Analyte concentration calibration method and analyte sensor

Abstract

The invention provides an analyte concentration calibration method and an analyte sensor, the analyte concentration is obtained through the analyte sensor, the analyte sensor comprises an implantation part capable of being placed under the skin and a temperature sensor capable of being placed on the body surface, and the analyte concentration calibration method comprises the following steps: before the analyte sensor is worn, the implantation part can be placed under the skin, and the temperature sensor can be placed on the body surface; sensitive information of the implanted part is obtained, wherein the sensitive information is the relation between the sensitivity of the implanted part and the temperature; the body surface temperature is obtained through a temperature sensor, and the subcutaneous temperature is obtained based on the body surface temperature; selecting a reference temperature; calibration information is obtained on the basis of the sensitive information, the reference temperature and the subcutaneous temperature, a response signal obtained by the implantation part is calibrated on the basis of the calibration information, and the response signal is response current or response voltage; and obtaining the analyte concentration based on a relationship between the response signal at the reference temperature and the change in the analyte concentration, and the calibrated response signal. Therefore, the accuracy of the obtained analyte concentration can be improved.

Description

[0001] This application is a divisional application of a patent application with an application date of October 12, 2021, an application number of 2021111879313, and an invention name of sensor and method for obtaining analyte concentration considering temperature compensation. Technical Field

[0002] The present disclosure relates generally to the field of medical devices, and more particularly to methods for calibrating analyte concentrations and analyte sensors. Background Art

[0003] Diabetes is a disease of a series of metabolic disorders such as sugar, protein, fat, water and electrolytes. If it is not well controlled, it may cause some complications, such as ketoacidosis, lactic acidosis, chronic renal failure and retinopathy. For diabetic patients, if the concentration of glucose can be monitored in real time and continuously, the occurrence of complications such as glucose and hyperglycemia can be predicted first.

[0004] Studies have shown that when the glucose concentration in the blood begins to decrease, the glucose concentration in the tissue fluid decreases before the glucose concentration in the blood. The decrease in the glucose concentration in the tissue fluid can predict the upcoming low glucose. A glucose sensor for sensing glucose concentration generally includes an implanted part that can be placed subcutaneously to sense changes in the glucose concentration in the subcutaneous tissue fluid, thereby being able to predict the glucose concentration in the blood.

[0005] However, the temperature of the implanted part will change due to the combined influence of the ambient temperature change and the body temperature change. The implanted part generally includes an enzyme that can catalyze the glucose reaction. Since the activity of the enzyme is affected by temperature, the response signal output by the implanted part will be biased, resulting in the glucose concentration calculated based on the response signal being inaccurate. Therefore, it is necessary to calibrate the output response signal while considering temperature compensation. Summary of the invention

[0006] The present disclosure is made in view of the above-mentioned prior art conditions, and its purpose is to provide a sensor and method for obtaining analyte concentration in consideration of temperature compensation, so as to improve the accuracy of the obtained analyte concentration.

[0007] To this end, the present disclosure provides a method for obtaining an analyte concentration while taking temperature compensation into consideration, wherein the analyte concentration is obtained by an analyte sensor, wherein the analyte sensor includes an implantable part that can be placed subcutaneously, and an application part that can be placed on the body surface and has a temperature sensor, and the method includes: before wearing the analyte sensor, obtaining sensitive information of the implantable part under a predetermined analyte concentration, wherein the sensitive information is the relationship between the sensitivity of the implantable part and the temperature; placing the implantable part subcutaneously and placing the application part on the body surface, obtaining the body surface temperature through the temperature sensor, and obtaining the subcutaneous temperature based on the body surface temperature; selecting a reference temperature; obtaining calibration information based on the sensitive information, the reference temperature and the subcutaneous temperature, and calibrating the response signal obtained by the implantable part based on the calibration information; and obtaining the analyte concentration based on the reference temperature and the calibrated response signal.

[0008] In the method disclosed herein, before wearing the analyte sensor, sensitive information of the implanted part is obtained under a predetermined analyte concentration, that is, the relationship between the sensitivity and temperature of the implanted part is obtained. The implanted part is placed subcutaneously and the applied part with a temperature sensor is placed on the body surface, the body surface temperature is obtained by the temperature sensor, and the subcutaneous temperature is obtained based on the body surface temperature. A reference temperature is selected, calibration information is obtained based on the sensitive information, the reference temperature and the subcutaneous temperature, and the response signal obtained by the implanted part is calibrated based on the calibration information, thereby obtaining a calibrated response signal. The analyte concentration is calibrated based on the reference temperature and the calibrated response signal, thereby improving the accuracy of the obtained analyte concentration.

[0009] In addition, in the method of the present disclosure, optionally, the implanted part is placed in a reagent containing the analyte, the temperature of the reagent is changed, and the sensitivity of the implanted part is measured as the temperature of the reagent changes, so as to obtain the sensitive information of the implanted part. In this case, before wearing the analyte sensor, the relationship between the sensitivity of the implanted part and the temperature is measured by using a reagent containing the analyte, thereby conveniently obtaining the sensitive information of the implanted part in advance.

[0010] In addition, in the method disclosed herein, optionally, the concentration of the analyte in the reagent is kept constant when the temperature of the reagent is changed. In this case, by controlling the concentration of the analyte in the reagent to be constant and changing the temperature of the reagent, the relationship between the sensitivity and temperature of the implanted portion can be more accurately obtained.

[0011] In addition, in the method disclosed herein, optionally, the calibration information is obtained based on the sensitivity information and the difference or ratio between the subcutaneous temperature and the reference temperature. In this case, by considering the relationship between the sensitivity and temperature of the implanted part and the relationship between the subcutaneous temperature of the implanted part and the reference temperature, temperature compensation can be facilitated.

[0012] In addition, in the method involved in the present disclosure, optionally, when the temperature sensor senses the temperature on the body surface and outputs the body surface temperature, the implanted part inserted under the skin simultaneously senses the analyte concentration under the skin and outputs a response signal. In this case, the subcutaneous temperature, i.e., the temperature at the location of the implanted part, and the response signal output by the implanted part sensing the analyte concentration can be obtained at the same time, thereby making it possible to perform temperature compensation on the response signal of the implanted part in real time, thereby improving the accuracy of analyte concentration calibration.

[0013] In addition, in the method of the present disclosure, optionally, there is no time delay between the implanted part outputting the response signal and the temperature sensor outputting the body surface temperature, thereby improving the accuracy of analyte concentration calibration.

[0014] In addition, in the method involved in the present disclosure, optionally, the analyte is one or more of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone and troponin. Thus, the concentration of analytes such as acetylcholine, amylase, bilirubin, etc. can be obtained.

[0015] In addition, in the method involved in the present disclosure, optionally, a calibrated analyte concentration is obtained based on the relationship between the response signal of the implanted part and the change in analyte concentration at the reference temperature, and the calibrated response signal.

[0016] The present disclosure also provides an analyte sensor for obtaining analyte concentration while taking temperature compensation into consideration, the analyte sensor comprising an implantable part that can be placed subcutaneously, an application part that can be placed on the body surface and has a temperature sensor, and a processing module, the processing module storing a first mapping relationship between subcutaneous temperature and body surface temperature obtained by the temperature sensor, sensitivity information of the implantable part, and a second mapping relationship between a response signal output by the implantable part and a change in analyte concentration at a predetermined temperature, wherein the sensitivity information is a relationship between the sensitivity of the implantable part and the temperature change under a predetermined analyte concentration; when the implantable part is placed subcutaneously and the application part is placed on the body surface, the temperature sensor senses the body surface temperature and outputs the body surface temperature; the processing module is configured to: obtain the subcutaneous temperature based on the body surface temperature and the first mapping relationship, select a reference temperature, obtain calibration information based on the sensitive information, the subcutaneous temperature and the reference temperature, calibrate the response signal obtained by the implantable part based on the calibration information, and obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping relationship.

[0017] In the analyte sensor involved in the present disclosure, the implanted part is placed subcutaneously and the applied part with the temperature sensor is placed on the body surface, the body surface temperature is obtained by the temperature sensor, and the subcutaneous temperature is obtained based on the body surface temperature. The processing module is configured to: obtain the subcutaneous temperature based on the body surface temperature and the first mapping relationship, select the reference temperature, obtain the calibration information based on the sensitive information, the subcutaneous temperature and the reference temperature, calibrate the response signal obtained by the implanted part based on the calibration information, and obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping relationship, thereby being able to obtain the analyte concentration in consideration of temperature compensation, thereby improving the accuracy of the analyte sensor in sensing the analyte concentration.

[0018] In addition, in the analyte sensor of the present disclosure, the implanted portion includes a working electrode capable of reacting with the analyte and a counter electrode forming a circuit with the working electrode, so that the implanted portion can sense the analyte concentration.

[0019] According to the present disclosure, a sensor and a method for obtaining an analyte concentration by taking temperature compensation into consideration can be provided, thereby improving the accuracy of the obtained analyte concentration. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 1 is a schematic diagram showing a wearing state of an analyte sensor for obtaining analyte concentration in consideration of temperature compensation according to an embodiment of the present disclosure.

[0021] Figure 2is a schematic structural diagram showing an implantable portion of an analyte sensor according to an embodiment of the present disclosure.

[0022] Figure 3 Schematic diagram showing the structure of the working electrode of the implanted part involved in the embodiment of the present disclosure.

[0023] Figure 4 is a diagram showing a first mapping relationship between the subcutaneous temperature and the body surface temperature obtained by the temperature sensor according to an embodiment of the present disclosure.

[0024] Figure 5A is a diagram showing a linear regression simulation result of a response current and temperature of an implanted portion involved in an embodiment of the present disclosure;

[0025] Figure 5B is shown with Figure 5A Table corresponding to the linear regression simulation result graph.

[0026] Figure 6 is a second mapping relationship diagram showing the response current and the analyte concentration involved in the embodiment of the present disclosure.

[0027] Figure 7 is a flow chart showing a method of obtaining analyte concentration taking temperature compensation into account according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0028] The present disclosure is further described in detail below in conjunction with the accompanying drawings and specific embodiments. In the accompanying drawings, the same components or components with the same functions are marked with the same symbols, and repeated descriptions thereof are omitted.

[0029] The present disclosure relates to a method for obtaining an analyte concentration with consideration of temperature compensation, which can calibrate the obtained analyte concentration with consideration of temperature compensation. The method of this embodiment can help improve the accuracy of the obtained analyte concentration.

[0030] In the method for obtaining analyte concentration under temperature compensation involved in the present disclosure, the analyte concentration can be obtained by an analyte sensor. For ease of understanding, the present disclosure first introduces an analyte sensor for obtaining analyte concentration under temperature compensation.

[0031] In some examples, the analyte sensor may also be sometimes referred to as an implantable analyte sensor, an analyte monitor, or an analyte monitor. It should be noted that the names are intended to indicate the analyte sensor involved in the present embodiment that can improve the accuracy of the obtained analyte concentration under consideration of temperature compensation, and should not be understood as limiting.

[0032] Figure 1 1 is a schematic diagram showing a wearing state of the analyte sensor 1 for obtaining the analyte concentration in consideration of temperature compensation according to an embodiment of the present disclosure.

[0033] In some examples, the analyte sensor 1 may include an implantable portion 2 that may be placed subcutaneously, an application portion 3 that may be placed on the body surface, and a processing module (see Figure 1 , the processing module is not shown). In some examples, when the implant portion 2 is placed subcutaneously, the implant portion 2 can sense the concentration of the analyte under the skin and output a response signal. In some examples, the application portion 3 can have a temperature sensor 4 (see Figure 1 ). In some examples, when the application portion 3 is placed on the body surface, the temperature sensor 4 can detect the temperature of the body surface and output the body surface temperature. In some examples, the processing module can receive the response signal output by the implant portion 2 and the body surface temperature output by the temperature sensor 4, and calculate and output the calibrated analyte concentration.

[0034] Figure 2 1 is a schematic diagram showing the structure of the implant portion 2 of the analyte sensor 1 according to an embodiment of the present disclosure.

[0035] In some examples, as described above, analyte sensor 1 may include implant portion 2 (see Figure 1 In some examples, the implantable portion 2 of the analyte sensor 1 can be placed subcutaneously and in contact with the subcutaneous tissue fluid (see Figure 1 ). The implanted portion 2 can sense the concentration of the analyte in the tissue fluid and output a response signal.

[0036] In some examples, the implant portion 2 may be flexible. The implant portion 2 may be disposed in a puncture needle (not shown), and the implant portion 2 may be detachable from the puncture needle. When the analyte sensor 1 is worn, the puncture needle wrapped with the implant portion 2 may be inserted into the tissue, and then the puncture needle may be pulled out and separated from the implant portion 2, so that the implant portion 2 is placed subcutaneously.

[0037] In some examples, the implant portion 2 can be configured in the arm (see Figure 1 ), abdomen, waist or legs, etc.

[0038] In some examples, the implant portion 2 can be inserted 3mm to 20mm under the skin. In some examples, the depth of the implant portion 2 inserted under the skin is determined according to the insertion position. When the fat layer is thicker, the implant portion 2 is inserted deeper, such as in the abdomen of the human body, and the insertion depth can be about 10mm to 15mm. When the fat layer is thinner, the implant portion 2 is inserted shallower, such as in the arm, and the insertion depth can be about 5mm to 10mm.

[0039] In some examples, the implant portion 2 may include a substrate S (see Figure 2 ).

[0040] In some examples, the substrate S may be flexible. The substrate S 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 substrate S 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. In some examples, the substrate S may also be non-flexible.

[0041] In some examples, implant portion 2 may include working electrode 10 and counter electrode 30 (see Figure 2 ). In some examples, working electrode 10 can form a loop with working electrode 10. Thus, implant portion 2 is able to sense analyte concentration.

[0042] In some examples, the implanted portion 2 may further include a reference electrode 20. In some examples, the implanted portion 2 may further include a contact 40 connected to the working electrode 10 via a lead wire (see Figure 2 ). Thus, the implant part 2 can transmit a response signal to the outside via the contact 40.

[0043] In some examples, the working electrode 10, the reference electrode 20, and the counter electrode 30 may be disposed on a substrate S (see Figure 2 ).

[0044] Figure 3 2 is a schematic diagram showing the structure of the working electrode 10 of the implant part 2 involved in the embodiment of the present disclosure.

[0045] In some examples, as described above, implant portion 2 may include working electrode 10 (see Figure 2 In some examples, the working electrode 10 may include a substrate layer 110, a nanoparticle layer 120, an analyte enzyme sensing layer 130, a semipermeable membrane 140, and a biocompatible membrane 150. The substrate layer 110, the nanoparticle layer 120, the analyte enzyme sensing layer 130, the semipermeable membrane 140, and the biocompatible membrane 150 may be stacked in sequence (see Figure 3 ).

[0046] In some examples, the base layer 110 may be conductive. In some examples, the base layer 110 may be made of at least one selected from gold, glassy carbon, graphite, silver, silver chloride, palladium, titanium, and iridium. In this case, the base layer 110 has good conductivity and can inhibit electrochemical reactions of the base layer 110, thereby improving the stability of the base layer 110.

[0047] In some examples, the base layer 110 may be disposed on the substrate S by a deposition or plating method. In some examples, the deposition method may include physical vapor deposition, chemical vapor deposition, etc. The plating method may include electroplating, chemical plating, vacuum plating, etc. In addition, in some examples, the base layer 110 may also be disposed on the substrate S by screen printing, extrusion, or electrolytic deposition.

[0048] In some examples, the substrate layer 110 may be provided with an analyte enzyme sensing layer 130 .

[0049] In some examples, the concentration of multiple analytes can be obtained by changing the analyte enzyme sensing layer 130 on the implant part 2. For example, in some examples, the analyte can be one or more of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone and troponin. In other examples, by changing the analyte enzyme sensing layer 130 on the implant part 2, the concentration of drugs in body fluids can also be monitored, such as antibiotics (gentamicin, vancomycin, etc.), digitoxin, digoxin, theophylline, and warfarin, etc.

[0050] In some examples, a nanoparticle layer 120 may be disposed on the substrate layer 110. That is, a nanoparticle layer 120 may be disposed between the substrate layer 110 and the analyte enzyme sensing layer 130. In this case, the nanoparticles can further catalyze the analyte reaction, reduce the operating voltage required for the analyte reaction, and increase the reaction rate.

[0051] Specifically, GO X (FAD) is used as an example of glucose oxidase. In the analyte sensing layer 130, when GO X When (FAD) encounters glucose in tissues, the following reactions occur:

[0052] Glucose + GOx(FAD) → Gluconolactone + GOx(FADH 2 )……Reaction formula (I)

[0053] GOx(FADH 2 )+O 2 →GOx(FAD)+H 2 O 2 ……Reaction formula (II)

[0054] In the above reaction process, there will be H in reaction formula (II) 2 O 2 The generation of H2 O 2 The aggregation of analyte enzymes will reduce the enzyme activity in the analyte enzyme sensing layer 130.

[0055] The nanoparticle layer 120 can act as a catalyst to 2 O 2 A decomposition reaction occurs, the specific reaction is as follows:

[0056] H 2 O 2 →2H + +O 2 +2e - ……Reaction formula (III)

[0057] Through the above reaction formula (I) to reaction formula (III), the reaction between the implant part 2 and glucose can be continuously carried out. In addition, the nanoparticle layer 120 catalyzes the decomposition of hydrogen peroxide, which can reduce the voltage required to be applied during the reaction process, thereby facilitating the improvement of the sensitivity of the implant part 2, extending the service life of the analyte sensor 1, and obtaining a low operating voltage. In other words, through the nanoparticle layer 120, a high-sensitivity sensing signal of tissue glucose can be continuously obtained, the service life of the analyte sensor 1 can be extended, and the low operating voltage is conducive to improving the anti-interference performance.

[0058] In some examples, the nanoparticle layer 120 may be porous. In this case, the analyte enzyme in the analyte enzyme sensing layer 130 may penetrate into the nanoparticle layer 120. Thus, the nanoparticle layer 120 can fully contact and catalyze the analyte reaction, thereby more effectively promoting the analyte reaction.

[0059] In some examples, the analyte enzyme may also be disposed in the conductive polymer nanofiber three-dimensional network, that is, the nanofiber three-dimensional network is disposed between the nanoparticle layer 120 and the analyte enzyme sensing layer 130. Thus, the adhesion of the analyte enzyme to the nanoparticle layer 120 is increased, and the immobilized amount of the analyte enzyme is increased.

[0060] In some examples, the analyte enzyme may also be disposed on the carbon nanotubes, wherein the carbon nanotubes are disposed on the nanoparticle layer 120. Thus, the adhesion and immobilization amount of the analyte enzyme on the nanoparticle layer 120 are increased.

[0061] In some examples, the semipermeable membrane 140 may be disposed on the analyte enzyme sensing layer 130. In some examples, the semipermeable membrane 140 may further include a diffusion control layer and an anti-interference layer stacked on the diffusion control layer.

[0062] In some examples, the diffusion control layer can be arranged outside the anti-interference layer. In the semipermeable membrane 140, the diffusion control layer can control the diffusion of the analyte molecules, and the anti-interference layer can prevent the diffusion of non-analyte substances. Thus, the tissue fluid or blood components passing through the semipermeable membrane 140 can be reduced first, and then the interferents can be blocked outside the semipermeable membrane 140 by the anti-interference layer. Common interferents can include uric acid, ascorbic acid, acetaminophen, etc. that are ubiquitous in the body. In other examples, the anti-interference layer can also be arranged outside the diffusion control layer. Thus, the inaccurate sensing results caused by the interference of impurities on the working electrode 10 can also be reduced, and the service life of the implanted part 2 can be extended.

[0063] In some examples, the semipermeable membrane 140 can control the passing rate of the analyte molecules, that is, the semipermeable membrane 140 can limit the number of analyte molecules in the tissue fluid or blood that reach the analyte enzyme sensing layer 130. Specifically, the diffusion control layer of the semipermeable membrane 140 can effectively reduce the number of analytes diffused to the analyte enzyme sensing layer 130 by a certain ratio.

[0064] In some examples, the biocompatible membrane 150 can be disposed on the semipermeable membrane 140. In some examples, the biocompatible membrane 150 can be made of plant materials. The plant material can be a natural material derivative such as sodium alginate, tragacanth gum, pectin, gum arabic, xanthan gum, guar gum, agar or starch derivatives, cellulose derivatives, etc. In other examples, the biocompatible membrane 150 can also be made of artificial synthetic materials. The artificial synthetic material can be polyolefins. Thus, the immune response of the human body to the implant part 2 can be reduced, and the service life of the implant part 2 can be extended.

[0065] In addition, in some examples, the semipermeable membrane 140 may also be biocompatible, thereby avoiding the use of the biocompatible membrane 150 and reducing the manufacturing cost.

[0066] In some examples, a nanoparticle layer 120 for promoting the analyte enzyme to catalyze the analyte reaction is disposed on the substrate 110 of the working electrode 10, and then an analyte enzyme sensing layer 130 is formed on this basis, and then a semipermeable membrane 140 coating is formed on the analyte enzyme sensing layer 130, and finally a biocompatible membrane 150 layer is formed on the semipermeable membrane 140 coating (see Figure 3 ). Thus, the service life of the implanted part 2 is prolonged, interference from other factors is reduced, and the response speed of the implanted part 2 to the analyte is improved.

[0067] In some examples, as described above, implant portion 2 may include counter electrode 30 (see Figure 2). In some examples, the counter electrode 30 may be made of platinum, silver, silver chloride, palladium, titanium or iridium. Thus, the electrochemical reaction at the working electrode 10 may not be affected while having good electrical conductivity. However, the present embodiment is not limited thereto. In other examples, the counter electrode 30 may also be made of at least one selected from gold, glassy carbon, graphite, silver, silver chloride, palladium, titanium or iridium. Thus, the influence on the working electrode 10 may be reduced while having good electrical conductivity.

[0068] In some examples, the implanted portion 2 involved in this embodiment can realize continuous monitoring, thereby achieving the purpose of continuously monitoring the concentration value of human analytes for a long time (for example, 1 day to 24 days).

[0069] In some examples, as described above, analyte sensor 1 also includes an applicator portion 3 (see Figure 1 and Figure 2 ).

[0070] In some examples, the application portion 3 may have a housing 31 (see Figure 1 In some examples, the temperature sensor 4 of the application portion 3 may be located within the housing 31 (see Figure 1 ).

[0071] In some examples, the temperature sensor 4 can be disposed on the inner wall surface of the housing 31 close to the body surface (see Figure 1 In some other examples, the temperature sensor 4 may be disposed on any wall surface of the housing 31 .

[0072] In some examples, the number of temperature sensors 4 of the application part 3 may be one. In other examples, the number of temperature sensors 4 of the application part 3 may be multiple, thereby improving the accuracy of body surface temperature sensing, thereby improving the accuracy of subcutaneous temperature obtained based on body surface temperature.

[0073] In some examples, the application part 3 can be connected to the implant part 2. In some examples, the part of the implant part 2 located on the body surface can be electrically connected to the application part 3 through the contact 40 (see Figure 2 ). Thus, the current signal generated by the implant part 2 can be transmitted to the application part 3 via the base layer 110 and the transmission wire via the contact 40.

[0074] In some examples, the application part 3 can be made of a flexible PCB and a flexible battery, so that it can be closely attached to the skin and reduce the impact on the user's daily life.

[0075] In some examples, as described above, the analyte sensor 1 further includes a processing module (not shown).

[0076] In some examples, the processing module can be installed in the application part 3. Thus, the current signal generated by the implant part 2 can be transmitted to the processing module through the contact 40 for analysis, and the body surface temperature output by the temperature sensor 4 can be transmitted to the processing module for analysis.

[0077] In some examples, the processing module may store a first mapping relationship between subcutaneous temperature and body surface temperature. In some examples, as described above, the body surface temperature can be obtained by the temperature sensor 4. In some examples, the processing module may store sensitive information of the implant part 2. In some examples, the processing module may store a second mapping relationship between a response signal output by the implant part 2 and a change in analyte concentration. Specifically, the second mapping relationship may be a second mapping relationship between a response signal output by the implant part 2 and a change in analyte concentration at a predetermined temperature.

[0078] In some examples, as described above, the processing module may store a first mapping relationship between the subcutaneous temperature and the body surface temperature obtained by the temperature sensor 4 .

[0079] Figure 4 2 is a diagram showing a first mapping relationship between the subcutaneous temperature and the body surface temperature obtained by the temperature sensor 4 according to an embodiment of the present disclosure.

[0080] In some examples, three temperature sensors 4 with the same process parameters can be placed in the external environment, the simulated living body surface, and about 10 mm below the skin of the simulated living body. In some examples, the temperature of the external environment is changed, and the three temperature sensors 4 can be set to output the corresponding sensed temperature every 1 minute. The first mapping relationship between the body surface temperature and the subcutaneous temperature can be obtained by outputting the temperature of the external environment, the body surface temperature, and the subcutaneous temperature of the three temperature sensors 4 respectively (see Figure 4 ).

[0081] The temperature sensors 4 with the same process parameters may refer to the temperature sensors 4 produced in the same batch during production, and usually may be the temperature sensors 4 produced in the same batch under the same process. This can reduce the systematic error of the measurements between different temperature sensors 4.

[0082] In some examples, as described above, the processing module can store sensitive information of implant portion 2.

[0083] In some examples, the sensitive information may be the relationship between the sensitivity and temperature of the implanted part 2. Specifically, in some examples, the sensitivity of the implanted part 2 may be a change value of the sensitivity of the implanted part 2 at a reference temperature.

[0084] In some examples, the change value of the sensitivity of the implant portion 2 can be obtained from the relationship between the response current of the implant portion 2 and the temperature at a reference temperature.

[0085] Figure 5A is a diagram showing a linear regression simulation result of the response current and temperature of the implant part 2 involved in the embodiment of the present disclosure; Figure 5B is shown with Figure 5A Table corresponding to the linear regression simulation result graph.

[0086] In some examples, the analyte sensor 1 can sense the concentration of glucose. The implanted portion 2 of the analyte sensor 1 is placed in a glucose solution. In some examples, the concentration of the glucose solution can be 5 mmol / L to 25 mmol / L. In some examples, the temperature of the glucose solution is changed to obtain a response signal output by the implanted portion 2 when the temperature of the glucose solution is 30°C, 34°C, 37°C, and 40°C (see Figure 5B In some examples, the response signal may be a response current (see Figure 5B ). In some other examples, the response signal may be a response voltage.

[0087] In some examples, the relationship between the response current and the temperature is analyzed, and the response current and the temperature may be linearly correlated (see Figure 5A ). In some other examples, the relationship between the response current and the temperature is analyzed, and the response current and the temperature may be nonlinearly related.

[0088] In some examples, the change value of the sensitivity of the implanted part 2 at the reference temperature may be the ratio of the slope (k value) of the linear regression equation of the linear simulation result to the response signal (see Figure 5A and Figure 5B ). For example, combined with Figure 5A and Figure 5B When 30℃ is selected as the reference temperature, the change value of the sensitivity of the implant part 2 at 30℃ can be 12.59% (0.428 / 3.40); when 34℃ is selected as the reference temperature, the change value of the sensitivity of the implant part 2 at 34℃ is 8.82% (0.428 / 4.85); when 37℃ is selected as the reference temperature, the change value of the sensitivity of the implant part 2 at 37℃ is 6.95% (0.428 / 6.16); when 40℃ is selected as the reference temperature, the change value of the sensitivity of the implant part 2 at 40℃ is 5.56% (0.428 / 7.70).

[0089] In some examples, the change value of the sensitivity of the implanted portion 2 at the reference temperature may be an average value of the results of repeated measurements of the same implanted portion 2. In other examples, the change value of the sensitivity of the implanted portion 2 at the reference temperature may be an average value of the measurement results of multiple implanted portions 2. In the above two cases, the calculation of the average value can reduce the system error and improve the accuracy of the calculation result, thereby being conducive to improving the accuracy of the obtained analyte concentration.

[0090] In some examples, as described above, the processing module may store a second mapping relationship between the response signal of implant portion 2 and the concentration of the analyte at a predetermined temperature.

[0091] In some examples, the predetermined temperature includes multiple temperature values. For example, in some examples, the predetermined temperature includes 34°C, 35°C, 36°C, 36.5°C, 37°C, 37.5°C, 38°C, 39°C, 40°C, and 41°C. In some examples, the reference temperature can be selected from one of the multiple temperature values. For example, in some examples, the reference temperature can be 34°C, 35°C, 36°C, 36.5°C, 37°C, 37.5°C, 38°C, 39°C, 40°C, or 41°C.

[0092] Figure 6 is a second mapping relationship diagram showing the response current and the analyte concentration involved in the embodiment of the present disclosure.

[0093] In some examples, the analyte sensor 1 can sense the concentration of glucose. 37°C is selected as the reference temperature. The implanted portion 2 of the analyte sensor 1 is placed in glucose solutions of different concentrations. In some examples, the concentration of the glucose solution can be 0 to 25 mmol (see Figure 6 ). The implanted part 2 senses glucose solutions of different concentrations and outputs corresponding response signals. In some examples, the response signal can be a response current (see Figure 6 ). In some other examples, the response signal may be a response voltage.

[0094] In some examples, the relationship between the response current and the analyte concentration is analyzed, and the response current and the glucose concentration can be linearly correlated (see Figure 6 ), that is, the second mapping relationship is a linear relationship. In other examples, the relationship between the response current and the analyte concentration is analyzed, and the response current and the analyte concentration may be nonlinearly correlated, that is, the second mapping relationship is a nonlinear relationship.

[0095] In some examples, the processing module is configured to obtain subcutaneous temperature. For example, the processing module is configured to obtain subcutaneous temperature based on body surface temperature and a first mapping relationship. In some examples, the processing module is configured to select a reference temperature. In some examples, the processing module is configured to obtain calibration information. For example, the processing module is configured to obtain calibration information based on sensitive information, subcutaneous temperature, and reference temperature. In some examples, the processing module is configured to calibrate the response signal. For example, the processing module is configured to calibrate the response signal obtained by the implant part 2 based on the calibration information. In some examples, the processing module is configured to obtain an analyte concentration. For example, the processing module is configured to obtain an analyte concentration based on a reference temperature, a calibrated response signal, and a second mapping relationship.

[0096] In some examples, as described above, the processing module is configured to obtain the subcutaneous temperature based on the body surface temperature and the first mapping relationship. Specifically, the temperature sensor 4 can transmit the sensed body surface temperature to the processing module, and the processing module obtains the subcutaneous temperature based on the body surface temperature and the first mapping relationship according to the first mapping relationship preset in the processing module.

[0097] In some examples, as described above, the processing module is configured to select a reference temperature. In some examples, the reference temperature selected by the processing module configuration may be 37°C. In this case, the reference temperature is closer to the average body temperature of the human body, thereby improving the effect of calibrating the analyte concentration with temperature compensation. In other examples, the reference temperature may also be other temperatures. For example, the reference temperature may be 35°C, 36°C, 36.5°C, 37.5°C, or 38°C, etc.

[0098] In some examples, as described above, the processing module is configured to obtain calibration information based on the sensitivity information, the subcutaneous temperature, and the reference temperature. Specifically, in some examples, the processing module is configured to calculate the difference between the reference temperature and the subcutaneous temperature, and then calculate the product of the difference and the change in sensitivity of the implanted part 2 at 37°C, thereby obtaining the calibration information.

[0099] In some examples, as described above, the processing module is configured to calibrate the response signal obtained by the implant part 2 based on the calibration information. Specifically, in some examples, the response signal generated by the implant part 2 can be transmitted to the processing module through the contact 40, and the processing module is configured to perform mathematical calculations on the calibration information and the response signal to calibrate the response signal obtained by the implant part 2.

[0100] In some examples, the calibration formula for the response signal obtained by the implant part 2 can be: b=a(1+ΔT×Z), where ΔT represents the difference between the reference temperature and the subcutaneous temperature, Z represents the change in sensitivity of the implant part 2 at the reference temperature, a represents the response signal output by the implant part 2 to the processing module, and b represents the calibrated response signal.

[0101] In some examples, as described above, the processing module is configured to obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping relationship. Specifically, in some examples, the processing module is configured to calculate the calibrated analyte concentration through the second mapping relationship at the reference temperature preset by the processing module and the calibrated response signal.

[0102] In some examples, the temperature sensor 4 and the implanted part 2 (especially during a period of time when fasting and after a meal) can transmit signals to the processing module at intervals, and the processing module can output the calibrated analyte concentration at intervals so that the user can promptly know the changing trend of the analyte concentration and thus control the changes in the analyte concentration.

[0103] In some examples, the analyte concentration signal obtained by the processing module can be transmitted via wireless communication such as Bluetooth, WiFi, etc. An external reading device, such as a mobile phone or a computer (not shown), can receive the analyte concentration signal sent by the processing module and display the concentration of the analyte.

[0104] In the analyte sensor 1 involved in the present disclosure, the implant part 2 is placed subcutaneously and the application part 3 with the temperature sensor 4 is placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature. The processing module is configured to: obtain the subcutaneous temperature based on the body surface temperature and the first mapping relationship, select the reference temperature, obtain the calibration information based on the sensitive information, the subcutaneous temperature and the reference temperature, calibrate the response signal obtained by the implant part 2 based on the calibration information, and obtain the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping relationship. In this way, the analyte concentration can be obtained in consideration of temperature compensation, which improves the accuracy of the analyte concentration sensing of the analyte sensor 1.

[0105] In the following, in combination with the analyte sensor 1 described above, a method for obtaining analyte concentration in consideration of temperature compensation according to the present disclosure is introduced.

[0106] The method for obtaining the analyte concentration under the condition of considering temperature compensation involved in the present embodiment may also be referred to as a method for calibrating the analyte concentration, a method for calibrating the analyte concentration with temperature compensation, a method for calibrating the analyte concentration with temperature compensation, etc. It should be noted that each name is used to indicate the method involved in the present embodiment that can improve the accuracy of the obtained analyte concentration under the condition of considering temperature compensation, and should not be understood as limiting.

[0107] Figure 7 is a flow chart showing a method of obtaining analyte concentration taking temperature compensation into account according to an embodiment of the present disclosure.

[0108] Combination Figure 7 The method for obtaining analyte concentration while considering temperature compensation involved in the present disclosure may include: obtaining sensitive information of the implanted part 2 before wearing the analyte sensor 1 (step S100); obtaining the body surface temperature, and obtaining the subcutaneous temperature based on the body surface temperature (step S200); selecting a reference temperature (step S300); obtaining calibration information, and calibrating the response signal based on the calibration information (step S400); and obtaining the analyte concentration based on the reference temperature and the calibrated response signal (step S500).

[0109] In step S100, as described above, sensitive information of implanted portion 2 may be obtained before wearing analyte sensor 1. In some examples, sensitive information of implanted portion 2 may be obtained under a predetermined analyte concentration before wearing analyte sensor 1.

[0110] In some examples, in step S100, the predetermined analyte concentration may be a known and identical analyte concentration. In some examples, the implant part 2 may be placed in the analyte, and the implant part 2 senses a response signal output by the analyte concentration to obtain sensitive information of the implant part 2.

[0111] In some examples, in step S100, the sensitive information may be the relationship between the sensitivity of the implanted part 2 and the temperature.

[0112] In some examples, in step S100, the sensitivity of the implanted portion 2 may increase with the increase of temperature. Specifically, in some examples, within a predetermined temperature range, the sensitivity of the implanted portion 2 may increase with the increase of temperature. In some examples, the sensitivity of the implanted portion 2 may be linearly related to the temperature. In other examples, the sensitivity of the implanted portion 2 may also be nonlinearly related to the temperature.

[0113] In other examples, in step S100, the sensitivity of the implanted portion 2 may decrease as the temperature increases. Specifically, in some examples, in step S100, within a predetermined temperature range, the sensitivity of the implanted portion 2 may decrease as the temperature increases. In some examples, the sensitivity of the implanted portion 2 may be linearly related to the temperature. In other examples, the sensitivity of the implanted portion 2 may also be nonlinearly related to the temperature.

[0114] In some examples, as described above, the sensitive information may be the change value of the sensitivity of the implanted part 2 at the reference temperature. For example, in some examples, as described above, the sensitive information may be the change value of the sensitivity of the implanted part 2 at 37° C., that is, 6.95%.

[0115] In some examples, in step S100, the implant 2 may be placed in a reagent containing an analyte, and the sensitivity information of the implant 2 may be obtained by changing the temperature of the reagent and measuring the change in sensitivity of the implant 2 with the temperature of the reagent. That is, the temperature of the environment (location) where the implant 2 is located is changed by changing the temperature of the reagent to obtain the relationship between the sensitivity of the implant 2 and the temperature of the environment (location) where the implant 2 is located. In this case, before wearing the analyte sensor 1, the relationship between the sensitivity of the implant 2 and the temperature is measured by using a reagent containing an analyte, thereby making it possible to conveniently obtain the sensitivity information of the implant 2 in advance.

[0116] In some examples, in step S100, the concentration of the analyte in the reagent is kept constant when the temperature of the reagent is changed. In this case, when the temperature of the reagent is changed, the change in temperature does not affect the change in the concentration of the analyte, thereby improving the accuracy of the sensitivity sensing of the implant part 2.

[0117] In step S200, as described above, the body surface temperature is obtained, and the subcutaneous temperature is obtained based on the body surface temperature. Specifically, in some examples, in step S200, the implant part 2 can be placed subcutaneously and the application part 3 can be placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature.

[0118] In some examples, in step S200, when the application part 3 is placed on the body surface, the temperature sensor 4 of the application part 3 is placed on the body surface. Thus, the temperature sensor 4 can sense the temperature of the body surface and output the body surface temperature.

[0119] In some examples, in step S200, as described above, there may be a first mapping relationship between the body surface temperature and the subcutaneous temperature. When the body surface temperature is obtained, the subcutaneous temperature may be obtained through the first mapping relationship.

[0120] In some examples, in step S200, the surface temperature and subcutaneous temperature of the simulated living body may be simultaneously sensed at different ambient temperatures to obtain a first mapping relationship between the surface temperature and the subcutaneous temperature.

[0121] In some examples, in step S200, the body surface temperature and the subcutaneous temperature are affected by both the ambient temperature and the internal temperature. The body surface temperature is affected more by the ambient temperature than the subcutaneous temperature, and the body surface temperature is affected less by the internal temperature than the subcutaneous temperature; therefore, the body surface temperature and the subcutaneous temperature may be nonlinearly correlated. That is, the first mapping relationship may be a nonlinear mapping relationship.

[0122] In some examples, in step S200, the implant part 2 may be placed 3 mm to 20 mm below the skin. It is understandable that the distance between 3 mm below the skin and 20 mm below the skin is small, and the temperature is roughly the same, which will not cause the response signal output by the implant part 2 to have a statistical difference.

[0123] In step S300 , as described above, a reference temperature may be selected.

[0124] In some examples, in step S300, 37°C may be selected as the reference temperature. In this case, the reference temperature is closer to the average body temperature of the human body, thereby improving the effect of calibrating the analyte concentration through temperature compensation. In other examples, the reference temperature may also be other temperatures. For example, the reference temperature may be 35°C, 36°C, 36.5°C, 37.5°C, or 38°C.

[0125] In step S400, as described above, calibration information may be obtained based on the sensitive information, the reference temperature, and the subcutaneous temperature, and the response signal obtained by the implant part 2 may be calibrated based on the calibration information.

[0126] In some examples, in step S400, the sensitive information may be the relationship between the sensitivity of the implanted part 2 and the temperature change as described above. In some examples, specifically, the sensitive information may be the sensitivity of the implanted part 2 at a reference temperature. Further, the sensitive information may be a change value of the sensitivity of the implanted part 2 at the reference temperature.

[0127] In some examples, in step S400, calibration information can be obtained based on the difference between the subcutaneous temperature and the reference temperature, and the sensitivity information. In this case, by considering the relationship between the sensitivity and temperature of the implanted part 2, and the relationship between the subcutaneous temperature of the implanted part 2 and the reference temperature, temperature compensation can be facilitated.

[0128] Specifically, in some examples, the calibration information may be the difference between the reference temperature and the subcutaneous temperature, multiplied by the sensitivity of the implanted part 2 at the reference temperature. Further, the calibration information may be the difference between the reference temperature and the subcutaneous temperature, multiplied by the change in the sensitivity of the implanted part 2 at the reference temperature.

[0129] In other examples, in step S400, the calibration information may be obtained based on the sensitivity information and the ratio of the subcutaneous temperature to the reference temperature. Specifically, in some examples, the calibration information may be the ratio of the reference temperature to the subcutaneous temperature, multiplied by the sensitivity of the implanted part 2 at the reference temperature. Further, the calibration information may be the ratio of the reference temperature to the subcutaneous temperature, multiplied by the change value of the sensitivity of the implanted part 2 at the reference temperature.

[0130] In some examples, in step S400, the calibrated response signal may be the product of the pre-calibrated response signal and the calibration information, plus the pre-calibrated response signal. That is, the calibrated response signal may be the product of the calibration information plus one and the pre-calibrated response signal.

[0131] In some other examples, in step S400, the calibrated response signal may be the quotient of the pre-calibrated response signal and the calibration information. In some other examples, in step S400, the calibrated response signal may be the sum / difference of the pre-calibrated response signal and the calibration information.

[0132] In some examples, in step S400, when the temperature sensor 4 senses the temperature of the body surface and outputs the body surface temperature, the implant part 2 inserted subcutaneously can simultaneously sense the analyte concentration under the skin and output a response signal. In this case, the subcutaneous temperature, i.e., the temperature at the location of the implant part 2, and the response signal output by the implant part 2 sensing the analyte concentration can be obtained simultaneously, thereby making it possible to perform temperature compensation on the response signal of the implant part 2 in real time, thereby improving the accuracy of the analyte concentration calibration.

[0133] In some examples, in step S400, there is no time delay between the output of the response signal by the implanted part 2 and the output of the body surface temperature by the temperature sensor 4. In this case, the subcutaneous temperature (i.e., the temperature at the location where the implanted part 2 is located) is obtained based on the body surface temperature, and the response signal output by the implanted part 2 at the subcutaneous temperature at this time can be obtained without time delay, thereby further improving the accuracy of the analyte concentration calibration.

[0134] In step S500 , as described above, the analyte concentration may be obtained based on the reference temperature and the calibrated response signal.

[0135] In some examples, in step S500, the relationship between the response signal of implant part 2 and the concentration of the analyte may be obtained at the reference temperature. In some examples, at the reference temperature, there may be a second mapping relationship between the response signal of implant part 2 and the concentration of the analyte.

[0136] In some examples, in step S500, the response signal of the implanted part 2 may be linearly correlated with the analyte concentration. That is, the second mapping relationship may be a linear mapping relationship. In other examples, the response signal of the implanted part 2 may be nonlinearly correlated with the analyte concentration. That is, the second mapping relationship may be a nonlinear mapping relationship.

[0137] In some examples, in step S500, at a reference temperature, implant part 2 is placed in analyte solutions of different concentrations, and a response signal output by implant part 2 is measured to obtain a second mapping relationship between the response signal of implant part 2 and the analyte concentration.

[0138] In some examples, in step S500, the maximum concentration of the analyte used to detect the second mapping relationship is lower than the maximum sensing concentration of the implanted portion 2. In some examples, the concentration gradient of the analyte used to detect the second mapping relationship is increased. In some examples, the concentration of the analyte used to detect the second mapping relationship is close to the concentration of the subcutaneous analyte. In this case, the concentration of the analyte is close to the concentration of the subcutaneous analyte, which can make the system error of the detection relatively small, thereby improving the accuracy of the detection.

[0139] In some examples, in step S500, the calibrated analyte concentration can be obtained based on the relationship between the response signal of the implanted part 2 at the reference temperature and the change in the analyte concentration, and the calibrated response signal. That is, the calibrated analyte concentration can be obtained through the second mapping relationship and the response signal of the implanted part 2 calibrated in step S400.

[0140] In the method disclosed herein, before wearing the analyte sensor 1, the sensitive information of the implant part 2 is obtained under a predetermined analyte concentration, that is, the relationship between the sensitivity of the implant part 2 and the temperature change is obtained. The implant part 2 is placed subcutaneously and the application part 3 having the temperature sensor 4 is placed on the body surface, the body surface temperature is obtained by the temperature sensor 4, and the subcutaneous temperature is obtained based on the body surface temperature. A reference temperature is selected, calibration information is obtained based on the sensitive information, the reference temperature and the subcutaneous temperature, and the response signal obtained by the implant part 2 is calibrated based on the calibration information, thereby obtaining a calibrated response signal. The analyte concentration is calibrated based on the reference temperature and the calibrated response signal, thereby improving the accuracy of the obtained analyte concentration.

[0141] Although the present disclosure is specifically described above in conjunction with the accompanying drawings and embodiments, 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 calibrating an analyte concentration, wherein the analyte concentration is obtained by an analyte sensor, wherein the analyte sensor comprises an implantable part that can be placed subcutaneously and a temperature sensor that can be placed on the body surface, It is characterized in that The method for calibrating the analyte concentration includes: before wearing the analyte sensor, obtaining sensitive information of the implanted part, the sensitive information being the relationship between the sensitivity of the implanted part and the temperature; obtaining the body surface temperature through the temperature sensor, and obtaining the subcutaneous temperature based on the body surface temperature; selecting a reference temperature; obtaining calibration information based on the sensitive information, the reference temperature and the subcutaneous temperature, and calibrating the response signal obtained by the implanted part based on the calibration information, the response signal being a response current or a response voltage; and obtaining the analyte concentration based on the relationship between the response signal of the implanted part at the reference temperature and the change in analyte concentration, and the calibrated response signal.

2. The method for calibrating the concentration of an analyte according to claim 1, It is characterized in that The analyte sensor further comprises an application portion which can be placed on a body surface and has the temperature sensor. When the implant portion is placed subcutaneously and the application portion is placed on a body surface, the temperature sensor obtains the body surface temperature.

3. The method for calibrating the analyte concentration according to claim 1, It is characterized in that A first mapping relationship between the surface temperature and the subcutaneous temperature is obtained by placing temperature sensors with the same process parameters in the external environment, the simulated living body surface and the simulated living body subcutaneous, and the subcutaneous temperature is obtained based on the surface temperature and the first mapping relationship.

4. The method for calibrating the concentration of an analyte according to claim 1, It is characterized in that The reference temperature is one of predetermined temperatures, and the predetermined temperature includes a plurality of temperatures.

5. The method for calibrating the analyte concentration according to claim 1, It is characterized in that The calibration information is obtained based on the sensitive information and a difference or a ratio between the subcutaneous temperature and the reference temperature.

6. The method for calibrating the concentration of an analyte according to claim 5, It is characterized in that The calibration information is the product of the difference between the reference temperature and the subcutaneous temperature and the change value of the sensitivity of the implanted part at the reference temperature; or The calibration information is the ratio of the reference temperature to the subcutaneous temperature, multiplied by the change in sensitivity of the implanted part at the reference temperature.

7. The method for calibrating the concentration of an analyte according to claim 1, It is characterized in that The calibrated response signal is the product of the pre-calibrated response signal and the calibration information, plus the pre-calibrated response signal.

8. The method for calibrating the analyte concentration according to claim 1, It is characterized in that When the temperature sensor senses temperature on the body surface and outputs the body surface temperature, the implant portion inserted subcutaneously simultaneously senses analyte concentration under the skin and outputs a response signal.

9. The method for calibrating the analyte concentration according to claim 8, It is characterized in that There is no time delay between the implanted part outputting the response signal and the temperature sensor outputting the body surface temperature.

10. An analyte sensor, It is characterized in that It includes an implantable part that can be placed subcutaneously, an application part that can be placed on the body surface and has a temperature sensor, and a processing module; the implantable part is configured to obtain a response signal, the temperature sensor is configured to sense the temperature of the body surface and output the body surface temperature, and the processing module is configured to obtain the analyte concentration based on the calibration method of the analyte concentration described in any one of claims 1 to 9.

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