A blood glucose data processing method applied to a non-invasive blood glucose monitoring device

Abstract

The application relates to the technical field of biomedical engineering, and particularly discloses a blood glucose data processing method applied to a noninvasive blood glucose monitoring device, which comprises the following steps: S101, acquiring a blood glucose concentration value; S102, judging whether the blood glucose concentration value is greater than or equal to a preset early warning threshold value; if yes, executing step S103: calculating a difference value between the blood glucose concentration value and the preset early warning threshold value; S104, judging whether the difference value is greater than or equal to a preset difference threshold value and whether the duration of the state is greater than or equal to a preset time threshold value; if yes, executing step S105: calculating the rising rate and acceleration of the blood glucose concentration; S106, judging whether the rising rate is greater than or equal to a preset rate threshold value and whether the acceleration is greater than or equal to a first preset acceleration threshold value; if yes, outputting the current blood glucose concentration value as a target value, so that corresponding pulse parameters can be matched in a blood glucose concentration-pulse parameter matching table pre-stored in a database based on the target value.

Description

Technical Field

[0001] This invention belongs to the field of biomedical engineering technology, specifically, it relates to a method for processing blood glucose data applied to non-invasive blood glucose monitoring devices. Background Technology

[0002] Diabetes is a global chronic disease requiring long-term blood glucose monitoring and insulin therapy to maintain stable blood glucose levels. Traditional diabetes management methods typically involve frequent finger-prick blood glucose testing and subcutaneous insulin injections. While effective, these methods have significant drawbacks: firstly, frequent blood draws cause pain and inconvenience for patients; secondly, subcutaneous insulin injections may lead to local tissue damage and infection risks; furthermore, while traditional insulin pump devices provide continuous insulin infusion, their invasiveness and inconvenience limit patients' quality of life. Additionally, existing technologies treat the blood glucose monitor and insulin delivery micropump as two separate devices, causing considerable inconvenience to users. Therefore, this paper proposes a method that integrates blood glucose monitoring and insulin delivery, simultaneously monitoring blood glucose and controlling the delivery module based on the monitoring results.

[0003] For example, CN119158115A provides a patch device for treating diabetes with good efficacy. It includes an electrically operated telescopic rod, a movable plate, a detection needle, and a blood glucose meter. Before insulin injection, the electric telescopic rod pulls the movable plate, allowing the detection needle to be inserted into the patient's skin for blood testing. The electric telescopic rod moves the movable plate to a centered position relative to the fixed plate, avoiding discomfort caused by prolonged needle insertion. This device offers advantages in efficacy and versatility. Furthermore, it includes a treatment needle, a micro-pump, and a placement shell. The insulin vial is placed inside the placement shell, and the micro-pump draws insulin. The electric telescopic rod pushes the movable plate, causing the vertical rod to move within a triangular groove, inserting the treatment needle into the patient's skin. Insulin enters through a catheter into the treatment needle, which then injects an appropriate amount of insulin into the patient's body, achieving the treatment of diabetes with good efficacy. However, this device causes skin trauma during blood glucose monitoring and insulin injection, lacks intelligence, and increases patient discomfort and inconvenience.

[0004] For example, Yiqun Liu et al. published an article in Microsystems & Nanoengineering, 2024, 10(1): 112 entitled “A wearable, rapidly manufacturable, stability-enhancing microneedle patch for closed-loop diabetes management.” They proposed a wearable, rapidly manufacturable, stability-enhancing microneedle patch for diabetes management, consisting of a graphene composite ink-printed sensor on hollow microneedles, an electroosmotic micropump integrating the microneedles, and a circuit board for precise, intelligent control of the sensor and pump to detect interstitial glucose and deliver insulin through hollow channels, featuring long-lasting effects. However, this microneedle patch requires skin penetration and is susceptible to passivation and contamination caused by the tissue environment, which can easily lead to inflammation and infection during long-term use.

[0005] However, the aforementioned insulin delivery devices all involve invasive detection and / or invasive drug delivery methods. This involves inserting a needle into the skin to collect blood samples for blood glucose testing, and / or using microneedles to puncture the skin to detect glucose in the interstitial fluid. These methods cause pain, discomfort, and potential infection risks for patients, and cannot fully meet their needs for safer, more convenient, and intelligent treatment options. In recent years, with the rapid development of wearable technology, non-invasive blood glucose monitoring and transdermal drug delivery technologies have become research hotspots in the field of diabetes management.

[0006] Among non-invasive blood glucose monitoring technologies, electroosmosis is a non-invasive blood glucose monitoring method that uses an electric field to drive the movement of ions in body fluids, enabling real-time and continuous blood glucose monitoring, thus avoiding the inconvenience and pain of traditional blood collection methods.

[0007] For example, patent application CN105486731A discloses a non-invasive blood glucose detection probe based on terahertz enhancement. It combines two detection modules and a DSP microprocessor through a polymer shell. Each detection module includes an electrochemical sensor and a terahertz counterion permeation enhancement array. Specifically, the terahertz generating array enhances the glucose concentration in the detected tissue fluid, greatly improving the measurement accuracy of the electrochemical sensor for blood glucose, achieving highly sensitive, accurate, rapid, and non-invasive human blood glucose measurement.

[0008] In transdermal drug delivery technology, electroporation technology has shown great potential. Electroporation temporarily increases cell membrane permeability by applying short-duration high-voltage pulses to the skin surface, thereby promoting the transdermal absorption of drugs such as insulin. This method not only avoids the pain and infection risks of traditional injections but also improves drug delivery efficiency.

[0009] For example, patent application CN108355241A discloses a transdermal drug delivery device, which acquires characteristic parameters corresponding to the drug to be delivered transdermally; finds the corresponding electrical stimulation parameter based on a pre-set correspondence between the characteristic parameters and electrical stimulation parameters; and generates an electrical pulse signal based on the found electrical stimulation parameter, which is then applied to the drug delivery site. Because the appropriate electrical stimulation parameter can be automatically selected based on different characteristic parameters, the diversity of electrical stimulation parameters is improved, enabling more efficient transdermal drug delivery.

[0010] For example, the invention patent application with publication number CN101926784A discloses a conductive hydrogel patch for transdermal drug delivery using instantaneous pulsed electric field. It involves applying a paste of traditional Chinese medicine conductive hydrogel patch obtained by stirring onto a medical non-woven fabric, and then combining it with an instantaneous pulsed electric field to promote the transdermal absorption of multiple components of traditional Chinese medicine. This solves the problem of inconvenience for patients who cannot take medication continuously due to gastrointestinal adverse reactions and liver and kidney damage caused by long-term oral medication.

[0011] However, current technologies still treat non-invasive blood glucose monitoring and non-invasive insulin delivery micropumps as two separate devices, lacking intelligent judgment of blood glucose levels and insulin delivery timing, requiring manual administration and lacking closed-loop control. This not only inconveniences users but also increases treatment costs if they have to purchase two devices simultaneously.

[0012] In addition, existing blood glucose data processing methods usually rely on machine learning models (e.g., Chinese invention patent with publication number CN113948207A) to process data, thereby avoiding errors caused by blood glucose fluctuations. This requires a large amount of training data and places high demands on the performance of the equipment (e.g., high chip computing power). This will undoubtedly increase the cost of the equipment and thus increase the treatment cost for users. Summary of the Invention

[0013] The purpose of this invention is to provide a blood glucose data processing method for non-invasive blood glucose monitoring devices, which partially solves or alleviates the above-mentioned shortcomings in the prior art. Without relying on AI algorithms such as machine learning, it analyzes and processes blood glucose data by setting difference thresholds and duration as dual filtering conditions, which greatly reduces the probability of the device generating pulse voltage due to short-term blood glucose fluctuations or device noise, and improves the robustness of the device.

[0014] To solve the aforementioned technical problems, the present invention specifically adopts the following technical solution:

[0015] A method for processing blood glucose data in a non-invasive blood glucose monitoring device, wherein the non-invasive blood glucose monitoring device includes a non-invasive blood glucose detection module for monitoring human blood glucose concentration based on reverse iontophoresis technology; a drug loading module for loading drugs, including insulin; and a transdermal drug delivery module connected to the drug loading module for generating corresponding pulse voltages based on preset pulse parameters; accordingly, the blood glucose data processing method specifically includes the following steps:

[0016] S101 Obtain the blood glucose concentration value G monitored in real time by the non-invasive blood glucose detection module, and execute step S102;

[0017] S102 determines whether the current blood glucose concentration value G is greater than or equal to the preset early warning threshold G. th If so, proceed to step S103; otherwise, proceed to step S101.

[0018] S103 calculates the current blood glucose concentration value G and the preset early warning threshold G. th If the difference ΔG is found, proceed to step S104;

[0019] S104 Determine whether the difference ΔG is greater than or equal to a preset difference threshold ΔG. th And the difference ΔG is greater than or equal to the preset difference threshold ΔG th If the duration T of the state is greater than or equal to the preset time threshold T0, proceed to step S105; otherwise, proceed to step S102.

[0020] S105 calculates the rate of increase and acceleration of blood glucose concentration based on multiple blood glucose concentration values ​​monitored within the duration T; wherein, the rate of increase is obtained by linearly fitting multiple blood glucose concentration values ​​within the duration T using the least squares method; and the acceleration is obtained by calculating multiple blood glucose concentration values ​​within the duration T using the second derivative or the difference method.

[0021] S106 Determine whether the rate of ascent is greater than or equal to a preset rate threshold and the acceleration is greater than or equal to a first preset acceleration threshold; if the rate of ascent is greater than or equal to the preset rate threshold and the acceleration is greater than or equal to the first preset acceleration threshold, execute step S107.

[0022] S107 outputs the current blood glucose concentration value as the target value.

[0023] In some embodiments, when it is determined that the rate of increase is greater than or equal to a preset rate threshold and the acceleration is greater than or equal to a first preset acceleration threshold, the current blood glucose concentration value is taken as the target value, so that the corresponding pulse parameter can be matched in the blood glucose concentration-pulse parameter lookup table pre-stored in the database based on the target value.

[0024] In some embodiments, the blood glucose data processing method applied to a non-invasive blood glucose monitoring device further includes the following steps:

[0025] S201 acquires the most recent N historical pulse voltage records, the historical pulse voltage records including the blood glucose concentration observation value after a first specified observation period T2 after each pulse voltage application;

[0026] S202 calculates the absolute value of the deviation between each observed blood glucose concentration value and the corresponding preset expected blood glucose concentration value;

[0027] S203 Calculate the mean of N deviation values ​​and determine whether the mean is greater than or equal to a preset deviation threshold; if the mean is greater than the preset deviation threshold, proceed to step S204.

[0028] S204 adjusts the pulse parameters according to the mean value, and the relationship between the pulse parameter change Y and the mean value X is as follows: 0.5 < k If the value is ≤1.5, proceed to step S102.

[0029] In some embodiments, the blood glucose data processing method applied to a non-invasive blood glucose monitoring device further includes the following steps:

[0030] S301 acquires multiple blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within the second specified observation time period T3;

[0031] S302 calculates the rate and acceleration of blood glucose decrease based on the acquired multiple blood glucose concentration values;

[0032] S303 identifies the risk level of hypoglycemia based on the rate and acceleration of the decline.

[0033] If the current rate of blood glucose decrease is less than the preset rate of decrease threshold and the acceleration of decrease is greater than the preset acceleration of decrease threshold, it is determined to be low risk, and step S101 is executed;

[0034] If the descent rate is greater than or equal to the preset descent rate threshold, but the descent acceleration is greater than the preset descent acceleration threshold, it is judged as medium risk, a risk warning is issued and recorded.

[0035] If the descent rate is greater than or equal to the preset descent rate threshold, and the descent acceleration is less than or equal to the preset descent acceleration threshold, it is judged as high risk, a risk warning is issued and recorded.

[0036] In some embodiments, the blood glucose data processing method further includes the step of, when determined to be of medium or high risk:

[0037] S304 acquires the most recent M historical pulse voltage records and determines whether the number of times it was judged as medium risk or high risk is greater than or equal to a preset number threshold. If so, execute steps S201-S204.

[0038] In some embodiments, the preset rate threshold is 1.5 mg / dL / min to 2 mg / dL / min.

[0039] In some embodiments, the first preset acceleration is 0.1 mg / dL / min² to 0.3 mg / dL / min².

[0040] In some embodiments, the preset rate of decline threshold is 1.1 mg / dL / min - 1.5 mg / dL / min.

[0041] In some embodiments, the preset descent acceleration threshold is (-0.3 mg / dL / min²) - 0.5 mg / dL / min².

[0042] Beneficial effects:

[0043] This invention provides a blood glucose data processing method for non-invasive blood glucose monitoring devices. Without relying on AI (for example, the prior art CN113948207A, which uses machine learning models such as support vector machines, requires a large amount of training data and has high requirements for device performance, greatly increasing the cost of the device), this invention introduces difference threshold and duration as dual filtering conditions, which greatly reduces the probability of the device generating pulse voltage due to short-term blood glucose fluctuations or device noise, improves the robustness of the device, and significantly reduces the cost of the device.

[0044] The blood glucose data processing method provided by this invention analyzes and adjusts pulse parameters based on the observed blood glucose concentration values ​​after multiple pulse voltage applications, and then adjusts the pulse parameters based on the difference between these values ​​and the expected blood glucose concentration values. This avoids the problem of poor flexibility caused by setting static, fixed pulse parameters, thus improving the flexibility of the device. Furthermore, it identifies risk levels based on the blood glucose data after applying pulse voltage, greatly improving the safety of the device (for example, it can avoid or reduce the risk of hypoglycemia due to premature drug administration to a certain extent).

[0045] This invention provides a non-invasive insulin delivery device. The device employs reverse iontophoresis technology to achieve non-invasive real-time monitoring of blood glucose concentration and uses electroporation technology to deliver insulin transdermally, thus combining blood glucose monitoring and insulin delivery. This achieves integrated closed-loop control of symptom diagnosis and treatment, and both functions are completely non-invasive, causing no damage to the patient's skin. Furthermore, a Bluetooth module or other wireless communication module is included for data transmission, meeting the requirements of intelligence and miniaturization, enabling wearable functionality, improving patient comfort, reducing pain, and partially solving or alleviating at least one of the problems mentioned in the background art. Attached Figure Description

[0046] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. The elements or parts in the drawings are not necessarily drawn to scale. Obviously, the drawings described below are some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0047] Figure 1A This is a schematic diagram of the internal structure of an embodiment of a portable insulin delivery device according to the present invention;

[0048] Figure 1B This is a schematic diagram of the assembled structure of an embodiment of the portable insulin delivery device of the present invention;

[0049] Figure 2 for Figure 1A A cross-sectional view of an embodiment of the portable insulin delivery device shown.

[0050] Figure 3A A fluorescence image of the delivery depth of insulin under the electroporation parameters in Example 2, obtained by fluorescence detection;

[0051] Figure 3BA fluorescence image of the delivery depth of insulin under the electroporation parameters in Example 1, obtained by fluorescence detection;

[0052] Figure 4A This is an example of the use of the portable insulin delivery device of the present invention for blood glucose monitoring and drug delivery in the abdomen;

[0053] Figure 4B This is an example of the use of the portable insulin delivery device of the present invention for blood glucose monitoring and drug delivery in the arm;

[0054] Figure 5 A flowchart of an embodiment of the blood glucose data processing method of the invention;

[0055] Figure 6 This is a flowchart of another embodiment of the blood glucose data processing method of the present invention;

[0056] Figure 7 This is a flowchart of another embodiment of the blood glucose data processing method of the present invention;

[0057] Figure 8 This is a physical sample of the electroporation electrodes arranged in a ring array according to the present invention.

[0058] The attached diagram is labeled as follows: Top cover 1, Circuit control module 2, Bottom cover 4, Extraction electrode 5, Working electrode 6, Drug-loaded hydrogel 7, Electroporation electrode 8, Skin stratum corneum barrier 9, Dermis 10. Detailed Implementation

[0059] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0060] In this document, suffixes such as "module," "part," or "unit" used to denote elements are used only for the purpose of illustrative purposes and have no specific meaning in themselves. Therefore, "module," "part," or "unit" may be used interchangeably.

[0061] In this document, the terms "upper," "lower," "inner," "outer," "front," "rear," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0062] In this document, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," "connected," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0063] In this document, "and / or" includes any and all combinations of one or more of the listed related items.

[0064] In this article, "multiple" means two or more, that is, it includes two, three, four, five, etc.

[0065] As used in this specification, the term "about" typically means + / -5% of the value, more typically + / -4% of the value, more typically + / -3% of the value, more typically + / -2% of the value, even more typically + / -1% of the value, and even more typically + / -0.5% of the value.

[0066] In this specification, certain embodiments may be disclosed in a range-bound format. It should be understood that this "range-bound" description is merely for convenience and brevity and should not be construed as a rigid limitation on the disclosed range. Therefore, the description of a range should be considered as having specifically disclosed all possible subranges and the individual numerical values ​​within those ranges. For example, a description of the range 1-6 should be considered as having specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and the individual numbers within those ranges, such as 1, 2, 3, 4, 5, and 6. This rule applies regardless of the breadth of the range.

[0067] See Figure 1A and Figure 1BThis invention provides a non-invasive treatment device for diabetes, comprising a top cover 1 and a bottom cover 4, and, from bottom to top, a receiving space formed by the snapping of the top cover 1 and the bottom cover 4: a non-invasive blood glucose detection module for monitoring human blood glucose concentration based on reverse ion electroosmosis technology; a drug loading module for loading drugs (e.g., insulin); and a transdermal drug delivery module connected to the drug loading module, for applying a pulse voltage to the skin to enhance the transdermal penetration efficiency of the skin when the monitored blood glucose concentration value is greater than a preset threshold, and simultaneously driving the drug in the drug loading module to penetrate into the dermis 10.

[0068] In some embodiments, the non-invasive blood glucose detection module includes: an extraction electrode 5 and a working electrode 6 disposed at the bottom of the drug delivery module, wherein the extraction electrode 5 is used for non-invasive extraction from a user-specified site (e.g., arm or abdomen, see below) based on reverse iontophoresis technology. Figure 4A and Figure 4B The device includes: a glucose in interstitial fluid; a working electrode 6 for converting the glucose concentration extracted by the extraction electrode 5 into a corresponding electrical signal; and a data processing unit electrically connected to the extraction electrode 5 and the working electrode 6 for applying a constant current to the extraction electrode 5 and a constant voltage to the working electrode 6; and calculating the user's current glucose concentration based on the electrical signal converted by the working electrode 6.

[0069] Preferably, a constant voltage of -0.05 V is applied to the working electrode 6 during operation, while the extraction electrode 5 operates in constant current mode with a current value of 50 μA.

[0070] In some embodiments, the transdermal drug delivery module includes:

[0071] The system includes a judgment unit configured to acquire the blood glucose concentration value G monitored in real time by the non-invasive blood glucose detection module and determine whether the current blood glucose concentration value G is greater than a preset warning threshold; a first calculation unit configured to match the current blood glucose concentration value with the corresponding current drug administration parameter in a pre-stored blood glucose concentration and drug administration parameter correspondence table when the judgment unit determines that the current blood glucose concentration value is greater than the preset warning threshold; a second calculation unit configured to match the current drug administration parameter with the corresponding current pulse parameter in a pre-stored drug administration parameter and pulse parameter correspondence table; an electroporation electrode 8 configured to apply a pulse voltage to the skin; and a pulse generation unit configured to generate a corresponding electrical pulse based on the matched current pulse parameter and apply the electrical pulse through the electroporation electrode 8.

[0072] The tables showing the correspondence between blood glucose concentration and drug administration parameters, and between drug administration parameters and pulse parameters, were obtained in advance based on a large number of experiments.

[0073] Because medication is administered only after the blood glucose concentration reaches a warning threshold, and because insulin takes time to take effect and the administration process also takes time, the user's blood glucose concentration may remain in a hyperglycemic window for a longer period before the insulin takes effect.

[0074] Therefore, in order to shorten this window period and even prevent the aforementioned preset warning threshold from being reached in advance, in some other embodiments, the transdermal drug delivery module includes the aforementioned judgment unit, first calculation unit, second calculation unit, electroporation motor, and pulse generation unit, and the working principle of each module is the same. The difference is that in this embodiment, the transdermal drug delivery module further includes:

[0075] The second judgment unit is configured to judge the monitored current blood glucose concentration value G. c Is it greater than or equal to the preset early warning threshold G? th ,

[0076] The third determination unit is configured to, when the second determination unit determines the current blood glucose concentration value G c Greater than or equal to the preset early warning threshold G th At that time, calculate its comparison with the preset early warning threshold G. th The difference between them is ΔG = |G c -G th | and determine whether the difference is greater than or equal to the preset difference threshold ΔG. th ;

[0077] The fourth judgment unit is configured to, when the third judgment unit determines that ΔG ≥ ΔG th And the difference ΔG is greater than or equal to the preset difference threshold ΔG th When the duration T of the state is greater than or equal to a preset time threshold T0, the rate of increase and acceleration of blood glucose concentration are calculated based on multiple blood glucose concentration values ​​monitored during the duration T (preferably, the rate of increase is obtained by linearly fitting multiple blood glucose concentration values ​​within the duration T using the least squares method; the acceleration is obtained by calculating multiple blood glucose concentration values ​​within the duration T using the second derivative or the difference method).

[0078] The pulse parameter configuration unit is configured to determine whether the rise rate is greater than or equal to a preset rate threshold and whether the acceleration is greater than or equal to a first preset acceleration threshold, and when it is determined that the rise rate is greater than or equal to the preset rate threshold and the acceleration is greater than or equal to the first preset acceleration threshold, to match the corresponding pulse parameter in a blood glucose concentration-pulse parameter lookup table pre-stored in the database based on the current blood glucose concentration value.

[0079] In this embodiment, drug administration is triggered based on the simultaneous fulfillment of both the rate of rise and acceleration, significantly reducing the false positive rate when rate is used as the sole triggering parameter. Existing technologies mostly utilize machine learning or neural networks to predict whether blood glucose levels are rising or falling; however, this approach relies too heavily on AI and increases equipment costs, making widespread adoption difficult. Therefore, this embodiment employs a dual-judgment mechanism based on both rate and acceleration.

[0080] Furthermore, the transdermal drug delivery module also includes:

[0081] The fifth judgment unit is configured to acquire the most recent N (e.g., 5) historical pulse voltage application records, including the blood glucose concentration observation value after a first specified observation period T2 (e.g., 15 minutes) following each pulse voltage application, and to calculate the absolute value of the deviation between each blood glucose concentration observation value and the corresponding expected blood glucose concentration value (which can be obtained through a large amount of experimental data). Then, the mean of the N deviation values ​​is calculated, and it is determined whether the mean is greater than or equal to a preset deviation threshold. If the mean is greater than the preset deviation threshold, the pulse parameter configuration unit is triggered to adjust the pulse parameters according to the mean, wherein the relationship between the pulse parameter change Y and the mean X is as follows: 0.5 < k ≤1.5.

[0082] Preferably, the change in pulse parameter Y refers to the change in pulse voltage.

[0083] Furthermore, the transdermal drug delivery module also includes:

[0084] The sixth judgment unit is configured to acquire multiple blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within the second specified observation time period T3; calculate the blood glucose decrease rate and decrease acceleration based on the acquired multiple blood glucose concentration values; and then identify the hypoglycemia risk level based on the decrease rate and decrease acceleration. If the current blood glucose decrease rate is less than a preset decrease rate threshold and the decrease acceleration is greater than a preset decrease acceleration threshold, it is judged as low risk; if the decrease rate is greater than or equal to the preset decrease rate threshold, but the decrease acceleration is greater than the preset decrease acceleration threshold, it is judged as medium risk, and a risk warning is issued and recorded; if the decrease rate is greater than or equal to the preset decrease rate threshold and the decrease acceleration is less than or equal to the preset decrease acceleration threshold, it is judged as high risk, and a risk warning is issued and recorded.

[0085] In some embodiments, the risk warning may specifically include a voice prompt, and accordingly, the device also includes a voice playback unit.

[0086] Furthermore, the aforementioned sixth judgment unit is also configured to, when determined to be of medium risk or high risk, acquire the most recent M historical pulse voltage records, and determine whether the number of times it has been determined to be of medium risk or high risk is greater than or equal to a preset number threshold. If so, the fifth judgment unit is triggered to acquire the most recent N historical pulse voltage records, and the pulse parameters are adjusted according to the records. The specific adjustment principle can be found in the description of the fifth judgment unit, which will not be repeated here.

[0087] In some embodiments, the transdermal drug delivery module includes two operating modes: an early intervention mode, the operating principle of which is described in the above description of the second to sixth judgment units or the data processing method in subsequent embodiment 5; and a conventional intervention mode, the operating principle of which is described in the above description of the first judgment unit, the first calculation unit, and the second calculation unit. Of course, the user can choose between the two operating modes.

[0088] In some embodiments, the electroporation electrode 8 adopts a gradient interdigitated structure, or the electroporation electrode is arranged in a ring array, see [reference]. Figure 8 Its thickness is 60μm, and its coverage area is slightly smaller than that of the drug-loaded hydrogel 7. During operation, a pulse voltage of 30 V / 5 ms is applied to the skin to enhance transdermal penetration efficiency. Figure 3A The image shows fluorescence at 20V / 1ms. Green fluorescence represents insulin delivery. It can be seen that under this voltage parameter, the transdermal delivery depth of insulin is shallow and the amount is small. Figure 3B The fluorescence image is at 30 V / 5 ms. At this voltage parameter, insulin can be delivered to a deeper depth and in greater quantities through transdermal administration.

[0089] In some embodiments, the drug-loading module is a drug-loaded hydrogel 7, which is connected to the extraction electrode 5 and the working electrode 6. Preferably, the drug-loaded hydrogel is a sodium alginate and calcium chloride crosslinking system, or a chitosan-sodium glycerophosphate thermosensitive system; or a bilayer structure, wherein one layer is a pH-responsive polyacrylic acid hydrogel and the other layer is a thermosensitive poloxamer hydrogel, and the electroporation electrode 8 in the transdermal drug delivery module is embedded between the two layers.

[0090] Preferably, the drug-loaded hydrogel 7 is designed to be 4 cm long, 3 cm wide, and 0.3 cm thick, which can stably load insulin and achieve drug delivery.

[0091] In some embodiments, the data processing unit, judgment unit, first calculation unit, second calculation unit, and pulse generation unit described above are integrated on a flexible integrated circuit board as circuit control module 2. The flexible circuit board has multi-mode control function and can independently adjust the constant current / constant voltage output of the electrochemical electrode (i.e., extraction electrode 5 and working electrode 6) and the pulse voltage parameters of the electroporation electrode 8.

[0092] In some embodiments, the non-invasive insulin delivery device further includes: a wireless communication module connected to the data processing unit, used to send the current blood glucose concentration calculated by the data processing unit to a user's mobile terminal; and / or to send pulse parameters sent by the user's mobile terminal to the pulse generating unit. For example, the wireless coil supports Bluetooth data transmission to achieve real-time communication with external devices.

[0093] In some embodiments, the transdermal drug delivery module further includes a parameter adjustment unit, configured to dynamically adjust the drug delivery parameters based on the historical drug delivery data of the current user stored in the database.

[0094] In other embodiments, the non-invasive insulin delivery device also includes a reference electrode.

[0095] In some embodiments, the overall dimensions of the non-invasive treatment device are optimized to 5 cm long × 4 cm wide × 2.5 cm high. The bottom cover 4 and the top cover 1 are connected by a snap-fit ​​to encapsulate the internal modules. The bottom cover 4 has an opening in the center, allowing the drug-loaded hydrogel 7, extraction electrode 5, and working electrode 6 to directly adhere to the skin surface. The detachable gel module 3 adopts a modular design, allowing for easy replacement of the hydrogel or maintenance of the electrodes when the top cover 1 is separated from the bottom cover 4. The electroporation electrode 8 is tightly attached above the drug-loaded hydrogel 7, enhancing the transdermal delivery of insulin through a pulsed electric field.

[0096] Working principle: The extraction electrode 5 first non-invasively extracts subcutaneous tissue fluid using reverse ion electroosmosis technology. The data processing unit and working electrode 6 analyze blood glucose concentration in real time. When a hyperglycemic signal is detected, the electroporation electrode 8 immediately applies a pulse voltage, instantly opening the skin stratum corneum barrier 9. At the same time, it drives the insulin in the drug-loaded hydrogel 7 to efficiently penetrate into the dermis 10 under the action of the electric field.

[0097] The non-invasive drug delivery device in this embodiment integrates reverse ion electroosmotic monitoring and electroporation drug delivery technology, eliminating the need for skin punctures and significantly reducing patient discomfort. The device features a compact design with a total thickness of only 2.5 cm. Combined with a wireless intelligent control module, it offers high-precision monitoring, non-invasive treatment, and wearable comfort, effectively solving the problems of invasiveness and operational complexity associated with traditional blood glucose monitoring and insulin pumps.

[0098] Example 1: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), which includes the above-mentioned components. The drug-loaded hydrogel 7 is made of bacterial cellulose hydrogel and chitosan, wherein the chitosan concentration is 1%, and its size is designed to be 4 cm long, 3 cm wide and 0.3 cm thick, which can stably load insulin and realize drug delivery.

[0099] Among them, the electroporation electrode 8 is made into an interdigital structure using a flexible circuit board printing process. It has a thickness of 60μm and a coverage area slightly smaller than that of the drug-loaded hydrogel. During operation, it applies a pulse voltage of 30V / 50ms to the skin to enhance transdermal penetration efficiency.

[0100] Example 2: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), which includes the above-mentioned components. The drug-loaded hydrogel adopts a chitosan-sodium glycerophosphate thermosensitive system, and its size is adjusted to 3.5 cm long × 2.5 cm wide × 0.2 cm thick. The electroporation electrodes are arranged in a ring array, and the applied pulse voltage is adjusted to 20 V / 100 ms.

[0101] The top cover 1 and the bottom cover 4 are fixed together by magnetic attraction. Specifically, the bottom cover 4 is provided with a magnetic ring corresponding to the top cover 1.

[0102] The constant current of the extraction electrode 5 is 40μA, and the constant voltage of the working electrode 6 is -0.3V.

[0103] In the preparation of the hydrogel, 2% chitosan solution and 10% sodium glycerophosphate were mixed at a volume ratio of 3:1 and a thermally reversible gel was formed at 37°C, with an insulin loading capacity of 25 IU / cm³.

[0104] The flexible circuit board has a thickness of 50 μm, and the interdigitated electrode spacing is 200 μm to improve electric field uniformity. For example... Figure 3A and Figure 3B As shown, fluorescence images of insulin delivery depth obtained by fluorescence detection under the electroporation parameters of Examples 1 and 2 are shown.

[0105] Example 3: This example provides a non-invasive insulin delivery device (or a non-invasive blood glucose monitoring device), whose structure and function are consistent with Example 1, but the overall size is reduced to 3.8 cm long × 3 cm wide × 2 cm high, so it can be worn on different parts of the body, such as... Figure 5 As shown. The drug-loaded hydrogel uses a hyaluronic acid-cellulose nanocomposite material, reducing the thickness to 0.15 cm and increasing oxygen permeability by 40%. The electroporation electrode adopts a gradient interdigitated width design (50 μm at the center, gradually increasing to 200 μm at the edge), applying a 10 V / 200 ms low-frequency pulse. The circuit control module integrates an AI algorithm, which can dynamically adjust the drug delivery parameters based on historical data. Electrochemical detection uses differential pulse voltammetry, with the working electrode scanning range from -0.1 V to +0.5 V, and a 50 Hz alternating current applied simultaneously to the extraction electrode. The encapsulation uses medical-grade silicone for complete coverage, achieving an IP68 waterproof rating.

[0106] Example 4: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), whose structure and function are consistent with Example 1. However, this example adopts a double hydrogel layer structure, with the upper layer being a pH-responsive polyacrylic acid hydrogel (0.1 cm thick) and the lower layer being a thermosensitive poloxamer hydrogel (0.2 cm thick). An electroporation electrode is embedded between the two layers, and an amplitude-modulated pulse (fundamental wave 30 V / 50 ms superimposed with a 10 kHz carrier wave) is applied. The circuit control module is equipped with an impedance monitoring unit to provide real-time feedback on skin condition adjustment parameters. Electrochemical detection adopts a three-electrode system, with the addition of a reference electrode to improve measurement accuracy. The extraction current is controlled by fuzzy PID (set value 60 μA ± 5%), and the working electrode uses a constant potential of -0.4 V combined with AC impedance spectroscopy analysis.

[0107] Example 5: Based on the above-mentioned non-invasive blood glucose monitoring device, the present invention also provides a blood glucose data processing method, specifically, see [link to example]. Figure 5 The data processing method includes:

[0108] S101 acquires the blood glucose concentration value monitored in real time by the non-invasive blood glucose detection module.

[0109] As described in the above embodiments, the non-invasive blood glucose detection module can monitor the blood glucose concentration value of the monitored user in real time. Therefore, the main control device of the device (including the first judgment unit to the sixth judgment unit in the above embodiments) can directly obtain the blood glucose concentration value of the monitored user from the non-invasive blood glucose detection module.

[0110] S102 determines whether the current blood glucose concentration is greater than or equal to the preset early warning threshold. If yes, proceed to step S103; otherwise, proceed to step S101.

[0111] To avoid the problem of a prolonged hyperglycemic window period caused by controlling the device to generate the corresponding pulse voltage only when a warning threshold for drug administration is detected, this embodiment sets an early warning threshold as a triggering mechanism.

[0112] In some embodiments, the current working mode can be preset in the device, one being a fasting mode and the other a post-meal mode; correspondingly, different early warning thresholds are preset for the fasting mode and the post-meal mode (specifically, the early warning threshold is less than the aforementioned warning threshold).

[0113] In some embodiments, the preset early warning threshold ranges from [early warning threshold - 2.24 mmol / L, early warning threshold - 0.84 mmol / L], thereby ensuring sufficient time for trend analysis while preventing excessive premature triggering of subsequent mechanisms.

[0114] For example, typically, the device will only generate a corresponding pulse voltage when the fasting blood glucose concentration of a patient with long-term type 2 diabetes reaches 7 mmol / L (early warning threshold I) or the postprandial blood glucose concentration reaches 10 mmol / L (early warning threshold II), resulting in a prolonged hyperglycemic window. Therefore, in this embodiment, an early warning threshold is set. For example, when the fasting blood glucose concentration of a patient with type 2 diabetes reaches 5 mmol / L (early warning threshold) or the postprandial blood glucose concentration reaches 8 mmol / L (early warning threshold), the device will initiate the subsequent "prediction process," namely steps S103-S105.

[0115] For example, typically, newly diagnosed type 2 diabetes patients will only generate a corresponding pulse voltage when their fasting blood glucose concentration reaches 11 mmol / L (early warning threshold I), resulting in a longer hyperglycemic window. Therefore, in this embodiment, an early warning threshold is set. For example, when the patient's blood glucose concentration reaches 9 mmol / L, the device will initiate the subsequent "prediction process," i.e., steps S103-S105.

[0116] When a user's blood glucose concentration is on an upward trend for a sustained period of time, the device is controlled in advance to generate corresponding pulse parameters. Based on these pulse parameters, the device generates a corresponding pulse voltage to achieve early intervention and reduce the window period for hyperglycemia.

[0117] Using algorithms such as neural networks to achieve this "prediction" would not only require a large amount of training data but also significantly increase the cost of the equipment, which would inevitably increase the medical costs for patients and hinder product promotion and implementation. Therefore, in order to balance cost and ensure a certain level of accuracy, this embodiment combines the rise in blood glucose over a period of time for "prediction," as detailed in the following description.

[0118] S103 calculates the difference ΔG between the two.

[0119] S104 determines whether the difference ΔG is greater than or equal to the preset difference threshold ΔG. th If so, and the difference is greater than or equal to the preset difference threshold △G th If the duration T of the state is greater than or equal to the preset time T0, proceed to step S104; otherwise, proceed to step S101.

[0120] S105 calculates the rate and acceleration of the rise in blood glucose concentration based on multiple glucose concentration values ​​monitored within the duration T.

[0121] In some embodiments, the least squares method (which is existing technology and has a simple calculation method that does not significantly increase device power consumption) can be used to linearly fit multiple blood glucose concentration values ​​within the duration T (e.g., 10 min-15 min). This algorithm is existing technology and will not be described in detail here. Its calculation method is simple and does not significantly increase device power consumption.

[0122] In some embodiments, the blood glucose acceleration during the duration T (e.g., 10 min-15 min) can be calculated using the second derivative or the difference method. This algorithm is existing technology and will not be described in detail here. Its calculation method is simple and will not significantly increase the power consumption of the device.

[0123] S106 determines whether the rate of ascent is greater than or equal to a preset rate threshold and the acceleration is greater than or equal to a first preset acceleration threshold; if yes, proceed to step S107; otherwise, proceed to step S101.

[0124] S107 outputs the current blood glucose concentration as the target value, so that the device can match the corresponding pulse parameter in the blood glucose concentration-pulse parameter lookup table pre-stored in the database based on the target value.

[0125] In some embodiments, the insulin dosage required for different blood glucose concentrations and the pulse parameters required for different insulin dosages are obtained in advance through extensive clinical trials, thereby obtaining a pulse parameter relationship table corresponding to different blood glucose concentration values ​​(obtaining the relationship between blood glucose concentration values ​​and pulse parameters through testing is prior art and is not the focus of this application, so it will not be elaborated here).

[0126] In some embodiments, since an early warning threshold is set and the user's blood glucose level changes dynamically, controlling the device to generate a pulse voltage simply by determining that the value is greater than or equal to the early warning threshold would inevitably increase the device's computational load, thereby increasing power consumption and potentially leading to misjudgments. Therefore, in this embodiment, when the current blood glucose concentration is detected to be greater than the preset early warning threshold, the difference between the two is calculated. Furthermore, when this difference is greater than or equal to the preset difference threshold (i.e., exceeding the preset early warning threshold to a certain extent), and this state persists for a period of time T (e.g., 5-15 minutes), and the blood glucose concentration shows an upward trend during this period—for example, the rate of increase is greater than or equal to a preset rate threshold (e.g., set to 1.5 mg / dL / min-2 mg / dL / min based on clinical experience), and the acceleration is greater than or equal to a first preset acceleration threshold (e.g., 0.1 mg / dL / min-0.3 mg / dL / min²)—the device is then controlled to match the corresponding pulse parameters to the current blood glucose concentration value, thereby generating a corresponding pulse voltage.

[0127] In this embodiment, since the early warning threshold is used as the basis, and the user's blood glucose concentration changes dynamically, a difference threshold ΔG is set to eliminate interference from small fluctuations. th Setting a duration threshold is to determine the stability of the user's blood glucose rise trend; setting a rate threshold is to identify the risk of rapid rise; and setting an acceleration threshold is to predict an impending out-of-control steep rise.

[0128] In this embodiment, judging the rate of ascent and acceleration is more effective in reflecting individual metabolic dynamics characteristics than using a fixed threshold.

[0129] Of course, furthermore, since fasting and postprandial blood glucose concentrations and their changes are different, different thresholds are set for fasting and postprandial states respectively. All the above thresholds have different values ​​for fasting and postprandial states. The specific values ​​can be obtained in advance through a large number of experiments and statistical analysis. This part is not the focus of this application, so it will not be elaborated here.

[0130] Furthermore, on the one hand, to verify whether the pulse parameters are set reasonably, and on the other hand, because the user's physiological state changes at different times or stages, it is necessary to determine whether the pulse parameters need to be adjusted based on the blood glucose lowering effect after each administration. For details, see [link to relevant documentation]. Figure 6 This embodiment also includes the following steps:

[0131] S201 Obtain the most recent N historical applied pulse voltage records, and proceed to step S202.

[0132] In some embodiments, the above-mentioned historical pulse voltage record includes the blood glucose concentration observation value after a first specified observation period T2 (e.g., 15 min) after each pulse voltage is applied, for example, the actual blood glucose concentration value after 15 min of pulse voltage application, which is used to subsequently determine whether the pulse parameters are reasonable (as mentioned above, after a large number of clinical trials, different dosages correspond to different pulse parameters. Therefore, determining whether the pulse parameters are reasonable is actually determining whether the amount of insulin is appropriate).

[0133] S202 Calculate the absolute value of the deviation between each observed blood glucose concentration value and the corresponding preset expected blood glucose concentration value, and then proceed to step S203.

[0134] Generally speaking, after applying a pulse voltage, the user's blood glucose concentration will decrease to a certain extent under the action of insulin after a period of time. However, due to different users' responses to insulin and different physiological states at different times, the actual blood glucose concentration may not reach the expected effect after a period of time after administration, for example, it may be less than or greater than the preset expected blood glucose concentration.

[0135] In some embodiments, each drug has its standard efficacy; for example, insulin has a specific duration of administration and a predetermined effect on blood glucose levels, which is prior art and will not be elaborated upon here. Accordingly, the expected blood glucose concentration value is the difference between the current blood glucose concentration value before the application of the pulse parameter and the corresponding decrease value.

[0136] S203 calculates the mean of N deviation values ​​and determines whether the mean is greater than or equal to a preset deviation threshold; if the mean is greater than the preset deviation threshold, proceed to step S204; otherwise, proceed to step S201.

[0137] In some embodiments, if the mean value is greater than a preset deviation threshold, it indicates that the observed blood glucose concentration values ​​obtained after multiple consecutive administrations deviate significantly from the expected blood glucose concentration value, which means that the dosage may be insufficient or too low. Therefore, it is necessary to adjust the pulse parameters, i.e., execute step S204. Here, N is taken as an empirical value of 5.

[0138] S204 adjusts the pulse parameters according to the mean value, and the relationship between the pulse parameter change Y and the mean value X is as follows: 0.5 < k ≤1.5.

[0139] In some embodiments, since the absolute value is calculated in step S202 above, if each observed blood glucose concentration is smaller than the expected blood glucose concentration (or for a preset number of times, for example, three observed blood glucose concentrations are all smaller than their corresponding expected blood glucose concentrations), it indicates that the dosage is too high, or the user is highly sensitive to the drug. Therefore, the pulse parameter is decreased. Similarly, if each observed blood glucose concentration is larger than the expected blood glucose concentration (or for a preset number of times, for example, three observed blood glucose concentrations are all larger than their corresponding expected blood glucose concentrations), it indicates that the dosage is too low, or the user is less sensitive to the drug. Therefore, the pulse parameter is increased.

[0140] Furthermore, since the early warning threshold is used as a benchmark, in order to reduce the risk of hypoglycemia, it is also necessary to obtain the real-time blood glucose data monitored by the non-invasive blood glucose detection module for a period of time after each pulse voltage application, and to infer whether the user is at risk of hypoglycemia, thus indirectly verifying the rationality of the aforementioned pulse parameters. Therefore, see Figure 7 In other embodiments, the method further includes the step of:

[0141] S301 Obtain multiple blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within the second specified observation time period T3, and execute step S302.

[0142] In some embodiments, the second specified observation time period T3 is less than the first specified observation time period T2 described above, for example, 10 min to 15 min.

[0143] S302 calculates the rate and acceleration of blood glucose decrease based on the acquired multiple blood glucose concentration values.

[0144] In some embodiments, the aforementioned rate of decline can also be obtained by linearly fitting all blood glucose concentration values ​​within a specified observation period T3 using the least squares method. This algorithm is existing technology and will not be described in detail here.

[0145] In some embodiments, the aforementioned descent acceleration can also be calculated using the second derivative or the finite difference method. These algorithms are existing technologies and will not be described in detail here.

[0146] S303 determines the risk level of hypoglycemia based on the rate and acceleration of the decline.

[0147] If the current rate of blood glucose decrease is less than the preset rate of decrease threshold and the acceleration of decrease is greater than the preset acceleration of decrease threshold, then the blood glucose decreases slowly and steadily. Therefore, it is determined to be low risk, and step S101 is executed.

[0148] If the rate of decline is greater than or equal to the preset rate of decline threshold, but the rate of decline is greater than the preset rate of decline threshold, it indicates that blood sugar is declining rapidly but not accelerating. Therefore, it is judged as medium risk and a risk warning is issued (e.g., "There is a risk of hypoglycemia, please eat as soon as possible"). At the same time, its risk level is recorded.

[0149] If the rate of decline is greater than or equal to the preset rate of decline threshold, and the acceleration of decline is less than or equal to the preset acceleration of decline threshold, it indicates that blood sugar is declining rapidly and accelerating. Therefore, it is judged as high risk, and a risk warning is issued (e.g., "High risk of hypoglycemia, please eat immediately"). At the same time, its risk level is recorded.

[0150] In some embodiments, the preset rate of decline threshold is a clinically empirical value of 1.1 mg / dL / min to 1.5 mg / dL / min.

[0151] In some embodiments, the preset descent acceleration threshold is a clinically empirical value of (-0.3 mg / dL / min²) - 0.5 mg / dL / min².

[0152] Furthermore, the blood glucose data processing method in this embodiment also includes the following steps:

[0153] S304 acquires the most recent M historical pulse voltage records and determines whether the number of times it was judged as high risk or medium risk is greater than or equal to a preset number threshold. If so, execute steps S201-S204.

[0154] In this embodiment, M times actually represents an adjustment cycle. That is, before adjustment, if the blood glucose concentration is the same, the corresponding pulse parameters are the same. Preferably, M ≥ 5, and correspondingly, M ≥ preset number threshold ≥ 3.

[0155] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0156] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims. All of these forms are within the protection scope of the present invention.

Claims

1. A blood glucose data processing method applied to a non-invasive blood glucose monitoring device, characterized in that, The non-invasive blood glucose monitoring device comprises a non-invasive blood glucose detection module for monitoring blood glucose concentration of a human body based on a counter-ion electro-osmotic technology; a drug loading module for loading a drug, the drug comprising insulin; and a transdermal drug delivery module connected to the drug loading module for generating a corresponding pulse voltage based on preset pulse parameters. S101 obtaining a blood glucose concentration value G monitored by the non-invasive blood glucose detection module in real time, and performing step S102; S102 determining whether the current blood glucose concentration value G is greater than or equal to a preset early warning threshold G th If yes, step S103 is executed, otherwise step S101 is executed. S103 calculates the difference AG between the current blood glucose concentration value G and the preset early warning threshold value G th , and executes step S104. S104 judges whether the difference AG is greater than or equal to a preset difference threshold AG th , and the duration T of the state that the difference AG is greater than or equal to the preset difference threshold AG th is greater than or equal to a preset time threshold T0, step S105 is executed, otherwise step S102 is executed; S105 calculating a rising rate and an acceleration of the blood glucose concentration based on a plurality of blood glucose concentration values monitored in the duration T; wherein the rising rate is obtained by linear fitting of the plurality of blood glucose concentration values in the duration T using a least square method; and the acceleration is obtained by calculating the plurality of blood glucose concentration values in the duration T using a second derivative or difference method; S106 determining whether the rising rate is greater than or equal to a preset rate threshold and the acceleration is greater than or equal to a first preset acceleration threshold; if the rising rate is greater than or equal to the preset rate threshold and the acceleration is greater than or equal to the first preset acceleration threshold, performing step S107; S107 outputting the current blood glucose concentration value as a target value.

2. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 1, wherein, The non-invasive blood glucose monitoring device can work in a fasting mode or a postprandial mode, and different early warning thresholds are set for the fasting mode or the postprandial mode. 3.The blood glucose data processing method applied to the non-invasive blood glucose monitoring device according to claim 2, wherein, Different preset rate thresholds are set for the fasting mode or the postprandial mode.

4. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 3, wherein, The value range of the early warning threshold is [early warning threshold-2.24 mmol / L, early warning threshold-0.84 mmol / L].

5. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 3, wherein, The duration T is 10 min-15 min.

6. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 1, wherein, The first preset acceleration is 0.1 mg / dL / min²-0.3 mg / dL / min².

7. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 1, wherein, The non-invasive blood glucose detection module comprises: an extraction electrode for non-invasively extracting glucose in interstitial fluid based on the counter-ion electro-osmotic technology; a working electrode for converting the glucose concentration extracted by the extraction electrode into a corresponding electrical signal; a data processing unit electrically connected to the extraction electrode and the working electrode, for applying a constant current to the extraction electrode and a constant voltage to the working electrode, and calculating the current glucose concentration based on the electrical signal converted by the working electrode.

8. The blood glucose data processing method for non-invasive blood glucose monitoring device according to claim 7, wherein, The drug loading module is a hydrogel, and is connected to the extraction electrode and the working electrode.

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