WO2023045383A1

WO2023045383A1 - Method and system for calibrating sensing data of analyte sensing assemblies

Info

Publication number: WO2023045383A1
Application number: PCT/CN2022/095711
Authority: WO
Inventors: 陈志�; 方骏飞; 韩明松; 王蕾; 陈立果; 王顺兵; 刚迎磊
Original assignee: 深圳硅基传感科技有限公司
Priority date: 2021-09-24
Filing date: 2022-05-27
Publication date: 2023-03-30
Also published as: CN115856273A; CN113848313A; CN115856272A; CN113848313B

Abstract

A method and system for calibrating sensing data of analyte sensing assemblies. The method comprises: preparing a plurality of analyte sensing assemblies, and binding the analyte sensing assemblies by using different barcodes; performing function testing on the analyte sensing assemblies to obtain sensing data of the analyte sensing assemblies, determining calibration information according to the comparison between the sensing data of the analyte sensing assemblies and a preset parameter range, and associating the calibration information with the barcodes corresponding to the analyte sensing assemblies; before the analyte sensing assemblies are used, identifying the barcodes, and obtaining the calibration information according to the barcodes; and calibrating the sensing data of the analyte sensing assemblies on the basis of the calibration information. The system comprises: a binding apparatus (11), a testing apparatus (12), an identification apparatus (131), and a calibration apparatus (132). Therefore, a method and system for using an in vitro calibration approach to perform effective calibration before a sensing assembly is used and providing better user experiences for a user can be provided.

Description

Method and system for calibrating sensing data of an analyte sensing assembly

technical field

The present disclosure generally relates to a calibration method and system, and more particularly to a calibration method and system for an analyte sensing component based on sensing data.

Background technique

Diabetes is a common disease worldwide. According to statistics from the International Diabetes Federation, the number of people suffering from diabetes worldwide in 2017 was about 425 million, and it is expected to reach 629 million by 2045. my country is the country with the largest number of diabetics in the world. In 2017, the number of diabetics was 114 million, and it is expected to reach about 150 million by 2045. For diabetics, monitoring blood sugar is an essential thing every day. The currently widely used blood glucose testing equipment 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 blood glucose monitor (CGM) emerges at the historic moment, and the rapid development of continuous blood glucose monitor (CGM) brings advantages such as comfort, flexibility and convenience to the monitoring of diabetes.

If the blood glucose measurement data is inaccurate, it will bring a very high risk of medication decision-making to the patient. Therefore, as an implantable sensor, the continuous blood glucose monitor requires comparable or even higher performance requirements than traditional sampling detection. In recent years, with the continuous advancement of biosensing technology, continuous blood glucose monitors have become increasingly mature in terms of biocompatibility and biofilm technology, especially in terms of performance, which has been close to meeting the equivalent or even higher requirements than traditional sampling testing. Due to the difference in manufacturing process 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 uses the sensor implanted into the patient's body. The previous method of performing multiple finger blood sampling calibrations still lacks comfort, convenience, and better user experience for patients.

Contents of the invention

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

The first aspect of the present disclosure provides a method for calibrating the sensing data of an analyte sensing component, which is used to calibrate the sensing data of the analyte sensing component using a barcode before using the analyte sensing component The method comprises: preparing a plurality of the analyte sensing components, and using the barcode to bind each of the analyte sensing components; performing a functional test on each of the analyte sensing components to obtain each of the analyte sensing components the sensing data of the analyte sensing component, and determine the calibration information according to the comparison between the sensing data of the analyte sensing component and the preset parameter range, and compare the calibration information with the barcode corresponding to the analyte sensor Associating; before using the analyte sensing component, identifying the barcode and obtaining the calibration information according to the barcode; and calibrating the sensing data of the analyte sensing component based on the calibration information.

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

According to the method involved in the present disclosure, optionally, the sensing data is a concentration change curve, which is to perform a functional test on each of the analyte sensing components using a plurality of different analyte concentrations and obtain each of the analysis The concentration change curve of the substance sensing component. In this case, the concentration data of the analyte can be presented more intuitively in the form of a curve, so that it is easier to analyze the change of the concentration of the analyte through the analysis of the slope or curvature of the concentration change curve.

According to the method involved in the present disclosure, optionally, the barcode information is stored in a server, and the analyte sensing component can be packaged, and the barcode information can be downloaded from the server and displayed on the package the barcode. In this case, the information of the barcode can be stored in the server after being associated with the sensor data, 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. This enables pre- and post-factory information tracking of the analyte sensing assembly.

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 analyte sensing component based on the analyte concentration, the rate of change of the analyte concentration, the time of detection of the analyte, the sensitivity of the sensor, and the rate of change of the sensitivity. The performance of the sensor components and the corresponding analysis and calibration.

According to the method involved in the present disclosure, optionally, the analyte sensing component can be bound by using the location of the batch and tooling as the information of the barcode. In this case, the tracking of the pre-factory information of the analyte sensing component can be accomplished by utilizing a barcode.

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 through the compensation model. In this case, by using the pre-factory sensing data obtained from the barcode and thereby obtaining the calibration information, the analyte sensing component can be calibrated using the pre-set compensation model before the use of the analyte sensing component, that is, after leaving the factory In vitro calibration, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method, and obtaining a better user experience.

According to the method involved in the present disclosure, optionally, a terminal device with a display function is used to match 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 display function can better and more intuitively display it to patients or other people who need to obtain accurate sensing data of the analyte sensing component, that is, more Easy access to information.

According to the method involved in the present disclosure, optionally, the calibration information includes at least one of a calibration action, a calibration factor, and a calibration coefficient. In this case, the calibration behavior can judge whether the sensor data needs to be calibrated and pass the judgment result to the next calibration process. The calibration factor can make the calibration information more complete. For example, it can be the simulation factor of the factory test equipment, the test The time period, test method, etc., and 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 the mathematical method.

A second aspect of the present disclosure provides a system for calibrating the sensing data of an analyte sensing component, which is used to perform barcode calibration on the sensing data of the analyte sensing component before using the analyte sensing component. A calibrated system, which may comprise: a binding device capable of binding each of a plurality of said analyte sensing components using said barcode; a test device capable of functionalizing each of said analyte sensing components test, obtain the sensing data of each of the analyte sensing components, and determine the calibration information according to the comparison between the sensing data of the analyte sensing components and the preset parameter range, and can compare the calibration information with the The bar code corresponding to the analyte sensor is associated; the identification device can identify the bar code and obtain the calibration information according to the bar code before using the analyte sensing component; the calibration device can be based on the calibration information Calibrating the sensing data of the analyte sensing component.

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

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, testing device, and identification device in the system can perform data communication through the communication device, such as obtaining barcode information, barcode binding information, sensing data, and information associated with barcode and sensing data , calibration information of analyte sensing components based on sensing data, etc., the user display device can better and more intuitively display to patients or other people who need to obtain accurate sensing data of analyte sensing components, that is, it is more convenient to obtain information.

According to the calibration system involved in the present disclosure, optionally, a server for data storage is further included, 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 identifying device in the system can transfer data to each other and be processed and stored by the server, thereby realizing data intercommunication and information tracking.

According to the calibration system involved in the present disclosure, optionally, the sensing data is a concentration change curve, which is to perform a functional test on each of the analyte sensing components using a variety of different analyte concentrations, so as to obtain each of the analyte sensing components. The concentration change curve of the analyte sensing component described above. In this case, the concentration change curve can be more convenient for the analysis and calibration of the sensing data, and it is also more intuitively presented to the personnel who need to obtain the sensing data.

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, and the information of the barcode can be downloaded from the server and can be The barcode is shown on the packaging. In this case, the information of the barcode can be stored in the server after being associated with the sensor data, 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. This enables pre- and post-factory information tracking of the analyte sensing assembly.

According to the calibration system of 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 analyte sensing component based on the analyte concentration, the rate of change of the analyte concentration, the time of detection of the analyte, the sensitivity of the sensor, and the rate of change of the sensitivity. The performance of the sensor components and the corresponding analysis and calibration.

According to the calibration system involved in the present disclosure, optionally, the analyte sensing component is bound by taking the position 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 accomplished by utilizing a barcode.

According to the calibration system of 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 through the compensation model. In this case, by using the pre-factory sensing data obtained from the barcode and thereby obtaining the calibration information, the analyte sensing component can be calibrated using the pre-set compensation model before the use of the analyte sensing component, that is, after leaving the factory In vitro calibration, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method, and obtaining a better user experience.

According to the calibration system involved in the present disclosure, optionally, a terminal device with a display function is used to match 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 display function can better and more intuitively display it to patients or other people who need to obtain accurate sensing data of the analyte sensing component, that is, more Easy access to information.

According to the calibration system of 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 judge whether the sensor data needs to be calibrated and pass the judgment result to the next calibration process. The calibration factor can make the calibration information more complete. For example, it can be the simulation factor of the factory test equipment, the test The time period, test method, etc., and 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 the mathematical method.

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 according to different needs in the form of probability analysis, fuzzy logic, decision function, etc.

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 the sensing data of the analyte sensing 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. Personnel who acquire sensing data and calibration information can more intuitively present compensation calibration information. .

A third aspect of the present disclosure provides an analyte sensing assembly that can have a chemical species that reacts with glucose and generates sensing data. In this case, the analyte sensing assembly can form a complete calibration system with the individual devices in the system described above.

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 sensing unit for transmitting the sensing data. communication unit. In this case, the sensing unit can obtain the sensing data required by the above-mentioned system or method and transmit it with each device in the system or method through the communication unit.

According to the analyte sensing component of 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 obtain the calibrated sensing data according to the calibration system, which can be intuitively displayed on the display with the communication unit function in the terminal device.

According to the analyte sensing component involved in the present disclosure, optionally, the sensing data is processed by the terminal device to generate a time-dependent concentration curve. In this case, the sensing data can be intuitively displayed in a terminal device with a display function.

According to the present disclosure, a method and system for calibrating the sensing data of an analyte sensing component can be provided, which is a method for calibrating the sensing data of an analyte sensing component using a barcode before using the analyte sensing component And a system, which can solve the problem of lack of comfort, convenience and better user experience for patients in the fingertip blood sampling calibration method in the prior art.

Description of drawings

FIG. 1 is a flowchart of a method for calibrating sensing data of an analyte sensing component according to the present disclosure.

FIG. 2 is a block diagram of a calibration system for calibrating sensing data of an analyte sensing component according to the present disclosure.

Fig. 3 is a schematic diagram of an application scenario of an analyte sensing component involved in the present disclosure.

4 is a schematic diagram of a method for calibrating sensing data of an analyte sensing component and/or a calibration result of a calibrating system according to the present disclosure.

FIG. 5 is a schematic diagram of a method for calibrating sensing data of an analyte sensing component and/or a calibration system using a compensation model of probability analysis according to the present disclosure.

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

FIG. 7 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 according to the present disclosure.

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

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. example. Based on the embodiments of the present utility model, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of the present utility model.

It should be noted that the terms "first", "second", "third" and "fourth" in the specification and claims of the present utility model and the above drawings are used to distinguish different objects, not Used to describe a specific sequence. Furthermore, the terms "comprising" and "having" and any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units is not limited to the listed steps or units, but optionally also includes unlisted steps or units, or optionally further includes For other steps or units inherent in these processes, methods, products or apparatuses. In the following description, the same reference numerals are given to the same components, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the ratio of dimensions between components, the shape of components, and the like may be different from the actual ones.

The present disclosure provides a method and system for calibrating 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, It can solve the problem of lack of comfort, convenience and better user experience for patients in the fingertip blood sampling calibration method in the prior art. A detailed description will be given below in conjunction with the accompanying drawings.

FIG. 1 is a flow chart illustrating a method for calibrating sensing data of an analyte sensing component according to the present disclosure.

As shown in FIG. 1 , the first aspect of the present disclosure provides a method for calibrating the sensing data of the analyte sensing component, which is used to use the barcode to detect the sensing data of the analyte sensing component before using the analyte sensing component Methods for performing calibration, including:

Step S001, preparing multiple analyte sensing components, and using different barcodes to bind each analyte sensing component;

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

Step S003, determining the calibration information according to 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;

Step S004, before using the analyte sensing component, identify the barcode and obtain calibration information according to the barcode;

Step S005, calibrate the sensing data of the analyte sensing component based on the calibration information.

In some examples, the preset parameter range may refer to preset analyte concentration data, change rate, sensitivity or sensitivity change rate, and the like.

In some examples, the analyte concentration can refer to the glucose concentration of the interstitial fluid in a human body. In other examples, the analyte concentration may refer to the concentration of lactate, vitamin C, uric acid, urea, glutamate, or transaminases.

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 can 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 can include PDF417, Data Matrix, Maxi Code, QR Code, Code 49, Code 16K, Code one, Veri code barcode, CP barcode, Coda block F barcode, field 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 to perform step S001 according to production and post-delivery requirements, which provides convenience for barcode binding.

In some examples, the barcode binding in step S001 can be the binding of information that can be used as an ID identification mark and the barcode that has been given corresponding batch and tooling information before the production of the analyte sensing component, that is, step S001 can be The analyte sensing component was completed when it was not produced. In some other examples, step S001 may be completed before the analyte sensing component has been produced and is to be tested. Thus, the analyte sensing component that has passed the binding step S001 can be identified and tracked in subsequent steps.

In some examples, in step S002, a functional test device may be used to perform a functional test on the analyte sensing component, where the functional test refers to a performance test of the simulated analyte sensing component in a usage scenario. Thereby, analyte sensing component sensing data can be obtained for analyzing its performance.

In some examples, step S003 can be completed in the test equipment in the aforementioned step S002. In some other examples, step S003 may also be performed on the server after obtaining the sensing data of the analyte sensing component tested by the testing device. Therefore, completing step S003 in the test equipment can reduce the processing load of the server, and completing S003 in the server can reduce the calculation processing of the test equipment.

In some examples, step S004 may be to use a terminal device with a 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 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.

In some examples, step S005 may 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.

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

In some examples, the sensing data may be a concentration change curve, which may be a function test of each analyte sensing component using a plurality of different analyte concentrations and obtaining a concentration change curve 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, so that it is easier to analyze the change of the concentration of the analyte through the analysis of the slope or curvature of the concentration change curve.

In some examples, the sensory data may also be a line or graph of concentration changes.

In some examples, the various assay concentrations may be in pure or impure analyte solutions. In this case, testing the analyte sensing component with a pure concentration of the analyte solution can reflect the true performance parameters of the analyte sensing component, and testing the analyte sensing component with an impure concentration of the analyte solution can reflect the analysis. The sensor components are close to the performance parameters in actual use.

In some examples, the barcode information can be stored in the server, and the analyte sensing component can be packaged, and the barcode information 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 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. This enables pre- and post-factory information tracking of the analyte sensing assembly.

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

In some examples, packaging may be one of manual packaging, packaging machine packaging. For example, using a packaging machine for packaging can quickly and efficiently complete the packaging task, and the connection between the packaging machine and the server can facilitate and quickly download and print barcodes to complete the packaging.

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

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

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

In some examples, the analyte detection time may refer to the contact reaction between the sensor of the analyte sensing component and the analyte solution or the interstitial fluid in the human body to generate an electrical signal and be acquired by the analyte sensing component to the sensor and the analyte solution Or the time when the interstitial fluid of the human body separates or stops reacting.

In some examples, sensor sensitivity can refer to the lower limit at which a sensor of an analyte sensing assembly reacts with an analyte.

In some examples, the rate of change of sensitivity may refer to the rate of change of the lower limit of the reaction between the sensor of the analyte sensing component and the analyte.

In some examples, the analyte sensing components can be bound by the location of the lot and tool as barcoded information. In this case, the tracking of the pre-factory information of the analyte sensing component can be accomplished by utilizing a barcode.

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

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 from the barcode and thereby obtaining the calibration information, the analyte sensing component can be calibrated using the pre-set compensation model before the use of the analyte sensing component, that is, after leaving the factory In vitro calibration, thereby reducing the discomfort or inconvenience of the traditional fingertip blood sampling calibration method, and obtaining a better user experience.

In some examples, the compensation model may be a plurality of corresponding compensation models preset in the terminal device and available for selection based on the calibration information. Specifically, for example, if the tested sensing data is larger than the preset parameter range, the compensation model can choose negative compensation; otherwise, the compensation model can choose positive compensation. Thus, the user can obtain more accurate analyte concentration data when using the analyte sensing component.

In some examples, a terminal device with a display function can be used to match 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 display function can better and more intuitively display to patients or other people who need to obtain accurate sensing data of the analyte sensing component, that is Easier access to information.

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, a tablet, or a personal computer with the function of analyzing the concentration of the analyte. Thus, it is convenient for the user to use the analyte sensing component to analyze the concentration of the analyte.

In some examples, the calibration information may include at least one of a calibration action, a calibration factor, and a calibration coefficient. In some examples, the calibration behavior can judge whether the sensor data needs to be calibrated and pass the judgment 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 factor of the pre-factory test equipment, The test time period, test method, etc., and 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 the mathematical method. In this case, calibration accuracy can be improved by setting various calibration information.

2 is a block diagram illustrating a calibration system for calibrating sensing data of an analyte sensing component according to the present disclosure; FIG. A schematic diagram of a method of sensing data and/or a calibration result of a calibration system; FIG. 5 is a schematic diagram illustrating a method of calibrating sensing data of an analyte sensing component and/or a calibration system using probability analysis compensation according to the present disclosure A schematic diagram of the calibration result of the model; FIG. 6 is a schematic diagram showing a method of calibrating the sensing data of the analyte sensing component involved in the present disclosure and/or a calibration system using a fuzzy logic compensation model of the calibration result; FIG. 7 is A schematic diagram showing 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 is a schematic diagram of a calibration result.

As shown in FIG. 2 , the second aspect of the present disclosure provides a calibration system 10 for calibrating the sensing data of an analyte sensing component, which is used to calibrate the analyte sensing component using a barcode before using the analyte sensing component. The calibration system 10 is calibrated by sensing data.

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 .

In some examples, binding device 11 may bind each of the plurality of analyte sensing components using a different barcode. In some examples, the test device 12 can perform a functional test on each analyte sensing component, obtain the sensing data of each analyte sensing component, and can The calibration information is determined by comparison, and at the same time, the calibration information can be associated with the barcode corresponding to the analyte sensor. In some examples, the identification device 131 can identify a barcode and obtain calibration information according to the barcode before using the analyte sensing component. In some examples, the calibration device 132 can calibrate the sensing data of the analyte sensing component based on the calibration information.

In this case, the calibration information can be obtained before using the analytical 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 shortcomings of the fingertip blood sampling method in the prior art , for example, can improve the convenience of blood glucose collection of patients, provide users with a better sense of experience, and can also overcome the problems of lack of comfort for patients in the prior art.

In some examples, the binding means 11 may be an information binding means 11 in the server 15 . In some other examples, the binding device 11 can be independent from the server 15 and communicate with the server 15, thereby facilitating the remote planning of the workshop of the factory. In other examples, the binding device 11 can be integrated with the testing device 12, thereby facilitating the binding of information and barcodes before the production of the analyte sensing components is completed and to be tested, reducing the binding of other production processes. set steps.

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

In some examples, the identification device 131 may be a scanning identification device 131 such as a code scanning gun or a code scanning machine. 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, and the like.

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

In some examples, the calibration system 10 may also include a communication device 14 for communication of information 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, barcode and The information associated with the sensing data, the calibration information of the analyte sensing components based on the sensing data, etc., the user display device can be better and more intuitive for patients or other people who need to obtain the sensing data of the accurate analyte sensing components. Display, that is, more convenient to obtain information.

In some examples, the communication device 14 can communicate with the binding device 11 and the testing device 12 through the field bus 16 . In some examples, the communication device 14 can exchange information with the identification device 131 and the calibration device 132 through a cloud, local area network or Internet connection.

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

In some examples, the calibration system 10 may further include a server 15 for data storage, and the server 15 may perform data communication 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.

In some examples, the server 15 may not be set. 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.

In some examples, the sensing data may be a concentration change curve, which is to perform a functional test on each analyte sensing component using a plurality of different analyte concentrations, so as to obtain a 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 intuitively presented to the personnel who need to obtain the sensing data. Therefore, the analysis of the change of the concentration of the analyte can be more conveniently analyzed through the analysis of the slope or curvature of the concentration change curve.

In some examples, the barcode information can be stored on the server 15, and the analyte sensing assembly 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 information of the barcode 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 , so that the pre-factory and post-factory information tracking of the analyte sensing component can be formed.

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

In some examples, packaging may be one of manual packaging, packaging machine packaging. For example, packaging with a packaging machine can quickly and efficiently complete the packaging task, and the connection between the packaging machine and the server 15 can facilitate and quickly download and print barcodes to complete the packaging.

In some examples, the analyte concentration may refer to the data generated by the conversion of chemical energy into electrical energy between the analyte and the sensor in the analyte sensing component, which may be a specific single analyte concentration data, or multiple sets Analyze the concentration data of the analyte.

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

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

In some examples, the compensation model may be a plurality of corresponding compensation models preset in the calibration device 132 and available for selection based on the calibration information. Specifically, for example, if the tested sensing data is larger than the preset parameter range, the compensation model can choose negative compensation; otherwise, the compensation model can choose positive compensation. Thus, the user can obtain more accurate analyte concentration data when using the analyte sensing component.

In some examples, the terminal device 13 with a display function can be used to match 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 better and more intuitively display to patients or other people who need to obtain accurate sensing data of the analyte sensing component, that is Easier access to information.

In some examples, the identifying device 131 and the calibrating device 132 may be specific analyte concentration analyzers with scanning and display functions. In some other examples, the identification device 131 and the calibration device 132 may be a mobile phone, a tablet, a personal computer, etc. that have the function of analyzing the concentration of the analyte. Thus, it is convenient for the user to use the analyte sensing component to analyze the concentration of the analyte.

In some examples, the calibration information may include at least one of a calibration action, a calibration factor, and a calibration coefficient. In this case, the calibration behavior can judge whether the sensor data needs to be calibrated and pass the judgment result to the next calibration process. The calibration factor can make the calibration information more complete. For example, it can be the simulation factor of the factory test equipment, the test The time period, test method, etc., and 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 the mathematical method. For example: as shown in Figure 4, if the sensing data before calibration is generally smaller than the preset parameter range, that is, as shown in curve 1 before calibration, it can be judged that positive compensation needs to be added according to the calibration behavior, and the result after calibration can be as shown in the curve after calibration 3; on the contrary, you can refer to the curve 2 before calibration. According to the calibration behavior, it can be judged that it needs to add negative compensation. The result after calibration can be shown in curve 3 after calibration.

In some examples, the compensation model may include at least one of probabilistic analysis, fuzzy logic, and decision functions. In this case, the compensation model can calibrate the sensing data according to different needs in the form of probability analysis, fuzzy logic, decision function, etc.

As shown in Figure 5, in the compensation model of probability analysis, for the sensing data of the same analyte sensing component: curve c is the curve of the normal sensing data or the curve of the calibrated sensing data, and the curves a and b are Sensing data curves that need to be calibrated, wherein, in the test, the sensing 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 by mathematical algorithms to be close to Curve c, that is, after the analyte sensor is used, although the actual sensing data may be a or b, it is still displayed as curve c after compensation calibration.

As shown in Figure 6, in the compensation model of fuzzy logic, for the sensing data of the same analyte sensing component: the curve f is the curve of the normal sensing data or the curve of the calibrated sensing data, and the curves d and e are Sensing data curves that need to be calibrated, wherein, in the test, the sensing data of curves d and e completely match or coincide with the sensing data of part of the detection time period of curve f, and the other time periods do not match, then fuzzy logic is used Compensation model for curves d and e is compensated and calibrated, that is, the parts of curves d and e that match curve f are reserved through fuzzy algorithm, and the rest are compensated accordingly.

As shown in Figure 7, in the compensation model of the decision function, for the sensing data of the same analyte sensing component: the curve k is the curve of the normal sensing data or the curve of the calibrated sensing data, and the curves h and g are Sensing data curves that need to be calibrated, wherein, in the test, if the sensing data of the curves h and g can only correspond to but not completely match the curve k in a certain detection period x (x=x2-x1), then select The decision function model compensates and calibrates the curves h and g, that is, the abnormal data outside the detection period x is not calculated and only the sensing data of the detection period x is compensated.

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 the sensing data of the analyte sensing 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. Personnel who acquire sensing data and calibration information can more intuitively present compensation calibration information.

Fig. 3 is a schematic diagram showing an application scenario of an analyte sensing component involved in the present disclosure; Fig. 8 is a method and/or illustrating a method for calibrating sensing data of an analyte sensing component involved in the present disclosure Or a schematic diagram of the calibration results of the calibration system displayed in the terminal device.

As shown in FIG. 3, the third aspect of the present disclosure provides an analyte sensing component 02, which can have a chemical substance that reacts with glucose, and is the analyte used in the above method or calibration system Sensing component 02. In this case, the analyte sensing assembly 02 can form a complete calibration system with the various devices in the system described above.

In some examples, the analyte sensing component 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 above-mentioned calibration system or method and transmit it with each device in the calibration system or method through the communication unit.

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

In some examples, the sensing data may 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 the real-time sensing data in the human body and obtain the calibrated sensing data according to the calibration system, which can be visually displayed on the communication unit with display function in the terminal device 13.

In some examples, the sensing data can be processed by the terminal device 13 to generate a time-dependent concentration change curve. In this case, the sensing data can be intuitively displayed in the terminal device 13 having a display function.

According to the present disclosure, a method and system for calibrating the sensing data of an analyte sensing component can be provided, which is used to calibrate the sensing data of the analyte sensing component by using a barcode before using the analyte sensing component A method and a calibration system, which can solve the problem of lack of comfort, convenience and better user experience for patients in the fingertip blood sampling calibration method in the prior art.

Although the present utility model has been specifically described in conjunction with the accompanying drawings and examples, it can be understood that the above description does not limit the present utility model in any form. Those skilled in the art can modify and change the utility model as required without departing from the spirit and scope of the utility model, and these variations and changes all fall within the scope of the utility model.

Claims

A method for calibrating the sensing data of an analyte sensing component is a method for calibrating the sensing data of the analyte sensing component using a barcode before using the analyte sensing component, characterized in that ,Include:

preparing a plurality of the analyte sensing components, and using the barcode to bind each of the analyte sensing components;

Perform a functional test on each of the analyte sensing components, obtain sensing data of each of the analyte sensing components, and determine calibration information based on a comparison between the sensing data of the analyte sensing components and a preset parameter range , and associate the calibration information with the barcode corresponding to the analyte sensor;

prior to using the analyte sensing assembly, identifying the barcode and obtaining the calibration information based on the barcode; and

The sensing data of the analyte sensing component is calibrated based on the calibration information.
The method according to claim 1, characterized in that,

The sensing data is a concentration change curve, and a function test is performed on each of the analyte sensing components using a variety of different analyte concentrations to obtain a concentration change curve of each of the analyte sensing components.
The method according to claim 1, characterized in that,

The information of the barcode is stored in the server, and the analyte sensing component is packaged, the information of the barcode is downloaded from the server and the barcode is displayed on the package.
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.
The method according to claim 1, characterized in that,

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

A compensation model is generated based on the calibration information, and the sensing data of the analyte sensing component is calibrated by the compensation model.
The method according to claim 1, characterized in that,

A terminal device with a display function is used to match the analyte sensing component, and the calibrated sensing data is displayed on the terminal device.
The method according to claim 1, characterized in that,

The calibration information includes at least one of calibration actions, calibration factors and calibration coefficients.
A calibration system for calibrating the sensing data of an analyte sensing component is a system for calibrating the sensing data of the analyte sensing component using a barcode before using the analyte sensing component, and its features is, including:

a binding device for binding each of a plurality of said analyte sensing elements using said barcode;

A test device, which performs a functional test on each of the analyte sensing components, obtains the sensing data of each of the analyte sensing components, and performs a functional test based on the sensing data of the analyte sensing components and the preset parameter range comparing and determining the calibration information, and associating the calibration information with the barcode corresponding to the analyte sensor;

an identification device, which identifies the barcode and obtains the calibration information according to the barcode before using the analyte sensing component;

a calibration device for calibrating the sensing data of the analyte sensing component based on the calibration information.
The calibration system according to claim 9, characterized in that,

The calibration system also includes communication means for information transfer, user display means for display.
The calibration system according to claim 9, characterized in that,

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

The sensing data is a concentration change curve, and a variety of different analyte concentrations are used to perform a functional test on each of the analyte sensing components to obtain a concentration change curve of each of the analyte sensing components.
The calibration system according to claim 11, characterized in that,

The information of the barcode is stored in the server, and the analyte sensing component is packaged, the information of the barcode is downloaded from the server and the barcode is displayed on the package.
The calibration system according to claim 9, 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.
The calibration system according to claim 9, characterized in that,

The analyte sensing component is bound by using the location of the batch and tooling as the information of the barcode.
The calibration system according to claim 9, characterized in that,

A compensation model is generated based on the calibration information, and the sensing data of the analyte sensing component is calibrated by the compensation model.
The calibration system according to claim 9, characterized in that,

A terminal device with a display function is used to match the analyte sensing component, and the calibrated sensing data is displayed on the terminal device.
The calibration system according to claim 9, characterized in that,

The calibration information includes at least one of calibration actions, calibration factors and calibration coefficients.
The calibration system according to claim 16, characterized in that,

The compensation model includes at least one of probability analysis, fuzzy logic and decision function.
The calibration system according to claim 16, characterized in that,

The compensation model also includes a display model including at least one of parameter compensation corrections, curve curvature compensation corrections, and image compensation corrections.
An analyte sensing assembly, characterized in that the analyte sensing assembly has a chemical substance that reacts with glucose and generates sensing data.
The analyte sensing assembly of claim 21, wherein,

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.
The analyte sensing assembly of claim 21, wherein,

The sensing data is sent to a terminal device for processing and/or displaying the sensing data through the communication unit.
The analyte sensing assembly of claim 21, wherein,

The sensory data is processed by the terminal device to generate the concentration change curve that changes with time.