A smart blood glucose meter with automatic calibration function and a calibration method thereof

Abstract

This specification provides an embodiment of an intelligent blood glucose meter with automatic calibration function, including a housing, a display screen and a test strip slot disposed on the housing, and the following components disposed inside the housing: a detection module, used to collect the initial electrochemical signal generated by the reaction between the blood sample and the test strip reagent when the test strip is inserted into the test strip slot and a blood sample is added; an environmental monitoring module, used to monitor the current ambient temperature in real time and collect environmental compensation parameters that affect the accuracy of blood glucose detection; a storage module, used to store preset standard calibration curves and dynamic compensation algorithm models; an automatic calibration module, connected to the detection module, environmental monitoring module and storage module respectively, used to receive the initial electrochemical signal and environmental compensation parameters, and to perform correction calculations on the initial electrochemical signal according to the dynamic compensation algorithm model to generate a calibrated blood glucose value; and a display module, used to output the calibrated blood glucose value to the display screen for display.

Description

Technical Field

[0001] This document relates to the field of medical testing equipment technology, and in particular to an intelligent blood glucose meter with automatic calibration function and its calibration method. Background Technology

[0002] The global prevalence of diabetes continues to rise, and blood glucose monitoring, as a core component of diabetes management, directly impacts treatment planning and prognosis assessment. Traditional finger-prick blood glucose meters have significant limitations: they require regular manual calibration, are complex to operate, and are prone to calibration errors due to operational mistakes; over long-term use, factors such as sensor aging, changes in environmental temperature and humidity, and batch differences in test strips lead to a gradual accumulation of detection errors, with each additional 100 tests potentially increasing the error by 0.3-0.8 mmol / L.

[0003] Current automatic calibration technologies for smart blood glucose meters still have shortcomings: some devices use a fixed-period calibration mode, which cannot respond to changes in environmental parameters in real time; calibration algorithms are mostly based on simple linear regression, which is difficult to adapt to individual metabolic differences; and the reference sensor configuration is limited, only monitoring temperature or humidity, lacking the ability to perform multi-parameter collaborative calibration. Although the blood glucose meter data processing method developed by Beijing Huayi Jingdian Biotechnology Co., Ltd. achieves automatic calibration upon startup, it is insufficiently responsive to dynamic environmental changes during use, such as temperature fluctuations and differences in test strip insertion pressure, resulting in a fluctuation error of ±0.2-0.5 mmol / L in the test results.

[0004] Furthermore, existing devices have shortcomings in automatic test strip identification and parameter matching: enzyme activity and electrode conductivity vary between different batches of test strips, and traditional identification methods, relying solely on barcode scanning, cannot detect the actual state of the test strips in real time; lag in calibration parameter updates leads to inaccurate test results. Therefore, developing an intelligent blood glucose meter with real-time multi-parameter monitoring, adaptive calibration algorithms, and intelligent test strip status identification is of great significance for improving the efficiency of diabetes management and reducing medical costs. Summary of the Invention

[0005] This specification provides one or more embodiments of a smart blood glucose meter with automatic calibration function, including a housing, a display screen and a test strip slot disposed on the housing, and further including: The detection module is used to collect the initial electrochemical signal generated by the reaction between the blood sample and the reagent on the test strip when the test strip is inserted into the test strip slot and a blood sample is dripped in. The environmental monitoring module is used to monitor the current ambient temperature in real time and collect environmental compensation parameters that affect the accuracy of blood glucose testing. The storage module is used to store preset standard calibration curves and dynamic compensation algorithm models based on different environmental conditions and test strip batches. An automatic calibration module is connected to the detection module, the environmental monitoring module, and the storage module respectively. The automatic calibration module is used to receive the initial electrochemical signal and the environmental compensation parameters, and to perform correction calculations on the initial electrochemical signal according to the dynamic compensation algorithm model to generate a calibrated blood glucose value. The display module is used to output the calibrated blood glucose value to the display screen for display.

[0006] Furthermore, the environmental monitoring module includes a temperature sensor, a humidity sensor, a micro-pressure sensor, and a light intensity sensor; the environmental compensation parameters include at least the ambient temperature value and the ambient humidity value.

[0007] Furthermore, the automatic calibration module includes: A signal receiving unit is used to receive the initial electrochemical signal; The compensation calculation unit has the dynamic compensation algorithm model built in, which is used to perform temperature compensation and humidity compensation calculations on the initial electrochemical signal based on the environmental compensation parameters. The curve matching unit is used to retrieve the corresponding standard calibration curve from the storage module based on the batch information of the current test strip, and map the signal after compensation calculation to the final blood glucose concentration value.

[0008] Furthermore, it also includes: A test strip recognition module is located at the test strip slot and is used to read the coded information on the inserted test strip. The coded information includes the factory calibration parameters of the batch of test strips. The automatic calibration module is further used to correct the standard calibration curve according to the factory calibration parameters.

[0009] Furthermore, the automatic calibration module has a pre-stored time-based self-learning algorithm to record the blood glucose value change trend after multiple calibrations for the same patient, and when continuous abnormal fluctuations are detected, it issues a retest reminder or test strip failure reminder through the display module.

[0010] Furthermore, the detection module includes: A constant potential circuit is used to input a stable voltage to the working electrode and reference electrode of the test paper; A current-to-voltage conversion circuit is used to convert the weak current signal generated by the blood sample reaction into a voltage signal. An analog-to-digital converter is used to convert the voltage signal into the initial electrochemical signal in digital format.

[0011] Furthermore, the housing is also equipped with a communication module, which is used to wirelessly transmit the calibrated blood glucose value to a smart terminal or cloud server.

[0012] Furthermore, the automatic calibration module obtains the latest dynamic compensation algorithm model from the cloud server through the communication module and updates the algorithm in the storage module.

[0013] This specification provides one or more embodiments of an automatic calibration method for a smart blood glucose meter, including: S1. In response to the insertion of the test strip and the dripping of the blood sample, the initial electrochemical signal generated by the blood sample reaction is collected; S2. Synchronously collect the current ambient temperature and humidity; S3. Based on the current ambient temperature and humidity, call the pre-stored dynamic compensation algorithm model to correct the initial electrochemical signal; S4. Substitute the corrected signal value into the standard calibration curve that matches the batch of test strips to calculate the final blood glucose value; S5. Output and display the final blood glucose value.

[0014] Furthermore, prior to step S1, the following is also included: Read the coding information on the inserted test strip, which contains the factory calibration parameters for this batch of test strips; The standard calibration curve is corrected according to the factory calibration parameters.

[0015] Using this invention, the environmental monitoring module collects multi-dimensional parameters such as temperature and humidity in real time, and combines them with a dynamic compensation algorithm model to accurately correct the initial electrochemical signal, effectively eliminating the interference of environmental factors on the detection results. At the same time, the test strip recognition module automatically reads the batch code, ensuring that the standard calibration curve is accurately matched with the factory parameters of each batch of test strips, avoiding the tedious operation and potential errors of manually entering calibration codes. It records individual blood glucose change trends and actively issues warnings when abnormalities occur, supports data cloud synchronization and remote algorithm updates, enabling the device to continuously evolve while ensuring measurement accuracy, providing diabetic patients with a more intelligent, reliable and convenient blood glucose monitoring experience.

[0016] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and in order to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in one or more embodiments of this specification or in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this specification. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 A diagram illustrating the internal module composition of a smart blood glucose meter housing with automatic calibration function, provided for one or more embodiments of this specification; Figure 2 This is a flowchart illustrating an automatic calibration method for a smart blood glucose meter provided in one or more embodiments of this specification. Detailed Implementation

[0019] To enable those skilled in the art to better understand the technical solutions in one or more embodiments of this specification, the technical solutions in one or more embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this specification, and not all of the embodiments. Based on one or more embodiments of this specification, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of this document.

[0020] According to an embodiment of the present invention, a smart blood glucose meter with automatic calibration function is provided, including a housing, a display screen and a test strip slot disposed on the housing. Figure 1 This specification provides a diagram illustrating the internal module composition of a smart blood glucose meter housing with automatic calibration function, as shown in one or more embodiments. Figure 1 As shown, an internal module of a smart blood glucose meter housing with automatic calibration function according to an embodiment of the present invention specifically includes: The detection module 10 is used to collect the initial electrochemical signal generated by the reaction between the blood sample and the reagent on the test strip when the test strip is inserted into the test strip socket and the blood sample is dripped in.

[0021] The detection module includes a constant potential circuit, a current / voltage conversion circuit, and an analog-to-digital converter. First, the constant potential circuit provides a stable voltage to the working electrode and reference electrode of the test strip. In electrochemical detection, the working electrode is where the glucose reacts with the reagent in a redox reaction, while the reference electrode provides a constant potential reference point. The constant potential circuit, through feedback control, ensures that the potential difference between the two electrodes remains stable at a preset value, thus creating an ideal electric field environment for the reaction. Applying a stable voltage eliminates current interference caused by external voltage fluctuations, ensuring that the Faraday current generated on the test strip is only related to the glucose concentration in the blood sample.

[0022] When a blood sample is dropped onto the test strip, the electron migration generated by the reaction of glucose with the reagent forms an extremely weak current signal, typically in the microamplitude or even nanoamplitude range. At this point, a current-to-voltage conversion circuit (IV-V converter) is used to convert this weak current signal into a voltage signal. A high-precision operational amplifier is used to proportionally amplify the weak current and convert it into a voltage signal of appropriate amplitude, while effectively suppressing noise and stray interference.

[0023] The converted voltage signal is a continuously changing analog quantity, which must be digitized to be read and processed by the microcontroller or automatic calibration module. Therefore, the voltage signal is converted into the initial electrochemical signal in digital format by an analog-to-digital converter. The analog voltage is quantized with extremely high sampling rate and resolution, and the continuous voltage value is discretized into binary digital code to form the initial electrochemical signal. This signal encapsulates the original response value of glucose concentration in the blood sample and can be directly stored in the storage module or sent to the automatic calibration module. It is then corrected by combining environmental compensation parameters and dynamic compensation algorithm model to finally generate the calibrated blood glucose value.

[0024] The environmental monitoring module 12 is used to monitor the current ambient temperature in real time and collect environmental compensation parameters that affect the accuracy of blood glucose testing.

[0025] The environmental monitoring module integrates a temperature sensor, a humidity sensor, a micro-pressure sensor, and a light intensity sensor to construct a multi-dimensional environmental sensing system. The environmental compensation parameters include at least the ambient temperature and humidity values. Specifically, the temperature sensor is placed inside the housing near the test strip slot to monitor the current ambient temperature in real time, continuously outputting the ambient temperature value with a millisecond-level response speed and an accuracy of ±0.05℃, providing the primary correction basis for subsequent compensation calculations. The humidity sensor is responsible for collecting ambient humidity values, with a measurement range of 0-100%RH and an accuracy of ±2%, monitoring the absolute or relative humidity in the environment in real time, and using these humidity values ​​as an important component of the environmental compensation parameters. This embodiment further introduces a micro-pressure sensor and a light intensity sensor. The micro-pressure sensor is used to detect subtle changes in atmospheric pressure, and the light intensity sensor monitors ambient light. The data collected by these two types of sensors are also incorporated into the environmental compensation parameter set.

[0026] Storage module 14 is used to store preset standard calibration curves and dynamic compensation algorithm models based on different environmental conditions and test strip batches.

[0027] The storage module contains preset standard calibration curves, which are standard curves showing the functional relationship between electrochemical signal intensity and blood glucose concentration under ideal conditions, generated based on fitting a large amount of laboratory data. Because different batches of test strips have slight differences in manufacturing processes and reagent coating amounts, and because actual usage environments vary greatly, a single standard curve cannot cover all scenarios. Therefore, the storage module also contains dynamic compensation algorithm models based on different environmental conditions and test strip batches. These algorithms can dynamically adjust and correct the algorithm according to real-time environmental parameters such as temperature and humidity, as well as the characteristics of specific test strip batches.

[0028] The automatic calibration module 16 is connected to the detection module, the environmental monitoring module and the storage module respectively. The automatic calibration module is used to receive the initial electrochemical signal and the environmental compensation parameters, and to perform correction calculations on the initial electrochemical signal according to the dynamic compensation algorithm model to generate the calibrated blood glucose value.

[0029] The automatic calibration module includes a signal receiving unit, a compensation calculation unit, and a curve matching unit. The signal receiving unit receives the initial electrochemical signal and is connected to the analog-to-digital converter output of the detection module. It captures the raw signal value in digital format via a high-speed data interface and temporarily stores it in a buffer. The compensation calculation unit has a built-in dynamic compensation algorithm model. It reads the current ambient temperature and humidity values ​​and uses them as environmental compensation parameters in a preset compensation algorithm to perform temperature and humidity compensation calculations on the initial electrochemical signal based on these parameters. The curve matching unit retrieves the corresponding standard calibration curve from the storage module based on the batch information of the current test strip and maps the compensated signal to the final blood glucose concentration value. Since the sensitivity of different batches of test strips may vary slightly, the curve matching unit first obtains the batch code of the currently inserted test strip through the test strip identification module, then accurately retrieves the standard calibration curve matching that batch from the storage module. Subsequently, it substitutes the signal value after temperature and humidity compensation calculations into the curve equation and, through interpolation or mapping calculations, finally outputs the calibrated blood glucose value in mmol / L or mg / dL.

[0030] Display module 18 is used to output the calibrated blood glucose value to the display screen for display. The display module adopts a 5-inch AMOLED touch screen with a resolution of 480×800, supports multi-touch operation, displays the test results in real time, and has a digital display accuracy of 0.01mmol / L; it also supports voice broadcast function to facilitate use by visually impaired users.

[0031] In one embodiment, the smart blood glucose meter further includes a test strip recognition module disposed at the test strip slot for reading the coded information on the inserted test strip. The coded information is typically printed or embedded on the test strip substrate in the form of a barcode, QR code, or resistive chip. When the user inserts a test strip, the test strip recognition module automatically reads the code via optical scanning or electrical contact and parses it to extract the factory calibration parameters for that batch of test strips. The automatic calibration module then further corrects the standard calibration curve based on the factory calibration parameters.

[0032] The automatic calibration module pre-stores a time-based self-learning algorithm to record the trend of blood glucose values ​​after multiple calibrations for the same patient. Each calibrated blood glucose value is automatically stored and timestamped, forming a personalized time-series database of blood glucose fluctuations. By analyzing the trends of this historical data, a personalized blood glucose baseline model is constructed for each user. When continuous abnormal fluctuations in blood glucose values ​​are detected, an early warning mechanism is triggered, which can issue a retest reminder or a test strip expiration reminder through the display module.

[0033] The housing also includes a communication module integrated within it, supporting wireless transmission protocols such as Bluetooth, Wi-Fi, or cellular networks. This communication module wirelessly transmits the calibrated blood glucose values ​​to a smart terminal or cloud server, enabling real-time synchronization of measurement results. Users can view long-term blood glucose curves on a smartphone app. It supports seamless integration with hospital HIS systems and telemedicine platforms, allowing doctors to view patient blood glucose data in real time for remote diagnosis. Data synchronization to the cloud is supported, and blockchain technology ensures data immutability. The automatic calibration module obtains the latest dynamic compensation algorithm model from the cloud server through the communication module and updates the algorithm in the storage module.

[0034] The beneficial effects of this invention are as follows: The environmental monitoring module collects multi-dimensional parameters such as temperature and humidity in real time, and combines them with a dynamic compensation algorithm model to accurately correct the initial electrochemical signal, effectively eliminating the interference of environmental factors on the test results. At the same time, the test strip recognition module automatically reads the batch code, so that the standard calibration curve is accurately matched with the factory parameters of each batch of test strips, avoiding the tedious operation and potential errors of manually entering calibration codes. It records individual blood glucose change trends and actively issues warnings when abnormalities occur. It supports data cloud synchronization and remote algorithm updates, enabling the device to continuously evolve while ensuring measurement accuracy, providing diabetic patients with a smarter, more reliable and convenient blood glucose monitoring experience.

[0035] According to embodiments of the present invention, an automatic calibration method for a smart blood glucose meter is provided. Figure 2The flowchart illustrates an automatic calibration method for a smart blood glucose meter provided in one or more embodiments of this specification, such as... Figure 2 As shown, the automatic calibration method for a smart blood glucose meter according to an embodiment of the present invention specifically includes: S1. In response to the insertion of the test strip and the dripping of the blood sample, the initial electrochemical signal generated by the blood sample reaction is collected; S2. Synchronously collect the current ambient temperature and humidity; S3. Based on the current ambient temperature and humidity, call the pre-stored dynamic compensation algorithm model to correct the initial electrochemical signal; S4. Substitute the corrected signal value into the standard calibration curve that matches the batch of test strips to calculate the final blood glucose value; S5. Output and display the final blood glucose value.

[0036] The embodiments of the present invention are usage method embodiments corresponding to the above-described intelligent blood glucose meter embodiments. The specific operation of each module can be understood by referring to the description of the intelligent blood glucose meter embodiments, and will not be repeated here.

[0037] The computer-readable storage media described in this embodiment include, but are not limited to, ROM, RAM, disk, or optical disk.

[0038] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A smart blood glucose meter with automatic calibration function, comprising a housing and a display screen and a test strip slot disposed on the housing, characterized in that, It also includes those located inside the housing: The detection module is used to collect the initial electrochemical signal generated by the reaction between the blood sample and the reagent on the test strip when the test strip is inserted into the test strip slot and a blood sample is dripped in. The environmental monitoring module is used to monitor the current ambient temperature in real time and collect environmental compensation parameters that affect the accuracy of blood glucose testing. The storage module is used to store preset standard calibration curves and dynamic compensation algorithm models based on different environmental conditions and test strip batches. An automatic calibration module is connected to the detection module, the environmental monitoring module, and the storage module respectively. The automatic calibration module is used to receive the initial electrochemical signal and the environmental compensation parameters, and to perform correction calculations on the initial electrochemical signal according to the dynamic compensation algorithm model to generate a calibrated blood glucose value. The display module is used to output the calibrated blood glucose value to the display screen for display.

2. The intelligent blood glucose meter with automatic calibration function according to claim 1, characterized in that, The environmental monitoring module includes a temperature sensor, a humidity sensor, a micro-pressure sensor, and a light intensity sensor; the environmental compensation parameters include at least the ambient temperature value and the ambient humidity value.

3. The intelligent blood glucose meter with automatic calibration function according to claim 1, characterized in that, The automatic calibration module includes: A signal receiving unit is used to receive the initial electrochemical signal; The compensation calculation unit has the dynamic compensation algorithm model built in, which is used to perform temperature compensation and humidity compensation calculations on the initial electrochemical signal based on the environmental compensation parameters. The curve matching unit is used to retrieve the corresponding standard calibration curve from the storage module based on the batch information of the current test strip, and map the signal after compensation calculation to the final blood glucose concentration value.

4. A smart blood glucose meter with automatic calibration function according to claim 1, characterized in that, Also includes: A test strip recognition module is located at the test strip slot and is used to read the coded information on the inserted test strip. The coded information includes the factory calibration parameters of the batch of test strips. The automatic calibration module is further used to correct the standard calibration curve according to the factory calibration parameters.

5. A smart blood glucose meter with automatic calibration function according to claim 4, characterized in that, The automatic calibration module has a pre-stored time-based self-learning algorithm to record the trend of blood glucose value changes after multiple calibrations for the same patient. When continuous abnormal fluctuations are detected, the display module will issue a retest reminder or a test strip expiration reminder.

6. A smart blood glucose meter with automatic calibration function according to claim 1, characterized in that, The detection module includes: A constant potential circuit is used to input a stable voltage to the working electrode and reference electrode of the test paper; A current-to-voltage conversion circuit is used to convert the weak current signal generated by the blood sample reaction into a voltage signal. An analog-to-digital converter is used to convert the voltage signal into the initial electrochemical signal in digital format.

7. A smart blood glucose meter with automatic calibration function according to claim 1, characterized in that, The housing is also equipped with a communication module, which is used to wirelessly transmit the calibrated blood glucose value to a smart terminal or cloud server.

8. A smart blood glucose meter with automatic calibration function according to claim 7, characterized in that, The automatic calibration module obtains the latest dynamic compensation algorithm model from the cloud server through the communication module and updates the algorithm in the storage module.

9. An automatic calibration method for a smart blood glucose meter according to any one of claims 1 to 8, characterized in that, include: S1. In response to the insertion of the test strip and the dripping of the blood sample, the initial electrochemical signal generated by the blood sample reaction is collected; S2. Synchronously collect the current ambient temperature and humidity; S3. Based on the current ambient temperature and humidity, call the pre-stored dynamic compensation algorithm model to correct the initial electrochemical signal; S4. Substitute the corrected signal value into the standard calibration curve that matches the batch of test strips to calculate the final blood glucose value; S5. Output and display the final blood glucose value.

10. The automatic calibration method according to claim 9, characterized in that, The steps preceding step S1 also include: Read the coding information on the inserted test strip, which contains the factory calibration parameters for this batch of test strips; The standard calibration curve is corrected according to the factory calibration parameters.

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