Personalized closed-loop artificial pancreas system

Abstract

A personalized closed-loop artificial pancreas system, comprising: a measurement module (100) for continuously measuring the blood glucose level of a patient; an infusion module (102) for infusing insulin into the body of the patient; and a program module (101) for controlling the measurement module (100) and the infusion module (102). At least on the basis of the blood glucose level measured by the measurement module (100), the program module (101) generates an insulin infusion instruction, and controls the infusion module (102) to perform infusion; the program module (101) comprises a user interface; in response to the input of the patient, the program module (101) executes functions of corresponding meal patterns; the meal patterns comprise a high-carbohydrate pattern and a normal-carbohydrate pattern; and on the basis of the input of the patient, the program module (101) executes the function of the high-carbohydrate pattern or the normal-carbohydrate pattern. The present invention can be adapted to people having different carbohydrate consumption habits, improve the adaptability of a closed-loop artificial pancreas to different people, and enable people having different carbohydrate consumption habits to maintain a satisfactory blood glucose control effect.

Description

A personalized closed-loop artificial pancreas system Technical Field

[0001] The present invention mainly relates to the field of medical devices, and in particular to a personalized closed-loop artificial pancreas system. Background Art

[0002] In a healthy individual, the pancreas automatically secretes insulin and glucagon based on blood sugar levels, maintaining a healthy blood sugar range. However, in diabetics, pancreatic function is abnormal, preventing the body from producing the necessary insulin. Diabetes is a metabolic disease, a lifelong condition. Current medical technology cannot cure diabetes; instead, it can control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to monitor their blood sugar before injecting insulin. Currently, most monitoring methods use in-vivo blood glucose monitoring devices to continuously monitor blood sugar. These devices use disposable transcutaneous sensors inserted into the skin to measure the blood sugar concentration in the interstitial fluid and transmit this data in real time to an external device via a transmitter for easy viewing by the patient. This monitoring method is called continuous glucose monitoring (CGM). Based on the blood sugar level detected by the CGM, an insulin pump automatically adjusts the amount of insulin required by the patient and delivers the insulin subcutaneously, thus forming a closed-loop artificial pancreas.

[0004] While current closed-loop artificial pancreas control schemes allow insulin pumps to monitor and adjust a patient's blood glucose level in a largely continuous and autonomous manner, because the control schemes cannot accurately identify the type and size of a patient's meals, insulin infusions are often manually initiated before or during meals, such as with meal boluses or correction boluses, to prevent fluctuations in the patient's blood glucose level that could be caused by the upcoming carbohydrate consumption and the control scheme's response time. Furthermore, because dietary habits vary significantly across different regions and age groups, using a unified control scheme may result in suboptimal blood glucose control for some individuals.

[0005] Therefore, the existing technology urgently needs a personalized closed-loop artificial pancreas system that can be suitable for people with different diets or carbohydrate consumption habits.

[0006] Summary of the Invention

[0007] An embodiment of the present invention discloses a personalized closed-loop artificial pancreas system, including a detection module for continuously detecting a patient's blood sugar level; an infusion module for infusing insulin into the patient's body; a program module for controlling the detection module and the infusion module. At least based on the blood sugar level detected by the detection module, the program module generates an insulin infusion instruction and controls the infusion module to perform the infusion. The program module includes a user interface. In response to the patient's input, the program module executes the corresponding meal mode function. The meal mode includes a high-carbohydrate mode and a normal-carbohydrate mode. Based on the patient's input, the program module executes the functions of the high-carbohydrate mode or the normal-carbohydrate mode. The system is suitable for people with different carbohydrate consumption habits, thereby improving the adaptability of the closed-loop artificial pancreas to different people and enabling people with different carbohydrate consumption habits to maintain satisfactory blood sugar control effects.

[0008] The present invention discloses a personalized closed-loop artificial pancreas system, comprising a detection module for continuously detecting a patient's blood sugar level; an infusion module for infusing insulin into the patient's body; and a program module for controlling the detection module and the infusion module. The program module generates an insulin infusion instruction based on at least the blood sugar level detected by the detection module and controls the infusion module to perform the infusion. The program module comprises a user interface. In response to the patient's input, the program module executes a corresponding meal mode function. The meal modes include a high-carbohydrate mode and a normal-carbohydrate mode.

[0009] According to one aspect of the present invention, the input is a pass code, and the setting of the pass code is related to the patient's carbohydrate consumption habits.

[0010] According to one aspect of the present invention, the patient's carbohydrate consumption habits are the result of a comprehensive judgment made by the system or doctor based on one or more of the patient's gender, age, eating habits, exercise habits, health status, insulin sensitivity, carbohydrate sensitivity, and non-automatic mode usage results.

[0011] According to one aspect of the invention, the passcode is the patient's response to a set of short questions.

[0012] According to one aspect of the present invention, the passcode is one or more of numeric characters, alphabetic characters and other symbols.

[0013] According to one aspect of the present invention, the passcode is one or more of a tapping or sliding action performed by the patient on the user interface.

[0014] According to one aspect of the present invention, the high carbohydrate mode includes at least a large meal mode and a regular meal mode.

[0015] According to one aspect of the present invention, the system employs an infusion strategy of pre-infusion and supplemental infusion.

[0016] According to one aspect of the present invention, the amount of insulin infused during pre-infusion is at least related to the actual blood glucose level or blood glucose change rate during pre-infusion and the estimated meal size.

[0017] According to one aspect of the present invention, the amount of insulin infused during pre-infusion is also related to the IOB in the patient.

[0018] According to one aspect of the present invention, the amount of insulin infused during supplemental infusion is at least related to the actual blood glucose level or blood glucose change rate at the time of supplemental infusion and the estimated meal size.

[0019] According to one aspect of the present invention, the amount of insulin infused during supplemental infusion is also related to the IOB in the patient.

[0020] According to one aspect of the present invention, the system determines whether to change the level of the next pre-infusion based on whether high or low blood sugar occurs within a predetermined time period after the pre-infusion.

[0021] According to one aspect of the present invention, the system determines whether to perform supplemental infusion based on at least a blood glucose level a predetermined time after the completion of the pre-infusion.

[0022] According to one aspect of the present invention, the system determines whether to change the level of the next supplemental infusion based on whether high or low blood sugar occurs within a predetermined time period after the supplemental infusion.

[0023] According to one aspect of the present invention, the high carbohydrate mode and the normal carbohydrate mode also include a small meal mode.

[0024] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0025] The personalized closed-loop artificial pancreas system disclosed in the present invention includes a detection module, an infusion module and a program module. The program module generates insulin infusion instructions based on at least the blood glucose value detected by the detection module and controls the infusion module to perform infusion. The program module includes a user interface. In response to the patient's input, the program module executes the corresponding meal mode function. The meal mode includes at least a high-carbohydrate mode and a normal-carbohydrate mode. Based on the patient's input, the program module executes the function of the high-carbohydrate mode or the normal-carbohydrate mode. It can be suitable for people with different carbohydrate consumption habits, improve the adaptability of the closed-loop artificial pancreas to different people, and enable people with different carbohydrate consumption habits to maintain satisfactory blood glucose control effects.

[0026] Furthermore, the setting of the pass code is related to the patient's carbohydrate consumption habits. The patient's carbohydrate consumption habits are the result of a comprehensive judgment made by the system or doctor based on one or more of the patient's gender, age, eating habits, exercise habits, health status, insulin sensitivity, carbohydrate sensitivity, and non-automatic mode usage results, rather than the patient's self-judgment based on his or her own subjective consciousness, to prevent misjudgment, which may result in inaccurate insulin infusion and affect the patient's blood sugar control effect.

[0027] Furthermore, the user input is a pass code, which includes answers to a set of small questions, so that the system can judge the patient's carbohydrate consumption habits based on the user's answers, improve the accuracy of the judgment, and thus improve the patient's blood sugar control effect.

[0028] Furthermore, the high carbohydrate mode includes at least a large meal mode and a regular meal mode. Therefore, even patients with high carbohydrate consumption can choose the regular meal mode. When patients with high carbohydrate consumption eat a relatively small amount of food, the system can accurately infuse and improve the patient's blood sugar control level.

[0029] Furthermore, the high-carb mode and normal-carb mode also include a small meal mode. When the patient chooses the small meal mode, the system infuses insulin based on the default estimated meal size, while taking into account the patient's actual blood sugar value or blood sugar change rate when eating small meals, as well as the body's IOB, so that the patient's blood sugar level can be effectively controlled when eating different amounts of carbohydrates at different times.

[0030] Furthermore, after the patient chooses the meal mode, the system adopts the infusion strategy of pre-infusion and supplementary infusion. Compared with the one-time large-dose infusion method of meal, the infusion strategy of pre-infusion and supplementary infusion is more flexible and can be adjusted according to the blood sugar situation after pre-infusion, so that the patient's blood sugar control effect is better.

[0031] Furthermore, the amount of insulin infused during pre-infusion not only takes into account the actual blood glucose value or blood glucose change rate and the estimated meal size at the time of pre-infusion, but also takes into account the IOB in the body at that time, making the amount of insulin infused during pre-infusion more accurate and improving the patient's blood glucose control level.

[0032] Furthermore, the amount of insulin infused during supplemental infusion not only takes into account the actual blood glucose value or blood glucose change rate and the estimated meal size at the time of supplemental infusion, but also takes into account the IOB in the body at that time, making the amount of insulin infused during supplemental infusion more accurate and improving the patient's blood glucose control level.

[0033] Furthermore, the system determines whether to perform supplementary infusion based on at least the blood glucose level at a predetermined time after the completion of the pre-infusion, determines whether to change the level of the next pre-infusion based on whether high or low blood glucose occurs within a predetermined time period after the pre-infusion, and determines whether to change the level of the next supplementary infusion based on whether high or low blood glucose occurs within a predetermined time period after the supplementary infusion, thereby maintaining the patient's blood glucose level at a stable level. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system;

[0035] FIG2 is a schematic structural diagram of an integrated CGM according to an embodiment of the present invention;

[0036] FIG3 is a schematic structural diagram of a split-type CGM according to an embodiment of the present invention;

[0037] FIG4 a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention;

[0038] FIG4 b is a schematic structural diagram of a split-type insulin pump according to an embodiment of the present invention;

[0039] FIG5a is a schematic diagram of a main interface of a control system in a first working mode according to an embodiment of the present invention;

[0040] FIG5 b is a schematic diagram of the main interface of the control system according to an embodiment of the present invention when the control system is in the second working mode;

[0041] 6a-6c are schematic diagrams of different operations of enabling the insulin pump function of a control system according to an embodiment of the present invention;

[0042] 7a-7c are schematic diagrams of different operations of turning on the automatic mode function of a control system according to an embodiment of the present invention;

[0043] 8a-8b are schematic diagrams of the APP interface before and after the automatic mode function is turned on in the control system according to an embodiment of the present invention;

[0044] FIG9a is a schematic diagram of the interface when the system is in high carbohydrate mode according to an embodiment of the present invention;

[0045] FIG9 b is a schematic diagram of the interface for selecting a large meal in the high-carbohydrate mode of the system according to an embodiment of the present invention;

[0046] FIG9c is a schematic diagram of an interface for selecting a regular meal in a high-carbohydrate mode in a system according to an embodiment of the present invention;

[0047] FIG9 d is a schematic diagram of the interface when the system according to an embodiment of the present invention is in normal carbohydrate mode;

[0048] FIG. 10 is a process diagram of an infusion strategy of pre-infusion and supplemental infusion according to an embodiment of the present invention. DETAILED DESCRIPTION

[0049] As mentioned above, due to the large differences in dietary habits among people in different regions or at different age groups, the use of a unified control plan may lead to poor blood sugar control in some people. Therefore, a personalized closed-loop artificial pancreas is needed to meet the needs of people with different dietary or carbohydrate consumption habits, so that the blood sugar levels of people with different dietary or carbohydrate consumption habits can be maintained at an ideal level.

[0050] To solve this problem, the present invention provides a personalized closed-loop artificial pancreas system, including a detection module, an infusion module and a program module. The program module generates insulin infusion instructions based on at least the blood glucose value detected by the detection module and controls the infusion module to perform infusion. The program module includes a user interface. In response to the patient's input, the program module executes the corresponding meal mode function. The meal mode includes a high-carbohydrate mode and a normal-carbohydrate mode. Based on the patient's input, the program module executes the functions of the high-carbohydrate mode or the normal-carbohydrate mode. It can be suitable for people with different carbohydrate consumption habits, improves the adaptability of the closed-loop artificial pancreas to different people, and enables people with different carbohydrate consumption habits to maintain satisfactory blood glucose control effects.

[0051] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that unless otherwise specifically stated, the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments should not be construed as limiting the scope of the present invention.

[0052] In addition, it should be understood that for ease of description, the sizes of the various components shown in the drawings are not necessarily drawn according to actual proportional relationships. For example, the thickness, width, length or distance of certain units may be enlarged relative to other structures.

[0053] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present invention, its application, or use in any sense. Technologies, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but to the extent applicable, such technologies, methods, and apparatuses should be considered part of this specification.

[0054] It should be noted that like reference numerals and letters denote like items in the following figures, and thus, once an item is defined or described in one figure, it will not need to be further discussed in the subsequent figure descriptions.

[0055] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system.

[0056] The closed-loop artificial pancreas insulin infusion control system disclosed in the embodiment of the present invention mainly includes a detection module 100 , a program module 101 and an infusion module 102 .

[0057] The detection module 100 is used to continuously monitor the patient's current blood glucose level. Typically, the detection module 100 is a continuous glucose monitoring (CGM), which can detect the patient's current blood glucose level in real time, monitor blood glucose changes, and transmit the current blood glucose information to the program module 101. The CGM includes an implantable sensor connected to a transmitter. The transmitter also includes a memory, a processor, a communication interface, etc. The transmitter is used to transmit at least the blood glucose data monitored by the CGM and the CGM identifier information.

[0058] Infusion module 102 includes the necessary mechanical structures and electronic control unit for insulin infusion, such as a drug reservoir, a drive mechanism, an infusion line and needle, a power supply, and a circuit board. It is controlled by program module 101. Typically, infusion module 102 is an insulin pump, and the electronic control unit includes a memory, a processor, and a communication interface. Based on the current insulin infusion volume data transmitted by program module 101, infusion module 102 infuses the patient's body with the currently required insulin. Simultaneously, the infusion status of infusion module 102 is also fed back to program module 101 in real time.

[0059] Program module 101 is used to control the operation of detection module 100 and infusion module 102. Based on at least the blood glucose level detected by detection module 100, program module 101 generates insulin infusion instructions and controls infusion module 102 to perform infusion. The program module 101 includes memory, a processor, a communication interface, a display, a patient interface, and other components. The memory stores programming instructions, and the processor executes the programming instructions in the memory. Program module 101 is connected to detection module 100 and infusion module 102, respectively. This connection can include conventional electrical or wireless connections.

[0060] The embodiments of the present invention do not limit the specific positions and connection relationships of the detection module 100, the program module 101 and the infusion module 102, as long as the aforementioned functional conditions are met.

[0061] In one embodiment of the present invention, the three modules are electrically connected to form a single integrated structure. Therefore, they can be applied to the same location on the patient's skin. By connecting the three modules into a single unit and applying them to the same location, the number of devices applied to the patient's skin is reduced, thereby minimizing interference with patient activity caused by multiple devices. Furthermore, this effectively resolves the issue of wireless communication reliability between separate devices, further enhancing the patient experience.

[0062] In another embodiment of the present invention, the program module 101 and the infusion module 102 are interconnected to form an integrated structure, while the detection module 100 is separately provided in another structure. In this case, the detection module 100 and the program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, the program module 101 and the infusion module 102 are attached to a certain location on the patient's skin, while the detection module 100 is attached to another location on the patient's skin.

[0063] In another embodiment of the present invention, program module 101 and detection module 100 are interconnected to form a single device, while infusion module 102 is located in a separate structure. Infusion module 102 and program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, program module 101 and detection module 100 can be attached to a specific location on a patient's skin, while infusion module 102 can be attached to another location on the patient's skin.

[0064] In another embodiment of the present invention, the three modules are disposed in separate structures. Thus, the three modules are attached to different locations on the patient's skin. In this case, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to establish connections.

[0065] In another embodiment of the present invention, the three modules are arranged in separate structures. Thus, the detection module 100 and the infusion module 102 are attached to different locations on the patient's skin, while the program module 101 does not need to be attached to the skin. Instead, the detection module 100 and the infusion module 102 are controlled by a handheld or portable device, such as a PDM or a smartphone. In this case, the program module 101 transmits wireless signals to and from the detection module 100 and the infusion module 102, respectively, to establish a connection between them.

[0066] The wireless described in the foregoing embodiments may be achieved through, for example, but not limited to, radio frequency (RF) communication (e.g., radio frequency identification (RFID), Zigbee communication protocol, WiFi, infrared, wireless universal serial bus (USB), ultra-wideband (UWB), Communication protocols and cellular communications, such as Code Division Multiple Access (CDMA) or Global System for Mobile Communications (GSM).

[0067] Figure 2 is a schematic diagram of the structure of an integrated CGM according to an embodiment of the present invention. Figure 3 is a schematic diagram of the structure of a split CGM according to an embodiment of the present invention.

[0068] CGM includes a sensor and a transmitter, which are installed on the patient through an auxiliary installation device and inserted subcutaneously. The sensor is used to collect blood sugar content in the human body and transmit the collected blood sugar content information. The transmitter is connected to the sensor and is used to receive blood sugar data information transmitted by the sensor implanted subcutaneously and convert it into a wireless signal output. Each CGM has a unique identifier, such as a device identifier, hardware identifier, universally unique identifier, serial number, communication protocol-based identifier (such as BLE ID), manufacturer's identifier, etc. The identifier is formed by a combination of multiple randomly combined numbers and letters, which can be set on the CGM shell or packaging, and can also have different settings for different types of CGM.

[0069] Figure 2 is a schematic diagram of the structure of an integrated CGM. This means that the CGM's sensor and transmitter are integrated before use. This CGM is a single-use product that is discarded after use. As shown in Figure 2, the integrated CGM includes a sensor 201, a housing 202, and a transmitter (not shown) housed within housing 202. Sensor 301 monitors the patient's blood glucose data and transmits this data to the transmitter via internal circuitry. The transmitter then transmits this data to a receiver. The identifier can be placed on the CGM's outer housing, packaging, or within the CGM.

[0070] Figure 3 is a schematic diagram of the structure of a split-type CGM. Prior to use, the CGM's sensor and transmitter are two separate components, packaged separately. They are integrated together during use. The split-type CGM includes a base housing 301 and a transmitter 302. The base housing is provided with a sensor 3011, while the transmitter 302 has a separate housing. The base housing 301 and transmitter 302 are provided with snap-fit ​​structures 3012 and 3022, respectively. During use, the base housing 301 and transmitter 302 are snapped together into a single unit via the snap-fit ​​structures. The sensor 3011 is electrically connected to the transmitter 302 via an electrical connector 3013. The sensor 301 monitors a patient's blood glucose data and transmits this data to the transmitter 302 via the electrical connector 3013. The transmitter 302 then transmits this data to the receiver.

[0071] In one embodiment of the present invention, both the sensor and transmitter of a split-type CGM are disposable products that are discarded after use. Therefore, the identifier can be placed on the housing or outer packaging of the sensor or transmitter. In another embodiment of the present invention, only the sensor of the split-type CGM is a disposable product, while the transmitter is a reusable product. Therefore, in this embodiment, preferably, the identifier is placed on the housing or outer packaging of the transmitter. This can reduce the frequency of binding patient information and the identifier, thereby improving the patient experience. This will be described in detail below.

[0072] When the identifier is provided on the housing or outer packaging of the CGM or transmitter, it may be provided in the form of, but not limited to, a QR code, a barcode, or an NFC tag.

[0073] FIG4 a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention; FIG4 b is a schematic structural diagram of a split insulin pump according to an embodiment of the present invention.

[0074] In an embodiment of the present invention, the insulin pump is a patch-type insulin pump, that is, an insulin pump that does not include a long catheter, includes an infusion structure and a control structure, and is adhered as a whole to the patient's skin surface by a same adhesive patch. The drug is directly infused from the drug storage cartridge along the infusion needle into the subcutaneous tissue.

[0075] Each insulin pump has a unique identifier, such as a device identifier, hardware identifier, universally unique identifier, serial number, communication protocol-based identifier, manufacturer's identifier, etc. The identifier is formed by a multi-digit random combination of numbers and letters, which can be set on the housing or packaging of the insulin pump, and can also have different settings for different types of insulin pumps.

[0076] Figure 4a is a schematic diagram of the structure of an integrated insulin pump, that is, the infusion structure 410 and the control structure 400 of the insulin pump are arranged inside the same housing 10, the two are connected by a wire, and are affixed to a certain position on the patient's skin through an adhesive patch 420, and are discarded as a whole after one-time use; the identifier can be set on the outer housing or outer packaging of the insulin pump or inside the insulin pump.

[0077] Figure 4b is a schematic diagram of the structure of a split-type insulin pump, in which the infusion mechanism 410 and control mechanism 400 of the insulin pump are housed in separate housings, connected by a waterproof plug or directly snapped together and electrically connected to form a single unit. The identifier can be placed on the outer housing, packaging, or inside the insulin pump itself.

[0078] In one embodiment of the present invention, both the infusion structure and the control structure of a split-type insulin pump are disposable products that are discarded after use. Therefore, the identifier can be set on the housing or outer packaging of the infusion structure and / or the control structure. In another embodiment of the present invention, only the infusion structure of the split-type insulin pump is a disposable product, while the control structure is a reusable product. Therefore, preferably, in this embodiment, the identifier is set on the housing or outer packaging of the control structure. This can reduce the frequency of binding patient information and the identifier, thereby improving the patient experience. This will be described in detail below.

[0079] When the identifier is provided on the housing or outer packaging of the insulin pump or control structure, it may be provided in the form of, but not limited to, a QR code, a barcode, or an NFC tag.

[0080] According to the different degrees of illness of the patients and the patients' personal physical health conditions, some patients may only need CGM for continuous blood glucose monitoring, while some patients may not only need CGM for continuous blood glucose monitoring, but also need insulin pump for drug infusion. When the doctor determines that the patient only needs to use CGM for continuous blood glucose monitoring, since CGM only involves monitoring of the patient's blood glucose, the patient's use of CGM on his own will not pose a risk to the patient's life safety. Therefore, the patient can purchase CGM on his own. Before the CGM is installed on the patient's skin surface, the patient can search and download a special APP for controlling CGM in the application store of the smartphone, and create a new account on the special APP, pair the patient's personal information with the CGM information to be worn, thereby achieving pairing and control of the smartphone and CGM. The CGM and insulin pump in the embodiment of the present invention are developed and produced by the same manufacturer, so they can be controlled by the same special APP in the smartphone. Since the insulin pump is not required by all patients, only CGM-related content is involved in the default main screen of the special APP, as shown in Figure 5a. On the one hand, the interface of the APP can be simplified, providing the patient's visual experience, and on the other hand, preventing the patient from misoperating the insulin pump function and affecting the normal use of the CGM function.

[0081] In one embodiment of the present invention, when the doctor determines that the patient needs to use an insulin pump for drug infusion, as shown in Figure 6a, the doctor sends an application to the backend administrator, requesting that the patient's account be added to the whitelist, allowing the patient to use the insulin pump function. The backend administrator receives the whitelist addition application sent by the doctor, adds the patient's account to the whitelist list, and sends feedback to the doctor that the whitelist addition has been completed. Furthermore, the backend administrator directly opens the insulin pump function of the APP interface used by the patient. At this time, the APP interface changes from Figure 5a to Figure 5b. Compared with the interface of Figure 5a, the interface of Figure 5b adds two function keys related to insulin infusion, "Insulin Delivery" and "Easyloop". In another embodiment of the present invention, the backend administrator does not directly open the insulin pump function of the APP interface used by the patient, but sends a security code to the patient account. The patient can use the security code to open the insulin pump function of the APP interface when needed or convenient.

[0082] In another embodiment of the present invention, when a doctor determines that a patient requires an insulin pump for medication infusion, as shown in Figure 6b, the patient can directly submit a request to enable the insulin pump function to the backend administrator. Upon receiving the request, the backend administrator will verify whether the patient's account is on a whitelist. If the patient's account is on the whitelist, the backend administrator will enable the insulin pump function in the patient's app interface, and the app interface will change from Figure 5a to Figure 5b. If the patient's account is not on the whitelist, the backend administrator will send a feedback message to the patient's account, reminding the patient to ask the doctor to submit a request to add the patient to the whitelist. After the doctor sends the whitelist request to the backend administrator, the backend administrator can directly enable the insulin pump function in the patient's app interface. If the doctor does not receive a response from the backend administrator within a certain period of time (e.g., 1 minute, 2 minutes, or 5 minutes), the backend administrator can submit another request to enable the insulin pump function to the backend administrator, or ask the doctor to submit a whitelist request to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly enable the insulin pump function in the patient's app interface. Instead, the backend administrator sends a security code to the patient's account, which the patient can use to enable the insulin pump function in the app interface when needed or convenient.

[0083] In another embodiment of the present invention, when the doctor determines that the patient needs to use an insulin pump for drug infusion, as shown in Figure 6c, the doctor sends an application to the backend administrator, requesting that the patient's account be added to the whitelist, allowing the patient to use the insulin pump function. The backend administrator receives the whitelist addition application sent by the doctor and adds the patient's account to the whitelist list. At the same time, feedback is sent to the doctor that the whitelist addition has been completed. Further, the doctor notifies the patient that he or she can apply to use the insulin pump function; after receiving the doctor's notification, the patient sends an application to open the insulin pump function to the backend administrator. After the backend administrator receives the application to open the insulin pump function sent by the patient, the backend administrator directly opens the insulin pump function on the APP interface used by the patient. In another embodiment of the present invention, after the backend administrator receives the application to open the insulin pump function sent by the patient, it can also first verify whether the patient's account exists in the whitelist. If it is determined that the patient's account is in the whitelist list, the backend administrator opens the insulin pump function on the APP interface used by the patient. In another embodiment of the present invention, the backend administrator does not directly open the insulin pump function on the APP interface used by the patient, but sends a security code to the patient's account. The patient can use the security code to open the insulin pump function on the APP interface when needed or convenient.

[0084] When the doctor determines that the patient no longer needs to have the insulin pump function enabled, the patient can disable the insulin pump function on the app. The app will automatically send a message to the backend administrator, who will then delete the patient account from the whitelist. The doctor and / or patient can also send a request to the backend administrator to disable the insulin pump function. The backend administrator will disable the insulin pump function on the patient's app and delete the patient account from the whitelist. If the patient needs to re-enable the insulin pump function, the patient account will need to be re-added to the whitelist using one of the methods described in Figures 6a-6c.

[0085] It should be noted that when turning on the insulin pump function of the app, it is necessary to ensure that the insulin pump is correctly installed on the skin and to pair the patient's personal information with the insulin pump information, thereby achieving pairing and control of the smartphone and the insulin pump. The patient's personal information includes name, age, gender, mobile phone number, etc., and the information of the CGM and / or insulin pump worn includes the identifier information of the CGM and / or insulin pump. At the same time, the smartphone uploads the patient's personal information and the identifier information of the CGM and / or insulin pump to a remote server. The remote server can store the information uploaded by the smartphone and verify whether the identifier information of the CGM and / or insulin pump is valid. If a certain identifier information already exists in the remote server, the remote server will send a prompt to the smartphone to remind the patient that the CGM or insulin pump has been used and needs to be replaced. When the CGM and / or insulin pump is installed on the patient's skin and successfully activated, the CGM and / or insulin pump begins to work. The CGM transmitter sends the monitored blood sugar information to the smartphone and further uploads it to the remote server. The control structure of the insulin pump receives the insulin infusion information and controls the infusion structure to infuse insulin. At the same time, the infusion status is sent to the smartphone and further uploaded to the remote server.

[0086] It should be noted that the CGM and insulin pump in the embodiment of the present invention are developed and produced by the same manufacturer, and therefore can be controlled by the same dedicated APP in the smartphone. When the patient needs both CGM and insulin pump and CGM at the same time, even if the CGM or insulin pump is produced by other manufacturers, the CGM or insulin pump can be directly controlled by the dedicated APP, which can also avoid the inconvenience caused to the patient by using different APPs to control the CGM and insulin pump respectively, thereby improving the patient experience.

[0087] When the CGM and / or insulin pump worn by the patient needs to be replaced due to reaching the usage cycle or failure, the unique identifier information of the new CGM and / or insulin pump also needs to be paired and updated with the patient's personal information through the smartphone and further uploaded to the remote server. The patient's personal information is entered manually, and the identifier information of the CGM and / or insulin pump can also be entered manually or by scanning the QR code, barcode, or NFC tag on the shell or outer packaging of the CGM and / or insulin pump.

[0088] When the CGM has a split structure and the transmitter is reusable, the CGM identifier is set on the transmitter's outer shell or packaging. When the patient replaces the CGM, he only needs to replace the sensor without replacing the transmitter. The CGM identifier also remains unchanged. Therefore, there is no need to update the pairing of the CGM identifier and the patient's personal information through a smartphone, nor is there any need to upload it to a remote server. This can reduce the number of operating steps and improve the patient experience.

[0089] When the insulin pump has a split structure and the control structure is reusable, the identifier of the insulin pump is set on the outer shell or packaging of the control structure. When the patient replaces the insulin pump, he only needs to replace the infusion structure without replacing the control structure. The identifier of the insulin pump also remains unchanged. Therefore, there is no need to update the pairing of the insulin pump identifier and the patient's personal information through a smartphone, nor is there any need to upload it to a remote server. This can reduce the number of operating steps and improve the patient experience.

[0090] The smartphone and the CGM and / or insulin pump, as well as the remote server, communicate wirelessly via, for example, but not limited to, radio frequency (RF) communication (e.g., radio frequency identification (RFID), Zigbee communication protocol, WiFi, infrared, wireless universal serial bus (USB), ultra-wide band (UWB), Communication protocols and cellular communications, such as Code Division Multiple Access (CDMA) or Global System for Mobile Communications (GSM). Preferably, the smartphone and the remote server communicate via WiFi and / or cellular, and the smartphone and the CGM and / or insulin pump communicate via Communication protocol communication.

[0091] When the doctor determines that the patient can enable automatic mode, the app reads the current blood glucose level monitored by the CGM and the insulin information infused by the insulin pump, calculates the future blood glucose trend, and controls the insulin pump infusion based on the calculated blood glucose trend, including increasing, decreasing, or stopping insulin infusion, to achieve the purpose of influencing the blood glucose level, forming an automated closed-loop control cycle. As shown in Figure 7a, the doctor sends a request to the backend administrator to add the patient's account to the whitelist, allowing the patient to use the automatic mode function. The backend administrator receives the doctor's whitelist addition request and adds the patient's account to the whitelist list. At the same time, it sends feedback to the doctor that the whitelist addition has been completed. Furthermore, the automatic mode function of the app interface used by the patient is directly enabled. At this time, the app interface changes from Figure 8a to Figure 8b. The interface of Figure 8b has an "Auto Mode" function key associated with the automatic mode compared to the interface of Figure 8a. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function of the app interface used by the patient, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function of the app interface when needed or convenient.

[0092] In another embodiment of the present invention, when the doctor determines that the patient can enable automatic mode, as shown in Figure 7b, the patient can directly send a request to enable the automatic mode function to the backend administrator. After receiving the request, the backend administrator verifies whether the patient's account is on the whitelist. If the patient's account is on the whitelist, the backend administrator enables the automatic mode function on the patient's app interface, and the app interface changes from Figure 8a to Figure 8b. If the patient's account is not on the whitelist, the backend administrator sends a feedback message to the patient's account, reminding the patient to ask the doctor to send a whitelisting request to the backend administrator. After the doctor sends the whitelisting request to the backend administrator, the backend administrator can directly enable the automatic mode function on the patient's app interface. If the doctor does not receive a response from the backend administrator within a certain period of time (e.g., 1 minute, 2 minutes, or 5 minutes), the backend administrator can send another request to enable the automatic mode function to the backend administrator, or ask the doctor to send a whitelisting request to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function on the patient's app interface, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function on the app interface when needed or convenient.

[0093] In another embodiment of the present invention, when the doctor determines that the patient needs to use the automatic mode, as shown in Figure 7c, the doctor sends a request to the backend administrator to add the patient's account to the whitelist, allowing the patient to use the automatic mode function. The backend administrator receives the doctor's whitelist addition request and adds the patient's account to the whitelist list. At the same time, it sends feedback to the doctor that the whitelist addition has been completed. Further, the doctor notifies the patient that he or she can apply to use the automatic mode function. After receiving the doctor's notification, the patient sends a request to enable the automatic mode function to the backend administrator. After receiving the patient's request to enable the automatic mode function, the backend administrator directly enables the automatic mode function on the APP interface used by the patient. In another embodiment of the present invention, after the backend administrator receives the patient's request to enable the automatic mode function, it can also first verify whether the patient's account is on the whitelist. If it is determined that the patient's account is on the whitelist, the backend administrator enables the automatic mode function on the APP interface used by the patient. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function on the APP interface used by the patient, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function on the APP interface when needed or convenient.

[0094] When the doctor determines that the patient no longer needs automatic mode, the patient can turn it off on the app. The app will automatically send a message to the backend administrator, who will then remove the patient account from the whitelist. The doctor and / or patient can also send a request to the backend administrator to turn off automatic mode. The backend administrator will turn off automatic mode on the patient's app and remove the patient account from the whitelist. If the patient needs to turn automatic mode back on, the patient account will need to be re-added to the whitelist using one of the methods shown in Figures 7a-7c.

[0095] In an embodiment of the present invention, the security code sent by the backend when requesting the insulin pump function and the automatic mode function can be any number or combination of a series of numeric characters, alphabetic characters, and other symbols. It can also be a series of taps, a series of inputs, complex or simple gestures (e.g., sliding or other movements on a touch screen, drawing an image), etc. In some cases, the security code can also include a quiz or set of questions. The security code sent by the backend each time is random.

[0096] Because dietary habits vary significantly across regions and age groups, a unified blood sugar control plan may result in poor blood sugar control for some individuals. Therefore, when the automatic mode function is enabled, patients are required to enter a passcode to access different automatic mode interfaces. For those with high carbohydrate consumption, entering the passcode will enter the high-carb mode interface. The automatic mode interface is shown in Figure 9a. A large meal option appears on the high-carb mode interface, and patients can choose whether to enable the large meal module. After enabling the large meal mode, the infusion screen will display two options: "Regular" and "Large Meal," as shown in Figures 9b and 9c. Selecting "Regular" will infuse at least the insulin dose corresponding to a normal carbohydrate intake. Selecting "Large Meal" will infuse at least the insulin dose corresponding to a higher carbohydrate intake. For those with low carbohydrate consumption, entering the passcode will enter the normal-carb mode interface. The automatic mode interface is shown in Figure 9d. The normal-carb mode interface does not have a large meal option and defaults to "Regular" mode. The system infuses at least the insulin dose corresponding to a normal carbohydrate intake.

[0097] In embodiments of the present invention, the passcode can be a set of short questions, such as "Are you a carb lover?", "Is your age within the AB range?", "What is your gender?", "Where do you live?", "What are your fitness hobbies?", "Do you have any special medical conditions?", "Have you used non-automatic mode before turning on automatic mode?", etc. Based on the patient's answers, the system automatically determines whether the patient is a high carb consumer. In other embodiments of the present invention, the passcode is communicated to the patient in advance by the doctor after diagnosis, or the doctor sends information indicating whether the patient is a high carb consumer to the backend administrator at the same time as submitting a request for automatic mode whitelisting. The backend administrator then automatically assigns the patient a corresponding passcode. The passcode can be any number or combination of numeric characters, alphabetic characters, and other symbols, or a series of taps, inputs, complex or simple gestures (e.g., swiping or other movements on a touch screen, drawing an image), etc. The backend administrator can send the passcode to the patient when helping them turn on automatic mode, send the passcode to the patient at the same time as sending the security code, or send the passcode to the patient after confirming that the patient has turned on the automatic mode function using the security code. In an embodiment of the present invention, the security code and the pass code are both randomly generated, and their generation rules may be the same or different. Preferably, the generation rules of the security code and the pass code are different to avoid confusion and thus trouble for the patient.

[0098] In an embodiment of the present invention, the system or doctor may determine whether a patient has a high carbohydrate consumption based on a comprehensive judgment of the patient's gender, age, eating habits, exercise habits, health status, insulin sensitivity, carbohydrate sensitivity, and non-automatic mode usage results. When the patient has a non-automatic mode usage record, the non-automatic mode usage record is used as the main basis for judgment.

[0099] After the patient selects a meal, including "regular" and "large meal", the automatic mode adopts the drug infusion strategy of pre-infusion and supplementary infusion, as shown in Figure 10. During pre-infusion and supplementary infusion, the estimated meal size corresponding to the pre-infusion amount and supplementary infusion amount for regular meals and large meals are divided into different levels, as shown in Table 1 below:

[0100] The amount of insulin administered during pre-infusion is at least related to the actual blood glucose level or blood glucose rate of change during pre-infusion, as well as the estimated meal size. In other embodiments of the present invention, the pre-infusion amount may also be related to the body's IOB. Similarly, the amount of insulin administered during supplemental infusion is at least related to the actual blood glucose level or blood glucose rate of change during supplemental infusion, as well as the estimated meal size. In other embodiments of the present invention, the supplemental infusion amount may also be related to the body's IOB. In this embodiment of the present invention, meal size refers to the carbohydrate content of the meal.

[0101] The large, medium and small estimated meal sizes corresponding to pre-infusion and the large, medium and small estimated meal sizes corresponding to supplementary infusion are all independent parameters. The estimated meal size corresponding to pre-infusion of the same level is larger than the estimated meal size corresponding to supplementary infusion, but there is no fixed correspondence between the two. The system can be set according to actual needs. For large meals, the minimum estimated meal size corresponding to pre-infusion is not less than the maximum estimated meal size corresponding to regular meals, and the minimum estimated meal size corresponding to supplementary infusion is not less than the maximum value of regular meals. In an embodiment of the present invention, during pre-infusion, the estimated meal size range for a regular meal may be 40-80g, 30-60g, etc., and the estimated meal size range for a large meal may be 80-120g, 60-100g, etc., and then divided into large, medium, small, or more levels according to certain rules; during supplemental infusion, the estimated meal size range for a regular meal may be 20-40g, 10-30g, etc., and the estimated meal size range for a large meal may be 40-60g, 30-50g, etc., and then divided into large, medium, small, or more levels according to certain rules. In other embodiments of the present invention, the estimated meal size range for a regular meal and a large meal during pre-infusion or supplemental infusion may also be any other reasonable range, and then divided into large, medium, small, or more levels according to certain rules.

[0102] In step 1001, the patient selects the meal type at time T0 and pre-infuses a default insulin amount. The default pre-infussion insulin amount can be the pre-infussion insulin amount corresponding to any small, medium, or large estimated meal size. Preferably, the default pre-infussion insulin amount is the insulin infusion amount corresponding to the small estimated meal size. Selecting a small initial pre-insulin infusion amount can prevent excessive insulin infusion and reduce the risk of hypoglycemia.

[0103] Step 1002, at time T1, compare the current blood glucose value monitored by the CGM with a preset blood glucose threshold, such as 140, 150, 160, 170, 180, 190, 200 mg / mL, etc. If the current blood glucose value is greater than the preset blood glucose threshold, a default supplemental insulin amount is infused; otherwise, no supplemental infusion amount is infused. The default supplemental infusion amount can be the supplemental insulin amount corresponding to any small, medium, or large estimated meal size. Preferably, the default supplemental insulin amount is the insulin infusion amount corresponding to the small estimated meal size. Selecting a small initial supplemental insulin infusion amount can prevent excessive insulin infusion and reduce the risk of hypoglycemia. Time T1 may be 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, etc. after time T0. In other embodiments of the present invention, whether to perform supplemental infusion can also be determined in combination with the blood glucose change rate at time T1.

[0104] Step 1003: within the ΔT0 time after the T0 moment, such as within 3 hours, 4 hours, 5 hours, etc., if the patient has hyperglycemia, the next pre-infusion is upgraded, that is, the amount of insulin corresponding to the larger estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body; if the patient has hypoglycemia, the next pre-infusion is downgraded, that is, the amount of insulin corresponding to the smaller estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body; if the patient has neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, that is, the amount of insulin corresponding to the same estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body.

[0105] It should be noted that, in the embodiment of the present invention, the change in the infusion level means the change in the level of the estimated meal size during infusion, while taking into account the actual blood glucose value or blood glucose change rate at the time of infusion, or the IOB in the body. Therefore, in the embodiment of the present invention, the change in the estimated meal size level also means the change in the infusion level, that is, the infusion level and the estimated meal size level can be understood to be consistent.

[0106] Step 1004, within the ΔT1 time after T1, such as 3h, 4h, 5h, etc., if the patient has hyperglycemia, the next supplementary infusion is upgraded, that is, the supplementary insulin amount corresponding to the larger estimated meal amount is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration; if the patient has hypoglycemia, the next supplementary infusion is downgraded, that is, the insulin amount corresponding to the smaller estimated supplementary meal amount is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration; if the patient has neither hyperglycemia nor hypoglycemia, the next supplementary infusion level remains unchanged, that is, the insulin amount corresponding to the same supplementary estimated meal amount is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration.

[0107] In step 1005, the patient selects the meal type at time T2 and pre-infuses the insulin according to the result of step 1003, i.e., pre-infuses a larger, smaller, or unchanged amount of insulin corresponding to the estimated meal size, while taking into account the actual blood glucose value or blood glucose change rate at time T2, or the body's IOB.

[0108] At time T3, step 1006 compares the current blood glucose level monitored by the CGM with a preset blood glucose threshold, such as 140, 150, 160, 170, 180, 190, or 200 mg / mL. If the current blood glucose level is greater than the preset blood glucose threshold, a supplemental infusion is performed based on the result of step 1004, i.e., a supplemental insulin infusion corresponding to a larger, smaller, or unchanged supplemental meal size, taking into account the actual blood glucose level or blood glucose rate of change, or the body's 10B at time T3. If the current blood glucose level is not greater than the preset blood glucose threshold, no supplemental infusion is performed. In other embodiments of the present invention, the determination of whether to perform a supplemental infusion may also be made based on the blood glucose rate of change at time T3.

[0109] Step 1007, within the △T0 time after the T2 moment, such as within 3 hours, 4 hours, 5 hours, etc., if the patient has hyperglycemia, the next pre-infusion is upgraded, that is, the amount of insulin corresponding to the larger estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body; if the patient has hypoglycemia, the next pre-infusion is downgraded, that is, the amount of insulin corresponding to the smaller estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body; if the patient has neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, that is, the amount of insulin corresponding to the same estimated meal size is infused, while considering the actual blood glucose value or blood glucose change rate at the next pre-infusion moment, or the IOB in the body.

[0110] Step 1008, within the △T1 time after T3, such as 3h, 4h, 5h, etc., if the patient has hyperglycemia, the next supplementary infusion is upgraded, that is, a larger amount of supplementary insulin corresponding to the estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration; if the patient has hypoglycemia, the next supplementary infusion is downgraded, that is, a smaller amount of insulin corresponding to the estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration; if the patient has neither hyperglycemia nor hypoglycemia, the next supplementary infusion level remains unchanged, that is, the same amount of insulin corresponding to the estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion is taken into consideration.

[0111] When pre-infusion and supplemental infusion are required at the next moment, steps 1005-1008 are repeated.

[0112] Generally, according to the patient's eating habits and in order to maintain the stability of the patient's blood sugar level, the patient chooses the same meal type at T2 and T0, that is, if the patient chooses a regular meal at T0, then he will also choose a regular meal at T2. If he chooses a large meal at T0, then he will also choose a large meal at T2. Therefore, the next pre-infusion insulin selection and supplementary insulin infusion selection can depend on the results of the previous pre-infusion insulin selection and supplementary insulin infusion selection. However, if the patient's next meal selection is inconsistent with the previous meal selection, such as the next When the patient's meal selection is different from the previous meal selection for the first time, the patient's pre-infusion and supplemental infusion levels will be restored to the initial default levels during the next meal to prevent inaccurate insulin infusion due to changes in meal patterns. When the meal selection is different again, that is, the next selection is restored to be consistent with the previous selection, the levels of the next pre-infusion and supplemental infusion will be consistent with the previous pre-infusion and supplemental infusion levels. Based on the infusion levels of the previous same meal pattern, the insulin infusion during the current meal will be more accurate and the patient's blood sugar level will be better controlled. For example, assuming that the patient's previous five selections were all regular meals, with the pre-infusion and supplemental infusion levels being medium, and the sixth selection is a large meal, the pre-infusion and supplemental infusion levels for the sixth meal will be the default levels. When the patient's choice is restored to a regular meal for the seventh time, the pre-infusion and supplemental infusion levels for the seventh meal will be consistent with the pre-infusion and supplemental infusion levels for the fifth regular meal, that is, also medium.

[0113] It should be noted here that if the estimated meal size corresponding to the current pre-infusion amount is already the largest estimated meal size in the selected meal type, if hyperglycemia still occurs within the △T0 time after T0 or T2, the next pre-infusion amount will not be upgraded, and the insulin amount corresponding to the large estimated meal size will still be pre-infused, while taking into account the actual blood sugar value or blood sugar change rate at the next pre-infusion time, or the IOB in the body. Similarly, if the meal size corresponding to the current pre-infusion amount is already the smallest meal size in the selected meal type, if hypoglycemia still occurs within the △T0 time after T0 or T2, the next pre-infusion amount will not be downgraded, and the insulin amount corresponding to the small estimated meal size will still be pre-infused, while taking into account the actual blood sugar value or blood sugar change rate at the next pre-infusion time, or the IOB in the body. That is, the safe infusion limit of insulin infusion is limited to effectively prevent hyperglycemia and hypoglycemia.

[0114] Similarly, if the estimated meal size corresponding to the current supplementary infusion amount is already the largest estimated meal size for the selected meal type, if hyperglycemia still occurs within △T1 time after T1 or T3, the next supplementary infusion amount will not be upgraded, and the insulin amount corresponding to the large supplementary estimated meal size will still be pre-infused, while taking into account the actual blood sugar value or blood sugar change rate, or the IOB in the body at the time of the next supplementary infusion. Similarly, if the meal size corresponding to the current supplementary infusion amount is already the smallest supplementary meal size for the selected meal type, if hypoglycemia still occurs within △T1 time after T or T3, the next supplementary infusion amount will not be downgraded, and the insulin amount corresponding to the small supplementary estimated meal size will still be pre-infused, while taking into account the actual blood sugar value or blood sugar change rate, or the IOB in the body at the time of the next supplementary infusion. This limits the safe infusion limit of insulin infusion, effectively preventing hyperglycemia and hypoglycemia.

[0115] In other embodiments of the present invention, the estimated meal sizes corresponding to pre-infusion and supplemental infusion are not necessarily graded, that is, the estimated meal size during pre-infusion may only have a default size, while during supplemental infusion, the estimated meal size may have three different levels of large, medium and small. Therefore, during the pre-infusion stage, only the amount of insulin corresponding to the default meal size is infused for each pre-infusion; or the estimated meal size during pre-infusion may have three different levels of large, medium and small, while during supplemental infusion, the estimated meal size may only have a default size. Therefore, during supplemental infusion, only the amount of insulin corresponding to the default meal size is infused for each supplemental infusion.

[0116] Similarly, the level settings for the estimated meal amounts corresponding to pre-infusion and supplementary infusion in large meals and regular meals are not necessarily consistent. That is, for each meal mode, the estimated meal amount corresponding to pre-infusion and the estimated meal amount corresponding to supplementary infusion can be selected as graded or ungraded (default amount), and can be set according to the patient's actual needs.

[0117] In other embodiments of the present invention, the high carbohydrate mode and the normal carbohydrate mode also include a small meal mode. For example, when a patient eats snacks, the small meal mode can be selected. When the patient selects the small meal mode, since the carbohydrate content range in the small meal is relatively small, the system performs insulin infusion based on the default estimated meal amount, while taking into account the patient's actual blood sugar value or blood sugar change rate when eating a small meal, as well as the IOB in the body, and the default estimated meal amount in the small meal mode is smaller than the lowest level estimated meal amount in the regular mode.

[0118] In summary, the present invention discloses a personalized closed-loop artificial pancreas system, including a detection module for continuously detecting a patient's blood sugar level; an infusion module for infusing insulin into the patient's body; a program module for controlling the detection module and the infusion module. At least based on the blood sugar level detected by the detection module, the program module generates an insulin infusion instruction and controls the infusion module to perform infusion. The program module includes a user interface. In response to the patient's input, the program module executes the corresponding meal module function. The meal mode includes a high-carbohydrate mode and a normal-carbohydrate mode. Based on the patient's input, the program module executes the function of the high-carbohydrate mode or the normal-carbohydrate mode. The system is suitable for people with different carbohydrate consumption habits, thereby improving the adaptability of the closed-loop artificial pancreas to different people and enabling people with different carbohydrate consumption habits to maintain satisfactory blood sugar control effects.

[0119] Although some specific embodiments of the present invention have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present invention. It should be understood by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. A personalized closed-loop artificial pancreas system, comprising: A detection module, used for continuously detecting the patient's blood sugar level; an infusion module, for infusing insulin into a patient; A program module is used to control the detection module and the infusion module. At least according to the blood sugar value detected by the detection module, the program module generates an insulin infusion instruction and controls the infusion module to perform infusion, characterized in that: The program module includes a user interface. In response to the patient's input, the program module executes a corresponding meal mode function, and the meal mode includes a high-carbohydrate mode and a normal-carbohydrate mode.

2. The personalized closed-loop artificial pancreas system according to claim 1, characterized in that: The input is a pass code, and the setting of the pass code is related to the patient's carbohydrate consumption habits.

3. The personalized closed-loop artificial pancreas system according to claim 2, characterized in that: The patient's carbohydrate consumption habit is the result of a comprehensive judgment by the system or doctor based on one or more of the patient's gender, age, eating habits, exercise habits, health status, insulin sensitivity, carbohydrate sensitivity, and non-automatic mode usage results.

4. The personalized closed-loop artificial pancreas system according to claim 3, characterized in that: The passcode is the patient's answer to a set of short questions.

5. The personalized closed-loop artificial pancreas system according to claim 3, characterized in that: The passcode is one or more of numeric characters, alphabetic characters and other symbols.

6. The personalized closed-loop artificial pancreas system according to claim 3, characterized in that: The pass code is one or more of tapping and sliding actions performed by the patient on the user interface.

7. The personalized closed-loop artificial pancreas system according to claim 1, characterized in that: The high-carb mode includes at least a large meal mode and a regular meal mode.

8. The personalized closed-loop artificial pancreas system according to claim 7, characterized in that: The system employs an infusion strategy of pre-infusion and supplemental infusion.

9. The personalized closed-loop artificial pancreas system according to claim 8, characterized in that: The amount of insulin infused during pre-infusion is at least related to the actual blood glucose value or blood glucose change rate when the pre-infusion is performed, and the estimated meal size.

10. The personalized closed-loop artificial pancreas system according to claim 9, characterized in that: The amount of insulin infused during the pre-infusion is also related to the IOB in the patient.

11. The personalized closed-loop artificial pancreas system according to claim 8, characterized in that: The amount of insulin infused during the supplemental infusion is at least related to the actual blood glucose value or blood glucose rate of change at the time of the supplemental infusion and the estimated meal size.

12. The personalized closed-loop artificial pancreas system according to claim 11, characterized in that: The amount of insulin infused during the supplemental infusion is also related to the IOB in the patient.

13. The personalized closed-loop artificial pancreas system according to claim 8, characterized in that: The system determines whether to change the level of the next pre-infusion according to whether high or low blood sugar occurs within a predetermined time period after the pre-infusion.

14. The personalized closed-loop artificial pancreas system according to claim 8, characterized in that: The system determines whether to perform supplementary infusion based on at least the blood glucose level after a predetermined time after the completion of the pre-infusion.

15. The personalized closed-loop artificial pancreas system according to claim 14, characterized in that: The system determines whether to change the level of the next supplemental infusion according to whether high or low blood sugar occurs within a predetermined time period after the supplemental infusion.

16. The personalized closed-loop artificial pancreas system according to claim 1, characterized in that: The high-carb mode and the normal-carb mode also include a small meal mode.

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