Blood glucose data processing method applied to noninvasive blood glucose monitoring equipment

Abstract

The invention relates to the technical field of biomedical engineering, and particularly discloses a blood glucose data processing method applied to noninvasive blood glucose monitoring equipment, which comprises the following steps: S101, acquiring a blood glucose concentration value; s102, judging whether the pre-warning threshold value is greater than or equal to a preset pre-warning threshold value or not, and if so, executing a step S103: calculating a difference value between the pre-warning threshold value and the preset pre-warning threshold value; s104, whether the difference value is larger than or equal to a preset difference value threshold value or not is judged, and when the duration time of the state is larger than or equal to a preset time threshold value, the step S105 is executed, and the rising rate and the acceleration of the blood glucose concentration are calculated; s106, whether the rising speed is larger than or equal to a preset speed threshold value or not and whether the acceleration is larger than or equal to a first preset acceleration threshold value or not are judged; if so, outputting the current blood glucose concentration value as a target value, so that a corresponding pulse parameter can be matched in a blood glucose concentration-pulse parameter comparison table pre-stored in a database based on the target value.

Description

Technical Field

[0001] The present invention belongs to the field of biomedical engineering technology, and in particular relates to a blood glucose data processing method applied to a non-invasive blood glucose monitoring device. Background Art

[0002] Diabetes is a global chronic disease, and patients need long-term blood sugar monitoring and insulin treatment to maintain stable blood sugar levels. Traditional diabetes management methods usually include frequent fingertip blood sampling to detect blood sugar levels and subcutaneous insulin injection to control blood sugar. Although these methods are effective, they have obvious shortcomings: first, frequent blood sampling causes pain and inconvenience to patients; second, subcutaneous insulin injection may cause local tissue damage and infection risks; in addition, although traditional insulin pump devices can provide continuous insulin infusion, their invasiveness and inconvenience limit the daily quality of life of patients. In addition, the existing technology treats blood glucose monitors and insulin delivery micropumps as two independent devices, which brings great inconvenience to users. Based on this, the existing technology proposes a method that integrates blood glucose monitoring and insulin delivery, realizes blood glucose monitoring at the same time, and controls the delivery module to deliver the drug based on the blood glucose monitoring results.

[0003] For example, CN119158115A provides a good use effect of the application device for treating diabetes, which is provided with an electric telescopic rod, a movable plate, a detection needle and a blood glucose meter. Before insulin injection, the electric telescopic rod pulls the movable plate, so that the detection needle is inserted into the patient's skin, and then the patient's blood is tested; the electric telescopic rod moves the movable plate to a central position relative to the fixed plate, avoiding the discomfort caused by the needle being inserted into the skin for a long time, and has the advantages of good use effect and diverse functions; and by providing a treatment needle, a micro pump and a placement shell, the insulin bottle is placed in the inner cavity of the placement shell, the micro pump is used to extract insulin, and the electric telescopic rod pushes the movable plate. At this time, the vertical rod moves in the triangular groove, so that the treatment needle is inserted into the patient's skin, and insulin enters the treatment needle through the catheter. The treatment needle injects an appropriate amount of insulin into the patient's body, achieving the treatment operation of diabetes with good use effect. However, this device causes trauma to the skin during the blood glucose monitoring and insulin injection processes, lacks intelligence, and increases the pain and inconvenience of the patient.

[0004] For example, Yiqun Liu et al. in Microsystems & nanoengineering, 2024, 10(1): 112, in the article “A wearable, rapidly manufacturable, stability-enhancing microneedle patch for closed-loop diabetes management”, propose a wearable, rapidly manufacturable, stability-enhancing microneedle patch for closed-loop diabetes management, consisting of a sensor printed on a hollow microneedle by graphene composite ink, a microneedle-integrated electroosmotic micropump, and a circuit board for precise and intelligent control of the sensor and pump to detect interstitial glucose and deliver insulin through the hollow channel, with long duration. However, this microneedle patch needs to be inserted into the skin and is susceptible to passivation and contamination by the tissue environment, and can easily cause inflammation and infection during long-term use.

[0005] However, the above insulin administration devices are all invasive detection and / or invasive administration methods, i.e. using a detection needle to pierce the skin to collect a blood sample for blood glucose detection, and / or using a microneedle to pierce the skin to detect glucose in the interstitial fluid, which can cause pain, discomfort and potential infection risk to the patient, and cannot fully meet the patient's demand 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 technology have become a research hotspot in the field of diabetes management.

[0006] Among non-invasive blood glucose monitoring technologies, electroosmosis technology, as a non-invasive blood glucose monitoring method, can achieve real-time and continuous blood glucose monitoring by utilizing the movement of ions in body fluids driven by an electric field, avoiding the inconvenience and pain of traditional blood sampling methods.

[0007] For example, the patent application for invention with publication number CN105486731A discloses a non-invasive blood glucose detection probe based on terahertz enhancement, which combines two detection modules and a DSP microprocessor together through a high polymer shell, wherein each detection module includes an electrochemical sensor and a terahertz counterion permeation enhancement array. That is, the terahertz generation array is used to enhance the glucose concentration in the detected tissue fluid, greatly improving the measurement accuracy of the electrochemical sensor for tenting blood glucose, and achieving high sensitivity, accuracy, rapidity and non-invasive human blood glucose measurement.

[0008] Among transdermal drug delivery technologies, electroporation shows great potential. Electroporation applies short, high-voltage pulses to the skin surface, temporarily increasing the permeability of cell membranes and 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 and apparatus that obtains characteristic parameters corresponding to a drug to be transdermally delivered; searches for electrical stimulation parameters corresponding to the characteristic parameters based on a pre-defined relationship between the characteristic parameters and electrical stimulation parameters; and generates an electrical pulse signal based on the searched electrical stimulation parameters to be applied to the site of drug delivery. Because the corresponding electrical stimulation parameters can be automatically selected based on different characteristic parameters, this increases the diversity of electrical stimulation parameters, 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 a transient pulse electric field. The paste of the conductive hydrogel patch of traditional Chinese medicine obtained by stirring is applied to a medical non-woven fabric, and then combined with a transient pulse electric field to promote the transdermal absorption of multiple components of traditional Chinese medicine, thereby solving the problem of inconvenience in medication 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, existing technologies still use the non-invasive blood glucose monitoring unit and the non-invasive insulin delivery micropump as two separate devices. These devices lack 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 (for example, Chinese invention patent publication number CN113948207A) to perform data processing to avoid errors caused by blood glucose fluctuations, etc., which requires a large amount of training data and high performance requirements for the equipment (for example, high chip computing and operating capabilities), which will undoubtedly increase the cost of the equipment and thus increase the user's treatment cost. Summary of the Invention

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

[0014] In order to solve the above-mentioned technical problems, the present invention specifically adopts the following technical solutions: A blood glucose data processing method for 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 counter-ion electroosmosis technology; a drug loading module for loading a drug, wherein the drug includes insulin; and a transdermal drug delivery module connected to the drug loading module for generating a corresponding pulse voltage based on preset pulse parameters. Accordingly, the blood glucose data processing method specifically includes the following steps: S101 obtains the blood glucose concentration value G monitored in real time by the non-invasive blood glucose detection module, and executes step S102; S102 determines whether the current blood glucose concentration value G is greater than or equal to the preset early warning threshold value G th If yes, go to step S103, otherwise go to step S101; S103 Calculate the current blood glucose concentration G and the preset early warning threshold G th The difference △G is obtained, and step S104 is executed; S104: Determine whether the difference ΔG is greater than or equal to a preset difference threshold ΔG. th , and the difference △G is greater than or equal to the preset difference threshold △G th When the duration T of the state is greater than or equal to the preset time threshold T0, step S105 is executed, otherwise step S102 is executed; S105 calculates the rate of increase and acceleration of the blood glucose concentration based on the multiple blood glucose concentration values ​​monitored during the duration T; wherein the rate of increase is obtained by linearly fitting the multiple blood glucose concentration values ​​during the duration T using the least squares method; and the acceleration is obtained by calculating the multiple blood glucose concentration values ​​during the duration T using the second derivative or difference method; S106: Determine 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, execute step S107; S107 outputs the current blood sugar concentration value as the target value.

[0015] In some embodiments, when it is determined that 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, the current blood glucose concentration value is used as the target value, so that the corresponding pulse parameters can be matched in the blood glucose concentration-pulse parameter comparison table pre-stored in the database based on the target value.

[0016] In some embodiments, the blood glucose data processing method for a non-invasive blood glucose monitoring device further comprises the steps of: S201 obtains the most recent N historical records of applied pulse voltages, wherein the historical records include the observed blood glucose concentration value after a first designated observation period T2 after each application of the pulse voltage; S202 calculates the absolute value of the deviation between each of the observed blood glucose concentration values ​​and the corresponding preset expected blood glucose concentration value; S203 calculates the mean of the 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, executes step S204; S204 adjusts the pulse parameter according to the mean value. The relationship between the pulse parameter change Y and the mean value X is: , 0.5< k ≤1.5, go to step S102.

[0017] In some embodiments, the blood glucose data processing method for a non-invasive blood glucose monitoring device further comprises the steps of: S301: obtaining a plurality of blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within a second designated observation time period T3; S302: Calculating the blood sugar decrease rate and decrease acceleration based on the acquired multiple blood sugar concentration values; S303 identifies the hypoglycemia risk level based on the falling rate and falling acceleration. If the current blood sugar drop rate is less than the preset drop rate threshold and the drop acceleration is greater than the preset drop acceleration threshold, it is determined to be low risk and step S101 is executed; 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 and a risk warning is issued and recorded; 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, and a risk warning is issued and recorded.

[0018] In some embodiments, when the patient is determined to be at medium risk or high risk, the blood glucose data processing method further comprises the steps of: S304 obtains the records of the last M times of the history applied pulse voltage, and determines whether the number of times determined as medium risk or the number of times determined as high risk is greater than or equal to a preset number threshold, if yes, executes steps S201-S204.

[0019] In some embodiments, the preset rate threshold is 1.5 mg / dL / min-2 mg / dL / min.

[0020] In some embodiments, the first preset acceleration is 0.1 mg / dL / min²-0.3 mg / dL / min².

[0021] In some embodiments, the preset rate threshold is 1.5 mg / dL / min-2 mg / dL / min.

[0022] In some embodiments, the preset rate threshold is 1.5 mg / dL / min-2 mg / dL / min.

[0023] Advantages: The present application provides a blood glucose data processing method applied to a non-invasive blood glucose monitoring device, which greatly reduces the probability of triggering the device to generate a pulse voltage due to transient blood glucose fluctuations or device noise, improves the robustness of the device, and greatly reduces the cost of the device, by introducing a difference threshold and a duration as double filtering conditions, without relying on AI (for example, the prior art CN113948207A requires a large amount of training data and high device performance requirements through a machine learning model such as a support vector machine, greatly increasing the cost of the device).

[0024] The blood glucose data processing method provided by the present application avoids the problem of poor flexibility caused by setting static fixed pulse parameters by observing and analyzing the blood glucose concentration observations after applying a pulse voltage multiple times, and then adjusting the pulse parameters based on the difference between the observations and the expected blood glucose concentration value, thereby improving the flexibility of the device. Moreover, the risk level is also identified based on the blood glucose data after applying the pulse voltage, thereby greatly improving the safety of the device (for example, it can to some extent avoid or reduce the risk of hypoglycemia caused by early medication).

[0025] The application provides a non-invasive insulin administration device, which realizes non-invasive real-time monitoring of blood glucose concentration of a human body by adopting reverse ion electrophoresis technology, and realizes transdermal delivery of insulin by adopting electroporation technology, namely, non-invasive administration, so that the functions of blood glucose concentration monitoring and insulin delivery are combined, integrated closed-loop control of symptom diagnosis and treatment is realized, and in the realization of the two functions, complete non-invasiveness can be achieved, and no damage is caused to the skin of the patient. Further, a wireless communication module such as a Bluetooth module is arranged to perform data transmission, so as to meet the requirements of intelligence and miniaturization, realize the wearability of the device, improve the comfort of the patient, and reduce the pain, and at least one problem mentioned in the above background art can be solved or alleviated. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. In all the drawings, similar elements or parts are generally identified by similar reference signs. In the drawings, each element or part is not necessarily drawn according to the actual proportion. Obviously, the drawings described below are some embodiments of the application, and those skilled in the art can obtain other drawings according to these drawings without paying creative labor.

[0027] Figure 1A FIG. 1 is a structural schematic diagram of an embodiment of the internal structure of a portable insulin administration device of the application; Figure 1B FIG. 2 is a structural schematic diagram of an embodiment of the assembled structure of a portable insulin administration device of the application; Figure 2 FIG. 3 is a sectional view of an embodiment of the portable insulin administration device shown in FIG. 1; Figure 1A Figure 3A FIG. 4 is a fluorescence picture of the delivery depth of insulin under the electroporation parameters in Example 2 obtained by fluorescence detection; Figure 3B FIG. 5 is a fluorescence picture of the delivery depth of insulin under the electroporation parameters in Example 1 obtained by fluorescence detection; Figure 4A FIG. 6 is a use example of the portable insulin administration device of the application for blood glucose monitoring and administration on the abdomen; Figure 4B FIG. 7 is a use example of the portable insulin administration device of the application for blood glucose monitoring and administration on the arm; Figure 5 FIG. 8 is a flowchart of an embodiment of the blood glucose data processing method of the application; Figure 6 FIG. 9 is a flowchart of another embodiment of the blood glucose data processing method of the application; ​Figure 7 is a flow chart of another embodiment of the blood glucose data processing method of the present invention; Figure 8 This is a physical sample picture of the electroporation electrodes arranged in a circular array in the present invention.

[0028] Reference numerals in the figure: 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 DESCRIPTION

[0029] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0030] Herein, suffixes such as "module," "component," or "unit" used to represent elements are only used to facilitate description of the present invention and have no specific meaning. Therefore, "module," "component," or "unit" may be used interchangeably.

[0031] As used herein, terms such as "upper," "lower," "inner," "outer," "front," "back," "one end," and "the other end" indicate positions or locations based on those shown in the accompanying drawings. These terms are intended solely to facilitate and simplify the description of the present invention and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate 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.

[0032] As used herein, unless otherwise expressly specified or limited, the terms "installed," "provided with," and "connected" should be understood broadly. For example, "connected" may refer to a fixed connection, a detachable connection, or an integral connection; it may refer to a mechanical connection, a direct connection, an indirect connection via an intermediate medium, or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention on a case-by-case basis.

[0033] As used herein, "and / or" includes any and all combinations of one or more of the associated listed items.

[0034] Herein, "plurality" means two or more than two, ie, it includes two, three, four, five, etc.

[0035] As used in this specification, the term "about", when used in reference to a value, typically means + / - 5% of the stated value, more typically + / - 4% of the stated value, more typically + / - 3% of the stated value, more typically + / - 2% of the stated value, even more typically + / - 1% of the stated value, and even more typically + / - 0.5% of the stated value.

[0036] In this specification, certain embodiments can be disclosed in one specific format in a range. It should be understood that such "in a range" description is merely for the convenience and brevity, and should not be interpreted as a rigid limitation to the disclosed range. Therefore, the range description should be considered to have disclosed all possible sub-ranges and individual numerical values within the range. For example, the description of the range 1-6 should be considered to have disclosed the sub-ranges 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., as well as the individual numbers within the range, such as 1, 2, 3, 4, 5 and 6. The above rule applies regardless of the breadth of the range.

[0037] Referring to Figure 1A and Figure 1B , the present application provides a non-invasive diabetes treatment device, which comprises a top cover 1 and a bottom cover 4, and from bottom to top, sequentially arranged in the accommodating space formed by the top cover 1 and the bottom cover 4: a non-invasive blood glucose detection module for monitoring the blood glucose concentration of the human body based on the counter-ion electro-osmosis technology; a drug loading module for loading drugs (such as insulin); a transdermal drug delivery module connected with 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 value, while driving the drug in the drug loading module to penetrate into the dermis 10.

[0038] In some embodiments, the non-invasive blood glucose detection module comprises: an extraction electrode 5 and a working electrode 6 arranged at the bottom of the drug loading module, wherein the extraction electrode 5 is used to extract glucose in the interstitial fluid of the user's designated part (such as arm or abdomen, see Figure 4A and Figure 4B ) based on the counter-ion electro-osmosis technology; the working electrode 6 is used to convert the glucose concentration extracted by the extraction electrode 5 into a corresponding electrical signal; further comprising: a data processing unit electrically connected with 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 current glucose concentration of the user based on the electrical signal converted by the working electrode 6.

[0039] Preferably, the working electrode 6 applies a constant voltage of -0.05 V when working, and the extraction electrode 5 operates in a constant current mode with a current value of 50 μA.

[0040] In some embodiments, the transdermal drug delivery module comprises: The judgment unit is configured to obtain the blood glucose concentration value G monitored in real time by the non-invasive blood glucose detection module, and to judge whether the current monitored blood glucose concentration value G is greater than a preset warning threshold value; the first calculation unit is configured to match the corresponding current medication parameter in a pre-stored blood glucose concentration and medication parameter correspondence table based on the current blood glucose concentration value when the judgment unit judges that the current blood glucose concentration value is greater than the preset warning threshold value; the second calculation unit is configured to match the corresponding current pulse parameter in a pre-stored medication parameter and pulse parameter correspondence table based on the current medication parameter; the electroporation electrode 8 is used to apply a pulse voltage to the skin; the pulse generating unit is used to generate a corresponding electric pulse based on the matched current pulse parameter, and apply the electric pulse through the electroporation electrode 8.

[0041] The above-mentioned table of correspondence between blood glucose concentration and drug administration parameters and the table of correspondence between drug administration parameters and pulse parameters are obtained in advance based on a large number of experiments.

[0042] Since drug administration is controlled only after the blood sugar concentration reaches the warning threshold, and since it takes a certain amount of time for insulin to take effect, and the drug administration process also takes a certain amount of time, it may cause the user's blood sugar concentration to be in a high blood sugar window period for a longer period before the insulin takes effect.

[0043] Therefore, in order to shorten the window period or even prevent the preset warning threshold from being reached in advance, in other embodiments, the transdermal drug delivery module includes the above-mentioned judgment unit, the first calculation unit, the second calculation unit, the electroporation motor, and the pulse generation unit, and the working principles of each module are the same. The difference is that in this embodiment, the transdermal drug delivery module also includes: The second judgment unit is configured to judge the current blood glucose concentration value G c Is it greater than or equal to the preset early warning threshold G th , 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 When the value of the threshold is calculated, the difference between the threshold value and the preset early warning threshold value 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 ; The fourth judgment unit is configured to: when the third judgment unit judges that ΔG≥ΔG th , and the difference △G is greater than or equal to the preset difference threshold △G thWhen the duration T of the state is greater than or equal to a preset time threshold T0, the rate of increase and the acceleration of the blood glucose concentration are calculated based on the multiple blood glucose concentration values ​​monitored during the duration T (preferably, the rate of increase is obtained by linearly fitting the multiple blood glucose concentration values ​​within the duration T using the least squares method; and the acceleration is obtained by calculating the multiple blood glucose concentration values ​​within the duration T using the second derivative or difference method); The pulse parameter configuration unit is configured to determine whether the rising 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 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, the corresponding pulse parameter is matched in a blood glucose concentration-pulse parameter comparison table pre-stored in the database based on the current blood glucose concentration value.

[0044] In this embodiment, drug administration is triggered based on the simultaneous satisfaction of the rising rate and acceleration parameters, significantly reducing the false positive rate associated with using rate as the triggering parameter alone. Existing technologies often use machine learning or neural networks to predict whether blood sugar levels are rising or falling. However, this approach relies heavily on AI and increases equipment costs, making it difficult to implement. Therefore, this embodiment utilizes a dual judgment mechanism based on both rate and acceleration.

[0045] Furthermore, the transdermal drug delivery module further comprises: The fifth judgment unit is configured to obtain the most recent N (e.g., five) historical records of applied pulse voltages, including the observed blood glucose concentration value after a first specified observation period T2 (e.g., 15 minutes) after each application of the pulse voltage, and calculate the absolute value of the deviation between each observed blood glucose concentration value and the corresponding expected blood glucose concentration value (which can be obtained through a large amount of test data), then calculate the average of the N deviation values, and determine whether the average is greater than or equal to a preset deviation threshold; if the average is greater than the preset deviation threshold, trigger the above-mentioned pulse parameter configuration unit to adjust the pulse parameters according to the average, wherein the relationship between the pulse parameter change amount Y and the average value X is: , 0.5< k ≤1.5.

[0046] Preferably, the pulse parameter variation Y refers to the pulse voltage variation.

[0047] Furthermore, the transdermal drug delivery module further comprises: The sixth judgment unit is configured to obtain multiple blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within the second specified observation time period T3; and calculate the blood glucose decline rate and decline acceleration based on the obtained multiple blood glucose concentration values, and then identify the hypoglycemia risk level based on the decline rate and decline acceleration. If the current blood glucose decline rate is less than the preset decline rate threshold and the decline acceleration is greater than the preset decline acceleration threshold, it is judged as low risk; if the decline rate is greater than or equal to the preset decline rate threshold, but the decline acceleration is greater than the preset decline acceleration threshold, it is judged as medium risk, and the risk prompt is recorded; if the decline rate is greater than or equal to the preset decline rate threshold, and the decline acceleration is less than or equal to the preset decline acceleration threshold, it is judged as high risk, and the risk prompt is recorded.

[0048] In some embodiments, the risk prompt may specifically include a voice prompt, and accordingly, the device also includes a voice playback unit.

[0049] Furthermore, the above-mentioned sixth judgment unit is also configured to obtain the most recent M historical records of applied pulse voltage when it is judged to be medium risk or high risk, and judge whether the number of times it is judged to be medium risk or the number of times it is judged to be high risk is greater than or equal to a preset number threshold. If so, the fifth judgment unit is triggered to obtain the most recent N historical records of applied pulse voltage, and adjust the pulse parameters according to the record. The specific adjustment principle can be referred to the description part of the fifth judgment unit, which will not be repeated here.

[0050] In some embodiments, the transdermal drug delivery module includes two operating modes: one is an early intervention mode, and its corresponding operating principles refer to the descriptions of the second to sixth judgment units or the data processing method in the subsequent embodiment 5; the other is a conventional intervention mode, and its corresponding operating principles refer to the descriptions of the first judgment unit, the first calculation unit, and the second calculation unit. Of course, the two operating modes can be selected by the user.

[0051] In some embodiments, the electroporation electrodes 8 adopt a gradient interdigital structure, or the electroporation electrodes are arranged in a circular array, see Figure 8 Its thickness is 60 μm, 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 This is a fluorescence image at 20V / 1 ms. The green fluorescence represents the insulin delivery effect. It can be seen that under this voltage parameter, the transdermal delivery depth of insulin is shallow and the amount is small. Figure 3B This is a fluorescence image at 30 V / 5 ms. Under this voltage parameter, the transdermal delivery depth of insulin is deeper and the amount is greater.

[0052] In some embodiments, the drug-loaded 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 adopts a sodium alginate and calcium chloride crosslinking system, or a chitosan-sodium glycerophosphate temperature-sensitive system; or adopts a double-layer structure, one layer of which is a pH-responsive polyacrylic acid hydrogel and the other layer is a temperature-sensitive poloxamer hydrogel, and the electroporation electrode 8 in the transdermal drug delivery module is embedded between the two layers.

[0053] Preferably, the size of the drug-loaded hydrogel 7 is designed to be 4 cm in length, 3 cm in width, and 0.3 cm in thickness, which can stably load insulin and achieve drug delivery.

[0054] In some embodiments, the data processing unit, judgment unit, first calculation unit, second calculation unit, and pulse generation unit are integrated onto a flexible integrated circuit board (FIC) serving as circuit control module 2. The FIC possesses multi-mode control capabilities, enabling independent regulation of the constant current / constant voltage outputs of the electrochemical electrodes (i.e., extraction electrode 5 and working electrode 6) and the pulse voltage parameters of the electroporation electrode 8.

[0055] In some embodiments, the non-invasive insulin delivery device further includes a wireless communication module connected to the data processing unit, configured to transmit the current blood glucose concentration calculated by the data processing unit to a user's mobile terminal and / or transmit pulse parameters received from the user's mobile terminal to the pulse generating unit. For example, the wireless coil supports Bluetooth data transmission, enabling real-time communication with external devices.

[0056] In some embodiments, the transdermal drug delivery module further includes: a parameter adjustment unit, configured to dynamically adjust drug delivery parameters according to historical drug delivery data of the current user stored in a database.

[0057] In other embodiments, the non-invasive insulin delivery device further includes a reference electrode. In some embodiments, the overall dimensions of the noninvasive treatment device are optimized to 5 cm long, 4 cm wide, and 2.5 cm high. The bottom cover 4 and top cover 1 are connected via a snap-fit ​​connection to encapsulate the internal module. A central opening is provided in the bottom cover 4, allowing the drug-loaded hydrogel 7, extraction electrode 5, and working electrode 6 to directly contact the skin surface. The removable gel module 3 utilizes a modular design, allowing for convenient replacement of the hydrogel or maintenance of the electrodes after the top cover 1 and bottom cover 4 are separated. The electroporation electrode 8 fits snugly above the drug-loaded hydrogel 7, synergistically enhancing the transdermal delivery of insulin through a pulsed electric field.

[0058] Working principle: The extraction electrode 5 first non-invasively extracts subcutaneous tissue fluid through counter-ion electroosmosis technology, and the data processing unit and working electrode 6 analyze the blood glucose concentration in real time; when a high blood glucose signal is detected, the electroporation electrode 8 immediately applies a pulse voltage to instantaneously open the skin stratum corneum barrier 9, and at the same time drive the insulin in the drug-loaded hydrogel 7 to efficiently penetrate into the dermis 10 under the action of the electric field.

[0059] This noninvasive drug delivery device integrates reverse ion electroosmosis monitoring and electroporation drug delivery technology, eliminating the need for skin puncture and significantly reducing patient pain. The device features a compact design, only 2.5 cm thick, and incorporates a wireless intelligent control module, combining high-precision monitoring, noninvasive treatment, and wearable comfort. It effectively addresses the invasiveness and operational complexity of traditional blood glucose monitors and insulin pumps.

[0060] Example 1: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), which includes the above-mentioned components, wherein the drug-loaded hydrogel 7 uses bacterial cellulose hydrogel and chitosan, wherein the chitosan concentration is 1%, and its dimensions are designed to be 4 cm long, 3 cm wide, and 0.3 cm thick, which can stably load insulin and achieve drug delivery.

[0061] Among them, the electroporation electrode 8 is made into a cross-finger structure through a flexible circuit board printing process, with a thickness of 60 μm and a coverage area slightly smaller than the drug-loaded hydrogel. When working, a pulse voltage of 30 V / 50 ms is applied to the skin to enhance the transdermal penetration efficiency.

[0062] Example 2: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), which includes the above-mentioned components, wherein the drug-loaded hydrogel adopts a chitosan-sodium glycerophosphate temperature-sensitive system, and the dimensions are adjusted to 3.5 cm long × 2.5 cm wide × 0.2 cm thick; the electroporation electrodes are arranged in a circular array, and the applied pulse voltage is adjusted to 20 V / 100 ms.

[0063] The top cover 1 and the bottom cover 4 are fixed by magnetic attraction. Specifically, the bottom cover 4 is provided with a magnetic ring corresponding to the top cover 1 .

[0064] The constant current of the extraction electrode 5 is 40 μA, and the constant voltage of the working electrode 6 is -0.3 V.

[0065] When preparing the hydrogel, 2% chitosan solution and 10% sodium glycerol phosphate were mixed in a volume ratio of 3:1 to form a thermoreversible gel at 37°C, with an insulin loading capacity of 25 IU / cm³.

[0066] The thickness of the flexible circuit board is 50 μm, and the distance between the interdigitated electrodes is 200 μm to improve the uniformity of the electric field. Figure 3A and Figure 3BAs shown, fluorescence images of the delivery depth of insulin under the electroporation parameters of Example 1 and Example 2 were obtained by fluorescence detection.

[0067] Example 3: This example provides a non-invasive insulin delivery device (or non-invasive blood glucose monitoring device), the structure and function of which are consistent with those of 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-nanocellulose composite material, with a thickness reduced to 0.15 cm and an oxygen permeability increased by 40%. The electroporation electrode adopts a gradient interdigital width design (50 μm in the center and gradually increasing to 200 μm at the edge), and applies 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 a working electrode scanning range of -0.1 V to +0.5 V, and a 50 Hz alternating current applied synchronously to the extraction electrode. The package is fully coated with medical-grade silicone, and the waterproof level reaches IP68.

[0068] Example 4: This example provides a noninvasive insulin delivery device (or noninvasive blood glucose monitoring device). Its structure and functionality are consistent with Example 1, but this example utilizes a dual-hydrogel layer structure: an upper layer of pH-responsive polyacrylic acid hydrogel (0.1 cm thick) and a lower layer of temperature-sensitive poloxamer hydrogel (0.2 cm thick). An electroporation electrode is embedded between the two layers, applying amplitude-modulated pulses (fundamental wave 30 V / 50 ms superimposed on a 10 kHz carrier). The circuit control module includes an impedance monitoring unit, providing real-time feedback on skin condition adjustment parameters. Electrochemical detection utilizes a three-electrode system, with the addition of a reference electrode to enhance measurement accuracy. Fuzzy PID control is implemented for the drawn current (set value 60 μA ± 5%), and the working electrode is maintained at a constant potential of -0.4 V in conjunction with AC impedance spectroscopy.

[0069] Example 5: Based on the above non-invasive blood glucose monitoring device, the present invention also provides a blood glucose data processing method. Specifically, see Figure 5 , the data processing method includes: S101 obtains the blood glucose concentration value monitored in real time by the non-invasive blood glucose detection module.

[0070] 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.

[0071] S102 determines whether the current blood glucose concentration value is greater than or equal to the preset early warning threshold value. If so, execute step S103; otherwise, execute step S101.

[0072] In order to avoid the problem of a longer hyperglycemia window period caused by controlling the device to generate a corresponding pulse voltage only when the warning threshold for drug administration is detected, in this embodiment, an early warning threshold is set as a trigger mechanism.

[0073] In some embodiments, the current working mode can be set in advance in the device, one is the fasting mode and the other is the post-meal mode; accordingly, different early warning thresholds are set in advance for the fasting mode and the post-meal mode (specifically, the early warning threshold is less than the aforementioned warning threshold).

[0074] In some embodiments, the preset early warning threshold value has a value range of [early warning threshold value -2.24 mmol / L, early warning threshold value -0.84 mmol / L], thereby ensuring sufficient time for trend analysis while preventing the subsequent mechanism from being triggered too early.

[0075] For example, in a patient with long-standing type 2 diabetes, the device is typically controlled to generate a corresponding pulse voltage only when the fasting blood glucose concentration reaches 7 mmol / L (early warning threshold I), or the postprandial blood glucose concentration reaches 10 mmol / L (early warning threshold II). 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 initiates the subsequent "prediction process," i.e., steps S103-S105.

[0076] For example, in newly diagnosed type 2 diabetes patients, the device will only generate the corresponding pulse voltage when the fasting blood glucose concentration reaches 11 mmol / L (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," namely steps S103-S105.

[0077] When the user's blood sugar concentration is on an upward trend for a period of time, the device is controlled in advance to generate corresponding pulse parameters, so that the device generates corresponding pulse voltage based on the pulse parameters to achieve early intervention and reduce the window period of high blood sugar.

[0078] Using algorithms like neural networks to achieve this "prediction" would not only require a large amount of training data but would also significantly increase the cost of the equipment, which would inevitably increase patients' medical costs and hinder product promotion. Therefore, to balance cost and accuracy, this embodiment uses a combination of blood sugar rises over a period of time to perform "prediction." For details, see the following description.

[0079] S103 calculates the difference ΔG between the two.

[0080] 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 When the duration T of the state is greater than or equal to the preset time T0, step S104 is executed; otherwise, step S101 is executed.

[0081] S105 calculates the rising rate and acceleration of the blood sugar concentration based on the multiple sugar concentration values ​​monitored during the duration T.

[0082] In some embodiments, the least squares method (which is an existing technology and has a simple calculation method and does not significantly increase the power consumption of the device) can be used to perform linear fitting on multiple blood glucose concentration values ​​within the duration T (for example, 10 min-15 min). This algorithm is an existing technology and will not be described in detail here. Its calculation method is simple and does not significantly increase the power consumption of the device.

[0083] In some embodiments, the blood glucose acceleration within the duration T (e.g., 10 min-15 min) can be calculated using a quadratic derivative or differential method. This algorithm is a prior art and will not be described in detail here. The calculation method is simple and will not significantly increase device power consumption.

[0084] S106 determines 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 so, execute step S107, otherwise, execute step S101.

[0085] 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 comparison table pre-stored in the database based on the target value.

[0086] In some embodiments, a large number of clinical trial tests are conducted in advance to obtain the required insulin dosage for different blood glucose concentrations and the pulse parameters required for different insulin dosages, thereby obtaining a pulse parameter relationship correspondence table corresponding to different blood glucose concentration values ​​(obtaining the correspondence between blood glucose concentration values ​​and pulse parameters through testing is a prior art and is not the focus of this application, so it will not be repeated here).

[0087] In some embodiments, because 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 blood glucose level is greater than or equal to the early warning threshold would inevitably increase the device's computational workload, thereby increasing power consumption and making it prone to misjudgment. 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 values ​​is calculated. Only when this difference is greater than or equal to the preset difference threshold, i.e., exceeds the preset early warning threshold by a certain degree, and this state persists for a period of time T (e.g., 5-15 minutes), and during this period, the blood glucose concentration shows an upward trend—for example, when 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), is the device controlled to match the corresponding pulse parameters to the current blood glucose concentration value, thereby generating the corresponding pulse voltage.

[0088] In this embodiment, since the early warning threshold is used as a benchmark and the user's blood glucose concentration changes dynamically, in order to eliminate the interference of small fluctuations, the difference threshold ΔG is set. th The duration threshold is set to determine the stability of the user's blood sugar rising trend; the rate threshold is set to identify the risk of rapid rise, and the acceleration threshold is set to predict a steep rise trend that is about to get out of control.

[0089] In this embodiment, judging the rising rate and acceleration can better reflect the individual metabolic dynamics characteristics compared to using a fixed threshold.

[0090] Of course, further, since fasting and postprandial blood glucose concentrations and their changing patterns are different, different thresholds are set for fasting and postprandial states, respectively. All of 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 and will not be elaborated here.

[0091] Furthermore, on the one hand, in order to verify whether the pulse parameter settings are reasonable, on the other hand, the physiological state of the user changes at different times or stages. Therefore, it is necessary to determine whether the pulse parameters need to be adjusted based on the hypoglycemic effect after each administration. Figure 6 , this embodiment further includes the steps of: S201 obtains the most recent N historical records of applied pulse voltages and executes step S202.

[0092] In some embodiments, the above-mentioned historical pulse voltage application record includes the blood glucose concentration observation value after a first specified observation period T2 (for example, 15 minutes) after each pulse voltage application, for example, the actual blood glucose concentration value 15 minutes after the pulse voltage application, which is used for subsequent judgment of whether the pulse parameters are reasonable (as mentioned above, different dosages correspond to different pulse parameters through a large number of clinical trials, and therefore, judging whether the pulse parameters are reasonable is actually judging whether the amount of insulin is appropriate).

[0093] S202 calculates the absolute value of the deviation value between each blood glucose concentration observation value and the corresponding preset expected blood glucose concentration value, and performs step S203.

[0094] Generally, after the pulse voltage is applied, the blood glucose concentration of the user will decrease to a certain extent under the action of the insulin, but due to different reactions of different users to the insulin and different physiological states in different periods, the actual blood glucose concentration value after a period of time after the administration may not achieve the expected effect, for example, less than or greater than the preset expected blood glucose concentration value.

[0095] In some embodiments, each drug has its standard drug effect, for example, how much the blood glucose decreases after how much time of taking the insulin, which is the prior art and will not be described here. Accordingly, the expected blood glucose concentration value is the difference between the current blood glucose concentration value before the pulse parameter is applied and the decrease value corresponding to the drug effect.

[0096] S203 calculates the mean value of the N deviation values and judges whether the mean value is greater than or equal to a preset deviation threshold value; if the mean value is greater than the preset deviation threshold value, step S204 is performed; otherwise, step S201 is performed.

[0097] In some embodiments, if the mean value is greater than the preset deviation threshold value, it indicates that the blood glucose concentration observation values obtained after continuous multiple administrations deviate from the expected blood glucose concentration value by a large margin, that is, the amount of administration may be insufficient or too little, and therefore, the pulse parameters need to be adjusted, that is, step S204 is performed. Wherein, the value of N is an empirical value 5.

[0098] S204 adjusts the pulse parameters according to the mean value, and the relationship between the pulse parameter change amount Y and the mean value X is , 0.5 < X < 1.5. k

[0099] ​In some embodiments, since the absolute value is calculated in step S202, if each observed blood glucose concentration value is lower than the expected blood glucose concentration value (or a predetermined number of times, for example, three observed blood glucose concentration values ​​are lower than their corresponding expected blood glucose concentration values), it indicates that the drug dosage is too large or the user is highly sensitive to the drug, and therefore, the pulse parameter is decreased. Similarly, if each observed blood glucose concentration value is higher than the expected blood glucose concentration value (or a predetermined number of times, for example, three observed blood glucose concentration values ​​are higher than their corresponding expected blood glucose concentration values), it indicates that the drug dosage is too small or the user is less sensitive to the drug, and therefore, the pulse parameter is increased.

[0100] 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 sugar data monitored by the non-invasive blood sugar detection module within a period of time after each pulse voltage is applied, and to infer whether the user is at risk of hypoglycemia based on this data, and to verify whether the above pulse parameters are reasonable. Figure 7 In some other embodiments, the method further comprises the steps of: S301 obtains multiple blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within the second specified observation time period T3, and executes step S302.

[0101] In some embodiments, the second designated observation time period T3 is smaller than the first designated observation time period T2, for example, 10 min-15 min.

[0102] S302 calculates the blood sugar decrease rate and decrease acceleration based on the acquired multiple blood sugar concentration values.

[0103] In some embodiments, the above-mentioned decline rate can also be obtained by performing linear fitting on all blood glucose concentration values ​​within the specified observation time period T3 using the least squares method. This algorithm is a prior art and will not be described in detail here.

[0104] In some embodiments, the descent acceleration may also be calculated using a quadratic derivative or differential method. This algorithm is a prior art and will not be described in detail here.

[0105] S303 determines the risk level of hypoglycemia based on the falling rate and falling acceleration. If the current blood sugar drop rate is less than the preset drop rate threshold and the drop acceleration is greater than the preset drop acceleration threshold, the blood sugar is slowly and steadily dropping, and therefore, it is determined to be low risk, and step S101 is executed; If the rate of decline is greater than or equal to the preset rate of decline threshold, but the acceleration of decline is greater than the preset acceleration of decline threshold, it means that blood sugar is declining rapidly but not accelerating. Therefore, it is judged as medium risk and a risk warning is given (for example, "There is a risk of hypoglycemia, please eat as soon as possible"), and the risk level is recorded; If the rate of decrease is greater than or equal to the preset rate of decrease threshold, and the acceleration of decrease is less than or equal to the preset acceleration of decrease threshold, it means that blood sugar is decreasing rapidly and accelerating. Therefore, it is judged as high risk and a risk warning is issued (for example, "High risk of hypoglycemia, please eat immediately"), and the risk level is recorded.

[0106] In some embodiments, the preset decrease rate threshold is a clinical experience value of 1.1 mg / dL / min-1.5 mg / dL / min.

[0107] In some embodiments, the preset descending acceleration threshold is a clinical experience value (-0.3 mg / dL / min²) - 0.5 mg / dL / min².

[0108] Furthermore, the blood glucose data processing method of this embodiment further includes the steps of: S304 obtains the most recent M historical records of applied pulse voltages and determines whether the number of times it is judged as high risk or the number of times it is judged as medium risk is greater than or equal to a preset number threshold. If so, execute steps S201-S204.

[0109] In this embodiment, M times is actually one adjustment cycle, that is, before the 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.

[0110] It should be noted that, in this document, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0111] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A blood glucose data processing method for a non-invasive blood glucose monitoring device, characterized in that: The non-invasive blood glucose monitoring device includes 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, wherein the drugs include insulin; and a transdermal drug delivery module connected to the drug loading module for generating a corresponding pulse voltage based on preset pulse parameters. Accordingly, the blood glucose data processing method specifically includes the following steps: S101 obtains the blood glucose concentration value G monitored in real time by the non-invasive blood glucose detection module, and executes step S102; S102 determines whether the current blood glucose concentration value G is greater than or equal to the preset early warning threshold value G th If yes, go to step S103, otherwise go to step S101; S103 Calculate the current blood glucose concentration G and the preset early warning threshold G th The difference △G is obtained, and step S104 is executed; S104: Determine whether the difference ΔG is greater than or equal to a preset difference threshold ΔG. th , and the difference △G is greater than or equal to the preset difference threshold △G th When the duration T of the state is greater than or equal to the preset time threshold T0, step S105 is executed, otherwise step S102 is executed; S105 calculates the rate of increase and acceleration of the blood glucose concentration based on the multiple blood glucose concentration values ​​monitored during the duration T; wherein the rate of increase is obtained by linearly fitting the multiple blood glucose concentration values ​​during the duration T using the least squares method; and the acceleration is obtained by calculating the multiple blood glucose concentration values ​​during the duration T using the second derivative or difference method; S106: Determine 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, execute step S107; S107 outputs the current blood sugar concentration value as the target value.

2. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 1, characterized in that: Also includes the steps: S201 obtains the most recent N historical records of applied pulse voltages, wherein the historical records include the observed blood glucose concentration value after a first designated observation period T2 after each application of the pulse voltage; S202 calculates the absolute value of the deviation between each of the observed blood glucose concentration values ​​and the corresponding preset expected blood glucose concentration value; S203 calculates the mean of the 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, executes step S204; S204 adjusts the pulse parameter according to the mean value. The relationship between the pulse parameter change Y and the mean value X is: , 0.5< k ≤1.5, go to step S102.

3. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 2, characterized in that: Also includes the steps: S301: obtaining a plurality of blood glucose concentration values ​​monitored by the non-invasive blood glucose detection module within a second designated observation time period T3; S302: Calculating the blood sugar decrease rate and decrease acceleration based on the acquired multiple blood sugar concentration values; S303 identifies the hypoglycemia risk level based on the falling rate and falling acceleration. If the current blood sugar drop rate is less than the preset drop rate threshold and the drop acceleration is greater than the preset drop acceleration threshold, it is determined to be low risk and step S101 is executed; 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 and a risk warning is issued and recorded; 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, and a risk warning is issued and recorded.

4. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 3, characterized in that: When the risk is determined to be medium or high, the following steps are also included: S304 obtains the most recent M historical records of applied pulse voltages and determines whether the number of times it is determined to be medium risk or the number of times it is determined to be high risk is greater than or equal to a preset number threshold. If so, execute steps S201-S204.

5. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 3, characterized in that: The preset rate threshold is 1.5 mg / dL / min-2 mg / dL / min.

6. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 1, characterized in that: 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 equipment according to claim 3, characterized in that: The preset decline rate threshold is 1.1 mg / dL / min-1.5 mg / dL / min.

8. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 3, characterized in that: The preset descending acceleration threshold is (-0.3 mg / dL / min²)-0.5 mg / dL / min².

9. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 1, characterized in that: The non-invasive blood glucose detection module includes: An extraction electrode for non-invasively extracting glucose from interstitial fluid based on reverse ion electroosmosis technology; a working electrode, configured to convert the glucose concentration extracted by the extraction electrode into a corresponding electrical signal; A data processing unit is electrically connected to the extraction electrode and the working electrode, and is used to apply a constant current to the extraction electrode and a constant voltage to the working electrode; and calculate the current glucose concentration based on the electrical signal converted by the working electrode.

10. The blood glucose data processing method for non-invasive blood glucose monitoring equipment according to claim 1, characterized in that: The drug-carrying module is a hydrogel and is connected to the extraction electrode and the working electrode.

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