Analyte monitoring method, readable storage medium and analyte monitoring system

Abstract

The invention discloses an analyte monitoring method, a readable storage medium and an analyte monitoring system. The analyte monitoring method comprises the following steps: acquiring a first electric signal and a second electric signal; obtaining a correction factor for representing the deviation between the first interference signal and the second interference signal based on the ratio of the thickness of the second film layer to the thickness of the first film layer; an analyte electrical signal is obtained based on the first electrical signal, the second electrical signal, and a correction factor. Therefore, the accuracy of the monitored electric signal of the analyte can be improved, namely the accuracy of the concentration value of the monitored analyte is improved.

Description

Technical Field

[0001] The present disclosure relates generally to the biopharmaceutical industry, and more particularly to an analyte monitoring method, a readable storage medium, and an analyte monitoring system. Background Art

[0002] Monitoring the concentration of at least one analyte in an organism plays an important role in preventing and treating various diseases. The analytes may include, but are not limited to, glucose, lactate, blood ketones or other types of analytes. For example, for diabetic patients, timely acquisition of the patient's blood glucose level is conducive to timely implementation of treatment measures. The continuous glucose monitoring system (CGM) is a mobile device for diabetic patients. By inserting a sensor with an enzyme fixed under the skin, a chemical reaction occurs with glucose in the tissue fluid or blood in the body to generate an electrical signal. According to the relationship between the detected electrical signal and the glucose concentration, the analyte is detected, and the blood glucose level can be tested around the clock to obtain real-time blood glucose level information.

[0003] The accuracy of analyte concentration monitoring is critical to the treatment of patients. For example, diabetic patients need to refer to the concentration of blood glucose monitoring for insulin injection treatment, so inaccurate blood glucose testing will bring very high risks to patients. In actual operation, a blank electrode without enzyme is set on the sensor to detect interference signals. By detecting the output of the working electrode and comparing it with the output of the blank electrode, the monitoring error caused by the interference signal can be reduced. In this way, the concentration of the analyte can be obtained more accurately.

[0004] However, due to the slight differences in structure between the working electrode and the blank electrode, there will be a certain offset or deviation between the interference signal measured by the blank electrode and the interference signal measured by the working electrode. Therefore, it is difficult to effectively reduce the measurement error of the analyte concentration by simply comparing the output of the working electrode with the output of the blank electrode. Summary of the invention

[0005] The present disclosure is proposed in view of the above situation, and its purpose is to provide an analyte monitoring method, a readable storage medium and an analyte monitoring system, which can improve the accuracy of the monitored analyte electrical signal.

[0006] To this end, the first aspect of the present disclosure provides an analyte monitoring method, which is a method for obtaining an analyte electrical signal through a sensor, the sensor comprising a working electrode, a blank electrode, and a film layer at least partially covering the working electrode and the blank electrode, the working electrode being used to obtain a first electrical signal comprising the analyte electrical signal and a first interference signal, the blank electrode being used to obtain a second electrical signal comprising a second interference signal, the film layer covering the working electrode being the first film layer, and the film layer covering the blank electrode being the second film layer, the analyte monitoring method comprising: obtaining the first electrical signal and the second electrical signal; obtaining a correction factor for characterizing the deviation between the first interference signal and the second interference signal based on the ratio of the thickness of the second film layer to the thickness of the first film layer; and obtaining the analyte electrical signal based on the first electrical signal, the second electrical signal, and the correction factor.

[0007] In the present disclosure, the sensor can use the working electrode and the blank electrode to respectively measure a first electrical signal including a first interference signal and a second electrical signal including a second interference signal, and the first interference signal is negatively correlated with the thickness of the first film layer, and the second interference signal is negatively correlated with the thickness of the second film layer. In this case, a correction factor is obtained based on the ratio of the thickness of the second film layer to the thickness of the first film layer, so that the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference in the thickness of the second film layer and the thickness of the first film layer. Thus, a more accurate analyte electrical signal can be obtained based on the first electrical signal, the second electrical signal, and the correction factor, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0008] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, the deviation between the first interference signal and the second interference signal also includes the deviation caused by the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode, and the analyte monitoring method further includes: obtaining the correction factor based on the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode. In this case, considering that the surface area of ​​the electrode is positively correlated with the size of the interference signal, the correction factor is obtained by dividing the surface area of ​​the working electrode by the surface area of ​​the blank electrode, so that the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the surface area of ​​the blank electrode and the surface area of ​​the working electrode, thereby, based on the first electrical signal, the second electrical signal, and the correction factor can obtain a more accurate analyte electrical signal, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0009] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, the ratio of the thickness of the second film layer to the thickness of the first film layer is optionally set to a first ratio, the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode is set to a second ratio, and the correction factor is obtained based on the product of the first ratio and the second ratio. In this case, by correcting the analyte electrical signal by combining the difference between the film layer thickness and the difference between the electrode surface areas, the deviation between the first interference signal and the second interference signal caused by the difference between the surface area of ​​the blank electrode and the surface area of ​​the working electrode, and the difference between the thickness of the first film layer and the thickness of the second film layer can be reduced at the same time, thereby further improving the measurement accuracy of the analyte concentration value.

[0010] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, the deviation between the first interference signal and the second interference signal also includes the deviation caused by the difference between the background noise signal of the working electrode and the background noise signal of the blank electrode, and the analyte monitoring method further includes: obtaining the correction factor based on the ratio of the background noise signal of the working electrode to the background noise signal of the blank electrode. In this case, considering that the background noise signal of the electrode is positively correlated with the size of the interference signal, the correction factor is obtained by dividing the background noise signal of the working electrode by the background noise signal of the blank electrode, so that the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the blank electrode and the background noise signal of the working electrode, thereby, based on the first electrical signal, the second electrical signal, and the correction factor can obtain a more accurate analyte electrical signal, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0011] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, the ratio of the thickness of the second film layer to the thickness of the first film layer is set to a first ratio, the ratio of the background noise signal of the working electrode to the background noise signal of the blank electrode is set to a third ratio, and the correction factor is obtained based on the product of the first ratio and the third ratio. In this case, by correcting the second electrical signal by combining the difference between the film layer thicknesses and the difference between the electrode background noise signals, the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode and the background noise signal of the blank electrode, and the difference between the thickness of the first film layer and the thickness of the second film layer can be reduced at the same time, thereby further improving the measurement accuracy of the concentration value of the analyte.

[0012] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, the deviation between the first interference signal and the second interference signal includes the deviation caused by the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode, and the analyte monitoring method further includes: setting the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode to be a second ratio, and obtaining the correction factor based on the first ratio, the second ratio, and the third ratio. In this case, the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode and the background noise signal of the blank electrode, the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode, and the difference between the thickness of the second film layer and the thickness of the first film layer. Thereby, the measurement accuracy of the concentration value of the analyte can be further improved.

[0013] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, the sensor includes a substrate, and the working electrode and the blank electrode are located on both sides of the substrate. In this case, by separating the working electrode and the blank electrode, the mutual interference between the working electrode and the blank electrode can be reduced, thereby improving the sensitivity of the sensor.

[0014] In addition, in the analyte monitoring method involved in the first aspect of the present disclosure, optionally, a correction signal is obtained based on the second electrical signal and the correction factor, and the analyte electrical signal is obtained based on the first electrical signal and the correction signal. In this case, a correction signal can be obtained using the correction factor and the second electrical signal, and the correction signal can be substantially equivalent to the first interference signal, thereby, a more accurate analyte electrical signal can be obtained based on the first electrical signal and the correction signal, that is, the measurement accuracy of the analyte concentration value can be improved.

[0015] The second aspect of the present disclosure provides a readable storage medium, wherein the readable storage medium stores at least one instruction, and when the at least one instruction is executed by a processor, the analyte monitoring method as described in any one of the first aspects is implemented. Thus, it is convenient to use a computer device to realize the automated processing of the analyte monitoring method.

[0016] The third aspect of the present disclosure provides an analyte monitoring system, wherein the analyte monitoring system obtains an analyte electrical signal by executing the analyte monitoring method according to any one of the first aspects, and the analyte monitoring system includes a processing device, and the processing device is configured to execute the analyte monitoring method. In this case, the correction factor can reduce the deviation between the first interference signal measured by the working electrode and the second interference signal measured by the blank electrode due to the difference between the working electrode and the blank electrode, so that the analyte monitoring system can obtain a more accurate analyte electrical signal from the first electrical signal based on the second interference signal measured by the blank electrode, the first electrical signal measured by the working electrode and the correction factor, that is, a more accurate analyte concentration value, thereby improving the accuracy of the analyte monitoring system.

[0017] According to the present disclosure, an analyte monitoring method, a readable storage medium, and an analyte monitoring system can be provided, which can improve the accuracy of analyte monitoring. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present disclosure will now be explained in further detail, by way of example only, with reference to the accompanying drawings.

[0019] Figure 1A is a diagram showing an application scenario of the analyte monitoring system involved in the example of the present disclosure.

[0020] Figure 1B is a schematic diagram showing a sensor involved in an example of the present disclosure.

[0021] Figure 1C is a block diagram illustrating an analyte monitoring system to which examples of the present disclosure relate.

[0022] Figure 1D is a block diagram showing electronic modules involved in the examples of the present disclosure.

[0023] Figure 2 Schematic diagram showing an embodiment of a sensor involved in the examples of the present disclosure.

[0024] Figure 3A is a first flow chart showing an analyte monitoring method involved in the examples of the present disclosure.

[0025] Figure 3B is a second flow chart showing the analyte monitoring method involved in the examples of the present disclosure.

[0026] Figure 4 2 is a diagram showing the test results of Example 1 according to the present disclosure.

[0027] Figure 5 2 is a diagram showing the test results of Example 2 according to the present disclosure.

[0028] Figure 6 Schematic diagram showing the background noise signals of the working electrode and the blank electrode involved in the examples of the present disclosure.

[0029] Figure 7 2 is a diagram showing the test results of Example 3 according to the present disclosure. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments filled in by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0031] It should be noted that the terms "first", "second", "third" and "fourth" etc. in the specification and claims of the present disclosure and the above-mentioned drawings are used to distinguish different objects rather than to describe a specific order. It should be noted that the terms "including" and "having" and any variations thereof in the present disclosure, such as a process, method, system, product or device including or having a series of steps or units, are not necessarily limited to those steps or units clearly listed, but may include or have other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0032] Hereinafter, the preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same symbols are assigned to the same components, and repeated descriptions are omitted. In addition, the accompanying drawings are only schematic diagrams, and the ratio of the dimensions of the components or the shapes of the components may be different from the actual ones.

[0033] In the present disclosure, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium. In addition, the term "coupling" can be a way of achieving electrical connection for signal transmission. "Coupling" can be a direct electrical connection or an indirect electrical connection through an intermediate medium. In addition, the term "accuracy" can be understood as the degree of conformity between a measured value and a true value (correct standard).

[0034] An electrochemical biosensor is a device that uses biological reactions to detect specific analytes. When a specific analyte (such as glucose, lactic acid, uric acid, protein or drug, etc.) undergoes a biological reaction with the sensor (such as an enzyme reaction or an immune reaction), an electrochemical reaction will occur, such as the transfer of electrons, the transfer of ions, etc. These electrochemical reactions can be detected by the sensor and converted into an electrical signal, which can be called an analyte electrical signal, which can be used to reflect the content of a specific analyte, that is, the concentration value of the analyte. In some examples, the electrical signal can be a current signal or a voltage signal. In the present disclosure, there is no limitation on the specific form of the electrical signal.

[0035] A first aspect of the present disclosure provides an analyte monitoring method, which may also be referred to as an analyte monitoring method for reducing interference signals or a method for improving analyte monitoring accuracy.

[0036] The second aspect of the present disclosure provides a readable storage medium, which can store at least one instruction, and the at least one instruction can be executed by a processor to implement the analyte monitoring method of the first aspect of the present disclosure. Thus, it is convenient to use a computer device to realize the automated processing of the analyte monitoring method.

[0037] The third aspect of the present disclosure provides an analyte monitoring system, which may also be referred to as an analyte monitoring device. The analyte monitoring system may acquire an analyte electrical signal by executing the analyte monitoring method according to the first aspect of the present disclosure.

[0038] In the present disclosure, the term "analyte" may be a chemical compound present in a solution. In some examples, the analyte may be one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, or troponin. In addition, the analyte may also be a drug in a solution. For example, the analyte may be digitoxin, digoxin, theophylline, warfarin, or an antibiotic (such as gentamicin or vancomycin, etc.).

[0039] In some examples, the solution may be a body fluid of a human or animal. In some examples, the solution may also be a test sample used in a laboratory environment. In the present disclosure, a human or an animal may be collectively referred to as a host.

[0040] Figure 1A is a diagram showing an application scenario of the analyte monitoring system 10 involved in the example of the present disclosure. Figure 1B is a schematic diagram showing a sensor 20 according to an example of the present disclosure. Figure 1Cis a block diagram illustrating an analyte monitoring system 10 to which examples of the present disclosure relate. Figure 1D is a block diagram showing an electronic module 30 to which the example of the present disclosure relates.

[0041] For some examples, see Figure 1A , the analyte monitoring system 10 can be applied to a host to monitor the concentration of an analyte in the host. In some examples, the analyte monitoring system 10 can be used in a laboratory for in vitro experiments.

[0042] For some examples, see Figure 1A , the analyte monitoring system 10 may include a sensor 20. In this case, the sensor 20 can generate an analyte electrical signal by electrochemically reacting with the analyte to represent the concentration value of the analyte.

[0043] For some examples, see Figure 1B The sensor 20 may include a distal portion 20a and a proximal portion 20b, wherein the distal portion 20a may be placed at a selected location of the host, for example, the distal portion 20a may be implanted under the host's skin layer to contact the host's body fluids, and the proximal portion 20b may be provided with an electrical contact 201.

[0044] For some examples, see Figure 1C The analyte monitoring system 10 may include an electronic module 30, and the sensor 20 may be electrically connected to the electronic module 30 via an electrical contact 201. Thus, the electrical signal measured by the sensor 20 can be sent to the electronic module 30 for processing.

[0045] For some examples, see Figure 1D The electronic module 30 may include a power supply 31, a signal processing element 32, and a signal transmission element 33. In some examples, the power supply 31, the signal processing element 32, and the signal transmission element 33 may be placed on a printed circuit board. Thus, the integration of the electronic module 30 can be improved.

[0046] In some examples, the signal processing element 32 may be an application specific integrated circuit (ASIC) chip. In some examples, the sensor 20 may be coupled to the signal processing element 32, and the signal processing element 32 may process the electrical signal measured by the sensor 20 and convert it into a third electrical signal. In some examples, the third electrical signal may be a digital signal. For example, the electrical signal obtained by the sensor 20 may be an analog signal, and the signal processing element 32 may convert the analog signal into a digital signal, thereby facilitating signal processing of the third electrical signal using digital processing technology, such as digital filtering, etc.

[0047] In some examples, the signal transmission element 33 may send the third electrical signal to the outside through the communication link 331. In some examples, the communication link 331 may be wireless transmission, in which case the form of wireless transmission can make data transmission more convenient.

[0048] In some examples, the communication link 331 may be wired transmission, for example, the communication link 331 may be a standard wired transmission cable such as a USB cable, thereby increasing the scope of application of the analyte monitoring system 10 .

[0049] For some examples, see Figure 1C , the analyte monitoring system 10 may also include a processing device 40 (see Figure 1C ), the processing device 40 can be configured to execute the analyte monitoring method proposed in the first aspect of the present disclosure (described in detail later).

[0050] In some examples, processing device 40 may be integrated with electronic module 30. In some examples, processing device 40 may be a separate and independent device from electronic module 30. In some examples, processing device 40 may be integrated into monitor 50 (described in detail later).

[0051] For some examples, see Figure 1D , the analyte monitoring system 10 may include a monitor 50. Thus, the concentration value of the analyte can be indicated by the monitor 50, which is convenient for the host to perceive the concentration value of the analyte.

[0052] In some examples, the monitor 50 can be coupled to the signal transmission element 33, and can receive, process and indicate the third electrical signal. In some examples, the monitor 50 can indicate the third electrical signal, i.e., the concentration value of the analyte, through an auditory signal and / or a visual signal. In some examples, the auditory signal can be a voice broadcast of the concentration value of the analyte or a voice alarm message when the concentration value of the analyte exceeds a threshold value. In some examples, the visual signal can be a display of the concentration value of the analyte on a display screen of the monitor 50.

[0053] In some examples, the monitor 50 may be a smart terminal, such as a smart mobile phone, thereby facilitating the portability of the analyte monitoring system 10 and enabling the host to monitor the concentration of the analyte on a daily basis without the need for special analyte monitoring in a hospital.

[0054] In some examples, the monitor 50 may also be an electronic measuring instrument, for example, the monitor 50 may be a special measuring instrument such as an oscilloscope, a current tester, etc. In this case, the concentration value of the analyte can be accurately measured by the special measuring instrument, so that the analyte monitoring system 10 can be suitable for application in a hospital environment or a laboratory environment.

[0055] Figure 2 Schematic diagram showing an embodiment of a sensor 20 according to an example of the present disclosure.

[0056] For some examples, see Figure 2 The sensor 20 may include a working electrode 202, which may be used to obtain a first electrical signal. The first electrical signal may include an analyte electrical signal, which may also be referred to as a net analyte concentration value.

[0057] In some examples, the first electrical signal may also include a first interference signal, in other words, the first electrical signal may include an electrical signal characterizing the analyte and the first interference signal. In this case, the analyte electrical signal can characterize the concentration value of the analyte, so that a more accurate concentration value of the analyte can be obtained by removing the first interference signal from the first electrical signal.

[0058] In some examples, the working electrode 202 may include a sensing layer 2021. In some examples, the sensing layer 2021 may promote an electrochemical reaction between the working electrode 202 and the analyte to generate a first electrical signal. Thus, the concentration value of the analyte can be obtained by measuring the first electrical signal of the working electrode 202.

[0059] In some examples, the sensing layer 2021 may also be referred to as a catalyst layer or an electroactive material layer, and a catalyst layer corresponding to the analyte may be provided on the working electrode 202 for different analytes. In some examples, the sensing layer 2021 may be glucose oxidase or glucose dehydrogenase. In this case, for a glucose sensor, when the analyte is glucose or blood sugar, by providing glucose oxidase or glucose dehydrogenase on the working electrode 202, the working electrode 202 of the glucose sensor can react electrochemically with glucose or blood sugar, thereby obtaining a first electrical signal including an analyte electrical signal, wherein the analyte electrical signal can refer to an analyte electrical signal of a glucose concentration value.

[0060] In some examples, the sensor 20 may include a blank electrode 203 , and the blank electrode 203 may be used to obtain a second electrical signal, and the second electrical signal may include a second interference signal.

[0061] In some examples, the blank electrode 203 may not include the sensing layer 2021. In other words, the blank electrode 203 may not undergo an electrochemical reaction with the analyte, that is, the blank electrode 203 may not generate an analyte electrical signal related to the concentration value of the analyte. In this case, the second electrical signal measured by the blank electrode 203 may not include an electrical signal related to the analyte, that is, the second electrical signal may be equated with the second interference signal.

[0062] In some examples, the first interference signal may include an electrical signal generated by an electrochemical reaction between other substances in the solution other than the analyte to be monitored and the working electrode 202. In some examples, the second interference signal may include an electrical signal generated by an electrochemical reaction between other substances in the solution other than the analyte to be monitored and the blank electrode 203.

[0063] In some examples, the first interference signal may also include a background noise signal generated by the working electrode 202 itself. In some examples, the second interference signal may also include a background noise signal generated by the blank electrode 203 itself. In the present disclosure, the background noise signal may be used to characterize the noise signal of the working electrode 202 or the blank electrode 203 itself, and may also be referred to as a bottom noise signal or bottom noise.

[0064] In some examples, compared with the working electrode 202, the blank electrode 203 is substantially the same as the working electrode 202 except that it does not have the sensing layer 2021. For example, the blank electrode 203 and the working electrode 202 can be made of the same material and have the same structure, and the working electrode 202 and the blank electrode 203 can be manufactured using the same manufacturing process. In this case, by minimizing the difference between the blank electrode 203 and the working electrode 202 as much as possible, on the one hand, the deviation between the first interference signal and the second interference signal can be reduced, and on the other hand, the factors affecting the deviation between the first interference signal and the second interference signal can be minimized, so that the relationship between the first interference signal and the second interference signal can be obtained more accurately, thereby, based on the first electrical signal and the second electrical signal, the analyte electrical signal, that is, the net analyte concentration value, can be obtained more accurately from the first electrical signal.

[0065] In some examples, the sensor 20 may include a counter electrode 204. Thus, the working electrode 202 can form a first loop with the counter electrode 204 to generate a first electrical signal; the blank electrode 203 can form a second loop with the counter electrode 204 to generate a second electrical signal.

[0066] In some examples, the working electrode 202 and the blank electrode 203 can be made of any one of platinum, gold, silver, lead, mercury, glassy carbon electrode, conductive glass, palladium, titanium or iridium. Thus, the working electrode 202 and the blank electrode 203 can have good conductivity, thereby improving the accuracy of the analyte monitoring system 10.

[0067] In some examples, the working electrode 202 and the blank electrode 203 may be made of the same material, thereby further reducing the deviation between the first interference signal and the second interference signal caused by the different materials of the working electrode 202 and the blank electrode 203 .

[0068] In some examples, the counter electrode 204 can be made of platinum, silver, silver chloride, palladium, titanium, or iridium, so that the electrochemical reaction at the working electrode 202 is not affected while having good electrical conductivity.

[0069] In some examples, the sensor 20 may include a reference electrode 205. In some examples, the reference electrode 205 may form a known and fixed potential difference with the solution. In this case, the potential difference between the working electrode 202 and the solution can be measured by the potential difference formed by the reference electrode 205 and the working electrode 202. As a result, the voltage generated by the working electrode 202 can be obtained more accurately. As a result, the voltage of the working electrode 202 can be automatically adjusted and maintained stable according to a preset voltage value, so that the measured electrical signal, that is, the first electrical signal, can more accurately reflect the analyte concentration in the solution. In some examples, the number of reference electrodes 205 can be one or more, for example, two.

[0070] In other examples, when the potential difference between the working electrode 202 and the solution does not fluctuate much, the reference electrode 205 may not be used. Thus, the manufacturing cost can be saved.

[0071] For some examples, see Figure 2 , the sensor 20 may include a working electrode 202, a blank electrode 203, a reference electrode 205, and a counter electrode 204. In this case, the working electrode 202, the reference electrode 205, and the counter electrode 204 can form a first three-electrode system, and the blank electrode 203, the reference electrode 205, and the counter electrode 204 can form a second three-electrode system. By sharing the reference electrode 205 and the counter electrode 204, the related factors affecting the difference between the first interference signal and the second interference signal can be reduced, thereby facilitating the accurate acquisition of the analyte electrical signal from the first electrical signal.

[0072] In some examples, the sensor 20 may include a substrate 206. In this case, the substrate 206 can provide support for various electrodes of the sensor 20, provide structural support for various electrodes, and ensure that the sensor 20 maintains structural stability during use. Thus, the substrate 206 can enhance the mechanical strength of the sensor 20 and prevent the sensor 20 from deformation or cracking.

[0073] In some examples, the working electrode 202 and the blank electrode 203 may be located on both sides of the substrate 206. In this case, by separating the working electrode 202 and the blank electrode 203, the mutual interference between the working electrode 202 and the blank electrode 203 can be reduced, thereby improving the sensitivity of the sensor 20.

[0074] In some examples, the working electrode 202, the blank electrode 203, the reference electrode 205, and the counter electrode 204 can be disposed on the substrate 206. In this case, by disposing various electrodes on the same substrate 206, the compactness of the sensor 20 can be improved, and the sensor 20 can be easily implanted in the skin layer of the host.

[0075] In some examples, the working electrode 202, the blank electrode 203, the reference electrode 205, and the counter electrode 204 can be placed on the substrate 206 in a stacked structure, see Figure 2 On one side of the substrate 206 , a working electrode 202 and a reference electrode 205 may be stacked in sequence, and on the other side of the substrate 206 , a blank electrode 203 and a counter electrode 204 may be stacked in sequence.

[0076] In this case, by arranging the electrodes in a stacked structure, the surface area of ​​the working electrode 202 can be significantly increased, and a larger surface area can provide more sensing layers 2021, thereby improving the sensitivity of the sensor 20; the design of the stacked structure electrode can allow the combination of different material layers, and the stacked structures of different material layers can complement each other, thereby improving the stability and durability of the sensor 20. For example, the introduction of a material with higher stability as a protective layer can prevent oxidation, corrosion or degradation of the electrode, thereby extending the service life of the sensor 20; the sensor 20 usually requires a small size and portability, and through the stacked structure electrode design, more functional integration can be achieved in a limited space, and multiple functional layers can be integrated in a compact electrode structure, thereby improving space utilization efficiency.

[0077] For some examples, see Figure 2 The sensor 20 may further include a first electrical insulating layer 207, a second electrical insulating layer 208, a third electrical insulating layer 209 and a fourth electrical insulating layer 210. In this case, by providing the electrical insulating layer, the short circuit of each electrode can be reduced.

[0078] In some examples, substrate 206 may be a flexible substrate. The flexible substrate may be substantially made of at least one of polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polyethylene terephthalate (PET), and polyethylene naphthalate (PEN). In addition, in other examples, the flexible substrate may also be substantially made of metal foil, ultra-thin glass, a single-layer inorganic film, a multi-layer organic film, or a multi-layer inorganic film.

[0079] In some examples, the sensor 20 may include a film layer at least partially covering the working electrode 202 and the blank electrode 203 , wherein the film layer covering the working electrode 202 may be the first film layer 211 , and the film layer covering the blank electrode 203 may be the second film layer 212 .

[0080] In some examples, the first film layer 211 and the second film layer 212 may have a thickness. In the present disclosure, the thickness of the first film layer 211 and the second film layer 212 may be obtained by the following method: selecting a plurality of predetermined points on the film layer for measurement, measuring the thickness at the predetermined point, and then taking the average value of the thickness at different predetermined points.

[0081] In some examples, the first membrane layer 211 and the second membrane layer 212 may include a semipermeable membrane. In this case, the semipermeable membrane can selectively pass the analyte and prevent other substances from passing through, thereby improving the accuracy of monitoring; in addition, the membrane layer is provided on the working electrode 202 and the blank electrode 203 at the same time, that is, the working environment or structure of the working electrode 202 and the blank electrode 203 is kept consistent, so that the deviation between the first interference signal and the second interference signal can be reduced as much as possible.

[0082] In some examples, the semipermeable membrane may include a diffusion control layer. In this case, the semipermeable membrane can control the passing rate of the analyte, that is, the semipermeable membrane can limit the amount of the analyte in the solution that reaches the sensing layer 2021, and can ensure that the sensing layer 2021 and other substances involved in the reaction are sufficient, so that the concentration of the analyte becomes the main (basically the only) factor that limits the size of the first electrical signal, so that the size of the first electrical signal can accurately reflect the concentration of the analyte, and can increase the linear range of the working electrode 202 to a great extent.

[0083] In some examples, the semipermeable membrane may further include an anti-interference layer stacked on the diffusion control layer, and the anti-interference layer may prevent the diffusion of substances different from the analyte, thereby reducing the interference of substances different from the analyte on the detection of the analyte concentration.

[0084] In some examples, the first membrane layer 211 and the second membrane layer 212 may include a biocompatible membrane, and the biocompatible membrane may be disposed on a semipermeable membrane. In this case, when the analyte monitoring system 10 is placed on a host body and the sensor 20 is implanted in the host's cortex to contact with body fluid or tissue fluid, the host's immune response to the sensor 20 can be reduced, thereby extending the service life of the sensor 20.

[0085] In some examples, when a solution containing an analyte is monitored, the solution often contains some interfering substances. For example, when a glucose sensor monitors glucose in a host, the blood or non-blood fluids in the host often contain interfering substances, such as ascorbic acid, uric acid, or acetaminophen, which are substances with strong reducing properties. These interfering substances are easy to react with the working electrode 202 or the blank electrode 203 to generate a first interference signal or a second interference signal. If the interference signal is large, it will cause the first interference signal to account for a large proportion in the first electrical signal detected by the working electrode 202, thereby causing a large deviation between the first electrical signal and the analyte electrical signal in the first electrical signal, that is, the accuracy of the concentration value of the analyte indicated by the first electrical signal is low.

[0086] As described above, in some examples, the sensor 20 may include a blank electrode 203, so that the working electrode 202 and the blank electrode 203 simultaneously participate in monitoring the concentration value of the analyte. After comparing the first electrical signal measured by the working electrode 202 with the second electrical signal (i.e., the second interference signal) measured by the blank electrode 203, a more accurate concentration value of the analyte can be obtained. In other words, the second interference signal can be equated with the first interference signal, and the analyte electrical signal can be obtained by removing the value of the second electrical signal from the first electrical signal.

[0087] However, in actual operation, there is usually a difference between the blank electrode 203 and the working electrode 202, resulting in that the first interference signal is usually not equal to the second interference signal, so that there is a deviation between the first interference signal and the second interference signal. In other words, assuming that the working electrode 202 and the blank electrode 203 are placed in the same solution environment without analyte at the same time, the electrical signals measured by the working electrode 202 and the blank electrode 203 are not the same, that is, there is a deviation between the first interference signal and the second interference signal. In this case, when the analyte electrical signal is obtained by comparing the first electrical signal with the second electrical signal including the second interference signal, the accuracy of the obtained analyte electrical signal will be affected by the deviation between the first interference signal and the second interference signal.

[0088] The difference between the blank electrode 203 and the working electrode 202 may be caused by inconsistency caused by errors in the manufacturing process, or may be caused by different manufacturing processes for producing the blank electrode 203 and the working electrode 202. In the present disclosure, the difference between the blank electrode 203 and the working electrode 202 is not limited in any way.

[0089] In some examples, the first interference signal may be positively correlated with the surface area of ​​the working electrode 202; the second interference signal may be positively correlated with the surface area of ​​the blank electrode 203. In this case, the larger the surface area of ​​the working electrode 202, the larger the first interference signal generated by the electrochemical reaction with the interfering substance in the solution; similarly, the larger the surface area of ​​the blank electrode 203, the larger the second interference signal generated by the electrochemical reaction with the interfering substance in the solution. Thus, when the difference between the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203 is large, the deviation between the first interference signal and the second interference signal is greater, and vice versa, the deviation between the first interference signal and the second interference signal is smaller.

[0090] In some examples, the deviation between the first interference signal and the second interference signal may include a deviation caused by a difference in the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203. In other words, when the surface area of ​​the working electrode 202 is inconsistent with the surface area of ​​the blank electrode 203, there will be a deviation between the first interference signal measured by the working electrode 202 and the second interference signal measured by the blank electrode 203.

[0091] In some examples, the first interference signal may be negatively correlated with the thickness of the first film layer 211; the second interference signal may be negatively correlated with the thickness of the second film layer 212. In this case, the greater the thickness of the first film layer 211, the lower the concentration of the interfering substance penetrating through the first film layer 211, thereby causing the first interference signal generated by the electrochemical reaction between the working electrode 202 and the interfering substance to be smaller; similarly, the greater the thickness of the second film layer 212, the smaller the second interference signal. Therefore, when the difference between the thickness of the first film layer 211 and the thickness of the second film layer 212 is large, the deviation between the first interference signal and the second interference signal is greater, and vice versa, the deviation between the first interference signal and the second interference signal is smaller.

[0092] In some examples, the deviation between the first interference signal and the second interference signal may include a deviation caused by a difference between the thickness of the second film layer 212 and the thickness of the first film layer 211. In other words, when the thickness of the second film layer 212 is inconsistent with the thickness of the first film layer 211, there will be a deviation between the first interference signal measured by the working electrode 202 and the second interference signal measured by the blank electrode 203.

[0093] In some examples, the first interference signal may be positively correlated with the background noise signal of the working electrode 202; and the second interference signal may be positively correlated with the background noise signal of the blank electrode 203. In this case, the larger the background noise signal of the working electrode 202, the larger the first interference signal; and the larger the background noise signal of the blank electrode 203, the larger the second interference signal.

[0094] In some examples, the deviation between the first interference signal and the second interference signal may include a deviation caused by a difference between a background noise signal of the blank electrode 203 and a background noise signal of the working electrode 202. In other words, when the background noise signal of the blank electrode 203 is inconsistent with the background noise signal of the working electrode 202, there will be a deviation between the first interference signal measured by the working electrode 202 and the second interference signal measured by the blank electrode 203.

[0095] From the above description, it can be seen that due to the difference between the working electrode 202 and the blank electrode 203, there is a difference between the first interference signal and the second interference signal, and the accuracy of the analyte electrical signal obtained by directly comparing the first electrical signal with the second electrical signal will be affected.

[0096] In the analyte monitoring method proposed in the first aspect of the present disclosure, the deviation between the first interference signal and the second interference signal can be corrected by using a correction factor. In other words, a correction signal can be obtained based on the second electrical signal and the correction factor. That is, by using the correction factor, the deviation between the first interference signal and the second interference signal caused by the difference between the working electrode 202 and the blank electrode 203 can be reduced, and the correction signal can be substantially equivalent to the first interference signal. Thus, a more accurate analyte electrical signal can be obtained by comparing the first electrical signal with the correction signal, thereby improving the accuracy of analyte monitoring.

[0097] Figure 3A is a first flow chart showing an analyte monitoring method involved in the examples of the present disclosure. Figure 3B is a second flow chart showing the analyte monitoring method involved in the examples of the present disclosure.

[0098] For some examples, see Figure 3A The analyte monitoring method may include: obtaining a first electrical signal and a second electrical signal (step S200); obtaining a correction factor based on the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211 (step S400); and obtaining an analyte electrical signal based on the first electrical signal, the second electrical signal, and the correction factor (S600).

[0099] In the present disclosure, the sensor 20 can use the working electrode 202 and the blank electrode 203 to respectively measure a first electrical signal including a first interference signal and a second electrical signal including a second interference signal, and the first interference signal and the thickness of the first film layer 211 can be negatively correlated, and the second interference signal and the thickness of the second film layer 212 can be negatively correlated. In this case, a correction factor is obtained based on the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211, so that the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211. Thus, a more accurate analyte electrical signal can be obtained based on the first electrical signal, the second electrical signal, and the correction factor, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0100] In some examples, in step S200, a first electrical signal and a second electrical signal may be acquired, the first electrical signal may include an analyte electrical signal and a first interference signal obtained by the working electrode 202, and the second electrical signal may include a second interference signal obtained by the blank electrode 203, thereby, the analyte electrical signal may be acquired by comparing the first electrical signal and the second electrical signal.

[0101] For some examples, see Figure 3B The analyte monitoring method may further include setting the working electrode 202 and the blank electrode 203 at a preset voltage potential (step S100). Thus, the working electrode 202 and the blank electrode 203 can be promoted to undergo electrochemical reactions, thereby generating a first electrical signal and a second electrical signal, respectively.

[0102] In some examples, in step S100, the working electrode 202 and the blank electrode 203 can be set at a preset voltage potential by a constant potentiostat. In the present disclosure, a constant potentiostat can be understood as a circuit structure that can output a required constant voltage according to actual needs.

[0103] In some examples, electronics module 30 may include a potentiostat.

[0104] In some examples, the same preset voltage potential may be set on the working electrode 202 and the blank electrode 203. In this case, the deviation between the first interference signal and the second interference signal caused by the difference in potential between the working electrode 202 and the blank electrode 203 can be eliminated.

[0105] In some examples, different preset voltage potentials may be set on the working electrode 202 and the blank electrode 203. In this case, different voltage potentials may be set to facilitate the study of electrochemical reactions occurring on the working electrode 202 and the blank electrode 203 under different conditions.

[0106] In some examples, the preset voltage potential may be related to the type of the sensing layer 2021. For example, when the sensing layer 2021 is glucose dehydrogenase, the preset voltage potentials applied to the working electrode 202 and the blank electrode 203 may be 50 mV.

[0107] In the present disclosure, for the convenience of description, the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211 is set to be a first ratio, the ratio of the surface area of ​​the working electrode 202 to the surface area of ​​the blank electrode 203 is set to be a second ratio, and the ratio of the background noise signal of the working electrode 202 to the background noise signal of the blank electrode 203 is set to be a third ratio; let f represent the correction factor, f1 represent the first ratio, f2 represent the second ratio, f3 represent the third ratio, I represent the analyte electrical signal, I1 represent the first electrical signal, I2 represent the second electrical signal, and I3 represent the correction signal.

[0108] In some examples, in step S400, a correction factor may be obtained based on the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211. In other words, the correction factor may be equal to the value of the thickness of the second film layer 212 divided by the thickness of the first film layer 211, that is, the correction factor may be equal to the first ratio, and there may be a formula 1: f=f1. In this case, considering that the thickness of the film layer is negatively correlated with the size of the interference signal, the correction factor is obtained by dividing the thickness of the second film layer 212 by the thickness of the first film layer 211, and a correction signal substantially equivalent to the first interference signal is obtained based on the correction factor and the second electrical signal, so that the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211.

[0109] In some examples, the correction factor can be used to characterize the deviation between the first interference signal and the second interference signal. In this case, by introducing the correction factor and obtaining a correction signal based on the correction factor and the second electrical signal, the correction signal can be substantially equivalent to the first interference signal, that is, the correction factor can reduce the deviation between the first interference signal and the second interference signal caused by the difference between the working electrode 202 and the blank electrode 203 (for example, the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211), thereby, by comparing the first electrical signal with the correction signal, the measurement accuracy of the concentration value of the analyte can be improved.

[0110] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the ratio of the surface area of ​​the working electrode 202 to the surface area of ​​the blank electrode 203. In other words, the correction factor may be equal to the value of the surface area of ​​the working electrode 202 divided by the surface area of ​​the blank electrode 203, that is, the correction factor may be equal to the second ratio, and there may be Formula 2: f=f2. In this case, considering that the surface area of ​​the electrode is positively correlated with the size of the interference signal, the correction factor is obtained by dividing the surface area of ​​the working electrode 202 by the surface area of ​​the blank electrode 203, so that the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference in the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203, thereby, based on the first electrical signal, the second electrical signal, and the correction factor can obtain a more accurate analyte electrical signal, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0111] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the ratio of the surface area of ​​the working electrode 202 to the surface area of ​​the blank electrode 203, and the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211. In this case, the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference in the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203, and the difference in the thickness of the second film layer 212 and the thickness of the first film layer 211.

[0112] In some examples, in step S400, the correction factor can be obtained based on the product of the first ratio and the second ratio, that is, there can be Formula 3: f = f1 × f2. In this case, by correcting the second electrical signal by combining the difference between the film thickness and the difference between the electrode surface areas, the deviation between the first interference signal and the second interference signal caused by the difference between the surface area of ​​the blank electrode 203 and the surface area of ​​the working electrode 202, and the difference between the thickness of the first film layer 211 and the thickness of the second film layer 212 can be reduced at the same time, thereby further improving the measurement accuracy of the concentration value of the analyte.

[0113] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the ratio of the background noise signal of the working electrode 202 to the background noise signal of the blank electrode 203. In other words, the correction factor may be equal to the value of the background noise signal of the working electrode 202 divided by the background noise signal of the blank electrode 203, that is, the correction factor may be equal to the third ratio, and there may be Formula 3: f=f3. In this case, considering that the background noise signal of the electrode is positively correlated with the size of the interference signal, the correction factor is obtained by dividing the background noise signal of the working electrode 202 by the background noise signal of the blank electrode 203, so that the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203. Thus, a more accurate analyte electrical signal can be obtained based on the first electrical signal, the second electrical signal, and the correction factor, that is, the accuracy of the monitored analyte electrical signal can be improved.

[0114] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the ratio of the background noise signal of the working electrode 202 to the background noise signal of the blank electrode 203, and the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211. In this case, the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203, and the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211.

[0115] In some examples, in step S400, the correction factor can be obtained based on the product of the first ratio and the third ratio, that is, there can be Formula 4: f = f1 × f3. In this case, by correcting the second electrical signal by combining the difference between the film thickness and the difference between the electrode background noise signals, the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203 and the difference between the thickness of the first film layer 211 and the thickness of the second film layer 212 can be reduced at the same time, thereby further improving the measurement accuracy of the concentration value of the analyte.

[0116] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the ratio of the background noise signal of the working electrode 202 to the background noise signal of the blank electrode 203, and the ratio of the surface area of ​​the working electrode 202 to the surface area of ​​the blank electrode 203. In this case, the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203, and the difference between the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203.

[0117] In some examples, in step S400, the correction factor can be obtained based on the product of the second ratio and the third ratio, that is, there can be Formula 5: f = f2 × f3. In this case, by correcting the second electrical signal by integrating the difference between the surface areas of the electrodes and the difference between the background noise signals of the electrodes, the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203 and the difference between the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203 can be reduced at the same time, thereby further improving the measurement accuracy of the concentration value of the analyte.

[0118] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on the first ratio, the second ratio, and the third ratio. In this case, the correction factor can reduce the deviation of the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203, the difference between the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203, and the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211. Thus, the measurement accuracy of the concentration value of the analyte can be further improved.

[0119] In some examples, in step S400, the correction factor can be obtained based on the product of the first ratio, the second ratio and the third ratio, that is, there can be Formula 6: f = f1×f2×f3. In this case, by correcting the second electrical signal by integrating three factors, namely, the difference between the surface areas of the electrodes, the difference between the background noise signals of the electrodes and the difference between the surface areas of the electrodes, the deviation between the first interference signal and the second interference signal caused by the difference between the background noise signal of the working electrode 202 and the background noise signal of the blank electrode 203, the difference between the thickness of the second film layer 212 and the thickness of the first film layer 211, and the difference between the surface area of ​​the working electrode 202 and the surface area of ​​the blank electrode 203 can be reduced at the same time, thereby further improving the measurement accuracy of the concentration value of the analyte.

[0120] In some examples, in step S400, the analyte monitoring method may include obtaining a correction factor based on at least one of the ratio of the thickness of the second film layer 212 to the thickness of the first film layer 211, the ratio of the background noise signal of the working electrode 202 to the background noise signal of the blank electrode 203, and the ratio of the surface area of ​​the working electrode 202 to the surface area of ​​the blank electrode 203. In this case, the correction factor can include multiple factors that cause the deviation between the first interference signal and the second interference signal, thereby further improving the accuracy of analyte monitoring.

[0121] In some examples, in step S600, an analyte electrical signal may be obtained based on the first electrical signal, the second electrical signal, and the correction factor.

[0122] In some examples, in step S600, a correction signal may be obtained based on the second electrical signal and a correction factor.

[0123] In some examples, in step S600, a correction signal may be obtained based on the product of the correction factor and the second electrical signal, that is, there may be Formula 7: I3 = f×I2.

[0124] In some examples, in step S600, the analyte electrical signal can be obtained based on the first electrical signal and the correction signal. In this case, the correction factor and the second electrical signal can be used to obtain the correction signal, and the correction signal can be substantially equivalent to the first interference signal, thereby, based on the first electrical signal and the correction signal, a more accurate analyte electrical signal can be obtained, that is, the measurement accuracy of the analyte concentration value can be improved.

[0125] In some examples, in step S600 , the analyte electrical signal may be equal to the first electrical signal minus the correction signal, that is, there may be Formula 8: I=I1-I3.

[0126] The following uses a glucose monitoring system as an example to illustrate the analyte monitoring method proposed in the first aspect. In this embodiment, the glucose monitoring system can be a specific application of the analyte monitoring system 10 proposed in the second aspect of the present disclosure.

[0127] In some examples, the glucose monitoring system may include a glucose sensor (referred to as sensor 20 for short), which may be implemented as follows: Figure 2 In the structure shown, the sensing layer 2021 can be glucose oxidase or glucose dehydrogenase.

[0128] Figure 4 2 is a diagram showing the test results of Example 1 according to the present disclosure. Figure 5 2 is a diagram showing the test results of Example 2 according to the present disclosure. Figure 6Schematic diagram showing the background noise signals of the working electrode and the blank electrode involved in the examples of the present disclosure. Figure 7 2 is a diagram showing the test results of Example 3 according to the present disclosure.

[0129] [Example 1]

[0130] The sensor having a working electrode and a blank electrode of Example 1 was prepared, the surface of the working electrode being covered with a semipermeable membrane (first membrane layer), and the surface of the blank electrode being covered with a semipermeable membrane (second membrane layer).

[0131] First, the thickness of the first film layer and the second film layer on the sensor of Example 1 are measured by an optical measuring instrument, and the ratio of the thickness of the second film layer to the thickness of the first film layer, that is, f1, is 1.04. Substituting into Formula 1: f=f1, f is 1.04. When measuring the film thickness, the average value of the data at multiple locations on the film is taken as the film thickness.

[0132] Next, the sensor of Example 1 was placed in a test solution containing 5 mM glucose, and a voltage of 50 mV was applied to the working electrode and the blank electrode for 20 minutes. Figure 4 The time-current diagram shown ( Figure 4 (0 to 20 minutes).

[0133] Next, the sensor was placed in a mixed solution containing 5 mM glucose and 0.085 mM ascorbic acid (interfering substance), and a 50 mV voltage was applied to the working electrode and the blank electrode for 20 minutes to obtain the following Figure 4 The time-current diagram shown ( Figure 4 20 to 40 minutes). In other words, Figure 4 2 is a diagram showing the test results of Example 1 according to the present disclosure.

[0134] exist Figure 4 In the figure, the results from 0 to 20 minutes (curve 1) are the test results of placing the sensor in a solution containing glucose and no interfering substances, and the results from 20 to 40 minutes are the test results of placing the sensor in a solution containing glucose and interfering substances. Figure 4It can be seen that in the stage between 0 minutes and 20 minutes (curve 1), the current measured between the working electrode and the counter electrode is 5.7nA (i.e., the analyte electrical signal representing the net analyte concentration is 5.7nA). In the stage between 20 minutes and 40 minutes, curve 2 is the curve of the first electrical signal measured by the working electrode, and after stabilization, the first electrical signal I1 measured by the working electrode is 7.8nA; curve 3 is the curve of the second electrical signal measured by the blank electrode, and similarly, after stabilization, the second electrical signal I2 measured by the blank electrode is 1.9nA; curve 4 is obtained by using the above formula 7 and formula 8: I = I1-f×I2, and the analyte electrical signal I is 5.82nA.

[0135] By comparison, it can be seen that, assuming that the sensor does not have a blank electrode, the measurement accuracy has an error of about 37% (the error is calculated according to: (first electrical signal-analyte electrical signal) / analyte electrical signal×100%, (7.8-5.7) / 5.7×100%≈37%), and when the sensor includes a blank electrode and takes into account the correction factor, the measurement accuracy has an error of about 2%. Therefore, by providing a blank electrode in the sensor and taking into account the difference between the thickness of the first film layer covering the working electrode and the thickness of the second film layer covering the blank electrode, the measurement accuracy of the sensor can be improved.

[0136] [Example 2]

[0137] A sensor having a working electrode and a blank electrode of Example 2 was prepared, the surface of the working electrode being covered with a semipermeable membrane (first membrane layer), and the surface of the blank electrode being covered with a semipermeable membrane (second membrane layer).

[0138] First, the surface area of ​​the working electrode and the surface area of ​​the blank electrode, the thickness of the second film layer and the thickness of the first film layer on the sensor of Example 2 are measured by an optical measuring instrument, and the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode, that is, f2 is 0.77, and the ratio of the thickness of the second film layer to the thickness of the first film layer, that is, f1 is 1.04, substituting into Formula 3: f=f1×f2, f is 0.8.

[0139] Next, the sensor of Example 2 was placed in a test solution containing 5 mM glucose, and a voltage of 50 mV was applied to the working electrode and the blank electrode for 20 minutes. Figure 5 The time-current diagram shown ( Figure 5 (0 to 20 minutes).

[0140] Next, the sensor was placed in a mixed solution containing 5 mM glucose and 0.085 mM ascorbic acid (interfering substance), and a 50 mV voltage was applied to the working electrode and the blank electrode for 20 minutes to obtain the following Figure 5The time-current diagram shown ( Figure 5 20 to 40 minutes). In other words, Figure 5 2 is a diagram showing the test results of Example 2 according to the present disclosure.

[0141] exist Figure 5 In the figure, the results from 0 minutes to 20 minutes (curve 5) are the test results of placing the sensor in a solution containing glucose and no interfering substances, and the results from 20 minutes to 40 minutes are the test results of placing the sensor in a solution containing glucose and interfering substances. Figure 5 It can be seen that in the stage between 0 minutes and 20 minutes (curve 5), the current measured between the working electrode and the counter electrode is 5.7nA (i.e., the analyte electrical signal representing the net analyte concentration is 5.7nA). In the stage between 20 minutes and 40 minutes, curve 6 is the first electrical signal curve measured by the working electrode, and after stabilization, the first electrical signal I1 measured by the working electrode is 7.4nA; curve 7 is the second electrical signal curve measured by the blank electrode, and similarly, after stabilization, the second electrical signal I2 measured by the blank electrode is 2.0nA; curve 8 is obtained by using the above formula 7 and formula 8: I = I1-f×I2, and the analyte electrical signal I is 5.8nA.

[0142] By comparison, it can be seen that, assuming that the sensor does not have a blank electrode, the measurement accuracy has an error of about 29.82% (the error is calculated according to: (first electrical signal-analyte electrical signal) / analyte electrical signal×100%, (7.4-5.7) / 5.7×100%≈29.82%), and when the sensor includes a blank electrode and takes into account the correction factor, the measurement accuracy has an error of about 1.75%. Therefore, by setting a blank electrode in the sensor and taking into account the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode, and the difference between the thickness of the second film layer and the thickness of the first film layer, the measurement accuracy of the sensor can be further improved.

[0143] [Example 3]

[0144] A sensor having a working electrode and a blank electrode of Example 3 was prepared, the surface of the working electrode being covered with a semipermeable membrane (first membrane layer), and the surface of the blank electrode being covered with a semipermeable membrane (second membrane layer).

[0145] First, the thickness of the first film layer and the second film layer on the sensor of Example 3, the surface area of ​​the working electrode and the surface area of ​​the blank electrode are measured by an optical measuring instrument, and the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode, that is, f2 is 0.77, and the ratio of the thickness of the second film layer to the thickness of the first film layer, that is, f1 is 1.04.

[0146] Next, the sensor of Example 3 was placed in a phosphate buffer solution (also known as PBS buffer solution) (i.e., a solution without glucose and interfering substances), and a voltage of 50 mV was applied to the working electrode and the blank electrode for 20 minutes to obtain the following: Figure 6 Shown are time-current plots of background noise signals for the working electrode and blank electrode.

[0147] Next, the sensor of Example 3 was placed in a test solution containing 5 mM glucose, and a voltage of 50 mV was applied to the working electrode and the blank electrode for 20 minutes to obtain the following results: Figure 7 The time-current diagram shown ( Figure 7 (0 to 20 minutes).

[0148] Then, the sensor was placed in a mixed solution containing 5 mM glucose and 0.085 mM ascorbic acid (interfering substance), and a voltage of 50 mV was applied to the working electrode and the blank electrode for 20 minutes to obtain the following Figure 7 The time-current diagram shown ( Figure 7 20 to 40 minutes). In other words, Figure 7 2 is a diagram showing the test results of Example 3 according to the present disclosure.

[0149] exist Figure 6 In the embodiment, the current signal between the working electrode and the counter electrode (curve 9) and the current signal between the blank electrode and the counter electrode (curve 10) are measured, wherein the stable current signal of the working electrode (curve 9) is 0.2nA, that is, the background noise signal of the working electrode is 0.2nA, and the stable current signal of the blank electrode (curve 10) is 0.18nA, that is, the background noise signal of the blank electrode is 0.18nA. Therefore, the ratio of the background noise signal of the working electrode to the background noise signal of the blank electrode, that is, f3, is 1.11. Therefore, in Example 3, substitute into Formula 6: f=f1×f2×f3, and f is 0.89.

[0150] exist Figure 7 In the figure, the results from 0 to 20 minutes (curve 11) are the test results of placing the sensor in a solution containing glucose and no interfering substances, and the results from 20 to 40 minutes are the test results of placing the sensor in a solution containing glucose and interfering substances. Figure 7It can be seen that in the stage between 0 minutes and 20 minutes (curve 11), the current measured between the working electrode and the counter electrode is 5.9nA (i.e., the analyte electrical signal representing the net analyte concentration is 5.9nA). In the stage between 20 minutes and 40 minutes, curve 12 is the first electrical signal curve measured by the working electrode, and after stabilization, the first electrical signal I1 measured by the working electrode is 7.67nA; curve 13 is the second electrical signal curve measured by the blank electrode, and similarly, after stabilization, the second electrical signal I2 measured by the blank electrode is 1.9nA; curve 14 is obtained by using the above formula 7 and formula 8: I = I1-f×I2, and the analyte electrical signal I is 5.98nA.

[0151] By comparison, it can be seen that, assuming that the sensor does not have a blank electrode, the measurement accuracy has an error of about 30% (the error is calculated according to: (first electrical signal-analyte electrical signal) / analyte electrical signal×100%, (7.67-5.9) / 5.9×100%≈30%), and when the sensor includes a blank electrode and takes into account the correction factor, the measurement accuracy has an error of about 1.36%. Therefore, by setting a blank electrode in the sensor and taking into account the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode, the difference between the thickness of the second film layer and the thickness of the first film layer, and the difference between the background noise signal of the working electrode and the background noise signal of the blank electrode, the measurement accuracy of the sensor can be further improved.

[0152] In an analyte monitoring system 10 according to the third aspect of the present disclosure, the analyte monitoring system 10 can obtain an analyte electrical signal by executing the analyte monitoring method according to the first aspect, and the analyte monitoring system 10 can include a processing device 40, and the processing device 40 can be configured to execute the analyte monitoring method. In this case, the correction factor can reduce the deviation between the first interference signal measured by the working electrode 202 and the second interference signal measured by the blank electrode 203 due to the difference between the working electrode 202 and the blank electrode 203, so that the analyte monitoring system 10 can obtain a more accurate analyte electrical signal from the first electrical signal based on the second interference signal measured by the blank electrode 203, the first electrical signal measured by the working electrode 202 and the correction factor, that is, a more accurate analyte concentration value, thereby improving the accuracy of the analyte monitoring system 10.

[0153] Although the present disclosure is specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the above description does not limit the present disclosure in any form. Those skilled in the art may modify and change the present disclosure as needed without departing from the essential spirit and scope of the present disclosure, and these modifications and changes all fall within the scope of the present disclosure.

Claims

1. A method for monitoring an analyte is a method for obtaining an analyte electrical signal through a sensor, characterized in that: The sensor includes a working electrode, a blank electrode, and a film layer that at least partially covers the working electrode and the blank electrode. The working electrode is used to obtain a first electrical signal including the analyte electrical signal and a first interference signal, and the blank electrode is used to obtain a second electrical signal including a second interference signal. The film layer covering the working electrode is assumed to be the first film layer, and the film layer covering the blank electrode is assumed to be the second film layer. The analyte monitoring method includes: obtaining the first electrical signal and the second electrical signal; obtaining a correction factor for characterizing the deviation between the first interference signal and the second interference signal based on the ratio of the thickness of the second film layer to the thickness of the first film layer; and obtaining the analyte electrical signal based on the first electrical signal, the second electrical signal, and the correction factor.

2. The analyte monitoring method according to claim 1, characterized in that: The deviation between the first interference signal and the second interference signal also includes the deviation caused by the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode. The analyte monitoring method also includes: obtaining the correction factor based on the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode.

3. The analyte monitoring method according to claim 2, characterized in that: Let the ratio of the thickness of the second film layer to the thickness of the first film layer be a first ratio, let the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode be a second ratio, and obtain the correction factor based on the product of the first ratio and the second ratio.

4. The analyte monitoring method according to claim 1, characterized in that: The deviation between the first interference signal and the second interference signal also includes the deviation caused by the difference between the background noise signal of the working electrode and the background noise signal of the blank electrode. The analyte monitoring method also includes: obtaining the correction factor based on the ratio of the background noise signal of the working electrode to the background noise signal of the blank electrode.

5. The analyte monitoring method according to claim 4, characterized in that: Let the ratio of the thickness of the second film layer to the thickness of the first film layer be a first ratio, let the ratio of the background noise signal of the working electrode to the background noise signal of the blank electrode be a third ratio, and obtain the correction factor based on the product of the first ratio and the third ratio.

6. The analyte monitoring method according to claim 4, characterized in that: The deviation between the first interference signal and the second interference signal includes the deviation caused by the difference between the surface area of ​​the working electrode and the surface area of ​​the blank electrode. The analyte monitoring method also includes: setting the ratio of the surface area of ​​the working electrode to the surface area of ​​the blank electrode as a second ratio, and obtaining the correction factor based on the first ratio, the second ratio, and the third ratio.

7. The analyte monitoring method according to claim 1, characterized in that: The sensor comprises a substrate, and the working electrode and the blank electrode are located on both sides of the substrate.

8. The analyte monitoring method according to any one of claims 1 to 7, characterized in that: A correction signal is obtained based on the second electrical signal and the correction factor, and the analyte electrical signal is obtained based on the first electrical signal and the correction signal.

9. A readable storage medium, characterized in that: The readable storage medium stores at least one instruction, and when the at least one instruction is executed by a processor, the analyte monitoring method according to any one of claims 1 to 8 is implemented.

10. An analyte monitoring system, characterized in that: The analyte monitoring system obtains an analyte electrical signal by executing the analyte monitoring method according to any one of claims 1 to 8, and the analyte monitoring system includes a processing device, and the processing device is configured to execute the analyte monitoring method.

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