Device control method, insulin infusion device, program product and closed loop infusion system

Abstract

The application relates to a device control method, an insulin infusion device, a program product and a closed-loop infusion system, which are applied to an insulin infusion device, the insulin infusion device comprising a touch screen, at least one memory and at least one processor, the touch screen being used for receiving user input, the memory storing executable instructions, and the processor being used for executing the executable instructions to realize the following method: monitoring whether a blood glucose influencing event occurs during operation of a closed-loop operation mode; the blood glucose influencing event comprises an event that a user's blood glucose level deviates from a target blood glucose range of a control parameter due to device operation and / or user activity; in the case that it is determined that the blood glucose influencing event occurs, triggering a safety protection program; and performing safety management on the closed-loop operation mode of the insulin infusion device through the safety protection program.

Description

Technical Field

[0001] This application relates to the field of medical technology, and in particular to a device control method, an insulin infusion device, a programmed product, and a closed-loop infusion system. Background Technology

[0002] Diabetes mellitus is a common metabolic endocrine disorder caused by the pancreas's inability to produce sufficient insulin, leading to hyperglycemia, or excessive glucose in the blood plasma. Currently, there is no cure for diabetes; external insulin infusion remains the most effective method for controlling blood sugar.

[0003] In related technologies, insulin infusion devices use a closed-loop operation mode to simulate an artificial pancreas for infusion control. However, some events that occur during closed-loop operation, such as device malfunctions and user hypoglycemia, affect the operational safety of the closed-loop mode. How to manage the safety of the closed-loop operation mode is an urgent problem to be solved. Summary of the Invention

[0004] Therefore, it is necessary to provide a device control method, insulin infusion device, program product, and closed-loop infusion system that can improve the safety management of closed-loop operation mode in response to the above-mentioned technical problems.

[0005] In a first aspect, this application provides a device control method applied to an insulin infusion device. The insulin infusion device includes a touch screen, at least one memory, and at least one processor. The touch screen is used to receive user input, the memory stores executable instructions, and the processor executes the executable instructions to implement the following method:

[0006] In response to the user's first interactive operation on the parameter graphic element displayed on the touch screen, the control parameters input by the user are obtained;

[0007] In response to a second interactive operation by the user on the device connection graphic element displayed on the touch screen, a communication connection is established with the blood glucose monitoring device through the second interactive operation to receive the blood glucose measurement value sent by the blood glucose monitoring device;

[0008] In response to the user's third interactive operation of the graphical element in response to the mode displayed on the touch screen, the closed-loop operation mode is initiated through the third interactive operation; wherein, the activation of the closed-loop operation mode is prohibited if no communication connection is established with the blood glucose monitoring device.

[0009] In closed-loop operation mode, the insulin infusion device is controlled to operate in the corresponding infusion mode based on blood glucose measurement values, historical infusion data and control parameters;

[0010] Monitor whether blood glucose-affecting events occur during the operation of the closed-loop operation mode; blood glucose-affecting events include events that cause the user's blood glucose level to deviate from the target blood glucose range of the control parameters due to equipment operation and / or user activities;

[0011] In the event that a blood glucose-impacting event has been identified, the safety protection procedure is triggered.

[0012] Safety management of the closed-loop operation mode of insulin infusion equipment is achieved through safety protection procedures.

[0013] Secondly, this application also provides an insulin infusion device, which includes a touch screen, at least one memory and at least one processor. The memory stores executable instructions, and the processor executes the executable instructions to implement the device control method described above.

[0014] Thirdly, this application also provides a program product that, when executed by a processor, implements the above-described device control method.

[0015] Fourthly, this application also provides a closed-loop infusion system, which includes the insulin infusion device described above.

[0016] The aforementioned device control method, insulin infusion device, program product, and closed-loop infusion system can respond to a user's first interactive operation on the parameter graphic element displayed on the touch screen, acquire user-input control parameters, and use these control parameters to initiate or maintain the closed-loop operation mode of the insulin infusion device. Furthermore, in response to a user's second interactive operation on the device connection graphic element displayed on the touch screen, a communication connection is established with the blood glucose monitoring device to receive blood glucose measurement values ​​sent by the monitoring device. Additionally, in response to a user's third interactive operation on the mode activation graphic element displayed on the touch screen, the closed-loop operation mode is initiated. Thus, the insulin infusion device can be controlled intuitively and efficiently via the touch screen, and the closed-loop operation mode can be initiated. Furthermore, since the activation of the closed-loop operation mode is prohibited without establishing a communication connection with the blood glucose monitoring device, the reliability of initiating the closed-loop operation mode is improved. Furthermore, in closed-loop operation mode, the system can control the insulin infusion device to operate in the corresponding infusion mode based on blood glucose measurements, historical infusion data, and control parameters. It also monitors for blood glucose-affecting events during closed-loop operation. If such an event is detected, a safety protection procedure is triggered to manage the closed-loop operation mode of the insulin infusion device. Blood glucose-affecting events include those caused by device operation and / or user activity that lead to the user's blood glucose level deviating from the target range of the control parameters. This allows for timely response to blood glucose-affecting events, thereby efficiently managing the closed-loop operation mode and improving its safety. Attached Figure Description

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

[0018] Figure 1 This is a schematic diagram of the structure of an insulin infusion device in one embodiment;

[0019] Figure 2 This is a flowchart illustrating a device control method in one embodiment;

[0020] Figure 3 This is a flowchart illustrating a temporary basal rate infusion mode in one embodiment;

[0021] Figure 4This is a flowchart illustrating another implementation of a temporary basal rate infusion mode in one embodiment;

[0022] Figure 5 This is a schematic diagram of a process for setting a large infusion dose in one embodiment;

[0023] Figure 6 This is a schematic diagram of a high-dose infusion mode in one embodiment;

[0024] Figure 7 This is a flowchart illustrating yet another device control method in one embodiment;

[0025] Figure 8 This is a schematic diagram of a menu page in one embodiment;

[0026] Figure 9 This is a schematic diagram of yet another menu page in one embodiment;

[0027] Figure 10 This is a schematic diagram of yet another menu page in one embodiment;

[0028] Figure 11 This is a schematic diagram of a CGM settings interface in one embodiment;

[0029] Figure 12 This is a schematic diagram of the binding mode in one embodiment;

[0030] Figure 13 This is a control parameter setting interface in one embodiment. Detailed Implementation

[0031] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0032] Figure 1 This is a schematic diagram of an insulin infusion device in one embodiment. The device control method provided in this embodiment can be applied to... Figure 1 In the insulin infusion device shown. For example... Figure 1 As shown, the insulin infusion device 100 includes a touch screen 101, at least one memory 102, and at least one processor 103.

[0033] The touch screen 101 is used to receive user input, that is, for human-computer interaction. The touch screen 101 can be implemented using display elements such as liquid crystal display (LCD), light emitting diode (LED) display, and active-matrix organic light emitting diode (AMOLED).

[0034] Memory 102 stores executable instructions. Memory 102 can be volatile memory or non-volatile memory, or it can include both volatile and non-volatile memory. The non-volatile memory can be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), or flash memory. The volatile memory can be random access memory (RAM), which is used as an external cache.

[0035] When processor 103 executes executable instructions in memory, it can implement the following device control method. Processor 103 includes, but is not limited to, at least one of a central processing unit (CPU), a digital signal processor (DSP), a field-programmable gate array (FPGA), or other programmable logic device.

[0036] Figure 2 This is a flowchart illustrating a device control method in one embodiment. In an exemplary embodiment, such as... Figure 2 As shown, a device control method is provided, which is applied to... Figure 1 Taking the processor in an insulin infusion device as an example, that is, when the processor executes executable instructions, it is used to implement the following steps S201 to S207.

[0037] S201, in response to the user's first interactive operation on the parameter graphic element displayed on the touch screen, obtains the control parameters input by the user.

[0038] In this embodiment, the touchscreen can display graphic elements, such as function icons. These graphic elements can be pre-set or user-defined. Optionally, each graphic element can be associated with a function and / or application (app) provided by the insulin infusion device.

[0039] Graphical elements include parametric graphical elements. Therefore, the user can initiate a first interactive operation on the parametric graphical elements displayed on the touchscreen. This first interactive operation may include, but is not limited to, touch input such as gesture touch, capacitive stylus touch, or other non-touch input. Other interactive operations described below are similar and will not be elaborated upon further.

[0040] For example, a user can tap a parameter graphic element displayed on the touchscreen and input control parameters via the touchscreen to initiate a first interactive operation. The processor can then respond to the first interactive operation and obtain the control parameters input by the user.

[0041] The control parameters are used to initiate or maintain the closed-loop operation mode of the insulin infusion device. These control parameters can also be understood as the parameters required to operate in the closed-loop mode. The control parameters include at least the target blood glucose range, which represents the desired range of the user's blood glucose measurement. Optionally, the target blood glucose range may include the upper and lower limits of the ideal blood glucose measurement, for example, a target blood glucose range of 90 mg / dL - 120 mg / dL.

[0042] Further optionally, the control parameters may include at least one of the following: duration of insulin action (DIA), target blood glucose (BG), insulin carbohydrate ratio (ICR), and insulin sensitivity factor (ISF).

[0043] Alternatively, the control parameters provided in this embodiment may include, for example, insulin sensitivity coefficient, daily insulin requirement, insulin limit, reference basal rate, reference fasting blood glucose, duration of action of active insulin, drug effect time constant, target blood glucose range, weight parameters, etc.

[0044] Control parameters may also include those used to automatically adjust the operating mode of the insulin infusion device in a personalized manner based on the current or real-time operating context (e.g., time of day, day of week, patient location, patient activities or behaviors, etc.), such as control targets or references for closed-loop operation modes. For example, based on the analysis of the relationship between the patient's historical blood glucose measurements during operation in closed-loop mode and corresponding blood glucose-affecting events, the correlation between specific blood glucose-affecting events and the patient's abnormal physiological state or condition, such as hyperglycemia (or hyperglycemia) events (e.g., glucose levels above a threshold), hypoglycemia (or hypoglycemia) events (e.g., glucose levels below a threshold), blood glucose abnormalities, etc. In this respect, events in which the user's blood glucose level deviates from the target blood glucose range of the control parameters due to device operation and / or user activities are improved by the device control method proposed in this application.

[0045] Insulin infusion devices have two control modes: closed-loop and open-loop. Open-loop mode refers to the control mode where the insulin infusion device adjusts the infusion mode according to a preset or user-defined method. Closed-loop mode refers to the control mode where the insulin infusion device, in conjunction with a blood glucose monitoring device, automatically adjusts the infusion mode based on changes in blood glucose levels.

[0046] Insulin infusion modes control how the device operates. These modes include high-dose infusion, basal rate infusion, and infusion-stop. Infusion-stop mode pauses the infusion process. High-dose infusion mode delivers a large dose over a short period to meet the user's specific insulin needs during activities such as eating or exercise.

[0047] High-dose infusion modes can include conventional high-dose infusion, square wave infusion, or dual-wave infusion. Conventional high-dose infusion refers to an infusion mode where the entire dose is administered in one continuous infusion. For example, if an immediate infusion of 15 units (U) of insulin is required, the insulin infusion device can be controlled to execute conventional high-dose infusion mode to deliver the 15U in one continuous infusion. Square wave infusion mode refers to an infusion mode where a large dose is injected over a period of time. In other words, if a 15U infusion is required over 2 hours, the insulin infusion device can be controlled to execute square wave infusion mode to deliver the 15U infusion within 2 hours. Dual-wave infusion mode includes both conventional high-dose infusion and square wave infusion modes. For example, if a user needs an immediate infusion of 7U and a subsequent infusion of 5U over 2 hours, dual-wave high-dose infusion can be executed, allowing the insulin infusion device to deliver the 7U in one continuous infusion and the 5U over 2 hours.

[0048] Basal rate infusion mode refers to a continuous, low-volume infusion pattern over a certain period of time to maintain daily metabolism. Basal rate infusion modes can include standard basal rate infusion mode or temporary basal rate infusion mode. Standard basal rate infusion mode refers to a mode infused with the standard basal rate according to a preset period. Temporary basal rate infusion mode refers to a mode infused with the temporary basal rate according to a preset period.

[0049] S202, in response to a second interactive operation by the user on a device connection graphic element displayed on the touch screen, establishes a communication connection with the blood glucose monitoring device through the second interactive operation to receive blood glucose measurement values ​​sent by the blood glucose monitoring device.

[0050] In this embodiment, the graphical element further includes a device connection graphical element. Therefore, the user can initiate a second interactive operation on the device connection graphical element displayed on the touchscreen. The second interactive operation is used to establish a communication connection between the insulin infusion device and the blood glucose monitoring device. Thus, the processor can respond to the second interactive operation and establish a communication connection with the blood glucose monitoring device through the second interactive operation. The blood glucose monitoring device for which the communication connection is established can be a blood glucose monitoring device specified by the user, or a blood glucose monitoring device selected from multiple candidate blood glucose monitoring devices found in the search; this embodiment is not limited to this.

[0051] The blood glucose monitoring device includes, but is not limited to, continuous glucose monitors (CGMs). The blood glucose monitoring device is used to acquire the user's blood glucose measurement values. Furthermore, once a communication connection is established between the processor and the blood glucose monitoring device, the processor can receive the blood glucose measurement values ​​sent by the blood glucose monitoring device.

[0052] Optionally, the processor can receive blood glucose measurements from the blood glucose monitoring device in real time, or it can receive blood glucose measurements from the device periodically or non-periodically. For example, the processor can receive blood glucose measurements from the monitoring device every second; for instance, the processor can receive the user's blood glucose measurement 1 in the first second, blood glucose measurement 2 in the second second, blood glucose measurement 3 in the third second, and so on.

[0053] It is understood that the insulin infusion device and the blood glucose monitoring device can be connected via wired or wireless communication. Wired communication connections include, but are not limited to, Universal Serial Bus (USB) connections, serial communication connections, and Ethernet connections. Wireless communication interfaces include, but are not limited to, Bluetooth connections, Wireless Fidelity (WIFI) connections, and ZigBee connections; this embodiment is not limited to these.

[0054] S203, responding to the user's third interactive operation of the graphical element in response to the mode displayed on the touch screen, the closed-loop operation mode is started through the third interactive operation; wherein, the start of the closed-loop operation mode is prohibited if no communication connection is established with the blood glucose monitoring device.

[0055] In this embodiment, the graphics element also includes a device mode activation element. Therefore, the user can initiate a third interactive operation on the mode activation graphics element displayed on the touchscreen. The third interactive operation is used to activate a closed-loop operation mode. Thus, the processor can respond to the third interactive operation and activate the closed-loop operation mode accordingly.

[0056] Optionally, the processor can initiate a closed-loop operation mode in response to a user's third interactive operation of a graphical element based on a mode displayed on the touchscreen, provided that a communication connection has been established with the blood glucose monitoring device. More optionally, the processor can also initiate a closed-loop operation mode in response to a user's third interactive operation of a graphical element based on a mode displayed on the touchscreen, provided that a communication connection has been established with the blood glucose monitoring device but the closed-loop operation mode has not been initiated.

[0057] Furthermore, the processor will prevent the closed-loop operation mode from starting if a communication connection is not established with the blood glucose monitoring device.

[0058] Optionally, the processor may not respond to the third interactive operation if a communication connection is not established with the blood glucose monitoring device. In other words, if the user initiates a third interactive operation with the graphical element of the mode displayed on the touch screen without establishing a communication connection with the blood glucose monitoring device, the processor will not respond to the third interactive operation and will not execute the action to start the closed-loop operation mode, thereby preventing the start of the closed-loop operation mode.

[0059] Alternatively, the processor can adjust the background color of the mode startup graphic element when no communication connection is established with the blood glucose monitoring device. For example, the processor can adjust the background color of the startup graphic element to gray to remind the user that the closed-loop operation mode is currently prohibited.

[0060] S204, in closed-loop operation mode, controls the insulin infusion device to operate in the corresponding infusion mode based on blood glucose measurement values, historical infusion data and control parameters.

[0061] In this embodiment, when operating in closed-loop mode, the processor can automatically control the insulin infusion device to operate in the corresponding infusion mode based on blood glucose measurements, historical infusion data, and control parameters. The historical infusion data indicates the historical infusion history of the insulin infusion device, which may include the infusion history of the insulin infusion device within a historical time period prior to the current moment. The historical time period can be set according to actual needs. For example, the historical infusion data may indicate when and how much insulin the insulin infusion device infused within two days prior to the current moment.

[0062] Optionally, the processor can control the insulin infusion device to operate in the corresponding infusion mode based on control parameters, the current blood glucose measurement value, and historical infusion data before the current time.

[0063] Optionally, a first correspondence can be established between blood glucose measurements, historical infusion data, control parameters, and infusion modes. This first correspondence may include, but is not limited to, a mathematical expression or mathematical model. Then, the processor can determine the corresponding infusion mode based on the blood glucose measurements, historical infusion data, control parameters, and the aforementioned first correspondence.

[0064] Optionally, the processor can also input blood glucose measurements, historical infusion data, and control parameters into a first machine learning model, which will then output a corresponding infusion pattern to control the insulin infusion device to operate accordingly. The first machine learning model can be trained based on blood glucose measurement samples, historical infusion data samples, control parameter samples, and the corresponding infusion pattern.

[0065] For example, the first machine learning model may include, but is not limited to, at least one of the following: Convolutional Neural Networks (CNN), Recurrent Neural Networks (RNN), Fully Convolutional Neural Networks (FCN), Generative Adversarial Networks (GAN), Back-propagation (BP) machine learning models, Radial Basis Functions (RBF) models, Deep Belief Networks (DBN) models, Elman models, or combinations thereof. Other machine learning models described below are similar and will not be elaborated upon further.

[0066] S205, monitor whether a blood glucose-affecting event occurs during the operation of the closed-loop operation mode; blood glucose-affecting events include events that cause the user's blood glucose level to deviate from the target blood glucose range of the control parameters due to equipment operation and / or user activities.

[0067] In this embodiment, during the operation of the closed-loop mode, the processor is able to monitor blood glucose-affecting events. That is, the processor monitors whether at least one blood glucose-affecting event occurs during the operation of the closed-loop mode.

[0068] Specifically, blood glucose-affecting events include events that cause a user's blood glucose level to deviate from the target blood glucose range of the control parameters due to device operation and / or user activity. Device operation refers to the operation of the insulin infusion device and / or the blood glucose monitoring device. For example, blood glucose-affecting events may include user hypoglycemia events, blood glucose loss events, abnormal blood glucose events, and strong magnetic environment events.

[0069] Optionally, the processor can determine whether a blood glucose-affecting event occurs during the operation of the closed-loop mode by monitoring the operating status of the insulin infusion device and / or the blood glucose monitoring device. The processor can also determine whether a blood glucose-affecting event occurs during the operation of the closed-loop mode by monitoring blood glucose measurements. The processor can also monitor whether a blood glucose-affecting event occurs during the operation of the closed-loop mode based on user input; this embodiment is not limited to this.

[0070] S206, triggers the safety protection procedure upon confirmation of a blood glucose-affecting event.

[0071] In this embodiment, if the processor detects a blood glucose-affecting event during closed-loop operation, it will trigger a safety protection program. This safety protection program is a program that can run on the processor. After triggering the safety protection program, the processor can execute it.

[0072] Optionally, the safety protection program can be stored in a preset space. Upon determining that a blood glucose-affecting event has occurred, the processor can recall the safety protection program from the preset space to trigger it. In some embodiments, the safety protection program can also be installed in the insulin infusion device.

[0073] S207 uses a safety protection procedure to manage the closed-loop operation mode of insulin infusion equipment.

[0074] In this embodiment, the safety protection program is used to manage the closed-loop operation mode. That is, the safety protection program can handle events affecting blood glucose levels to restore the user's changed blood glucose level to the target range. Therefore, when the safety protection program is triggered, the processor can manage the closed-loop operation mode of the insulin infusion device. Optionally, managing the closed-loop operation mode may include closing the closed-loop operation mode or maintaining it. Maintaining the closed-loop operation mode includes maintaining or adjusting the infusion mode corresponding to the insulin infusion device.

[0075] In the aforementioned device control method, in response to a user's first interactive operation with the parameter graphic element displayed on the touchscreen, control parameters input by the user are acquired. These control parameters are used to initiate or maintain the closed-loop operation mode of the insulin infusion device. Furthermore, in response to a user's second interactive operation with the device connection graphic element displayed on the touchscreen, a communication connection is established with the blood glucose monitoring device to receive blood glucose measurement values ​​sent by the device. Additionally, in response to a user's third interactive operation with the mode activation graphic element displayed on the touchscreen, the closed-loop operation mode is initiated. Thus, the insulin infusion device can be controlled intuitively and efficiently via the touchscreen, and the closed-loop operation mode can be initiated. Furthermore, since the activation of the closed-loop operation mode is prohibited when a communication connection with the blood glucose monitoring device is not established, the reliability of initiating the closed-loop operation mode is improved. Furthermore, in closed-loop operation mode, the system can control the insulin infusion device to operate in the corresponding infusion mode based on blood glucose measurements, historical infusion data, and control parameters. It also monitors for blood glucose-affecting events during closed-loop operation. If an event is detected, a safety protection procedure is triggered to manage the closed-loop operation mode of the insulin infusion device. Since blood glucose-affecting events include those caused by device operation and / or user activity that lead to the user's blood glucose level deviating from the target range of the control parameters, the system can respond promptly to such events, thereby efficiently managing the closed-loop operation mode and improving its safety.

[0076] Figure 3 This is a flowchart illustrating a temporary basal rate infusion pattern in one embodiment. In an exemplary embodiment, such as... Figure 3 As shown, the processor is also used to implement the following steps S301 to S306:

[0077] S301 receives motion information collected by a motion sensor or input by the user.

[0078] In this embodiment, the processor is able to determine motion information. This motion information characterizes the user's movement and includes, but is not limited to, the user's movement state, duration, distance, speed, amount of movement, or trajectory.

[0079] Optionally, the processor can receive motion information acquired by a motion sensor. The motion sensor, for example, is an accelerometer.

[0080] Optionally, the processor can also receive motion information input by the user. For example, the user can input their own motion information via a touchscreen.

[0081] Furthermore, the processor can receive motion information acquired by motion sensors or input by the user during operation in closed-loop mode.

[0082] S302 determines whether a user motion event has occurred based on motion information.

[0083] In this embodiment, blood glucose-affecting events include user movement events, which refer to events where a user's blood glucose level drops outside the target range due to user movement. In other words, user movement events have an impact on blood glucose levels.

[0084] Then, the processor receives motion information and determines whether a user motion event has occurred based on the running information. For example, the processor can analyze the motion information and determine that a user motion event has occurred if the motion information meets the motion triggering conditions. Motion triggering conditions may include, for example, motion duration exceeding a preset motion duration, motion amount exceeding a preset motion amount, or the motion state being running, etc. This embodiment is not limited thereto.

[0085] S303: Upon determining that a user movement event has occurred, the security protection procedure is triggered.

[0086] Similar to the principle of S206, the processor can trigger the security protection program when a user motion event is determined to have occurred.

[0087] S304: Obtain the blood glucose measurement value at the current moment when the user's exercise event occurs, and determine the predicted blood glucose value based on the exercise information, blood glucose measurement value, and historical blood glucose data.

[0088] In this embodiment, upon triggering the security protection program, the processor can determine at least one predicted blood glucose value after a user's movement event occurs. In this embodiment, the predicted blood glucose value refers to the blood glucose value predicted based on the blood glucose measurement value of the user's movement event. Since user movement events affect future blood glucose levels, by managing the current user's activity event through the security protection program, and by determining the predicted blood glucose value based on the current blood glucose measurement value, movement information, and historical blood glucose data at the time of the user's movement event, the infusion dosage can be automatically adjusted according to blood glucose changes. This ensures the safe operation of the closed-loop infusion mode and addresses the impact of user movement events on blood glucose fluctuations.

[0089] In one embodiment, the processor can determine a predicted blood glucose value based on exercise information, the current blood glucose measurement, historical infusion data, and control parameters. The current blood glucose measurement can be the blood glucose measurement sent by the blood glucose monitoring device when the predicted blood glucose value needs to be determined. Optionally, a second correspondence can be established between exercise information, blood glucose measurement, historical infusion data, control parameters, and the predicted blood glucose value. This second correspondence can be, but is not limited to, a mathematical expression or mathematical model. Then, the processor can determine the predicted blood glucose value based on the exercise information, the current blood glucose measurement, historical infusion data, control parameters, and the aforementioned second correspondence.

[0090] The processor can also input motion information, current blood glucose measurements, historical infusion data, and control parameters into a second machine learning model, which will then output the corresponding predicted blood glucose value. The second machine learning model can be trained based on motion information samples, blood glucose measurement samples, historical infusion data samples, control parameter samples, and the corresponding predicted blood glucose value.

[0091] In one embodiment, the processor can also determine a predicted blood glucose value based on motion information, the current blood glucose measurement, and historical blood glucose data. The historical blood glucose data indicates the historical blood glucose status of the insulin infusion device, and may include, for example, the blood glucose status of the insulin infusion device within a historical time period prior to the current moment. The historical time period can be set according to actual needs. For example, the historical blood glucose data may include blood glucose measurements received within two days prior to the current moment.

[0092] For example, a third correspondence can be established between exercise information, blood glucose measurements, historical blood glucose data, and predicted blood glucose values. This third correspondence can be, but is not limited to, a mathematical expression or mathematical model. Then, the processor determines the predicted blood glucose value based on the exercise information, the current blood glucose measurement, historical blood glucose data, and the aforementioned third correspondence. Alternatively, the processor can input the exercise information, the current blood glucose measurement, and historical blood glucose data into a third machine learning model, which then outputs the corresponding predicted blood glucose value. The third machine learning model can be trained based on exercise information samples, blood glucose measurement samples, historical blood glucose data samples, and the corresponding predicted blood glucose values.

[0093] In one embodiment, the processor can also determine the predicted blood glucose value based on exercise information and historical blood glucose data. For example, a fourth correspondence can be established between exercise information, historical blood glucose data, and the predicted blood glucose value. This fourth correspondence can be, but is not limited to, a mathematical expression or mathematical model. Then, the processor determines the predicted blood glucose value based on the exercise information, historical blood glucose data, and the aforementioned fourth correspondence. Alternatively, the processor can input the exercise information and historical blood glucose data into a fourth machine learning model, which then outputs the corresponding predicted blood glucose value. The fourth machine learning model can be trained based on exercise information samples, historical blood glucose data samples, and the corresponding predicted blood glucose values.

[0094] S305 uses a safety protection procedure to determine the infusion dose of the temporary basal rate based on predicted blood glucose values ​​and control parameters.

[0095] Once the predicted blood glucose level after a user's movement event is determined, the processor can use a safety protection program to determine the infusion dose of the temporary basal rate based on the predicted blood glucose level and control parameters. For example, a correspondence can be established between the predicted blood glucose level, control parameters, and the infusion dose of the temporary basal rate, allowing the processor to determine the infusion dose of the temporary basal rate based on the predicted blood glucose level, control parameters, and this correspondence. This correspondence can be, but is not limited to, a mathematical expression or mathematical model.

[0096] S306 controls the insulin infusion device to operate in temporary basal rate infusion mode based on the infusion dose of temporary basal rate.

[0097] In this embodiment, after determining the infusion dose of the temporary basal rate, the processor can control the insulin infusion device to run the temporary basal rate infusion mode according to the infusion dose of the temporary basal rate. That is, the processor controls the insulin infusion device to infuse the temporary basal rate according to the infusion dose of the temporary basal rate to run the temporary basal rate infusion mode.

[0098] Understandably, the infusion dose of the temporary basal rate can change dynamically during the operation of the temporary basal rate infusion mode. For example, during the first 5 minutes, the processor can control the insulin infusion device to run the temporary basal rate infusion mode based on infusion dose A, and during the second 5 minutes, the processor can control the insulin infusion device to run the temporary basal rate infusion mode based on infusion dose B.

[0099] In the above embodiments, motion information collected by motion sensors or input by the user can be received, and it can be determined whether a user motion event has occurred based on the motion information. If a user motion event is determined, a safety protection program is triggered. Since the predicted blood glucose value after the user motion event is determined, and the infusion dose of the temporary basal rate is determined based on the predicted blood glucose value and control parameters through the safety protection program, the insulin infusion device can be controlled to operate in the temporary basal rate infusion mode according to the infusion dose of the temporary basal rate when a user motion event occurs. The infusion dose of the temporary basal rate can be adjusted in a timely manner, making the closed-loop operation mode suitable for the user's motion scenario. This is beneficial for restoring the user's blood glucose level to the target blood glucose range and improving safety.

[0100] Figure 4 This is a flowchart illustrating another implementation of a temporary base rate infusion mode in one embodiment. In an exemplary embodiment, such as... Figure 4 As shown, the processor is also used to implement the following S401 to S405:

[0101] S401 determines the predicted blood glucose value for the current moment based on historical blood glucose data.

[0102] Historical blood glucose data can include historical blood glucose data for any time period in the past. Optionally, the predicted blood glucose value at the current moment can be determined based on the blood glucose measurement value at the previous moment. For example, based on the blood glucose measurement value at 10:30, the predicted blood glucose value at 10:35 can be determined. It should be noted that the previous moment can be the moment immediately preceding the current moment, or the moment preceding the current moment at a preset interval; this embodiment is not limited to this.

[0103] The processor can determine the predicted blood glucose value based on the current blood glucose measurement, historical infusion data, and control parameters; alternatively, it can determine the predicted blood glucose value based on the current blood glucose measurement and historical blood glucose data, or it can determine the predicted blood glucose value based solely on historical blood glucose data. The method for determining the predicted blood glucose value can be found in S304, and will not be elaborated upon here.

[0104] S402, based on the difference between the current blood glucose measurement and the current blood glucose prediction, and / or the meal monitoring sensor worn by the user, determine whether a user meal event has occurred.

[0105] In this embodiment, blood glucose impact events include user meal events, which refer to events in which a user's blood glucose level rises outside the target blood glucose range due to a user's meal.

[0106] Optionally, the processor can determine whether a user meal event has occurred based on the difference between the current blood glucose measurement and the current predicted blood glucose value. The current predicted blood glucose value is determined based on historical blood glucose data. Continuing the example above, assuming the current time is 10:35 AM, the difference between the predicted blood glucose value and the measured blood glucose value at 10:35 AM can be used to determine whether a user meal event has occurred.

[0107] Optionally, the processor can determine that a user meal event has occurred if the difference between the current blood glucose measurement and the current blood glucose prediction is greater than a preset difference.

[0108] In some embodiments, the processor may also determine whether a user eating event has occurred based on a user-worn meal monitoring sensor. The meal monitoring sensor may include a bone conduction sensor and / or a lip movement monitoring sensor to determine whether a meal event has occurred by monitoring maxillary bone movement and / or lip movement.

[0109] In some embodiments, the meal monitoring sensor can be worn at a preset location such as the user's temple. For example, the meal monitoring sensor can send a meal signal to the processor when the vibration generated by the user exceeds a preset vibration threshold, so that the processor can determine that a user meal event has occurred based on the meal signal.

[0110] In some embodiments, the processor can also determine whether a user meal event has occurred based on the blood glucose difference value and the meal monitoring sensor worn by the user. For example, the processor can determine that a user meal event has occurred only if the blood glucose difference value is greater than a preset difference and a meal monitoring sensor sends a meal signal. This embodiment is not limited to this.

[0111] Furthermore, the processor can determine whether a user meal event has occurred during operation in closed-loop mode based on blood glucose differences and / or meal monitoring sensors worn by the user.

[0112] S403 triggers the security protection procedure upon confirming that a user has eaten.

[0113] Similar to the principle of S206, the processor can trigger the security protection program when a user motion event is determined to have occurred.

[0114] S404, through a safety protection procedure, determines the infusion dose of the temporary basal rate based on predicted blood glucose values ​​and control parameters.

[0115] In this embodiment, upon triggering the safety protection procedure, the processor can determine the infusion dose of the temporary basal rate based on the predicted blood glucose value and control parameters. The process for determining the infusion dose of the temporary basal rate can be referred to in S305, and will not be repeated here.

[0116] S405 controls the insulin infusion device to operate in temporary basal rate infusion mode based on the infusion dose of temporary basal rate.

[0117] The principle of S405 is the same as that of S306, and will not be repeated here.

[0118] In the above embodiments, since the difference between the current blood glucose measurement and the current predicted blood glucose value, and / or the user's meal monitoring sensor monitors whether a user meal event has occurred, the user meal event can be monitored flexibly and accurately. Thus, when a user meal event is determined, a safety protection procedure can be triggered. This procedure, based on the predicted blood glucose value and control parameters, determines the temporary basal rate infusion dose. Based on the temporary basal rate infusion dose, the insulin infusion device is controlled to operate in temporary basal rate infusion mode. Therefore, the closed-loop operation mode is also applicable to user meal scenarios, which helps to restore the user's blood glucose level to the target blood glucose range and improves safety.

[0119] In some exemplary embodiments, optionally, the processor is also configured to implement the steps of method one, method two, or method three as follows.

[0120] Method 1 includes the following steps:

[0121] S1, obtain the carbohydrate value input by the user via the touchscreen; the carbohydrate value represents the total amount of food consumed by the user. For example, the carbohydrate value is, for instance, 50 grams. Optionally, the user can initiate a fourth interaction with a meal-aiding graphic element displayed on the touchscreen, so that the processor responds to the fourth interaction and obtains the carbohydrate value input by the user.

[0122] S2 triggers the security protection program based on the carbohydrate value. In other words, after the processor obtains the carbohydrate value input by the user, it can trigger the security protection program in response to the carbohydrate value.

[0123] S3, through a safety protection procedure, determines the first high dose based on carbohydrate value, blood glucose measurement value associated with the current user-input carbohydrate value, and control parameters.

[0124] The first large dose refers to the initial large dose that needs to be administered after the user inputs their carbohydrate value. The blood glucose measurement value associated with the moment the user inputs their carbohydrate value can be the same as the current time of input, or it can be a blood glucose measurement value whose difference from the current time of input is within a preset range. For example, assuming the user inputs their carbohydrate value at 10:35 AM, the processor, through a safety protection program, can determine the first large dose based on the carbohydrate value at 10:35 AM, the blood glucose measurement value at 10:35 AM, and control parameters. Of course, the processor, through a safety protection program, can also determine the first large dose based on the carbohydrate value at 10:35 AM, the blood glucose measurement value at 10:40 AM, and control parameters; this embodiment is not limited to this.

[0125] Optionally, a fifth correspondence can be established between carbohydrate values, blood glucose measurements, control parameters, and the bolus dose. The processor then determines the first bolus dose based on the carbohydrate values, the blood glucose measurements associated with the user's input of the carbohydrate values, the control parameters, and the aforementioned fifth correspondence. Alternatively, the processor can input the carbohydrate values, the blood glucose measurements associated with the user's input of the carbohydrate values, and the control parameters together into a fifth machine learning model to obtain the first bolus dose output by the fifth machine learning model. The fourth machine learning model can be trained based on carbohydrate value samples, blood glucose measurement samples, control parameter samples, and the corresponding bolus doses.

[0126] S4, The processor controls the insulin infusion device to operate in high-dose infusion mode according to the first high-dose infusion. That is, the processor controls the insulin infusion device to infuse according to the first high-dose infusion to operate in high-dose infusion mode.

[0127] S5, determine the predicted blood glucose value based on the blood glucose measurement value at the next time step from the current time step.

[0128] In this embodiment, the next moment after the current moment can be the next moment adjacent to the current moment, or it can be the next moment after a preset time interval from the current moment. This embodiment is not limited to this.

[0129] Furthermore, the processor can determine a predicted blood glucose value based on the blood glucose measurement value at the next moment from the current moment. It can be understood that the determined predicted blood glucose value can be a predicted blood glucose value at a future moment. Continuing the example above, the processor can determine the predicted blood glucose value at 10:45 based on the blood glucose measurement value at 10:40.

[0130] The blood glucose prediction value can be determined based on the current blood glucose measurement, historical infusion data, historical carbohydrate values, and control parameters; alternatively, the blood glucose prediction value can be determined based on the current blood glucose measurement and historical blood glucose data; or alternatively, the blood glucose prediction value can be determined based on historical blood glucose data.

[0131] For example, the processor can determine a predicted blood glucose level based on the current blood glucose measurement, historical infusion data, historical carbohydrate levels, and control parameters. Historical carbohydrate levels indicate the user's past carbohydrate intake, which may include carbohydrate intake over a historical period prior to the current moment. For instance, historical carbohydrate levels could indicate how much and when the user consumed carbohydrates within two days prior to the current moment.

[0132] Optionally, a sixth correspondence can be established between blood glucose measurements, historical infusion data, historical carbohydrate values, control parameters, and predicted blood glucose values. This sixth correspondence can be, but is not limited to, a mathematical expression or model. Then, the processor can determine the predicted blood glucose value based on the current blood glucose measurement, historical infusion data, historical carbohydrate values, control parameters, and the aforementioned sixth correspondence. Alternatively, the processor can input the current blood glucose measurement, historical infusion data, historical carbohydrate values, and control parameters into a sixth machine learning model, which will then output the corresponding predicted blood glucose value. The sixth machine learning model can be trained based on samples of blood glucose measurements, historical infusion data, historical carbohydrate values, control parameters, and the corresponding predicted blood glucose values.

[0133] Alternatively, the processor can determine the predicted blood glucose value based on the current blood glucose measurement and historical blood glucose data, or it can determine the predicted blood glucose value based on historical blood glucose data. The method for determining the predicted blood glucose value can be found in S304, and will not be elaborated upon here.

[0134] S6, through a safety protection procedure, determines the first supplemental high dose based on the predicted blood glucose value and control parameters.

[0135] In this embodiment, since the carbohydrate value input by the user may not be accurate enough, the processor will also determine the first supplementary bolus dose based on the predicted blood glucose value and control parameters through a safety protection procedure. The first supplementary bolus dose includes the bolus dose that the user still needs to infuse after the first bolus dose.

[0136] Optionally, a correspondence can be established between predicted blood glucose values, control parameters, and high-dose infusions, so that the processor can determine the first supplemental high dose based on the predicted blood glucose values, control parameters, and this correspondence. This correspondence may include, but is not limited to, mathematical expressions or mathematical models.

[0137] S7, the processor controls the insulin infusion device to operate in high-dose infusion mode according to the first supplementary high dose. That is, the processor can control the insulin infusion device to infuse again according to the first supplementary high dose to continue operating the high-dose infusion mode. Specifically, the processor can control the insulin infusion device to operate in high-dose infusion mode again according to the first supplementary high dose after the high-dose infusion mode has been completed according to the first initial high dose.

[0138] Method 2 includes the following steps:

[0139] S1, Obtain the pre-meal bolus dose input by the user via the touchscreen. The pre-meal bolus dose includes the large infusion dose that the user needs to receive before a meal. For example, a pre-meal bolus dose of 10U indicates that the user expects to receive 10U of insulin to maintain their specific need for eating.

[0140] S2 triggers the safety protection program by administering a large pre-meal dose. In other words, after the processor obtains the user's input of a large pre-meal dose, it can trigger the safety protection program by administering that large pre-meal dose.

[0141] S3, through a safety protection procedure, the second initial bolus dose is determined based on the pre-meal bolus dose and control parameters. In this embodiment, when the safety protection procedure is triggered, the processor can determine the second initial bolus dose based on the pre-meal bolus dose and control parameters. The first initial bolus dose refers to the first bolus dose that needs to be infused after the user inputs the pre-meal bolus dose. For example, the processor can correct the pre-meal bolus dose based on control parameters to obtain the second initial bolus dose.

[0142] S4, based on the second initial high-dose control insulin infusion device, operates in high-dose infusion mode. The principle of S4 in Method 2 is similar to that of S4 in Method 1, and will not be elaborated further here.

[0143] S5 determines the predicted blood glucose value based on the blood glucose measurement value at the next time step. The principle of S5 in Method 2 is the same as that in Method 1, and will not be repeated here.

[0144] S6, through a safety protection procedure, determines the second supplementary bolus dose based on the predicted blood glucose level and control parameters. In this embodiment, since the pre-meal bolus dose input by the user may not be accurate enough, the processor determines the second supplementary bolus dose based on the predicted blood glucose level and control parameters. The second supplementary bolus dose includes the bolus dose that the user still needs to infuse after the initial bolus dose. S6 in Method 2 is similar in principle to S6 in Method 1, and will not be described again here.

[0145] S7, according to the second supplementary high-dose controlled insulin infusion device, operates in high-dose infusion mode. The principle of S7 in Method 2 is the same as that in Method 1, and will not be repeated here.

[0146] Method 3 includes the following steps:

[0147] S1: Obtain the pre-meal dosage input by the user via the touchscreen. The principle of S1 in Method 3 is the same as that in Method 2, and will not be repeated here.

[0148] S2 triggers the safety protection procedure by administering a large dose before meals. The principle of S2 in Method 3 is the same as that in Method 2, and will not be repeated here.

[0149] S3, through a safety protection procedure, the processor controls the insulin infusion device to operate in high-dose infusion mode based on the pre-meal high-dose dosage. In this embodiment, the processor controls the insulin infusion device to infuse according to the pre-meal high-dose dosage to operate in high-dose infusion mode. That is, the processor infuses according to the pre-meal high-dose dosage specified by the user.

[0150] S4 determines the predicted blood glucose value based on the blood glucose measurement value at the next time step. The principle of S4 in Method 3 is the same as that of S5 in Method 2 and Method 1, and will not be repeated here.

[0151] S5, through a safety protection procedure, determines the third supplementary bolus dose based on the predicted blood glucose level and control parameters. The third supplementary bolus dose includes the bolus dose that the user still needs to infuse after the pre-meal bolus dose. S5 in Method 3 operates on the same principle as S6 in Methods 2 and 1, and will not be elaborated upon here.

[0152] S6, according to the third supplementary high-dose controlled insulin infusion device, operates in high-dose infusion mode. S6 in Method 3 is based on the same principle as S7 in Methods 2 and 1, and will not be repeated here.

[0153] In the above embodiments, regardless of whether it is method one, method two, or method three, it is possible to run the high-dose infusion mode based on the initial high-dose operation and then run the high-dose control insulin infusion mode based on the supplementary high-dose operation. In this way, the initial high-dose can be supplemented by the supplementary high-dose operation, reducing the phenomenon of inaccurate initial high-dose operation due to inaccurate user input and improving the reliability of the high-dose infusion mode.

[0154] Figure 5 This is a schematic diagram of a process for setting a large infusion dose in one embodiment. In an exemplary embodiment, such as... Figure 5 As shown, the processor is also used to implement the following S501 to S505:

[0155] S501 receives the initial infusion dose for performing the high-dose infusion mode.

[0156] In this embodiment, the initial infusion dose can be an infusion dose input by the user or an infusion dose defined by the processor.

[0157] In one exemplary embodiment, optionally, the processor may, in response to a fourth interactive operation by the user to a meal aid graphic element displayed on the touchscreen, obtain the carbohydrate value input in the fourth interactive operation, and receive the current blood glucose measurement value corresponding to the moment the user inputs the carbohydrate value, so as to generate a recommended high dose based on the carbohydrate value and / or the current blood glucose measurement value through a safety protection program. Further, the processor may, in response to a fifth interactive operation by the user to a high dose graphic element displayed on the touchscreen, set the initial infusion dose according to the recommended high dose based on the fifth interactive operation.

[0158] For example, a user can tap a food-related graphic element displayed on the touchscreen and input a carbohydrate value via the touchscreen to initiate a fourth interactive operation. The processor can then respond to this fourth interactive operation and retrieve the carbohydrate value input by the user.

[0159] The recommended maximal dose indicates the maximum infusion dose required given the user's carbohydrate intake; it can also be understood as a large food intake. Optionally, the processor can determine the recommended maximal dose based on the correspondence between the user-input carbohydrate value and / or the current blood glucose measurement and the maximal dose. For example, in this correspondence, 10 grams (g) of carbohydrates corresponds to a 10U maximal dose, 20g of carbohydrates corresponds to a 15U maximal dose, etc. If the actual carbohydrate input by the user is 10g, the processor can determine the recommended maximal dose to be 10U.

[0160] The fifth interactive operation is used to set the high-dose infusion dose based on the recommended high-dose setting. When a user needs to set the high-dose infusion dose based on the recommended high-dose setting, the user initiates the fifth interactive operation on the high-dose graphic element displayed on the touchscreen. For example, if the recommended high-dose is 15U, the user can set the high-dose infusion dose to 15U, or make minor adjustments based on 15U. In this way, the processor can receive the initial infusion dose for executing the high-dose infusion mode.

[0161] S502 monitors whether the initial infusion dose reaches the first and second infusion limits through a safety protection procedure.

[0162] The first infusion limit is used to constrain the total amount of large-volume infusions accumulated within a preset time period. The preset time period is, for example, 4 hours, which can be set according to actual needs.

[0163] For example, in the first infusion limit, the total sum of large-volume infusion doses accumulated within 4 hours is not allowed to exceed a first threshold. If, during the process of setting the large-volume infusion dose, it is determined that the total sum of large-volume infusion doses accumulated within 4 hours has reached the first threshold, the processor confirms that the first infusion limit has been reached. In other words, the processor can determine whether the first infusion limit has been reached using the initial infusion dose and the first threshold.

[0164] Optionally, if, during the process of setting the high-dose infusion dose, the processor determines that the total amount of high-dose infusion doses accumulated within 4 hours has reached a first threshold, the processor may issue a first prompt message to alert the user. In some embodiments, the processor may also stop setting the high-dose infusion dose, for example, by exiting the high-dose infusion setting interface; this embodiment is not limited thereto.

[0165] The second infusion limit is used to constrain the total amount of high-volume infusions input within a given day. For example, the second infusion limit prevents the total amount of high-volume infusions input within a day from exceeding a second threshold. If, during the setting of high-volume infusion doses, the total amount of high-volume infusions input within a day has already exceeded the second threshold, the processor confirms that the second infusion limit has been reached. In other words, the processor can determine whether the second infusion limit has been reached using the initial infusion dose and the second threshold.

[0166] Optionally, if the total amount of high-dose infusions entered on a given day has reached a second threshold, the processor may issue a second prompt message to alert the user. In some embodiments, the processor may also stop setting high-dose infusions, for example, by exiting the high-dose infusion settings interface; however, this embodiment is not limited to this.

[0167] S503, if the initial infusion dose does not reach the first infusion limit and the second infusion limit, control the insulin infusion device to operate in high-dose infusion mode; wherein, the first infusion limit is used to constrain the total amount of high-dose infusion doses accumulated within a preset time period, and the second infusion limit is used to constrain the total amount of high-dose infusion doses accumulated within the day.

[0168] Therefore, if the initial infusion dose does not reach the first and second infusion limits, the processor can control the insulin infusion device to operate in high-dose infusion mode. In other words, the processor can control the insulin infusion device to operate in high-dose infusion mode based on the initial infusion dose.

[0169] In the above embodiments, since the user's fourth interactive operation on the meal aid graphic element displayed on the touch screen can be responded to, the user's input carbohydrate value can be obtained, and a safety protection procedure can be triggered in response to the carbohydrate value. Through the safety protection procedure, a recommended high dose can be determined based on the carbohydrate value. Therefore, a suitable recommended high dose can be determined based on the user's actual carbohydrate intake. Furthermore, since the first infusion limit is used to constrain the total infusion dose of the high dose accumulated through the high dose graphic element within a preset time period, and the second infusion limit is used to constrain the total infusion dose of the second high dose accumulated through the high dose graphic element within the same day, the safety of the high-dose infusion mode can be improved by monitoring whether the initial infusion dose reaches the first and second infusion limits.

[0170] In one exemplary embodiment, optionally, if the initial infusion dose reaches a first infusion limit or a second infusion limit, the processor is further configured to implement at least one of the following methods:

[0171] (1) Calculate the dose difference between the initial infusion dose and the first infusion limit or the second infusion limit, and control the infusion dose difference of the insulin infusion device.

[0172] In this embodiment, optionally, if the first infusion limit is reached first, the processor calculates the dose difference between the initial infusion dose and the first infusion limit; if the second infusion limit is reached first, the processor calculates the dose difference between the initial infusion dose and the second infusion limit.

[0173] Taking the first infusion limit as an example, if the first threshold is 5U, and the cumulative large dose input within the preset time period before the initial infusion dose is 4.5U, while the initial infusion dose is 1U, then the processor can determine that the dose difference is 1-(5-4.5)=0.5U. The second infusion limit is similar and will not be elaborated here.

[0174] In this way, some of the user's infusion needs can be met while improving infusion safety.

[0175] (2) Receive the initial infusion dose input by the user on the touchscreen. If the initial infusion dose simultaneously reaches the first infusion limit and the second infusion limit, control the touchscreen to display a setting prompt to remind the user to reset the initial infusion dose. For example, if the initial infusion dose simultaneously reaches the first infusion limit and the second infusion limit, the processor can display a message on the touchscreen stating "The infusion limit for the day and the infusion limit for 4 hours have been reached. Please reset the infusion dose" to prompt the user to reset the initial infusion dose.

[0176] Figure 6 This is a schematic diagram of a process for operating a high-dose infusion mode in one embodiment. In an exemplary embodiment, such as... Figure 6 As shown, the processor is also used to implement the following S601 to S603:

[0177] S601 determines the predicted blood glucose value at the current moment based on historical blood glucose data, and determines the estimated value for the meal based on the difference between the measured blood glucose value at the current moment and the predicted blood glucose value at the current moment.

[0178] In this embodiment, after controlling the insulin infusion device to operate in temporary basal rate infusion mode according to the infusion dose of temporary basal rate, the processor can determine the predicted blood glucose value at the current moment based on historical blood glucose data. The process of determining the predicted blood glucose value at the current moment based on historical blood glucose data can refer to S401 above, and will not be repeated here.

[0179] Furthermore, based on the difference between the current blood glucose measurement and the predicted blood glucose value, an estimated meal intake can be determined. It's understandable that the estimated meal intake is a prediction for a future time.

[0180] Optionally, the processor can establish a correspondence between blood glucose difference values ​​and meal estimation values, and determine the meal estimation value based on the actual blood glucose difference value and this correspondence. Alternatively, the processor can input the blood glucose difference value between the current blood glucose measurement value and the current blood glucose prediction value into a trained meal estimation model, which will then output the meal estimation value. The meal estimation value can be determined based on samples of blood glucose difference values ​​and corresponding samples of meal estimation values.

[0181] S602 uses a safety protection procedure to determine micro-high doses based on predicted blood glucose levels, estimated meal intake, and control parameters.

[0182] In this embodiment, the processor can determine the micro-maximal dose based on the correspondence between predicted blood glucose levels, estimated meal intake, control parameters, and the maximal dose. The micro-maximal dose is the maximal dose required after the temporary basal rate infusion.

[0183] S603 controls the operation of insulin infusion devices in high-dose infusion mode based on micro-high-dose technology.

[0184] In this embodiment, after determining the micro-large dose, the processor can control the insulin infusion device to run in large-dose infusion mode according to the micro-large dose. That is, the processor controls the insulin infusion device to infuse according to the micro-large dose in order to run in large-dose infusion mode.

[0185] In the above embodiments, since the blood glucose prediction value and meal estimation value can be determined by triggering the safety protection program based on historical blood glucose data and the blood glucose measurement value at the next moment, and the micro-high dose can be determined based on the blood glucose prediction value, meal estimation value and control parameters through the safety protection program, so as to control the insulin infusion device to operate in high-dose infusion mode according to the micro-high dose, during the operation of the closed-loop operation mode, the user's blood glucose value can be predicted according to the actual situation after the temporary basal rate is infused, so as to maintain the user's blood glucose level through micro-high dose once or multiple times, thereby improving safety.

[0186] In some exemplary embodiments, optionally, the above-described device control method may further include at least one of the following:

[0187] (1) If a hypoglycemic event is detected during the operation of the closed-loop operation mode, the insulin infusion device is suspended through the safety protection procedure.

[0188] In this embodiment, the processor can monitor whether a user hypoglycemic event occurs during operation in closed-loop mode. A user hypoglycemic event refers to an event where the user's blood glucose level is lower than normal. For example, the insulin infusion device can determine that a user hypoglycemic event has occurred if all blood glucose measurements within a preset time period are below a hypoglycemic threshold, or if a preset proportion of blood glucose measurements within a preset time period are below the hypoglycemic threshold. This embodiment is not limited to these limitations.

[0189] Furthermore, if a hypoglycemic event is detected during the operation of the closed-loop mode, the processor can control the insulin infusion device to suspend infusion through a safety protection program.

[0190] The processor can control the insulin infusion device to pause infusion by pausing the infusion function. Optionally, the insulin infusion device can also control the drive mechanism within the device to a stopped state to pause the infusion function. This drive mechanism can be used to propel the injection mechanism of the reservoir in the insulin infusion device forward, causing the injection mechanism to dispense insulin from the reservoir.

[0191] Optionally, in one embodiment, if a hypoglycemic event is detected during operation of the closed-loop mode, the processor may switch from the closed-loop mode to the open-loop mode. After switching from the closed-loop to the open-loop mode, the processor operates the infusion mode control according to a preset or user-specified method. For example, during operation of the open-loop mode, the processor infuses according to a user-specified standard basal rate.

[0192] (2) If a hypoglycemic event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is running the standard basal rate infusion mode. If it is determined that the insulin infusion device is running the standard basal rate infusion mode, adjust the standard basal rate infusion mode to the temporary basal rate infusion mode through the safety protection procedure, and set the infusion dose of the temporary basal rate to the safe dose.

[0193] In this embodiment, if a user's hypoglycemia event is detected during the operation of the closed-loop mode, the processor will also monitor whether the insulin infusion device is running the standard basal rate infusion mode. That is, if the insulin infusion device is infusing at the standard basal rate when a user's hypoglycemia event occurs, it is determined that the insulin infusion device is running the standard basal rate infusion mode.

[0194] If the processor determines that the insulin infusion device is operating in standard basal rate infusion mode, it switches to temporary basal rate infusion mode and sets the temporary basal rate infusion dose to a safe dose. In other words, the processor can set the temporary basal rate infusion dose to a safe dose and operate the temporary basal rate infusion mode according to the safe dose. That is, the processor controls the insulin infusion device to infuse the temporary basal rate at a safe dose.

[0195] The safe dose can be set according to actual needs; it can be a value specified by the user based on experience or a value preset in the processor. In one embodiment, the safe dose is 0. It is understood that when the safe dose is 0, although the insulin infusion device is in temporary basal rate infusion mode, the insulin infusion device will not perform infusion.

[0196] (3) If a hypoglycemic event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is running the temporary basal rate infusion mode, and if it is determined that the insulin infusion device is running the temporary basal rate infusion mode, set the temporary basal rate infusion dose to a safe dose through the safety protection procedure.

[0197] In this embodiment, if a user's hypoglycemia event is detected during the operation of the closed-loop mode, the processor will also monitor whether the insulin infusion device is running a temporary basal rate infusion mode. That is, if the insulin infusion device is infusing a temporary basal rate when a user's hypoglycemia event occurs, it is determined that the insulin infusion device is running a temporary basal rate infusion mode.

[0198] If it is determined that the insulin infusion device is operating in temporary basal rate infusion mode, the processor will continue to set the temporary basal rate infusion dose to a safe dose through a safety protection procedure. In other words, the processor can set the temporary basal rate infusion dose to a safe dose. Optionally, the safe dose can be 0.

[0199] Therefore, the processor can then operate the temporary basal rate infusion mode according to the safe dosage. That is, the processor controls the insulin infusion device to infuse the temporary basal rate at a safe dosage to operate the temporary basal rate infusion mode.

[0200] (4) During the operation of the closed-loop operation mode, if a user hypoglycemia event occurs, monitor whether the insulin infusion device is running the temporary basal rate infusion mode and the high-dose infusion mode at the same time. If it is determined that the insulin infusion device is running the temporary basal rate infusion mode and the high-dose infusion mode, stop the high-dose infusion mode through the safety protection procedure, and set the infusion dose of the temporary basal rate to a safe dose through the safety protection procedure.

[0201] In this embodiment, if a user's hypoglycemia event is detected during the operation of the closed-loop mode, the processor will also monitor whether the insulin infusion device is simultaneously running a temporary basal rate infusion mode and a bolus infusion mode. That is, if the insulin infusion device is infusing both a temporary basal rate and a bolus infusion when a user's hypoglycemia event occurs, it is determined that the insulin infusion device is running both a temporary basal rate infusion mode and a bolus infusion mode.

[0202] If the insulin infusion device is determined to be running both temporary basal rate infusion mode and high-dose infusion mode, the processor will continue through a safety protection procedure. On the one hand, it will stop the high-dose infusion mode; on the other hand, it will set the temporary basal rate infusion dose to a safe dose, so that the temporary basal rate infusion mode will run according to the safe dose. In other words, the processor can set the currently running temporary basal rate infusion dose to a safe dose. Optionally, the safe dose can be 0.

[0203] (5) If a user hypoglycemia event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is running the high-dose infusion mode. If it is determined that the insulin infusion device is running the high-dose infusion mode, stop the high-dose infusion mode through the safety protection procedure, and run the temporary basal rate infusion mode through the safety protection procedure, and set the temporary basal rate infusion dose to a safe dose.

[0204] In this embodiment, if a user's hypoglycemia event is detected during the operation of the closed-loop mode, the processor will also monitor whether the insulin infusion device is running a high-dose infusion mode. That is, if the insulin infusion device is infusing a high dose when a user's hypoglycemia event occurs, such as infusing an initial high dose, a supplemental high dose, or a micro-high dose, then it is determined that the insulin infusion device is running a high-dose infusion mode.

[0205] If the insulin infusion device is determined to be operating in high-dose infusion mode, the processor will continue through a safety protection procedure. On one hand, it will stop operating the high-dose infusion mode; on the other hand, it will operate in temporary basal rate infusion mode through the safety protection procedure, setting the temporary basal rate infusion dose to a safe dose. In other words, the processor can set the infusion dose for the temporary basal rate to a safe dose, and operate the temporary basal rate infusion mode according to the safe dose. Optionally, the safe dose can be 0.

[0206] In the above embodiments, through the safety management of user hypoglycemia events, the insulin infusion device can be adjusted to a safer state in a timely manner when a user hypoglycemia event occurs, thereby improving safety.

[0207] In an exemplary embodiment, optionally, after switching from closed-loop operation mode to open-loop operation mode, the processor is further configured to implement at least one of the following methods:

[0208] (1) After the user’s hypoglycemia event is resolved, the sixth interactive operation of the graphical element is initiated in response to the user’s mode displayed on the touch screen, and the insulin infusion device is controlled to resume closed-loop operation mode.

[0209] In this embodiment, if the processor has switched from closed-loop operation mode to open-loop operation mode, the processor can also restore closed-loop operation mode, that is, switch from open-loop operation mode back to closed-loop operation mode.

[0210] The user can manually restore the closed-loop operation mode. If the insulin infusion device is in open-loop operation mode and the user's hypoglycemia event has been resolved, the user can initiate a sixth interactive operation by clicking the mode activation graphic element displayed on the touchscreen. For example, the user can initiate the sixth interactive operation by clicking the mode activation graphic element. In this way, the processor can respond to the sixth interactive operation and control the insulin infusion device to restore the closed-loop operation mode.

[0211] The process of resolving a user's hypoglycemia event can include resolving the hypoglycemia event according to the user's meal plan, or resolving the hypoglycemia event manually after the user replenishes their blood sugar.

[0212] (2) When the blood glucose measurement value is detected to be higher than the blood glucose recovery threshold and the insulin infusion device is in the paused infusion state, the insulin infusion device is controlled to automatically resume closed-loop operation mode.

[0213] In this embodiment, the processor can also automatically resume closed-loop operation. When the insulin infusion device is in open-loop operation mode, the processor continues to receive blood glucose measurements from the blood glucose monitoring device. If the processor detects that the blood glucose measurement is higher than the blood glucose recovery threshold and the insulin infusion device is paused, it controls the insulin infusion device to automatically resume closed-loop operation mode. The blood glucose recovery threshold can be set according to actual conditions.

[0214] In some embodiments, the processor may also control the insulin infusion device to resume closed-loop operation mode when it detects that the blood glucose measurement value is higher than the blood glucose recovery threshold, the insulin infusion device is in a paused infusion state, and in response to the sixth interactive operation.

[0215] In the above embodiments, since the insulin infusion device can be controlled to resume closed-loop operation mode in response to the user's sixth interactive operation of the graphic element in response to the mode displayed on the touch screen after the user's hypoglycemia event is resolved, or the insulin infusion device can be controlled to automatically resume closed-loop operation mode when the blood glucose measurement value is detected to be higher than the blood glucose recovery threshold and the insulin infusion device is in the paused infusion state, the closed-loop operation mode can also be efficiently resumed by manual and / or automatic means.

[0216] In one exemplary embodiment, optionally, the processor is also configured to implement at least one of the following:

[0217] (1) If an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode is maintained through the safety protection procedure, and the insulin infusion device is monitored to see if it is running the temporary basal rate infusion mode. If it is determined that the insulin infusion device is running the temporary basal rate infusion mode, the temporary basal rate infusion mode is switched to the standard basal rate infusion mode.

[0218] (2) If an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode shall be maintained through the safety protection procedure, and the insulin infusion device shall be monitored to see if it is running the high-dose infusion mode. If it is determined that the insulin infusion device is running the high-dose infusion mode, the high-dose infusion mode shall be maintained.

[0219] (3) If an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode shall be maintained through the safety protection procedure, and the standard basal rate infusion mode shall be monitored. If the standard basal rate infusion mode is monitored, the standard basal rate infusion mode shall be maintained.

[0220] In this embodiment, the processor is able to monitor for abnormal blood glucose events or blood glucose loss events during operation in closed-loop mode.

[0221] An abnormal blood glucose event indicates that the blood glucose measurement received by the insulin infusion device is abnormal. Specifically, the processor determines that an abnormal blood glucose event has occurred when the blood glucose measurement value shows an abnormal change within a preset time period. This abnormal change can be that all blood glucose measurements are higher than a first blood glucose threshold or all are lower than a second blood glucose threshold; it can also be that a second preset proportion of blood glucose measurements are higher than the first blood glucose threshold or lower than the second blood glucose threshold; it can also be that the difference between adjacent blood glucose measurements is not within the normal range; or it can be that the rate of change of blood glucose measurements is greater than a preset rate of change. This embodiment is not limited to these limitations.

[0222] A blood glucose loss event indicates that the insulin infusion device has failed to receive blood glucose measurements. The processor can determine a blood glucose loss event if it fails to receive multiple consecutive blood glucose measurements, if the percentage of lost blood glucose measurements reaches a preset percentage within a certain period, or if it fails to receive any blood glucose measurements for a certain period. This embodiment is not limited to these methods.

[0223] Furthermore, if a user's hypoglycemia event is detected during the operation of the closed-loop mode, the processor can maintain the closed-loop mode through a safety protection program.

[0224] While maintaining closed-loop operation, the processor continues to monitor whether the insulin infusion device is running at least one of the following modes: temporary basal rate infusion mode, high-dose infusion mode, or standard basal rate infusion mode.

[0225] Therefore, if the processor determines that the insulin infusion device is operating in temporary basal rate infusion mode, it will switch the temporary basal rate infusion mode to standard basal rate infusion mode. If the insulin infusion device is currently infusing at the temporary basal rate, that is, operating in temporary basal rate infusion mode, the processor will switch the temporary basal rate infusion mode back to standard basal rate infusion mode. Understandably, after switching from temporary basal rate infusion mode to standard basal rate infusion mode, the processor controls the insulin infusion device to infuse at the standard basal rate, thus operating the standard basal rate infusion mode. The standard basal rate can be a user-specified infusion dose or a preset infusion dose.

[0226] If the processor determines that the insulin infusion device is operating in high-dose infusion mode, it will maintain that mode. In other words, if the insulin infusion device is infusing a high dose, the processor will maintain that mode.

[0227] If the insulin infusion device is operating at the standard basal rate infusion mode, the processor will maintain that mode. In other words, if the insulin infusion device is operating at the standard basal rate, the processor will maintain that mode.

[0228] In the above embodiments, a timely response can be provided in the event of abnormal blood glucose events or blood glucose loss events, thereby improving the safety of the closed-loop operation mode.

[0229] In one exemplary embodiment, optionally, the processor is also configured to implement the following method:

[0230] If a high-level alarm event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode will be switched to the open-loop operation mode through the safety protection procedure, and the high-level alarm event will be managed for safety.

[0231] In this embodiment, during operation in closed-loop mode, the processor also determines whether a high-level alarm event has occurred. It should be noted that a high-level alarm event can be an alarm event from an insulin infusion device or an alarm event from a blood glucose monitoring device.

[0232] Furthermore, if a high-level alarm event is detected during the operation of the closed-loop mode, the processor can switch the closed-loop mode to the open-loop mode through the security protection program and perform security management on the high-level alarm event.

[0233] The process of switching from closed-loop operation mode to open-loop operation mode can be referred to the above embodiments, and will not be repeated here.

[0234] Security management of high-level alarm events may include, but is not limited to, controlling insulin infusion devices to pause infusion, maintaining standard basal rate infusion mode, and switching temporary basal rate infusion mode to standard basal rate infusion mode.

[0235] In the above embodiments, when a high-level alarm event is determined to occur during the operation of the closed-loop operation mode, the security protection program can switch the closed-loop operation mode to the open-loop operation mode and perform security management on the high-level alarm event, thereby reducing security risks.

[0236] In one exemplary embodiment, optionally, the high-level alarm event includes a first alarm event; the processor is also configured to implement the following method:

[0237] According to the safety protection procedures for the first alarm event, the insulin infusion device is controlled to suspend infusion.

[0238] In this embodiment, the first alarm event includes at least one of the following: excessively strong ambient magnetic field, depletion of medication, detachment of tubing, depletion of power, and tubing blockage.

[0239] An excessively strong ambient magnetic field indicates that the insulin infusion device or blood glucose monitoring device is in a strong magnetic environment. The processor can obtain the magnetic field strength of the environment in which the insulin infusion device or blood glucose monitoring device is located, and if the magnetic field strength exceeds the safe threshold, it will determine that a high-level alarm event of excessively strong ambient magnetic field has occurred.

[0240] Insulin depletion indicates that the insulin infusion device is about to run out of medication. The processor can compare the current medication level of the insulin infusion device with the depletion threshold. If the current medication level is less than the depletion threshold, a high-level alarm event of depletion has occurred.

[0241] A tubing detachment occurs when the tubing of an insulin infusion device becomes detached from the user. The processor can identify a high-level alarm event of tubing detachment if the insulin infusion device is in infusion mode and the pressure change value of the pressure sensor in the insulin infusion device is less than a preset threshold.

[0242] A battery depletion warning indicates that the insulin infusion device is about to run out of power. The processor can compare the battery voltage of the insulin infusion device with a voltage depletion threshold. If the battery voltage is lower than the voltage depletion threshold, a high-level alarm event of battery depletion has occurred.

[0243] A tubing blockage indicates a blockage in the infusion tubing of an insulin infusion device. The processor can identify a high-level alarm event of tubing blockage when the insulin infusion device is in infusion mode and the pressure value of the pressure sensor in the insulin infusion device exceeds the blockage threshold.

[0244] Furthermore, in response to the aforementioned first alarm event, the processor can trigger a safety protection program and, according to the program, control the insulin infusion device to suspend infusion. In other words, once the first alarm event occurs, the processor can control the insulin infusion device to suspend infusion according to the safety protection program. The principle behind controlling the insulin infusion device to suspend infusion can be found in the above embodiment and will not be repeated here.

[0245] In the above embodiments, since the insulin infusion device can be controlled to suspend infusion in response to the first alarm event, infusion abnormalities caused by problems such as magnetic field, drug dosage, tubing, and power can be prevented.

[0246] In one exemplary embodiment, optionally, the high-level alarm event includes a second alarm event, and the processor is further configured to implement at least one of the following methods:

[0247] (1) Based on the safety protection procedure for the safety management of the second alarm event, control the temporary basal rate infusion mode of the insulin infusion device to switch to the standard basal rate infusion mode.

[0248] (2) Based on the safety protection procedures, manage the second alarm event and control the insulin infusion equipment to maintain the standard basal rate infusion mode.

[0249] In this embodiment, the second alarm event may include insufficient lifespan of the blood glucose monitoring device. Specifically, the processor can determine whether the blood glucose monitoring device has insufficient lifespan based on the validity period of the received blood glucose measurement value.

[0250] Furthermore, during open-loop operation, optionally, the processor can control the insulin infusion device to switch from the temporary basal rate infusion mode to the standard basal rate infusion mode based on the safety management of the second alarm event according to the safety protection program. In other words, if a second alarm event indicating insufficient lifespan of the blood glucose monitoring device occurs, and the insulin infusion device is currently running in temporary basal rate infusion mode, the processor will switch the temporary basal rate infusion mode to the standard basal rate infusion mode.

[0251] Optionally, the processor can also manage the second alarm event according to the safety protection program, controlling the insulin infusion device to maintain the standard basal rate infusion mode. That is, if a second alarm event occurs indicating that the blood glucose monitoring device is nearing the end of its lifespan, and the insulin infusion device is currently in the standard temporary basal rate infusion mode, the processor can continue to maintain that standard basal rate infusion mode.

[0252] Because it can respond to a second alarm event to maintain or resume the standard basal rate infusion, it can avoid inaccuracies in the closed-loop control mode caused by insufficient lifespan of the blood glucose monitoring device, thus improving safety.

[0253] Figure 7 This is a flowchart illustrating another device control method in one embodiment. In an exemplary embodiment, such as... Figure 7 As shown, a device control method is also provided, which is applied to Figure 1 The following description is based on the processor in an insulin infusion device, including the following S701 to S703.

[0254] S701 displays a device connection graphic element on the touch screen; the device connection graphic element is used to guide the insulin infusion device to establish a communication connection with the blood glucose monitoring device.

[0255] For example, the touchscreen of an insulin infusion device may include at least one of a main interface, a menu page, and a negative one screen. Optionally, multiple user interfaces can be switched between. A user interface can also be understood as a human-computer interaction interface.

[0256] The graphic element includes a device connection graphic element, which allows the insulin infusion device to display the device connection graphic element on the touch screen. Furthermore, the device connection graphic element guides the insulin infusion device in establishing a communication connection with the blood glucose monitoring device.

[0257] Figure 8 This is a schematic diagram of a menu page in one embodiment, such as... Figure 8 As shown, the touchscreen can display a menu page 800, and the graphical elements on the menu page 800 may include a device-connected graphical element 802. Figure 8 For example, when a user needs to connect a blood glucose monitoring device to an insulin infusion device, they can click on the device connection graphic element 802 in the menu page 800 to initiate an interactive operation on the device connection graphic element 802. Then, the insulin infusion device can respond to the interactive operation and establish a communication connection with the blood glucose monitoring device.

[0258] S702 receives blood glucose measurements from a blood glucose monitoring device.

[0259] In this embodiment, the blood glucose monitoring device is used to acquire the blood glucose measurement value of the subject. When a communication connection is established between the insulin infusion device and the blood glucose monitoring device, the insulin infusion device can receive the blood glucose measurement value monitored by the blood glucose monitoring device through the communication interface.

[0260] S703, in response to interactive operations of the graphical elements activated by the mode displayed on the touch screen, controls the insulin infusion device to enter closed-loop operation mode.

[0261] In this embodiment, the graphic element also includes a mode-initiating graphic element. When the user needs to use the automatic infusion function, they can initiate an interactive operation on the mode-initiating graphic element displayed on the touch screen. In this way, the insulin infusion device can respond to the interactive operation and control itself to enter a closed-loop operation mode.

[0262] Please continue to refer to this. Figure 3 For example, the graphic elements on the menu page 300 may include a mode activation graphic element 301. When an automatic infusion of the temporary basal rate is required, the user can click on the mode activation graphic element 301 to initiate an interactive operation on the mode activation graphic element 301. Then, the insulin infusion device can respond to the interactive operation and enter a closed-loop operation mode.

[0263] S704 If an abnormal event occurs during the operation of the closed-loop operation mode, the closed-loop operation mode shall be managed in accordance with the infusion safety rules associated with the abnormal event.

[0264] In this embodiment, the insulin infusion device can monitor for abnormal events during closed-loop operation. These abnormal events are the aforementioned events affecting blood glucose levels.

[0265] The infusion safety rules are safety rules that manage the closed-loop operation mode. Infusion safety rules can be rules associated with abnormal events by the user, or rules pre-stored in the insulin infusion device; this embodiment does not impose any limitations. Infusion safety rules may include, but are not limited to, at least one of stopping the temporary basal rate, maintaining the closed-loop operation mode, and disabling the closed-loop operation mode.

[0266] In the aforementioned device control method, a device connection graphic element can be displayed on the touchscreen. This graphic element guides the insulin infusion device to establish a communication connection with the blood glucose monitoring device. Furthermore, it can receive blood glucose measurements from the monitoring device and, in response to the interactive operation of the graphic element displayed on the touchscreen, control the insulin infusion device to enter a closed-loop operation mode. Therefore, manual control of the insulin infusion device is unnecessary. Moreover, if an abnormal event occurs during operation in the closed-loop mode, the closed-loop operation mode can be managed according to the infusion safety rules associated with the abnormal event. On one hand, users do not need to use physical buttons to control the insulin infusion device; they can intuitively and efficiently control the establishment of a communication connection between the insulin infusion device and the blood glucose monitoring device, as well as control the delivery of temporary basal insulin infusions, through the touchscreen. This simplifies the operation steps, reduces the learning curve, and increases control efficiency. On the other hand, because the closed-loop operation mode can be managed through infusion safety rules associated with abnormal events, the safety of the insulin infusion device is improved.

[0267] In an exemplary embodiment, optionally, the "managing closed-loop operation mode according to infusion safety rules associated with abnormal events" in S704 above may include at least one of the following:

[0268] (1) In the event of an abnormal event including a user hypoglycemia event, the infusion of the temporary basal rate shall be stopped in accordance with the infusion safety rules associated with the user hypoglycemia event.

[0269] In this embodiment, since a user hypoglycemia event indicates that the blood glucose level of the subject is lower than normal, continuing infusion in this situation would pose a risk. Therefore, the infusion safety rules associated with a user hypoglycemia event include stopping the infusion of the temporary basal rate. Furthermore, in the event of an abnormal event including a user hypoglycemia event, that is, in the case of a user hypoglycemia event occurring during the operation of the closed-loop mode, the insulin infusion device will stop the infusion of the temporary basal rate.

[0270] In one embodiment, if the abnormal event includes a user hypoglycemia event, the insulin infusion device needs to stop not only the temporary basal rate infusion but also other infusions. In other words, in the event of a user hypoglycemia event, the insulin infusion device can stop all infusions.

[0271] Optionally, the insulin infusion device can stop the infusion of the temporary basal rate by disabling the closed-loop operation mode. For example, the insulin infusion device can stop the infusion of the temporary basal rate by stopping the infusion function.

[0272] Optionally, the insulin infusion device can be configured to disable its drive mechanism, thereby stopping the infusion function. This drive mechanism can propel the injection mechanism of the reservoir forward, causing it to dispense insulin from the reservoir. Understandably, in this scenario, the insulin infusion device will cease its closed-loop operation and enter a stopped infusion mode.

[0273] Optionally, the insulin infusion device can also stop the infusion of the temporary basal rate by setting the infusion dose of the temporary basal rate to 0. Understandably, in this case, the insulin infusion device does not stop operating in closed-loop mode, but remains in closed-loop operation mode.

[0274] In one embodiment, optionally, after the insulin infusion device stops the temporary basal rate infusion, if the blood glucose measurement value is within the normal range for a period of time, the temporary basal rate infusion can be resumed. Optionally, after the insulin infusion device stops the temporary basal rate infusion, the temporary basal rate infusion can also be resumed in response to a user-triggered resumption operation. The resumption operation can be an interactive operation on the stop infusion graphic element on the touchscreen, or an interactive operation on the mode start graphic element.

[0275] (2) In the event of abnormal events, including blood glucose loss events, maintain the closed-loop operation mode of infusion according to the infusion safety rules associated with the blood glucose loss event.

[0276] In this embodiment, the infusion safety rules associated with glucose loss events include maintaining closed-loop operation mode. Therefore, in the event of an abnormal event including a glucose loss event, that is, in the case of a glucose loss event occurring during operation of closed-loop mode, the insulin infusion device will maintain the closed-loop infusion operation mode.

[0277] Optionally, the insulin infusion device can maintain a closed-loop infusion mode based on a preset safe infusion dose, or it can maintain the closed-loop infusion mode based on the previous infusion dose during the operation of the closed-loop mode. For example, if the insulin infusion device infuses a temporary basal rate at infusion dose A during the first 5 minutes, and a glucose loss event occurs between the first 5 minutes and the second 5 minutes, the insulin infusion device will still infuse a temporary basal rate at infusion dose A during the second 5 minutes.

[0278] (3) In the event of an abnormal event, including a blood glucose abnormality, stop the infusion of the temporary basal rate according to the infusion safety rules associated with the blood glucose abnormality and control the insulin infusion device to enter the standard basal rate infusion mode.

[0279] In this embodiment, since an abnormal blood glucose event indicates an abnormal blood glucose measurement received by the insulin infusion device, there are safety concerns regarding using a temporary basal rate based on the abnormal blood glucose measurement. Therefore, the safe infusion rules for abnormal blood glucose events include stopping the infusion of the temporary basal rate and controlling the insulin infusion device to enter the standard basal rate infusion mode. Thus, when an abnormal event includes a blood glucose abnormality, that is, when an abnormal blood glucose abnormality occurs during the operation of the closed-loop mode, the insulin infusion device will stop the infusion of the temporary basal rate and control the insulin infusion device to enter the standard basal rate infusion mode.

[0280] Optionally, the insulin infusion device can stop the infusion of the temporary basal rate by setting the infusion dose of the temporary basal rate to 0. The insulin infusion device can also stop the infusion of the temporary basal rate by turning off the closed-loop operation mode.

[0281] Standard basal rate infusion mode refers to a mode in which the standard basal rate is infused according to a preset cycle. For example, during the operation of standard basal rate infusion mode, the insulin infusion device can infuse the standard basal rate every 5 minutes. The standard basal rate can be preset by the user; for example, the user can set the infusion dose of the standard basal rate for each infusion.

[0282] (4) In the event of an abnormal event including a strong magnetic environment event, the closed-loop operation mode shall be shut down in accordance with the infusion safety rules associated with the strong magnetic environment event.

[0283] In this embodiment, the insulin infusion device can acquire the magnetic field strength of the environment in which the islet infusion device is located, and determine that a strong magnetic environment event has occurred if the magnetic field strength is greater than the strength safety threshold.

[0284] Because using insulin infusion devices in strong magnetic environments poses safety risks, infusion safety rules associated with strong magnetic environment events include shutting down the closed-loop operation mode. Therefore, in the event of an abnormal event, including a strong magnetic environment event—that is, if a strong magnetic environment event occurs during operation in closed-loop mode—the insulin infusion device will shut down the closed-loop operation mode.

[0285] Optionally, the insulin infusion device can stop the infusion of the temporary basal rate by stopping the infusion function. For example, the insulin infusion device can control the drive mechanism in the insulin infusion device to a non-moving state to stop the infusion function. Optionally, the insulin infusion device can also close the closed-loop operation mode by means of powering off.

[0286] In some embodiments, if the abnormal event includes a strong magnetic environment event, the insulin infusion device needs to stop not only the temporary basal rate infusion but also other infusions. In other words, in the event of a strong magnetic environment event, the insulin infusion device can stop all infusions.

[0287] In the above embodiments, since the infusion of the temporary basal rate can be stopped according to the infusion safety rules associated with the user's hypoglycemia event in the case of abnormal events, the infusion closed-loop operation mode can be maintained according to the infusion safety rules associated with the blood glucose loss event in the case of abnormal events, the infusion of the temporary basal rate can be stopped according to the infusion safety rules associated with the blood glucose abnormality event in the case of abnormal events, and the insulin infusion device can be controlled to enter the standard basal rate infusion mode in the case of abnormal events, and the closed-loop operation mode can be closed according to the infusion safety rules associated with the strong magnetic environment event in the case of abnormal events, the closed-loop operation mode can be accurately and efficiently managed according to the infusion safety rules associated with abnormal events, thereby improving the safety of the insulin infusion device.

[0288] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0289] If the blood glucose measurement value is higher than the first blood glucose threshold or lower than the second blood glucose threshold within the first preset time period, the user's fingertip blood glucose measurement value is obtained, and the blood glucose measurement value monitored by the blood glucose monitoring device is compared with the fingertip blood glucose measurement value to determine whether a blood glucose-affecting event has occurred.

[0290] In this embodiment, the insulin infusion device can monitor blood glucose measurements. If the blood glucose measurement within a first preset time period is higher than a first blood glucose threshold or lower than a second blood glucose threshold, it indicates that the blood glucose measurement has an abnormal risk. The phrase "blood glucose measurement within the first preset time period is higher than the first blood glucose threshold or lower than the second blood glucose threshold" can mean that all blood glucose measurements within the first preset time period are higher than the first blood glucose threshold or all are lower than the second blood glucose threshold. The first and second blood glucose thresholds can be preset thresholds or thresholds input by the user via a touchscreen.

[0291] Furthermore, if the blood glucose measurement value within a first preset time period is higher than a first blood glucose threshold or lower than a second blood glucose threshold, the insulin infusion device will acquire the user's fingertip blood glucose measurement value. The fingertip blood glucose measurement value represents the blood glucose measurement value in the finger blood of the test subject. The fingertip blood glucose measurement value can be a value input by the user via a touchscreen, or a value received by the insulin infusion device from other devices.

[0292] Subsequently, the insulin infusion device determines whether a blood glucose-affecting event has occurred based on the fingertip blood glucose measurement and the blood glucose measurement monitored by the blood glucose monitoring device. Optionally, the fingertip blood glucose measurement and the blood glucose measurement monitored by the blood glucose monitoring device can be measured at the same time, and the difference between the measurement time of the fingertip blood glucose measurement and the measurement time of the blood glucose measurement can be less than a preset time difference.

[0293] Optionally, the insulin infusion device can compare the fingertip blood glucose measurement with the blood glucose measurement to determine whether a blood glucose-affecting event has occurred. For example, if the difference between the fingertip blood glucose measurement and the blood glucose measurement monitored by the blood glucose monitoring device is within a preset difference range, it can be determined that no blood glucose-affecting event has occurred; if the difference between the fingertip blood glucose measurement and the blood glucose measurement monitored by the blood glucose monitoring device is not within the preset difference range, it can also be determined that no blood glucose-affecting event has occurred.

[0294] In the above embodiments, since the user's fingertip blood glucose measurement value can be obtained when the blood glucose measurement value is higher than the first blood glucose threshold or lower than the second blood glucose threshold within the first preset time period, it is possible to accurately determine whether a blood glucose-affecting event has occurred based on the fingertip blood glucose measurement value and the blood glucose measurement value monitored by the blood glucose monitoring device.

[0295] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0296] If no blood glucose measurement value is received from the blood glucose monitoring device within a second preset time period, the touch screen is controlled to display a blood glucose loss reminder, and / or the insulin infusion device is controlled to issue an alarm reminder.

[0297] In this embodiment, the insulin device can monitor the blood glucose measurement value monitored by the blood glucose monitoring device. Therefore, if the insulin infusion device detects that it has not received a blood glucose measurement value monitored by the blood glucose monitoring device within a second preset time period, it can control the touch screen of the insulin infusion device to display a blood glucose loss reminder, or control the insulin infusion device to issue an alarm reminder, or both control the touch screen to display a blood glucose loss reminder and control the insulin infusion device to issue an alarm reminder.

[0298] The blood glucose loss alert may include, but is not limited to, text alerts, graphic alerts, color-coded alerts, and voice alerts. The corresponding alarm alert may include, but is not limited to, vibration alarms, buzzer alarms, or a combination of vibration and buzzer alarms. This embodiment does not limit the form and content of the blood glucose loss alert and alarm alerts.

[0299] In the above embodiments, if no blood glucose measurement value is received from the blood glucose monitoring device within the second preset time period, the touch screen is controlled to display a blood glucose loss reminder, and / or the insulin infusion device is controlled to issue an alarm reminder. Therefore, the user can be promptly reminded of blood glucose loss.

[0300] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0301] In the event of abnormal events, including strong magnetic field events, the touch screen will be controlled to display an alert indicating that the ambient magnetic field is too strong, and / or the insulin infusion device will be controlled to issue an alarm.

[0302] In this embodiment, when an abnormal event includes a strong magnetic environment event, that is, when a strong magnetic environment event is detected, the insulin infusion device can control the touch screen of the insulin infusion device to display an alert that the ambient magnetic field is too strong, or control the insulin infusion device to issue an alarm, or both control the touch screen to display an alert that the ambient magnetic field is too strong and control the insulin infusion device to issue an alarm.

[0303] Similarly, alerts for excessively strong ambient magnetic fields can include, but are not limited to, text alerts, graphic alerts, color-coded alerts, and voice alerts. Alarm alerts for strong magnetic field events can include, but are not limited to, vibration alarms, buzzer alarms, or a combination of vibration and buzzer alarms. This embodiment does not limit the form and content of strong magnetic field events and alarm alerts.

[0304] In the above embodiments, since the touch screen is controlled to display an alert that the ambient magnetic field is too strong in the event of abnormal events, including strong magnetic environment events, and / or the insulin infusion device is controlled to issue an alarm, the user can be promptly alerted that the insulin infusion device has entered a strong magnetic environment.

[0305] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0306] During operation in closed-loop mode, in response to interactive operations on the meal support graphic elements displayed on the touchscreen, the insulin infusion device is controlled to enter meal support mode; in response to interactive operations on the high-dose infusion graphic elements displayed on the touchscreen, the insulin infusion device is controlled to execute high-dose infusion mode; when the insulin infusion device enters meal support mode and the high-dose infusion mode ends, the insulin infusion device is controlled to enter micro-high-dose infusion mode.

[0307] In this embodiment, the graphic element also includes a meal assistance graphic element. In some scenarios where blood sugar levels rise, such as during meals, users can enter a meal assistance mode through the meal assistance graphic element.

[0308] Optionally, during closed-loop operation, the user can interact with the meal support graphic elements displayed on the touchscreen. The insulin infusion device will then respond to this interaction and enter meal support mode. Entering meal support mode means activating the meal support function, in which the insulin infusion device can deliver large doses.

[0309] In one embodiment, when the insulin infusion device enters meal support mode, the insulin infusion device can be controlled to exit meal support mode in response to an interactive operation on a meal support graphic element displayed on a touch screen.

[0310] For example, Figure 9 This is a schematic diagram of another menu page in one embodiment. Please refer to the reference. Figure 8 and Figure 9 After the user clicks to activate the graphics element 801, the touchscreen can display... Figure 9 The interface 900 shown includes a meal assistance graphic element 902. When the user clicks on the meal assistance graphic element 902, the insulin infusion device enters meal assistance mode. Once in meal assistance mode, clicking on the meal assistance graphic element 902 again will exit meal assistance mode.

[0311] In one embodiment, the closed-loop operation mode switch 901 is used to control whether the insulin infusion device enters or exits the closed-loop operation mode. For example, when the insulin infusion device is not in closed-loop operation mode, the user can click the mode activation graphic element 801, and the touch screen can display... Figure 9 As shown in interface 900, the user clicks the closed-loop operation mode switch 901 on interface 900 to control the insulin infusion device to enter closed-loop operation mode. When the insulin infusion device is in closed-loop operation mode, clicking the closed-loop operation mode switch 901 on interface 900 again will control the insulin infusion device to exit closed-loop operation mode.

[0312] When a large dose of insulin needs to be infused, the user can initiate an interactive operation on the large dose infusion graphic element displayed on the touch screen. The insulin infusion device will then respond to the interactive operation and control the insulin infusion device to execute the large dose infusion mode.

[0313] Figure 10 This is a schematic diagram of another menu page in one embodiment, such as... Figure 10 As shown, menu page 300 includes a high-dose infusion graphic element 1002. The user clicks on the high-dose infusion graphic element 1002 to initiate an interactive operation, thereby controlling the insulin infusion device to perform a high-dose infusion mode.

[0314] In this embodiment, the high-dose infusion mode ends after the corresponding infusion dose is completed. If the user has activated the meal support function beforehand, that is, when the insulin infusion device enters the meal support mode and the high-dose infusion mode ends, the insulin infusion device can be controlled to enter the micro-high-dose infusion mode. The micro-high-dose infusion mode is a supplement to the high-dose infusion mode, used to control the insulin infusion device to deliver a micro-high dose.

[0315] Optionally, when the insulin infusion device enters the meal support mode and the high-dose infusion mode ends, it is determined whether to activate the micro-high-dose infusion mode, and if it is determined to activate the micro-high-dose infusion mode, the insulin infusion device is controlled to execute the micro-high-dose infusion mode.

[0316] Optionally, the insulin infusion device can determine whether to activate the micro-maximal infusion mode based on blood glucose measurements and control parameters, and if so, the micro-maximal infusion dose. Thus, when micro-maximal infusion is required, the infusion can be performed according to the micro-maximal infusion dose to execute the micro-maximal infusion mode.

[0317] In the above embodiments, during the operation of the closed-loop mode, the insulin infusion device can be controlled to enter the meal support mode in response to interactive operations on the meal support graphic elements displayed on the touch screen; and the insulin infusion device can be controlled to execute the high-dose infusion mode in response to interactive operations on the high-dose infusion graphic elements displayed on the touch screen. Furthermore, when the insulin infusion device enters the meal support mode and the high-dose infusion mode ends, the insulin infusion device can be controlled to enter the micro-high-dose infusion mode. Therefore, it can be applied to some scenarios where blood glucose rises rapidly to supplement high-dose infusions.

[0318] In one embodiment, please refer to... Figure 10 The graphic element also includes a stop infusion graphic element 1001, which is used to stop the infusion function. For example, a user can click on the stop infusion graphic element 1001 to enter the stop infusion mode, thereby controlling the drive mechanism in the insulin infusion device to a stopped state to stop the infusion function.

[0319] In an exemplary embodiment, a device control method is also provided, which is illustrated by taking the application of the method to the processor in the figure as an example, and includes the following steps:

[0320] In response to interactive operations on the device connection graphic element displayed on the touch screen, a communication connection is established with the blood glucose monitoring device; the blood glucose measurement value monitored by the blood glucose monitoring device is received; the blood glucose measurement value is calibrated according to the calibration algorithm to determine the actual blood glucose value; in response to interactive operations on the mode activation graphic element displayed on the touch screen, the insulin infusion device is controlled to enter the closed-loop operation mode; during the operation of the closed-loop operation mode, the insulin infusion device is controlled to operate the corresponding infusion mode according to the actual blood glucose value.

[0321] In this embodiment, the process of establishing a communication connection with the blood glucose monitoring device and receiving the blood glucose measurement value monitored by the blood glucose monitoring device can refer to the above embodiment.

[0322] However, due to environmental and other factors, the blood glucose measurement values ​​sent by the blood glucose monitoring device may not be accurate. Therefore, in this embodiment, the processor will calibrate the blood glucose measurement values ​​according to the calibration algorithm to determine the actual blood glucose value.

[0323] The actual blood glucose value represents the actual blood glucose level of the subject being tested. For example, the actual blood glucose value can include the subject's actual blood glucose level 1 in the first second, the actual blood glucose level 2 in the second second, the actual blood glucose level 3 in the third second, and so on.

[0324] The calibration algorithm can be a pre-set algorithm in the insulin infusion device, which may include, but is not limited to, machine learning algorithms, bias compensation algorithms, and dynamic calibration algorithms. This embodiment is not limited to this.

[0325] Entering the closed-loop operation mode is described in the above embodiments and will not be repeated here. Optionally, during the operation of the closed-loop mode, the processor can control the insulin infusion device to operate the corresponding infusion mode based on the actual blood glucose value and the preset closed-loop control algorithm. Further, the processor can determine the predicted blood glucose value based on the actual blood glucose value and control the insulin infusion device to operate the corresponding infusion mode based on the predicted blood glucose value and control parameters.

[0326] The preset closed-loop control algorithm may include, but is not limited to, proportional-integral-derivative (PID) algorithm, model predictive control (MPC) algorithm, fuzzy logic (FL) algorithm, etc.

[0327] In some embodiments, the preset closed-loop control algorithm can be implemented by a machine learning model, which may include, but is not limited to, at least one of the following: Convolutional Neural Networks (CNN), Recurrent Neural Networks (RNN), Fully Convolutional Neural Networks (FCN), Generative Adversarial Networks (GAN), Back-propagation (BP) machine learning model, Radial Basis Function (RBF) model, Deep Belief Networks (DBN) model, Elman model, or a combination thereof.

[0328] In one embodiment, optionally, if an abnormal event occurs during the operation of the closed-loop operation mode, the processor can also perform safety management of the closed-loop operation mode according to the infusion safety rules associated with the abnormal event. The process of performing safety management of the closed-loop operation mode can be referred to the above embodiments, and will not be repeated here.

[0329] In one exemplary embodiment, optionally, the graphical element includes a finger-prick calibration graphical element. The finger-prick calibration graphical element can be used to update the calibration algorithm. The device control method described above further includes the following steps:

[0330] In response to interactive operations on the finger-prick calibration graphic element displayed on the touch screen, the finger-prick blood glucose measurement value of the subject is obtained, and the calibration algorithm is updated based on the finger-prick blood glucose measurement value and the corresponding blood glucose measurement value.

[0331] For example, please refer to Figure 10 Users can click on the finger-prick blood glucose calibration graphic element 1003 to initiate an interactive operation, which the processor responds to and acquires the finger-prick blood glucose measurement value of the subject. The processor can communicate with the finger-prick blood glucose collection device to acquire the finger-prick blood glucose measurement value of the subject, or it can receive the finger-prick blood glucose measurement value input by the user through the interactive interface.

[0332] Each fingertip blood glucose measurement corresponds to a blood glucose measurement. The measurement time for this blood glucose measurement can be the same as the fingertip blood glucose measurement time, or the difference between the two measurement times can be less than a preset time difference. Therefore, the processor can update the calibration algorithm based on the fingertip blood glucose measurement and its corresponding blood glucose measurement.

[0333] Optionally, the processor can update the calibration algorithm based on the difference between the finger-prick blood glucose measurement and the corresponding blood glucose measurement. Updating the calibration algorithm may include, but is not limited to, updating the parameters within the calibration algorithm.

[0334] In one embodiment, the processor can store the historical records of finger-prick blood calibration, which is the process of updating the calibration algorithm. Please continue to refer to [link / reference needed]. Figure 10 The finger-prick calibration history graphic element 1004 is used to display the history of finger-prick calibration. For example, after the user clicks on the finger-prick calibration history graphic element 1004, the touch screen can display when the user obtained the finger-prick blood glucose measurement value, and update the calibration algorithm based on the finger-prick blood glucose measurement value and the corresponding blood glucose measurement value.

[0335] In the above embodiments, since the graphic element includes a finger-prick calibration graphic element and can respond to interactive operations on the finger-prick calibration graphic element displayed on the touch screen, it can obtain the fingertip blood glucose measurement value of the subject to be tested, and update the calibration algorithm according to the fingertip blood glucose measurement value and the blood glucose measurement value corresponding to the fingertip blood glucose measurement value. Therefore, the user can update the calibration algorithm regularly to improve the accuracy of the actual blood glucose value.

[0336] In an exemplary embodiment, optionally, the above-mentioned "acquiring the fingertip blood glucose measurement value of the subject in response to an interactive operation on the finger-prick calibration graphic element displayed on the touch screen" can be implemented in the following way:

[0337] In response to interactive operations on the finger-prick calibration graphic element displayed on the touch screen, a finger-prick input interface is displayed on the touch screen, and in response to confirmation input based on the finger-prick input interface, and provided that the insulin infusion device meets preset conditions, the finger-prick blood glucose measurement value input by the user is acquired.

[0338] In this embodiment, please continue to refer to Figure 10 After the user clicks the finger-prick blood glucose calibration graphic element 1003, the processor can respond to the interactive operation of the finger-prick blood glucose calibration graphic element 1003 displayed on the touch screen and display the finger-prick blood glucose input interface (not shown in the figure) on the touch screen. The finger-prick blood glucose input interface can include input controls and confirmation controls. The input controls are, for example, input boxes, and the confirmation controls are, for example, "confirm" buttons. The user can enter the collected finger-prick blood glucose measurement value in the input space and click the confirmation control after entering the value to initiate a confirmation input based on the finger-prick blood glucose input interface.

[0339] Then, the processor can obtain the fingertip blood glucose measurement value entered by the user in response to the confirmation input based on the finger-prick blood input interface and when the insulin infusion device meets the preset conditions.

[0340] The processor can determine whether the insulin infusion device meets preset conditions. This determination can occur before or after a confirmation input via the finger-prick blood glucose input interface; this embodiment is not limited to this step. For example, the processor can respond to a confirmation input via the finger-prick blood glucose input interface, then determine whether the insulin infusion device meets the preset conditions, and if the insulin infusion device meets the preset conditions, acquire the finger-prick blood glucose measurement value input by the user.

[0341] In one embodiment, optionally, the preset conditions include at least one of the following:

[0342] (1) The blood glucose measurement value within the third preset time period is within the preset blood glucose range. Both the third preset time period and the preset blood glucose range can be set as needed. In one embodiment, the touch screen includes a main page, which may include a trend of blood glucose measurement values. The trend of blood glucose measurement values ​​can be represented by arrows. When the trend arrow of the blood glucose measurement values ​​is a horizontal arrow, diagonally upward, or diagonally downward, it indicates that the blood glucose fluctuation is small, that is, the blood glucose measurement value within the third preset time period is within the preset blood glucose range.

[0343] (2) Blood glucose measurement value has not expired. The blood glucose measurement values ​​sent by the blood glucose monitoring device have an expiration date. If the blood glucose measurement value has exceeded its expiration date, it means that the blood glucose measurement value received by the processor is incorrect. Conversely, if the blood glucose measurement value has not exceeded its expiration date, it means that the blood glucose measurement value has not expired, and the blood glucose measurement value received by the processor in this case is more accurate, which is beneficial for accurately updating the calibration algorithm. Optionally, the processor can determine whether the blood glucose measurement value has exceeded its expiration date based on the validity period of the blood glucose measurement value.

[0344] (3) Communication between the insulin infusion device and the blood glucose monitoring device is normal. Optionally, the processor can determine whether communication between the insulin infusion device and the blood glucose monitoring device is normal by means of heartbeat packets, etc.

[0345] In the above embodiments, since the finger-prick blood glucose measurement value can be obtained after responding to the interactive operation of the finger-prick calibration graphic element displayed on the touch screen, the finger-prick blood glucose input interface can be displayed on the touch screen, and the user-inputted finger-prick blood glucose measurement value can be obtained after responding to the confirmation input based on the finger-prick blood glucose input interface and the insulin infusion device meets the preset conditions, the reliability of the finger-prick blood glucose measurement value is improved.

[0346] In one exemplary embodiment, optionally, prior to an interactive operation on the finger-print calibration graphic element displayed on the touchscreen, the device control method further includes the following steps:

[0347] If the insulin infusion device does not meet the preset conditions, the control finger-prick calibration graphic element will be set to an input-unavailable state.

[0348] In this embodiment, controlling the finger-prick blood calibration graphic element to be in an uninputable state can be achieved by setting the background color of the finger-prick blood calibration graphic element to a preset color, which may include, but is not limited to, gray. Please continue to refer to... Figure 10 If the insulin infusion device does not meet the preset conditions before the user clicks on the finger-prick calibration graphic element 1003, such as not meeting any of the above three conditions, the processor will control the finger-prick calibration graphic element 1003 to be in an uninputable state.

[0349] In the above embodiments, if the insulin infusion device does not meet the preset conditions, the finger-prick calibration graphic element is controlled to be in an uninputable state. Therefore, in the case where the preset conditions are not met, inaccurate finger-prick blood glucose measurement values ​​can be avoided from updating the calibration algorithm, which is beneficial to improving the accuracy of the actual blood glucose value.

[0350] Figure 11 This is a schematic diagram of a CGM settings interface in one embodiment. In an exemplary embodiment, optionally, the graphical elements also include a CGM binding graphical element and a CGM switch graphical element; the above-described process of connecting the blood glucose monitoring device can be implemented in the following manner:

[0351] In response to an interactive operation on the CGM binding graphic element, bind the blood glucose monitoring device; in response to a confirmation connection input after binding the blood glucose monitoring device, or in response to an interactive operation on the CGM switch graphic element, connect the blood glucose monitoring device.

[0352] Please refer to Figure 8 After the user clicks to connect the graphics element 802 to the device, the touchscreen can display... Figure 11 The CGM settings interface 1100 shown includes a CGM switch graphic element 1101 and a CGM binding graphic element 1102. When a user clicks the CGM binding graphic element 1102, the processor can respond to the interactive operation on the CGM binding graphic element and bind the blood glucose monitoring device. For example, the processor stores the device identifier of the blood glucose monitoring device to bind the blood glucose monitoring device.

[0353] Furthermore, after the blood glucose monitoring device is bound, the touch screen can display a connection prompt, such as "Binding successful, do you want to connect the blood glucose monitoring device?" If the user clicks "Confirm Connection", it will initiate the confirmation connection input after binding the blood glucose monitoring device, and then the processor will connect to the blood glucose monitoring device.

[0354] In some embodiments, after the touchscreen displays "Pairing successful, connect blood glucose monitoring device?", the user can also exit without immediately connecting, in which case the CGM switch graphic element 1101 is in the off state. When it is necessary to connect the insulin infusion device and the blood glucose monitoring device, the user can click the CGM switch graphic element 1101 so that the insulin infusion device responds to the interactive operation of the CGM switch graphic element 1101 and then establishes a connection with the blood glucose monitoring device.

[0355] In one embodiment, after the insulin infusion device and the blood glucose monitoring device are successfully connected, the touchscreen can display a connection success message. In another embodiment, if the insulin infusion device and the blood glucose monitoring device fail to connect, the touchscreen can display a connection failure message and prompt the user to retry.

[0356] In the above embodiments, since the blood glucose monitoring device can be bound in response to the interactive operation of the CGM binding graphic element, and the blood glucose monitoring device can be connected in response to the confirmation connection input after binding the blood glucose monitoring device, or in response to the interactive operation of the CGM switch graphic element, the blood glucose monitoring device can be connected efficiently through the touch screen.

[0357] In one exemplary embodiment, optionally, the above-mentioned "binding the blood glucose monitoring device in response to an interactive operation on the CGM-bound graphical element" can be achieved through the following steps:

[0358] In response to interactive operations on the CGM-bound graphical element, a target binding mode is selected from multiple binding modes displayed on the touch screen; the blood glucose monitoring device is determined based on the target binding mode; and the device identifier of the blood glucose monitoring device is stored to bind the blood glucose monitoring device.

[0359] In this embodiment, Figure 12 This is a schematic diagram of the binding mode in one embodiment, such as... Figure 12 As shown, after the user clicks on the CGM binding graphic element 1102, multiple binding modes will be displayed on the touch screen. For example, the binding interface 1200 displays automatic binding 1201 and manual binding 1202. The user can then select the target binding mode from the multiple binding modes displayed on the touch screen.

[0360] The processor can then determine the blood glucose monitoring device based on the target binding mode. For example, if the user selects manual binding 1202, the user needs to specify the blood glucose monitoring device. If the user selects automatic binding 1201, the insulin infusion device can automatically determine the blood glucose monitoring device based on the communication signal quality; this embodiment does not impose any limitations.

[0361] Furthermore, after identifying the blood glucose monitoring device, that is, determining the device identifier of the blood glucose monitoring device, the processor will store the device identifier of the blood glucose monitoring device to bind the blood glucose monitoring device.

[0362] The device identifier includes the serial number (SN) of the insulin infusion device, and may also include the calibration code of the sensor; this embodiment does not impose any restrictions.

[0363] In one embodiment, after the blood glucose monitoring device is paired, the processor can display a successful pairing message on the touchscreen.

[0364] In the above embodiments, since the target binding mode is selected from multiple binding modes displayed on the touch screen in response to the interactive operation of the CGM binding graphic element, and the blood glucose monitoring device is determined according to the target binding mode, and then the device identifier of the blood glucose monitoring device is stored to bind the blood glucose monitoring device, the blood glucose monitoring device can be accurately bound.

[0365] In one exemplary embodiment, optionally, the above-mentioned "determining the blood glucose monitoring device based on the target binding pattern" can be implemented in the following way:

[0366] If the target binding mode is the first binding mode, then the candidate blood glucose monitoring devices within the preset search range are searched, and the blood glucose monitoring device is determined from each candidate blood glucose monitoring device in response to the user's selection input; if the target binding mode is the second binding mode, then the device identifier input by the user is obtained, and the blood glucose monitoring device is determined according to the device identifier.

[0367] In this embodiment, taking the automatic binding 1201 as the first binding mode as an example, if the user selects automatic binding 1201, the processor will search for candidate blood glucose monitoring devices within a preset search range. The preset search range can be set according to requirements. Each candidate blood glucose monitoring device within the preset search range will periodically broadcast its own device identifier, thus allowing the processor to perform the search.

[0368] Furthermore, the processor can display candidate blood glucose monitoring devices on the touchscreen, allowing the user to select one as the blood glucose monitoring device. The selection input can be a sliding selection input; for example, the user can slide up and down on the touchscreen to select the desired blood glucose monitoring device.

[0369] Taking the first binding mode, manual binding 1202, as an example, if the user selects automatic binding 1201, the processor will receive the device identifier input by the user. Then, the processor will determine the blood glucose monitoring device based on the device identifier. Optionally, the processor will search for blood glucose monitoring devices within a preset search range based on the device identifier. If the blood glucose monitoring device is found within the preset search range, then the blood glucose monitoring device is confirmed.

[0370] In one embodiment, if the processor fails to search N times consecutively within a preset search range, a first search failure message can be displayed on the touchscreen, prompting the user to retry. If the user chooses to retry, the processor can return to the search steps. If the search fails M times after returning to the previous steps, a second search failure message can be displayed on the touchscreen. Here, N and M can be set as needed and are integers greater than 0.

[0371] In the above embodiments, if the target binding mode is the first binding mode, candidate blood glucose monitoring devices within a preset search range are searched, and a blood glucose monitoring device is determined from among the candidate devices in response to the user's selection input; if the target binding mode is the second binding mode, the device identifier input by the user is obtained, and the blood glucose monitoring device is determined based on the device identifier. Therefore, blood glucose monitoring devices can be flexibly bound using different binding modes.

[0372] In one exemplary embodiment, optionally, the graphics element further includes a CGM information graphics element; the above-described device control method further includes the following steps:

[0373] In response to interactive operations on the CGM information graphic element, a preset information interface is displayed on the touch screen; the preset information interface includes device information of the blood glucose monitoring device.

[0374] In this embodiment, please continue to refer to Figure 11 Users can click on the CGM information graphic element 1103, and the insulin infusion device will then respond to the interactive operation of the CGM information graphic element 1103 by displaying a preset information interface on the touch screen. The preset information interface may include device information for the blood glucose monitoring device. This device information may include the device identifier (SN), calibration code, and activation time. The device identifier uniquely identifies the blood glucose monitoring device, the calibration code indicates the sensor batch within the device, and the activation time identifies the activation date of the blood glucose monitoring device.

[0375] In the above embodiments, since the graphic element also includes a CGM information graphic element and can respond to interactive operations on the CGM information graphic element, a preset information interface can be displayed on the touch screen. The preset information interface includes the device information of the blood glucose monitoring device. Therefore, users can conveniently view the device information of the blood glucose monitoring device.

[0376] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0377] In response to an interactive action that terminates the wearing of the graphic element, the blood glucose monitoring device is unbound.

[0378] In this embodiment, the preset information interface also includes a graphic element indicating the end of wearing the device. Users can click on the graphic element to initiate an interactive operation, and the processor can then respond to this interactive operation by unbinding the blood glucose monitoring device.

[0379] Optionally, the processor can remove the device identifier of the blood glucose monitoring device to unbind the blood glucose monitoring device.

[0380] In one embodiment, after unbinding the blood glucose monitoring device, the processor can display an unbinding prompt on the touchscreen, such as "The sensor will fail. Are you sure you want to stop wearing it?". After the user confirms, the processor will display "Unbinding successful. Please charge it promptly." In some embodiments, if unbinding fails, the processor can display an unbinding failure prompt on the touchscreen.

[0381] In the above embodiments, since the preset information interface also includes a graphic element indicating the end of wearing the device, and can unbind the blood glucose monitoring device in response to the interactive operation of the graphic element indicating the end of wearing the device, users can unbind the blood glucose monitoring device in a timely manner if they do not need to wear it.

[0382] In one exemplary embodiment, the above-described device control method may optionally include the following steps:

[0383] In response to interactive operations on the parameter graphic elements displayed on the touch screen, the value of the control parameter is determined.

[0384] For example, please continue to refer to Figure 8 The graphic element also includes a parametric graphic element 804; after the user clicks on the parametric graphic element 804, the touch screen can display the control parameter setting interface, which is used to set various control parameters.

[0385] Figure 13 In one embodiment, a control parameter setting interface is provided. Figure 13 For example, the control parameter setting interface 1300 includes a DIA graphic element 1301, a BG graphic element 1302, an ICR graphic element 1303, and an ISF graphic element 1304. The DIA graphic element 1301 is used to set the insulin activity retention time, the BG graphic element 1302 is used to set the target blood glucose, the ICR graphic element 1303 is used to set the carbohydrate coefficient, and the ISF graphic element 1304 is used to set the insulin sensitivity coefficient.

[0386] For example, a user clicks on the DIA graphic element 1301 and enters the desired insulin activity retention time. The insulin infusion device can then respond to the user's input and obtain the value of the insulin activity retention time. In this way, the insulin infusion device can determine the value of the control parameters.

[0387] In the above embodiments, since the graphic element also includes a parametric graphic element and can determine the value of the control parameter in response to the interactive operation of the parametric graphic element, and the control parameter includes at least one of insulin activity retention time, target blood glucose, carbohydrate coefficient and insulin sensitivity coefficient, the user can flexibly and quickly set the control parameter through the parametric graphic element in the touch screen.

[0388] In an exemplary embodiment, optionally, the graphics element further includes an object parameter graphics element; the above-described device control method further includes the following steps:

[0389] In response to interactive operations on the graphical elements of the object parameters displayed on the touch screen, the physiological parameters of the object under test are acquired, and the values ​​of the control parameters are determined based on the physiological parameters.

[0390] In this embodiment, please continue to refer to Figure 8 The graphical element includes an object parameter graphical element 803. The user can click on the object parameter graphical element 803 and input the physiological parameters of the subject to be tested. These physiological parameters may include, but are not limited to, weight. Subsequently, the insulin infusion device can acquire the physiological parameters of the subject to be tested and determine the values ​​of the control parameters based on these parameters.

[0391] Optionally, the insulin infusion device can store the correspondence between different physiological parameters and control parameters. Then, after obtaining the physiological parameters of the subject, the value of the control parameter can be determined based on the physiological parameters of the subject and the above correspondence.

[0392] In the above embodiments, since the physiological parameters of the object under test can be obtained in response to interactive operations on the graphical elements of the object parameters, and the values ​​of the control parameters can be determined based on the physiological parameters, the efficiency of setting the control parameters is improved.

[0393] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0394] In response to interactive operations on the graphical elements for viewing parameters, the values ​​of the control parameters are displayed on the touch screen.

[0395] In this embodiment, please continue to refer to Figure 9 Users can click on the parameter viewing graphic element 903, and then the insulin infusion device can respond to the interactive operation of the parameter viewing graphic element 903 and display the value of the control parameter on the touch screen.

[0396] In one embodiment, the insulin infusion device can also display the connection status with the blood glucose monitoring device when the control parameter values ​​are displayed, for example, by using "on" to indicate that the connection with the CGM is normal.

[0397] In the above embodiments, since the graphic element also includes a parameter viewing graphic element and can display the value of the control parameter on the touch screen in response to the interactive operation of the parameter viewing graphic element, the user can conveniently view the control parameter.

[0398] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0399] If the infusion dose or single infusion dose within the fourth preset time period is greater than or equal to the corresponding maximum infusion dose threshold, and in response to the interactive operation of the high-dose infusion graphic element, a first infusion prompt is displayed on the touch screen; in response to the confirmation input of the first infusion prompt, the user returns to the interface where the high-dose infusion graphic element is located.

[0400] In this embodiment, the fourth preset duration can be set according to requirements, such as 4 hours or one day. The maximum infusion dose threshold can also be set according to requirements. For example, the maximum infusion dose threshold corresponding to a single infusion dose is the maximum maximum dose, the maximum infusion dose threshold corresponding to an infusion dose within 4 hours is twice the maximum maximum dose, and the maximum infusion dose threshold corresponding to an infusion dose within one day is three times the maximum maximum dose.

[0401] Therefore, when a large-dose infusion is needed, the user will click on the large-dose infusion graphic element 1002. If the infusion dose within the fourth preset time period or the single infusion dose is greater than or equal to the corresponding maximum infusion dose threshold, it indicates that the remaining infusion volume is 0. The insulin infusion device will then display a first infusion prompt on the touchscreen to alert the user that the infusion dose has reached its maximum. After the user confirms the first infusion prompt, the insulin infusion device will respond to the confirmation input for that prompt by returning to the interface of the large-dose infusion graphic element 1002, for example, returning to... Figure 6 The menu page 300 shown indicates that the high-dose infusion has been exited.

[0402] In the above embodiments, since the infusion dose or single infusion dose within the fourth preset time period is greater than or equal to the corresponding maximum infusion dose threshold, if an interactive operation is performed on the high-dose infusion graphic element, a first infusion prompt is displayed on the touch screen, and in response to the confirmation input of the first infusion prompt, the user returns to the interface where the high-dose infusion graphic element is located. Therefore, when a user needs to perform a high-dose infusion, if the infusion dose within the fourth preset time period or single infusion dose is greater than or equal to the corresponding maximum infusion dose threshold, the user can be prevented from continuing to perform a high-dose infusion, thereby improving the safety of using the insulin infusion device.

[0403] In one exemplary embodiment, optionally, the above-described device control method further includes the following steps:

[0404] If an excessive dose is infused within the fifth preset time period, a second infusion prompt will be displayed on the touch screen in response to an interactive operation of the graphic element for the excessive dose infusion.

[0405] In this embodiment, the fifth preset duration can also be set according to needs, such as 1 hour. When a large-dose infusion is required, the user clicks on the large-dose infusion graphic element 1002. If the insulin infusion device determines that a large-dose infusion has been performed within the fifth preset duration, a second infusion prompt will be displayed on the touch screen, such as "Infused 1 hour ago". It should be noted that after the user confirms the second infusion prompt, that is, in response to the confirmation input for the second infusion prompt, the insulin infusion device will still continue the subsequent process of the large-dose infusion graphic element.

[0406] In the above embodiments, if an excessive dose is infused within the fifth preset time period, a second infusion prompt is displayed on the touch screen in response to the interactive operation of the graphic element for the excessive dose infusion. Therefore, the user can be promptly notified that an excessive dose has been infused, reducing the possibility of repeated infusions and improving safety.

[0407] It should be understood that although the steps in the flowcharts of the embodiments described above are shown sequentially according to the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless explicitly stated herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some steps in the flowcharts of the embodiments described above may include multiple steps or multiple stages. These steps or stages are not necessarily completed at the same time, but can be executed at different times. The execution order of these steps or stages is not necessarily sequential, but can be performed alternately or in turn with other steps or at least some of the steps or stages of other steps.

[0408] Based on the same inventive concept, in one embodiment, such as Figure 1 As shown, an insulin infusion device 100 is also provided, which includes a touch screen 101, at least one memory 102, and at least one processor 103.

[0409] In one embodiment, the insulin infusion device may be a wearable or portable insulin infusion device.

[0410] The touchscreen 101 is used to receive user input. The memory 102 stores executable instructions corresponding to the user input. The processor 103 is used to execute the executable instructions to implement any of the above-mentioned device control methods. The principle of the insulin infusion device can be referred to the above description of the device control method, and will not be repeated here.

[0411] In one embodiment, a computer device is provided, including a memory and a processor, wherein the memory stores a computer program, and the processor executes the computer program to implement the steps in the above-described method embodiments.

[0412] In one embodiment, a computer-readable storage medium is provided having a computer program stored thereon, which, when executed by a processor, implements the steps in the above method embodiments.

[0413] In one embodiment, a program product is provided, including a computer program that, when executed by a processor, implements the steps in the above method embodiments.

[0414] In one embodiment, a closed-loop infusion system is provided, the closed-loop infusion system including the insulin infusion device 100 of any of the above.

[0415] It should be noted that the user information (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for analysis, data stored, data displayed, etc.) involved in this application are all information and data authorized by the user or fully authorized by all parties, and the collection, use and processing of the relevant data must comply with relevant regulations.

[0416] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium, and when executed, it can include the processes of the embodiments of the above methods. Any references to memory, databases, or other media used in the embodiments provided in this application can include at least one of non-volatile memory and volatile memory. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetic random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), graphene memory, etc. Volatile memory can include random access memory (RAM) or external cache memory, etc. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM). The databases involved in the embodiments provided in this application may include at least one type of relational database and non-relational database. Non-relational databases may include, but are not limited to, blockchain-based distributed databases. The processors involved in the embodiments provided in this application may be general-purpose processors, central processing units, graphics processing units, digital signal processors, programmable logic devices, quantum computing-based data processing logic devices, artificial intelligence (AI) processors, etc., and are not limited to these.

[0417] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this application.

[0418] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. An insulin infusion device, characterized in that, The insulin infusion device uses a closed-loop operation mode to simulate an artificial pancreas. The infusion mode of the insulin infusion device is used to control the working mode of the insulin infusion device. The insulin infusion device includes a touch screen, at least one memory, and at least one processor. The touch screen is used to receive user input, the memory stores executable instructions, and the processor executes the executable instructions to implement the following method: In response to a user’s first interactive operation on a parameter graphic element displayed on the touch screen, the user-inputted control parameters are obtained; In response to a second interactive operation by the user on the device connection graphic element displayed on the touch screen, a communication connection is established with the blood glucose monitoring device through the second interactive operation to receive the blood glucose measurement value sent by the blood glucose monitoring device; In response to a user's third interactive operation of a graphical element in response to a mode displayed on the touchscreen, a closed-loop operation mode is initiated through the third interactive operation; wherein, if no communication connection is established with the blood glucose monitoring device, the third interactive operation is not responded to, thereby preventing the initiation of the closed-loop operation mode; When operating in the closed-loop mode, the insulin infusion device is controlled to operate in the corresponding infusion mode based on the blood glucose measurement value, historical infusion data, and the control parameters. Specifically, the blood glucose measurement value, historical infusion data, and control parameters are input into a first machine learning model, which outputs the corresponding infusion mode to control the insulin infusion device to operate in the corresponding infusion mode. The first machine learning model is trained based on blood glucose measurement value samples, historical infusion data samples, control parameter samples, and the corresponding infusion mode. Monitor whether blood glucose-affecting events occur during the operation of the closed-loop operation mode; the blood glucose-affecting events include events in which the user's blood glucose level deviates from the target blood glucose range of the control parameters due to equipment operation and / or user activity; Upon confirmation of the occurrence of the aforementioned blood glucose-affecting event, a safety protection procedure is triggered; wherein, the safety protection procedure is installed in the insulin infusion device and is directly invoked and executed by the processor; The safety protection program manages the closed-loop operation mode of the insulin infusion device; wherein, the safety protection program is used to handle the blood glucose impact event so that the user's blood glucose level returns to the target blood glucose range; the safety management includes closing the closed-loop operation mode or maintaining the closed-loop operation mode, and maintaining the closed-loop operation mode includes maintaining or adjusting the infusion mode corresponding to the insulin infusion device; The processor is further configured to implement at least one of the following methods: If a hypoglycemic event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is operating in the standard basal rate infusion mode; If it is determined that the insulin infusion device is running the standard basal rate infusion mode, the standard basal rate infusion mode is adjusted to the temporary basal rate infusion mode through the safety protection procedure, and the infusion dose of the temporary basal rate is set as a safe dose. or, If a hypoglycemic event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is running a temporary basal rate infusion mode; If it is determined that the insulin infusion device is operating the temporary basal rate infusion mode, the temporary basal rate infusion dose is set to the safe dose through the safety protection procedure; or, If a hypoglycemic event occurs during the operation of the closed-loop operation mode, the system monitors whether the insulin infusion device is simultaneously operating the temporary basal rate infusion mode and the high-dose infusion mode. If it is determined that the insulin infusion device is running the temporary basal rate infusion mode and the high-dose infusion mode, the high-dose infusion mode is stopped by the safety protection procedure, and the infusion dose of the temporary basal rate is set to a safe dose by the safety protection procedure. or, If a hypoglycemic event is detected during the operation of the closed-loop operation mode, monitor whether the insulin infusion device is operating the high-dose infusion mode; If it is determined that the insulin infusion device is running the high-dose infusion mode, the high-dose infusion mode is stopped by the safety protection procedure, and the temporary basal rate infusion mode is run by the safety protection procedure, and the temporary basal rate infusion dose is set to a safe dose. The processor is also used to implement the following methods: Receive the initial infusion dose for executing the high-dose infusion mode; The safety protection procedure monitors whether the initial infusion dose reaches the first infusion limit and the second infusion limit; If the initial infusion dose does not reach the first infusion limit and the second infusion limit, the insulin infusion device is controlled to operate the high-dose infusion mode; wherein, the first infusion limit is used to constrain the total sum of high-dose infusion doses accumulated within a preset time period, and the second infusion limit is used to constrain the total sum of high-dose infusion doses accumulated within the day; If the initial infusion dose reaches the first infusion limit or the second infusion limit, the processor is further configured to implement at least one of the following methods: Calculate the dose difference between the initial infusion dose and the first infusion limit or the second infusion limit, and control the insulin infusion device to infuse the dose difference; or; Receive the initial infusion dose input by the user on the touch screen; If the initial infusion dose simultaneously reaches the first infusion limit and the second infusion limit, the touch screen is controlled to display a setting prompt to remind the user to reset the initial infusion dose.

2. The insulin infusion device according to claim 1, characterized in that, The blood glucose impact events include user movement events, and the processor is also configured to implement the following methods: Receive motion information collected by motion sensors or input by the user; Determine whether the user's motion event has occurred based on the motion information; Upon confirming the occurrence of the user movement event, the security protection procedure is triggered. Obtain the blood glucose measurement value at the current moment when the user's exercise event occurs, and determine the blood glucose prediction value based on the exercise information, the blood glucose measurement value, and historical blood glucose data; The infusion dose for the temporary basal rate is determined based on the predicted blood glucose value and the control parameters through the aforementioned safety protection procedure. The insulin infusion device is controlled to operate in temporary basal rate infusion mode based on the infusion dose of the temporary basal rate.

3. The insulin infusion device according to claim 1, characterized in that, The blood glucose impact events include user meal events; the processor is also used to implement the following methods: Determine the predicted blood glucose level for the current moment based on historical blood glucose data; Based on the difference between the current blood glucose measurement and the current blood glucose prediction, and / or the meal monitoring sensor worn by the user, determine whether the user's meal event has occurred; Upon confirming the occurrence of the user dining event, the security protection procedure is triggered. The infusion dose for the temporary basal rate is determined based on the predicted blood glucose value and the control parameters through the aforementioned safety protection procedure. The insulin infusion device is controlled to operate in temporary basal rate infusion mode based on the infusion dose of the temporary basal rate.

4. The insulin infusion device according to claim 1, characterized in that, The processor is also used to implement the following methods: The system obtains the carbohydrate value input by the user through the touchscreen; the carbohydrate value is used to represent the total amount of food consumed by the user. The safety protection procedure is triggered by the aforementioned carbon content; The first high dose is determined through the safety protection procedure based on the carbohydrate value, the blood glucose measurement value associated with the user's input carbohydrate value at the current moment, and the control parameters. Based on the first initial high dose, the insulin infusion device is controlled to operate in high-dose infusion mode; Based on the blood glucose measurement value at the next moment from the current moment, determine the predicted blood glucose value; The first supplemental high dose is determined based on the blood glucose prediction value and the control parameters through the aforementioned safety protection procedure. Based on the first supplemental high dose, the insulin infusion device is controlled to operate in the high-dose infusion mode.

5. The insulin infusion device according to claim 1, characterized in that, The processor is also used to implement the following methods: Obtain the pre-meal dosage input by the user via the touchscreen; The safety protection procedure is triggered by the high dose taken before the meal. Through the aforementioned safety protection procedure, the insulin infusion device is controlled to operate in high-dose infusion mode according to the pre-meal high-dose control. Determine the predicted blood glucose value based on the blood glucose measurement value at the next time step from the current time step; Based on the predicted blood glucose level and the control parameters, the third supplemental high dose is determined through the aforementioned safety protection procedure. Based on the third supplemental high dose, the insulin infusion device is controlled to operate in the high-dose infusion mode.

6. The insulin infusion device according to claim 1, characterized in that, The processor is also used for: In response to a fourth interactive operation by the user on the food aid graphic element displayed on the touch screen, the carbohydrate value input by the fourth interactive operation is obtained; Receive the current blood glucose measurement value corresponding to the moment when the user inputs the carbohydrate value; The safety protection procedure generates a recommended high dose based on the carbohydrate value and / or the current blood glucose measurement; In response to a fifth interactive operation by the user on a large-scale graphic element displayed on the touchscreen; The initial infusion dose is set according to the fifth interactive operation, with reference to the recommended high dose.

7. The insulin infusion device according to claim 3, characterized in that, The processor is also used to implement the following methods: The predicted blood glucose value at the current moment is determined based on the historical blood glucose data, and the estimated meal intake value is determined based on the blood glucose difference between the measured blood glucose value at the current moment and the predicted blood glucose value at the current moment. The micro-dose is determined based on the blood glucose prediction value, the meal estimation value, and the control parameters through the aforementioned safety protection procedure. The insulin infusion device operates in high-dose infusion mode according to the micro-high-dose control.

8. The insulin infusion device according to claim 1, characterized in that, After switching from the closed-loop operation mode to the open-loop operation mode, the processor is further configured to implement at least one of the following methods: After the user's hypoglycemia event is resolved, in response to the user's sixth interactive operation of the graphical element in response to the mode displayed on the touch screen, the insulin infusion device is controlled to resume the closed-loop operation mode. Alternatively, if the blood glucose measurement value is detected to be higher than the blood glucose recovery threshold and the insulin infusion device is in a paused infusion state, the insulin infusion device can be controlled to automatically resume the closed-loop operation mode.

9. The insulin infusion device according to any one of claims 1 to 6, characterized in that, The processor is also configured to implement at least one of the following methods: If an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode is maintained by the safety protection procedure. Monitor whether the insulin infusion device is running a temporary basal rate infusion mode; if it is determined that the insulin infusion device is running the temporary basal rate infusion mode, switch the temporary basal rate infusion mode to the standard basal rate infusion mode; Alternatively, if an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode is maintained by the safety protection procedure; and the system monitors whether the insulin infusion device is operating in high-dose infusion mode. If it is determined that the insulin infusion device is operating in the high-dose infusion mode, the high-dose infusion mode shall be maintained; or, If an abnormal blood glucose event or blood glucose loss event is detected during the operation of the closed-loop operation mode, the closed-loop operation mode is maintained through the safety protection procedure; the insulin infusion device is monitored to see if it is operating in the standard basal rate infusion mode; While monitoring that the insulin infusion device is operating the standard basal rate infusion mode, maintain the standard basal rate infusion mode.

10. The insulin infusion device according to any one of claims 1-6, characterized in that, The processor is used to implement the following methods: If a high-level alarm event is detected during the operation of the closed-loop operation mode, the security protection program switches the closed-loop operation mode to the open-loop operation mode and performs security management on the high-level alarm event.

11. The insulin infusion device according to claim 10, characterized in that, The high-level alarm event includes a first alarm event, and the processor is further configured to implement the following method: According to the safety protection procedure for the first alarm event, the insulin infusion device is controlled to suspend infusion; wherein, the first alarm event includes at least one of the following: excessively strong ambient magnetic field, depletion of medication, tubing detachment, depletion of power, and tubing blockage.

12. The insulin infusion device according to claim 10, characterized in that, The high-level alarm event includes a second alarm event, and the processor is further configured to implement at least one of the following methods: According to the security protection procedure for the second alarm event, the temporary basal rate infusion mode currently running on the insulin infusion device is switched to the standard basal rate infusion mode. Alternatively, based on the security management of the second alarm event according to the security protection procedure, the insulin infusion device can be controlled to maintain the standard basal rate infusion mode. The second alarm event includes insufficient lifespan of the blood glucose monitoring device.

13. A closed-loop infusion system, characterized in that, The closed-loop infusion system includes the insulin infusion device as described in any one of claims 1-12.

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