcode before using the analyte sensing component; a calibrating device that calibrates the concentration change curve of the analyte sensing component based on the calibration information.

9. The calibration system according to claim 8, wherein A server for storing information of the barcode; after the analyte sensing component is packaged, downloading the information of the barcode from the server and displaying the barcode on the package.

10. The calibration system according to claim 9, wherein The binding device is an information binding device in the server.

11. The calibration system according to claim 9, wherein The binding device is independent of the server and communicates with the server.

12. The calibration system according to claim 9, wherein The server randomly generates a unique serial number as the information of the barcode and binds it to each analyte sensing component to be bound.

13. The calibration system according to claim 8, wherein The concentration change curve is obtained by testing each of the analyte sensing components using a variety of different analyte concentrations.

14. The calibration system according to claim 8, wherein The functional test of the analyte sensing component in the test device includes performance tests based on simulated analyte concentrations, sensitivity tests of the analysis sensing component, and tests of the electrical properties of the analyte sensing component.

15. The calibration system according to claim 8, wherein The calibration system further includes a communication device for information transfer, and the binding device, the test device, the identification device, and the calibration device perform data communication through the communication device and complete data processing.

16. The calibration system according to claim 8, wherein A terminal device with a display function is used to match with the analyte sensing component, and the calibrated concentration change curve is displayed on the terminal device.

17. The calibration system according to claim 8, wherein The concentration change curve of the analyte sensing component is calibrated by a plurality of compensation models preset in the calibration device and selectable based on the calibration information.

18. The calibration system according to claim 17, wherein The compensation model includes at least one of probability analysis, fuzzy logic, and decision function.

19. An analyte sensing assembly, which is an assembly calibrated by using the method according to any one of claims 1-7, is characterized in that, The analyte sensing component has a chemical substance that reacts with glucose and generates sensing data.

20. The analyte sensing component according to claim 19, wherein The analyte sensing component includes a sensing unit for detecting the concentration of the analyte to be analyzed and generating the sensing data, and a communication unit for transmitting the sensing data.

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