Wearable non-invasive continuous blood glucose monitoring equipment

Abstract

The invention provides wearable non-invasive continuous blood glucose monitoring equipment which comprises a packaging shell, a flexible sensor patch, an integrated circuit board, an intelligent touch display screen and a rechargeable battery. A microcontroller, a constant current output module, a multi-channel signal acquisition circuit, a weak current detection module, a weak voltage detection module, a digital-to-analog converter, a pre-filter amplifier and an FPC connector are arranged on the integrated circuit board; a blood glucose detection mechanism of the monitoring equipment is based on a non-invasive glucose extraction technology of counter ion electroosmosis, continuous and non-invasive subcutaneous interstitial fluid collection is achieved, and monitoring safety and user comfort are improved; meanwhile, the equipment is combined with a multi-parameter dynamic calibration model, the Na < + > concentration and the pH value change in the extracted subcutaneous interstitial fluid are fused, the glucose migration efficiency and the influence quantity generated on extraction and detection due to the skin state change are corrected in real time, and the accuracy and the individual adaptability of blood glucose detection are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of continuous glucose monitoring technology, and in particular to a wearable, non-invasive continuous glucose monitoring device. Background Technology

[0002] In modern society, the incidence of diabetes is increasing year by year. my country has a large number of diabetes patients, with long disease durations and significant individual differences, making centralized hospital management challenging. With the development of wearable devices and intelligent methods, "precise blood sugar control and personalized blood glucose management" is gradually becoming the future trend. Therefore, improving diabetes management is imperative. Diabetes management is a comprehensive process aimed at helping diabetic patients effectively control their blood sugar levels and prevent complications. Blood glucose monitoring is the prerequisite and foundation for improving diabetes management.

[0003] Traditional blood glucose monitoring methods are all invasive, including finger-prick measurement and continuous glucose monitoring (CGM). While finger-prick measurement is simple, it causes pain, discomfort, and is costly, and cannot achieve long-term monitoring. CGM is a subcutaneous implantable device that requires frequent replacement, is costly, has a short lifespan, and may cause discomfort, reducing patient acceptance and adherence. Therefore, developing a non-invasive, low-cost, wearable (long-term monitoring) blood glucose monitoring device is crucial for diabetes management.

[0004] Therefore, non-invasive blood glucose testing technologies have gradually attracted attention. Among them, methods based on near-infrared spectroscopy or electrochemical principles have certain feasibility, but they still have significant shortcomings in terms of stability, accuracy, and environmental adaptability. Furthermore, existing wearable non-invasive sensors are mostly integrated packaged structures, making sensor replacement inconvenient, lacking modular plug-and-play capabilities, complex to maintain, and exhibiting poor electrical connection stability, which affects data transmission quality. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a wearable non-invasive continuous blood glucose monitoring device.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0007] A wearable, non-invasive, continuous glucose monitoring device includes a housing 1, a flexible sensor patch 6, an integrated circuit board 9, a smart touch display 3, and a rechargeable battery 10. The integrated circuit board 9 is equipped with a weak current detection module, a weak voltage detection module, a pre-filter amplifier, a digital-to-analog converter (DAC), a microcontroller, a constant current output module of the DAC, a multi-channel signal acquisition circuit, and an FPC connector 5. The FPC connector 5 connects to the pre-filter amplifier, which is connected to the multi-channel signal acquisition circuit via the DAC. The pre-filter amplifier is also directly connected to the constant current output module, the weak current detection module, and the weak voltage detection module. The block, constant current output module, and multi-channel signal acquisition circuit are simultaneously connected to the microcontroller; the integrated circuit board 9 and the rechargeable battery 10 are placed inside the package shell 1, and the rechargeable battery 10 is used to continuously power the smart touch display 3 and the integrated circuit board 9; the smart touch display 3 is embedded in the surface of the package shell 1, and the smart touch display 3 is connected and communicates with the microcontroller set on the integrated circuit board 9 through the HDMI / MIPI / TTL interface, and is used to display blood glucose data curves in real time; the flexible sensor patch 6 is movably connected to the FPC connector 5 set on the integrated circuit board 9 through the open and close protective interface 4 on the side of the package shell 1 in a plug-in manner. This modular plug-in connection method facilitates the maintenance and replacement of the device.

[0008] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the upper surface of the encapsulation shell 1 is provided with a groove, and the smart touch display screen 3 is embedded in the groove.

[0009] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the flexible sensor patch 6 is movably connected to the integrated circuit board 9 via the FPC connector 5 in a plug-in manner. The flexible sensor patch 6 and the integrated circuit board 9 adopt a self-locking mechanical structure. After the flexible sensor patch 6 is inserted into the FPC connector 5, alignment guidance and physical self-locking are achieved to enhance the plug-in guidance and improve the stability of the electrical connection, ensuring that the flexible sensor patch 6 is stably connected in motion scenarios.

[0010] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the operating voltage of the constant current output module is controlled between 1 and 2V to provide driving power for the extraction of subcutaneous interstitial fluid.

[0011] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the spacing between the extraction electrodes 6b on the flexible sensor patch 6 is 0.5 to 1 cm. The extraction of subcutaneous interstitial fluid is achieved through the extraction electrodes 6b. By optimizing the electrode spacing, the extraction rate of interstitial fluid is improved, while avoiding the occurrence of burning or stinging sensations on the skin surface, thus ensuring user comfort.

[0012] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the integrated circuit board 9 has a size of 4.7cm × 4.6cm and an overall thickness of less than 5mm.

[0013] Preferably, in the aforementioned wearable non-invasive continuous glucose monitoring device, the microcontroller on the integrated circuit board 9 is equipped with a dynamic filtering and sodium ion-pH joint compensation algorithm to correct the detection results during exercise or long-term monitoring. The dynamic filtering and sodium ion-pH joint compensation algorithm is as follows: G ISF (t)=g·G p (tT ISF ), where G ISF (t): Glucose concentration in the interstitial fluid at time t. p (t): Blood glucose concentration at time t, T ISF : The response time of tissue fluid to blood glucose (generally 4-12 minutes), g: the concentration ratio coefficient of tissue fluid glucose to blood glucose under steady state (close to 1, variable for individuals).

[0014] The specific application of the above formula is as follows: The glucose concentration, sodium ion concentration, and pH concentration of the interstitial fluid are measured using the extraction electrode 6b and detection electrode 6c on the flexible sensor patch 6. Since the act of extracting subcutaneous interstitial fluid affects the glucose concentration G of the interstitial fluid... ISF The change in (t) has an impact, so the changes in individual sodium ion and pH concentrations are used as compensation to correct the effect of the extraction process on the change in interstitial fluid glucose concentration, thereby obtaining the accurate interstitial fluid glucose concentration G at time t after eliminating the influence. ISF (t). Initial calculation of blood glucose concentration G at time t. p When (t), the delay time T ISF Set to 8 minutes, and calculate the blood glucose concentration G. p (t) is compared with the blood glucose value measured by a commercial CGM, and the experiment is repeated multiple times with the delay time T modified. ISF Ultimately, the optimal delay time T for the individual is obtained. ISF Finally, the known concentration of glucose G in the interstitial fluid can be determined by measurement or determination. ISF (t) and the individual's delay time T ISF Determine the unknown blood glucose concentration G p (t).

[0015] The above dynamic filtering and sodium ion-pH joint compensation algorithm assumes that the glucose concentration in the subcutaneous interstitial fluid is G. ISF G ISF Unknown (needs to be solved); Sodium ion-pH joint correction input includes: glucose concentration detected by the detection electrode: G skin Na +Concentration: [Na+], pH value: pH, temperature: T; The glucose concentration in the subcutaneous interstitial fluid is obtained from the following formula:

[0016] G ISF (t)=f(G skin (t),[Na + ](t),pH(t),T(t))

[0017] The glucose concentration G in the subcutaneous interstitial fluid was calculated. ISF After the change in blood glucose level, the blood glucose value can be obtained using the following formula:

[0018] G ISF (t)=g·G p (tT ISF )

[0019] Among them, G ISF (t): Glucose concentration in the interstitial fluid at time t. p (t): Blood glucose concentration at time t, T ISF : The response time of tissue fluid to blood glucose (generally 4-12 minutes), g: the concentration ratio coefficient of tissue fluid glucose to blood glucose under steady state (close to 1, variable for individuals).

[0020] In the process of extracting subcutaneous tissue fluid using reverse iontophoresis to obtain epidermal glucose concentration and then calculating blood glucose, the actual measured values ​​are often affected by various physiological and environmental factors. Among these, sodium ion concentration (Na+) is a significant factor. + As one of the dominant factors in counterion electroosmotic migration flux, it directly affects the migration efficiency of glucose from the dermis to the epidermis; while pH changes affect skin impedance, electroosmotic driving force, and sensor response stability. Because these two parameters dynamically change in different individuals or at different times for the same subject, relying solely on epidermal glucose concentration for blood glucose calculations can easily lead to errors. Therefore, establishing a Na+... + The correction mechanism, which works in conjunction with pH, ​​helps improve the accuracy of blood glucose levels.

[0021] Preferably, in the aforementioned wearable non-invasive continuous glucose monitoring device, the smart touch display screen 3 is used for operating and controlling the device and acquiring glucose information. Since the device selects a smart touch display screen (model...)

[0022] The P183B001-CTP not only displays blood glucose changes but also supports manual curve sliding operation, allowing users to directly perform operations such as starting measurement, checking blood glucose, and setting prompts on this wearable blood glucose meter.

[0023] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the rechargeable battery 10 has a size not exceeding 2cm×2cm×5mm and is used to store and supply power to the integrated circuit board 9 and the smart touch display screen 3.

[0024] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, a flexible insulating layer for isolation and insulation is provided between the rechargeable battery 10 and the integrated circuit board 9.

[0025] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the flexible insulating layer has a thickness of 1 mm and is made of polydimethylsiloxane (PDMS), a flexible insulating material.

[0026] Preferably, in the above-mentioned wearable non-invasive continuous glucose monitoring device, the encapsulation shell 1 has a limiting component 1a inside, which is used to mechanically limit and fix the integrated circuit board 9 and the rechargeable battery 10 to prevent them from shifting during wearing or movement; the inner edge of the encapsulation shell 1 has a screw hole 1d, which is used to cooperate with the embedded brass nut to simultaneously fasten the internal integrated circuit board 9 and rechargeable battery 10, thereby maintaining stable thread strength during high-frequency disassembly and assembly, preventing plastic wear, and enhancing structural strength; the bottom of the encapsulation shell 1 has a detachable bottom cover 1c, which is movably connected to the encapsulation shell 1. The edges of the encapsulation shell 1 and the detachable bottom cover 1c are correspondingly provided with a snap-fit ​​structure 1b, which is used to snap and fix them, thereby realizing the quick installation and removal of the detachable bottom cover 1c, and thus supporting the quick disassembly and maintenance of the internal components of the encapsulation shell 1.

[0027] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the limiting components 1a are distributed at the four corners of the top surface inside the encapsulation shell 1. The limiting components 1a include protruding limiting posts and guide grooves. The protruding limiting posts are used to hold the four corners of the integrated circuit board 9, so that the integrated circuit board 9 is stably fixed and not easy to shake. The guide grooves are used to accurately position the integrated circuit board 9 along the grooves into the four limiting posts before fixing it, so as to facilitate subsequent stable fixing.

[0028] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the buckle structure 1b includes a protrusion and a slot, which are respectively set at the edges of the encapsulation shell 1 and the detachable bottom cover 1c, and adopt a single finger pressure assembly or a lifting disassembly and installation to simplify operation.

[0029] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the number of the buckle structures 1b is 4, which are evenly distributed on the edges of the encapsulation shell 1 and the detachable bottom cover 1c, and adopt an audible buckle feedback design to facilitate the user to judge the connection status.

[0030] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the detachable bottom cover 1c is provided with breathable micropores 7 to improve skin breathability and wearing comfort, and to assist in the diversion of sweat and the dissipation of heat from the sensor.

[0031] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the size of the encapsulation shell 1 does not exceed 3cm × 4cm × 1cm.

[0032] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the encapsulation shell 1 is made of TPU material, and the longitudinal section of the breathable micropores 7 is a trapezoidal structure, with the outer pore diameter being larger than the inner pore diameter (for example, the outer pore diameter is 200 μm and the inner pore diameter is 100-199 μm).

[0033] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the outer shell 1 has a double-layer structure, with the outer layer being made of TPU material and the inner layer being made of PDMS material. The overall structure is a skin-friendly curved surface, which balances mechanical strength and skin comfort.

[0034] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the encapsulation shell is prepared by 3D printing and partial encapsulation process to improve the sealing performance.

[0035] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, an openable protective cover is also provided next to the openable protective interface 4 on the side wall of the encapsulation shell to prevent dust, sweat and moisture from entering and to protect the FPC connector inside the encapsulation shell.

[0036] Preferably, the above-mentioned wearable non-invasive continuous blood glucose monitoring device also includes a charging interface 8 disposed at the bottom of the encapsulation shell 1. The charging interface 8 (as an interface for connecting the rechargeable battery 10 to the outside) is a universal Type-C interface, which can be used for fast charging and detection data transmission (an interface that can transmit the detected blood glucose, sodium ion, and pH data to a computer).

[0037] Preferably, the above-mentioned wearable non-invasive continuous blood glucose monitoring device further includes an adjustable strap 2, which is fixed to the encapsulation shell 1 and used to fix the device to the wearer's skin surface.

[0038] Preferably, in the above-mentioned wearable non-invasive continuous blood glucose monitoring device, the adjustable strap 2 is an adjustable Velcro strap.

[0039] A non-invasive continuous glucose monitoring method based on the above-mentioned wearable non-invasive continuous glucose monitoring device includes the following steps:

[0040] (1) Insert the flexible sensor patch 6 into the FPC connector 5 and lock it in to establish a signal path;

[0041] (2) The constant current output module provides a constant current for the reverse ion electroosmosis extraction, which promotes the migration of glucose in the subcutaneous interstitial fluid to the sensor surface.

[0042] (3) The detection electrode 6c detects an electrical signal, which is then processed by a pre-filter amplifier and a digital-to-analog converter and transmitted to a microcontroller for calculation.

[0043] (4) The microcontroller combines sodium ion-pH data to calibrate blood glucose values ​​and outputs the results in real time to the smart touch screen 3 in the form of a curve;

[0044] (5) When wearing or maintaining, remove the flexible sensor patch 6 through the open and closed protective interface 4 to complete the replacement.

[0045] Beneficial effects:

[0046] The aforementioned wearable non-invasive continuous blood glucose monitoring device is a lightweight, non-invasive, pluggable wearable device for continuous blood glucose monitoring. It has efficient and stable blood glucose monitoring capabilities, is suitable for various scenarios, and can achieve long-term stability, high accuracy, convenient pluggable and pluggable operation, and comfortable wear without invasiveness.

[0047] The wearable non-invasive continuous blood glucose monitoring device utilizes a detection mechanism based on non-invasive glucose extraction technology using reverse iontophoresis, enabling continuous and non-invasive body fluid collection, thus improving monitoring safety and user comfort. A multi-parameter dynamic calibration model is designed, incorporating Na... + Changes in concentration and pH value enable real-time correction of glucose migration efficiency and skin condition, significantly improving the accuracy and individual adaptability of blood glucose testing. The integrated structure and interface, employing a combination of a wearable detector and a pluggable flexible sensor patch, achieve stable connection between the sensor and detector module and modular sensor replacement, enhancing the device's maintainability and ease of use. Specifically:

[0048] 1. Enables non-invasive monitoring of blood glucose or other parameters: avoids the infection risks and user discomfort associated with traditional subcutaneous implantation, significantly improving safety and compliance.

[0049] 2. Use of pluggable flexible connection structure: Adopting a trapezoidal self-guiding structure and self-locking plate design, a stable pluggable connection between flexible sensors and rigid circuits is achieved, improving durability and extending pluggable life.

[0050] 3. Achieve high detection accuracy: Combining reverse ion electroosmosis drive with silver / silver chloride electrode array, glucose detection is performed with sodium ion correction and pH correction, achieving stable and highly sensitive glucose detection, and improving detection accuracy under different environmental and skin conditions.

[0051] 4. It offers a comfortable wearing experience, featuring a TPU flexible shell and breathable micropores to enhance breathability and skin compatibility, making it suitable for long-term wear.

[0052] 5. The multi-layer packaging structure of the outer shell and the trapezoidal slot design of the flexible sensor patch interface improve the overall stability and anti-interference capability of the device, ensure the continuity and reliability of signal acquisition, and enable multiple plug-and-play connections.

[0053] 6. The encapsulated shell is equipped with limiting components, which can accurately position and mechanically limit the core components such as control and detection integrated circuits, batteries, intelligent touch screens and pluggable interfaces, effectively preventing the device from shifting, shaking or signal distortion during user movement and wearing, and improving monitoring accuracy and data stability.

[0054] 7. The housing features a dual-connection design with both snap-fit ​​and screw holes, allowing for quick installation and removal of the bottom cover assembly. The snap-fit ​​structure supports tool-free assembly and disassembly, making it suitable for routine maintenance and rapid module replacement, significantly superior to traditional adhesive or unibody molded housings that are not removable.

[0055] 8. The device is wearable; the outer shell can be worn on the arm. Real-time blood glucose levels can be obtained through the display module, and active control can be performed through the touch screen.

[0056] 9. The packaged housing can be plugged into and connected to various microcontrollers, FPC flexible circuit boards, and rigid electrode modules in a standard plug-in manner, supporting modular assembly and system expansion, which facilitates later function upgrades and product maintenance.

[0057] 10. The materials and processes used are mature and have good mass production adaptability, making them suitable for widespread promotion in the wearable medical product market. Attached Figure Description

[0058] Figure 1 This is a schematic diagram of the overall structure of the wearable non-invasive continuous blood glucose monitoring device described in this invention.

[0059] Figure 2 This is a schematic diagram of the packaging shell of the wearable non-invasive continuous blood glucose monitoring device described in this invention.

[0060] Figure 3 This is a schematic diagram of the integrated circuit board of the wearable non-invasive continuous blood glucose monitoring device described in this invention.

[0061] Figure 4 This is a schematic diagram of the structure of the flexible sensor patch of the wearable non-invasive continuous blood glucose monitoring device described in this invention.

[0062] In the diagram: 1-Encapsulation shell, 1a-Limiting component, 1b-Snap-on structure, 1c-Removable bottom cover, 1d-Screw hole, 2-Adjustable strap, 3-Smart touch display screen, 4-Open / closed protective interface, 5-FPC connector, 6-Flexible sensor patch, 6a-Flexible substrate layer, 6b-Removable electrode, 6c-Detection electrode, 6d-Interface contact, 7-Ventilating micropore, 8-Charging interface, 9-Integrated circuit board, 10-Rechargeable battery. Detailed Implementation

[0063] The wearable non-invasive continuous blood glucose monitoring device of the present invention will be described below with reference to the embodiments and accompanying drawings.

[0064] The weak current detection module of this invention is used to receive nanoampere-level current signals output by a blood glucose sensor. It employs a high-precision, low-drift transimpedance amplifier MAX4238 (typical input bias current 1pA, gain resistor 10kΩ) to convert the weak current into a linear analog voltage signal. The transimpedance output range is ±2V, which is compatible with the input range of downstream digital-to-analog converters. The weak voltage detection module utilizes an INA333 amplifier and an ADS1115 converter to complete the current-to-voltage conversion, and then performs primary voltage regulation and impedance matching on the signal to ensure the integrity and consistency of the voltage signal in subsequent filtering and sampling processes. The pre-amplifier uses a low-noise operational amplifier RS8552 to construct a second-order passive low-pass filter (cutoff frequency approximately 10Hz) to perform anti-interference processing and moderate amplification on the analog signal, thereby suppressing high-frequency noise and electromagnetic interference and improving the signal-to-noise ratio. The digital-to-analog converter uses an ADS131A04 (Texas Instruments) high-precision 24-bit synchronous sampling ADC, featuring 4 input channels, a maximum sampling rate of 32kSPS, low input offset, and low power consumption. It is suitable for high-fidelity acquisition of bioelectrical signals, converting the filtered analog voltage signal into a digital signal for further analysis and processing by the main control unit. The multi-channel signal acquisition circuit integrates multiple ADS131A04 chips to construct a multi-channel synchronous acquisition array in parallel, supporting simultaneous sampling of up to 8 channels and expansion with multiple sensor types (such as sodium ions, pH, conductivity, etc.), meeting the needs of complex physiological information fusion modeling and enhancing the information dimension and diagnostic capabilities of the monitoring system. The microcontroller uses an STM32F407VET6 microcontroller (based on ARM). The device features a Cortex-M4 architecture (168MHz clock speed) and rich communication interfaces (SPI, I2C, USART, etc.) and interrupt management mechanisms, enabling efficient execution of data reception, filtering, signal fusion, and storage logic control. Its built-in floating-point unit (FPU) facilitates the implementation of real-time blood glucose estimation and anomaly detection algorithms; the constant current output module is composed of a DAC8531 (12-bit precision, I / O)... 2The C-interface digital-to-analog converter, combined with OPA2196 and OP07, forms a precision constant current source. An OMRON G6K series micro relay controls the current path, continuously applying a constant excitation current of 0.1μA to 10μA to the sensor's working electrode to promote transdermal glucose migration and stable sensing response. The rechargeable battery uses a 7.4V 1000mAh lithium polymer battery as a portable power source, with an IP2325 charging management chip for battery protection and overcharge control. In the power supply path, an MT3608 boost chip raises the battery voltage to 16V for the constant current circuit, a TPS54231 step-down voltage to 5V for the acquisition system, and TPS7A4701 and AMS1117-3.3 further provide low-noise, stable power to the core logic circuit and high-precision analog module, ensuring measurement accuracy and stability under different physiological conditions.

[0065] Example 1

[0066] like Figure 1-4 As shown, the wearable non-invasive continuous glucose monitoring device includes a housing 1, a flexible sensor patch 6, an integrated circuit board 9, a smart touch display 3, and a rechargeable battery 10. The housing 1 has a size not exceeding 3cm × 4cm × 1cm and is manufactured using 3D printing and partial encapsulation processes to improve sealing. The housing 1 has a double-layer structure, with an outer layer of TPU material and an inner layer of PDMS material. It has a skin-friendly curved structure that conforms to the curvature of the human arm or abdomen, balancing mechanical strength and skin comfort. The integrated circuit board 9 has a size of 4.7cm × 4.6cm and an overall thickness of less than 5mm, and it is equipped with a weak current detection module. The system includes a weak voltage detection module, a pre-filter amplifier, a digital-to-analog converter, a microcontroller, a constant current output module, a multi-channel signal acquisition circuit, and an FPC connector 5. The FPC connector 5 is connected to the pre-filter amplifier, which is connected to the multi-channel signal acquisition circuit via the digital-to-analog converter. The pre-filter amplifier is also directly connected to the constant current output module, the weak current detection module, and the weak voltage detection module. The weak current detection module, the weak voltage detection module, the constant current output module, and the multi-channel signal acquisition circuit are all connected to the microcontroller. The constant current output module operates at a voltage between 1 and 2V to provide driving power for extracting subcutaneous interstitial fluid.

[0067] The microcontroller on the integrated circuit board 9 is equipped with a dynamic filtering and sodium ion-pH joint compensation algorithm to correct detection results during motion or long-term detection. The dynamic filtering and sodium ion-pH joint compensation algorithm is as follows: G ISF (t)=g·G p (tT ISF ), where GISF (t): Glucose concentration in the interstitial fluid at time t. p (t): Blood glucose concentration at time t, T ISF : The response time of tissue fluid to blood glucose (generally 4-12 minutes), g: the concentration ratio coefficient of tissue fluid glucose to blood glucose under steady state (close to 1, variable for individuals).

[0068] The specific application of the above formula is as follows: The glucose concentration, sodium ion concentration, and pH concentration of the interstitial fluid are measured using the extraction electrode 6b and detection electrode 6c on the flexible sensor patch 6. Since the act of extracting subcutaneous interstitial fluid affects the glucose concentration G of the interstitial fluid... ISF The change in (t) has an impact, so the changes in individual sodium ion and pH concentrations are used as compensation to correct the effect of the extraction process on the change in interstitial fluid glucose concentration, thereby obtaining the accurate interstitial fluid glucose concentration G at time t after eliminating the influence. ISF (t). Initial calculation of blood glucose concentration G at time t. p When (t), the delay time T ISF Set to 8 minutes, and calculate the blood glucose concentration G. p (t) is compared with the blood glucose value measured by a commercial CGM, and the experiment is repeated multiple times with the delay time T modified. ISF Ultimately, the optimal delay time T for the individual is obtained. ISF Finally, the known concentration of glucose G in the interstitial fluid can be determined by measurement or determination. ISF (t) and the individual's delay time T ISF Determine the unknown blood glucose concentration G p (t).

[0069] The above dynamic filtering and sodium ion-pH joint compensation algorithm assumes that the glucose concentration in the subcutaneous interstitial fluid is G. ISF G ISF Unknown (needs to be solved); Sodium ion-pH joint correction input includes: glucose concentration detected by the detection electrode: G skin Na + Concentration: [Na+], pH value: pH, temperature: T; The glucose concentration in the subcutaneous interstitial fluid is obtained from the following formula:

[0070] G ISF (t)=f(G skin (t),[Na + ](t),pH(t),T(t))

[0071] The glucose concentration G in the subcutaneous interstitial fluid was calculated. ISF After the change in blood glucose level, the blood glucose value can be obtained using the following formula:

[0072] G ISF(t)=g·G p (tT ISF )

[0073] Among them, G ISF (t): Glucose concentration in the interstitial fluid at time t. p (t): Blood glucose concentration at time t, T ISF : The response time of tissue fluid to blood glucose (generally 4-12 minutes), g: the concentration ratio coefficient of tissue fluid glucose to blood glucose under steady state (close to 1, variable for individuals).

[0074] In the process of extracting subcutaneous tissue fluid using reverse iontophoresis to obtain epidermal glucose concentration and then calculating blood glucose, the actual measured values ​​are often affected by various physiological and environmental factors. Among these, sodium ion concentration (Na+) is a significant factor. + As one of the dominant factors in counterion electroosmotic migration flux, it directly affects the migration efficiency of glucose from the dermis to the epidermis; while pH changes affect skin impedance, electroosmotic driving force, and sensor response stability. Because these two parameters dynamically change in different individuals or at different times for the same subject, relying solely on epidermal glucose concentration for blood glucose calculations can easily lead to errors. Therefore, establishing a Na+... + The correction mechanism, which works in conjunction with pH, ​​helps improve the accuracy of blood glucose levels.

[0075] The integrated circuit board 9 and the rechargeable battery 10 are housed within the encapsulation shell 1. A flexible insulating layer, 1 mm thick and made of polydimethylsiloxane (PDMS), is provided between the rechargeable battery 10 and the integrated circuit board 9 for isolation and insulation. The rechargeable battery 10 has a size not exceeding 2 cm × 2 cm × 5 mm and is used to store and continuously power the smart touch display screen 3 and the integrated circuit board 9. A limiting component 1a is provided inside the encapsulation shell 1 to mechanically limit and fix the integrated circuit board 9 and the rechargeable battery 10, preventing them from being damaged during wear or transportation. Displacement occurs during operation; the inner edge of the encapsulation shell 1 is provided with screw holes 1d, which are used to cooperate with embedded brass nuts to simultaneously fasten the internal integrated circuit board 9 and rechargeable battery 10, thereby maintaining stable thread strength during high-frequency disassembly and assembly, preventing plastic wear, and enhancing structural strength; the bottom of the encapsulation shell 1 is provided with a removable bottom cover 1c, which is movably connected to the encapsulation shell 1. The edges of the encapsulation shell 1 and the removable bottom cover 1c are respectively provided with snap-fit ​​structures 1b, which are used for snap-fit ​​fixation, thereby realizing the quick installation and removal of the removable bottom cover 1c, and thus supporting the encapsulation. The enclosure 1 allows for quick assembly and disassembly of internal components; the limiting components 1a are distributed at the four corners of the top surface inside the enclosure 1. Each limiting component 1a includes raised limiting posts and guide grooves. The raised limiting posts secure the four corners of the integrated circuit board 9, ensuring its stable fixation and preventing wobbling. The guide grooves precisely position the integrated circuit board 9 within the four limiting posts before fixing it, facilitating subsequent stable fixation. The latching structure 1b includes hooks and slots, respectively located at the edges of the enclosure 1 and the removable bottom cover 1c. It employs single-finger pressure assembly or pull-out disassembly and installation, simplifying operation. The number of buckle structures 1b is four, evenly distributed at the edges of the encapsulation shell 1 and the detachable bottom cover 1c, and adopts an audible snap feedback design to facilitate users in judging the connection status; the detachable bottom cover 1c is provided with breathable micropores 7, which are prepared by laser control technology, and the outer diameter to the inner diameter is gradually distributed to enhance permeability and effectively eliminate sweat interference. The longitudinal section of the breathable micropores 7 is a trapezoidal structure, and its outer diameter is larger than its inner diameter (for example, the outer diameter is 200μm and the inner diameter is 100~199μm), which is used to improve skin breathability and wearing comfort, and assist in sweat diversion and sensor heat dissipation;

[0076] The upper surface of the encapsulation shell 1 has a groove, and the smart touch display screen 3 is embedded in the groove and fixed to the surface of the encapsulation shell 1. The smart touch display screen 3 is used to operate and control the device and obtain blood glucose information. The device selected is the P183B001-CTP smart touch display screen, which can not only display blood glucose changes, but also support manual curve sliding operation, so that operations such as starting measurement, blood glucose query, and setting prompts can be performed directly on this wearable blood glucose meter. It can be operated not only on third-party software (e.g., mobile phone), but also connected to third-party devices through the charging interface 8 (type-C interface), which can realize the operation functions of both the blood glucose meter itself and third-party software operation at the same time. The smart touch display screen 3 is connected via HDMI / MIPI / TTL interface. It connects and communicates with a microcontroller mounted on the integrated circuit board 9 to display blood glucose data curves in real time; an openable and closable protective cover is also provided next to the openable and closable protective interface 4 on the side wall of the package shell 1 to prevent dust, sweat and moisture from entering and to protect the FPC connector inside the package shell; a charging interface 8 is provided at the bottom of the package shell 1, which is a universal Type-C interface (serving as the interface for connecting the rechargeable battery 10 to the outside) and can be used for fast charging and detection data transmission (the interface for transmitting detected blood glucose, sodium ion and pH data to a computer); an adjustable strap 2 is also fixed on the package shell 1, which is an adjustable Velcro strap, and the shell is fixed to the wearer's skin surface by the adjustable strap 2;

[0077] The flexible sensor patch 6 is movably connected to the FPC connector 5 on the integrated circuit board 9 via the openable protective interface 4 on the side of the encapsulation shell 1 in a plug-in manner. The flexible sensor patch 6 and the integrated circuit board 9 adopt a self-locking mechanical structure. After the flexible sensor patch 6 is inserted into the FPC connector 5, it achieves alignment guidance and physical self-locking to enhance the plug-in guidance and improve the stability of the electrical connection, ensuring that the flexible sensor patch 6 is stably connected in motion scenarios, which facilitates the maintenance and replacement of the equipment.

[0078] The core detection principle of the aforementioned wearable non-invasive continuous glucose monitoring device is based on the principle of reverse iontophoresis to achieve continuous glucose monitoring. It measures the glucose content in the interstitial fluid extracted from human epidermal cells under reverse iontophoresis, and combines this with real-time dynamic correction using sodium ion concentration and pH concentration to calculate the human blood glucose level, thus achieving continuous glucose concentration monitoring. The sensor electrode detects the current signal generated by the glucose reaction; since the current intensity is proportional to the glucose concentration, glucose detection is achieved. Because the glucose concentration extracted by reverse iontophoresis is not equal to the body fluid or blood glucose concentration, and is affected by various factors (skin resistance, water flux, flow rate, etc.), sodium ion concentration and interstitial fluid pH are introduced for real-time calibration. Simultaneously with glucose detection, the electrode also detects the sodium ion concentration and pH value of the extracted subcutaneous interstitial fluid. +The concentration in the body fluid is used to compensate for errors caused by changes in skin properties and extraction rate during the extraction process, while the pH factor can compensate for errors caused by changes in skin barrier or electroosmotic efficiency. In the wearable non-invasive continuous blood glucose monitoring device, the integrated circuit board 9 serves as a detector for data acquisition and analysis, processing the glucose, sodium ion, and pH electrical signals, and is stably connected to the flexible sensor patch 6 via the FPC connector 5. The flexible sensor patch 6 can be referenced in "A thermally activated and differential self-calibrated flexible epidermal biomicrofluidic device for wearable accurate blood glucose monitoring". The patch-type glucose sensor described in glucosemonitoring includes a flexible substrate layer 6a made of PI material and, sequentially, screen-printed on the surface of the flexible substrate layer 6a, extraction electrodes 6b for reverse ion electroosmosis extraction, detection electrodes 6c for glucose detection, sodium ion detection, and pH detection, and interface contacts 6d. It detects and corrects for glucose and sodium ions in the subcutaneous interstitial fluid by driving them to migrate to the epidermal surface through low voltage. The extraction electrodes 6b are spaced 0.5–1 cm apart, and the extraction of subcutaneous interstitial fluid is achieved through these electrodes. Optimizing the electrode spacing improves the extraction rate of the interstitial fluid while avoiding burning or stinging sensations on the skin surface, ensuring user comfort. The electrode materials in the flexible sensor patch 6 are silver / silver chloride (Ag / AgCl) and carbon (carbon for glucose detection, and silver / silver chloride for sodium ion and pH detection), exhibiting excellent flexibility, conductivity, and biocompatibility, making it suitable for prolonged wear without causing skin irritation. The constant current output module, serving as the reverse ion electroosmosis driving module, provides the constant current required for extracting subcutaneous interstitial fluid, driving the reverse ion electroosmosis extraction process of the flexible sensor patch 6. This guides glucose in the interstitial fluid to migrate to the patch surface, where it is then detected by the extraction electrode 6b. The detection electrode 6c uses screen printing to print silver / silver chloride onto the flexible substrate layer 6a according to the electrode shape, with the positional relationship as follows: Figure 4As shown, the extraction electrode 6b and the detection electrode 6c are arranged side by side and are not connected to each other. The extraction electrode 6b and the detection electrode 6c are connected to the interface contact 6d through uniformly parallel printed wires. The detection process begins with the extraction electrode 6b extracting subcutaneous interstitial fluid. Then, the detection electrode 6c detects glucose in the interstitial fluid through its surface and glucose oxidase, which is sensitive to glucose. The specific detection principle is as follows: glucose diffuses onto the glucose oxidase membrane surface within the electrode interface. Glucose oxidase converts glucose into gluconic acid and hydrogen peroxide. Hydrogen peroxide decomposes on the electrode surface to generate electron flow and oxygen, resulting in a redox reaction at the electrode that generates a current signal. The intensity of the generated current is proportional to the glucose concentration. By detecting the voltage / current changes generated during this chemical reaction, the glucose concentration is calculated, and thus the blood glucose concentration is determined.

[0079] In summary, this continuous glucose monitoring system, through modular integration and high-performance component configuration, achieves a closed-loop control process encompassing low-noise acquisition of microcurrent-microvoltage signals, multi-channel synchronous processing, constant current control, and wearable low-power operation. It possesses excellent clinical scalability and potential for portable development.

[0080] Example 2

[0081] The method of using the wearable non-invasive continuous glucose monitoring device described in Example 1 is as follows:

[0082] In use, the user first accurately inserts the flexible sensor patch into the self-aligning wedge slot of the control detector. This slot uses a preset angle and a self-locking structure to quickly guide and stably fix the patch. After the flexible sensor patch 6 is inserted into the FPC connector 5 and locked, the sensor and the main control circuit are electrically connected, establishing a signal path. The patch is not easily loosened or detached during daily activities.

[0083] After the device is started, the constant current output module provides a constant current for the counterion electroosmosis extraction, which causes glucose in the subcutaneous interstitial fluid to migrate to the sensor surface. By applying a micro-electric field to the skin surface, glucose in the subcutaneous interstitial fluid is extracted and detected, and then captured by the sensor electrode and converted into an electrical signal.

[0084] The detection electrode 6c detects an electrical signal. This signal is amplified by analog circuitry and converted from analog to digital before entering the main control module for processing. Specifically, the signal is processed by a pre-filter amplifier and a digital-to-analog converter, and then transmitted to the microcontroller for calculation. The controller optimizes the glucose algorithm through a calibration process. The microcontroller combines sodium ion-pH data to jointly calibrate the blood glucose value and outputs the result in real time as a curve to the smart touch screen 3. The glucose concentration data can be displayed in real time for users to view and assess the blood glucose trend.

[0085] When finished wearing or during maintenance, the flexible sensor patch 6 can be removed through the openable protective interface 4 to complete the replacement. No skin breakage or tools are required, and the patch or detector slot will not be damaged. The operation is convenient and safe, significantly reducing the risk of infection and greatly improving the convenience and user compliance of non-invasive blood glucose monitoring. The overall structure is suitable for long-term continuous monitoring.

[0086] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A wearable, non-invasive, continuous glucose monitoring device, characterized in that: The device includes a housing, a flexible sensor patch, an integrated circuit board, a smart touchscreen display, and a rechargeable battery. The integrated circuit board is equipped with a weak current detection module, a weak voltage detection module, a pre-amplifier, a digital-to-analog converter, a microcontroller, a constant current output module, a multi-channel signal acquisition circuit, and an FPC connector. The FPC connector connects to the pre-amplifier, which is connected to the multi-channel signal acquisition circuit via the digital-to-analog converter. The pre-amplifier is also directly connected to the constant current output module, the weak current detection module, and the weak voltage detection module. These modules, along with the multi-channel signal acquisition circuit, are all connected to the microcontroller. The integrated circuit board and the rechargeable battery are housed within the housing. The rechargeable battery continuously powers the smart touchscreen display and the integrated circuit board. The smart touchscreen display is embedded in the surface of the housing and connects to and communicates with the microcontroller on the integrated circuit board via an HDMI / MIPI / TTL interface to display real-time blood glucose data curves. The flexible sensor patch is movably connected to the FPC connector on the integrated circuit board via an openable protective interface on the side of the encapsulation shell in a pluggable manner.

2. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: The flexible sensor patch is movably connected to the integrated circuit board via an FPC connector in a plug-in manner. A self-locking mechanical structure is adopted between the flexible sensor patch and the integrated circuit board. After the flexible sensor patch is inserted into the FPC connector, alignment guidance and physical self-locking are achieved to enhance the plug-in guidance and improve the stability of the electrical connection.

3. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: The operating voltage of the constant current output module is controlled between 1 and 2V; the spacing between the extracted electrodes on the flexible sensor patch is 0.5 to 1 cm.

4. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: The microcontroller on the integrated circuit board is equipped with a dynamic filtering and sodium ion-pH joint compensation algorithm to correct detection results during motion or long-term detection. The dynamic filtering and sodium ion-pH joint compensation algorithm is as follows: G ISF (t)=g·G p (tT ISF ), where G ISF (t): Glucose concentration in the interstitial fluid at time t. p (t): Blood glucose concentration at time t, T ISF : Response delay time of tissue fluid to blood glucose, g: Concentration ratio coefficient of tissue fluid glucose to blood glucose under steady state.

5. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: A flexible insulating layer is provided between the rechargeable battery and the integrated circuit board for isolation and insulation.

6. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: The encapsulation housing has a limiting component inside, which is used to mechanically limit and fix the integrated circuit board and the rechargeable battery. The inner edge of the encapsulation housing has screw holes for use with embedded brass nuts to simultaneously fasten the internal integrated circuit board and rechargeable battery. The bottom of the encapsulation housing has a detachable bottom cover, which is movably connected to the encapsulation housing. The edges of the encapsulation housing and the detachable bottom cover are respectively provided with buckle structures for snap-fit ​​fixation.

7. The wearable non-invasive continuous glucose monitoring device according to claim 6, characterized in that: The limiting components are distributed at the four corners of the top surface inside the package housing. The limiting components include raised limiting posts and guide grooves. The raised limiting posts are used to hold the four corners of the integrated circuit board. The guide grooves are used to accurately position the integrated circuit board inside the four limiting posts along the grooves before fixing it. The buckling structure includes a hook and a slot, which are respectively set at the edges of the package housing and the removable bottom cover.

8. The wearable non-invasive continuous glucose monitoring device according to claim 6, characterized in that: The removable bottom cover has ventilation micropores.

9. The wearable non-invasive continuous glucose monitoring device according to claim 6 or 8, characterized in that: The encapsulation shell is made of TPU material, and the longitudinal section of the breathable micropores is trapezoidal, with the outer diameter of the pores being larger than the inner diameter.

10. The wearable non-invasive continuous glucose monitoring device according to claim 1, characterized in that: It also includes an openable protective cover, an adjustable strap, and a charging port located at the bottom of the package housing. The openable protective cover is located on the side wall of the package housing next to the openable protective port; the adjustable strap is fixed to the package housing; and the charging port is a universal Type-C interface.

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