Subscription service management system of on-body function equipment

Abstract

The invention discloses a subscription service management system of on-body function equipment, which comprises on-body function equipment and personal management equipment, the personal management equipment comprises a subscription service management unit and an equipment management unit, and when the subscription service management system triggers a subscription service instruction, the equipment management unit sends the subscription service instruction to the on-body function equipment. The subscription service management unit and the equipment management unit implement the operation corresponding to the subscription service instruction, the function service of the equipment is not bound with the equipment for sale any more, the initial cost of the user is reduced, the user can select the suitable subscription service according to the own demand, and an equipment manufacturer can better know the user demand, so that the user experience is improved. Richer subscription service choices are provided for the user, the use experience of the user is improved, the cost of a supplier and a demander is optimized, when the user uses the subscription service, the subscription service management system provides a subscription service instruction and implements operation related to the subscription service, the user is prevented from being caught in blind operation, meanwhile, the user can be guided to use the subscription service, and the user experience is improved. And user experience is improved.

Description

Technical Field

[0001] The present invention mainly relates to the field of medical devices, and in particular to a subscription service management system for on-body functional devices. 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; it can only control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic users need to monitor their blood sugar before injecting insulin into their bodies. Currently, most monitoring methods are to achieve continuous monitoring of blood sugar through in-body blood sugar monitoring devices. In-body blood sugar monitoring devices use disposable transcutaneous sensors inserted into the skin to measure the blood sugar concentration in the interstitial fluid and send the blood sugar data to an external device in real time through a transmitter for the user to view. This monitoring method is called continuous glucose monitoring (CGM). According to the blood sugar value detected by CGM, the insulin pump automatically adjusts the amount of insulin infusion required by the user and injects insulin subcutaneously, thereby forming a closed-loop artificial pancreas. CGM and insulin pump can be collectively referred to as on-body functional devices.

[0004] Currently, in the field of CGM and insulin pumps, the functional services provided by CGM and insulin pumps are mostly sold on a traditional buyout basis. These functional services are bundled with CGM and insulin pumps, resulting in excessively high initial costs for users, which has affected sales of CGM and insulin pumps and is also detrimental to the treatment of diabetes users. Subscription services are gradually emerging in other industries, such as music, movies, television, and even the automotive industry. Subscription services can provide users with a richer selection of subscription services. Users can choose personalized services based on their needs. Device manufacturers can better understand user needs and continuously improve and optimize service quality, enhance the user experience, and optimize costs for both supply and demand. Considering the above advantages of subscription services, the CGM and insulin pump fields can also try to implement subscription services. When using subscription services, users need to trigger the subscription service indicator to prompt subscription service information to avoid users falling into blind operation.

[0005] Therefore, the prior art urgently needs a subscription service management system for on-body functional devices. Summary of the Invention

[0006] The present invention discloses a subscription service management system for on-body functional devices, comprising on-body functional devices and personal management devices. The personal management devices comprise a subscription service management unit and a device management unit. When the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication. The functional services of the device are no longer sold in conjunction with the device, thereby reducing the user's initial costs. Moreover, the user can select applicable subscription services according to their own needs. Device manufacturers can also better understand user needs, provide users with more abundant subscription service options, improve user experience, and optimize costs for both supply and demand sides. When the user uses the subscription service, the subscription service management system provides a subscription service indication and implements operations related to the subscription service to avoid the user falling into blind operation. At the same time, it can also guide the user to use the subscription service, thereby improving the user experience.

[0007] An embodiment of the present invention discloses a subscription service management system for an on-body functional device, comprising an on-body functional device, wherein the on-body functional device includes an insulin infusion module and / or a blood glucose monitoring module, the insulin infusion module is used to perform the insulin infusion function, and the blood glucose monitoring module is used to perform the blood glucose monitoring function; and a personal management device, wherein the personal management device is wirelessly connected to the on-body functional device, the personal management device includes a subscription service management unit and a device management unit, the subscription service management unit is used to manage the subscription service; the device management unit is used to manage the operating status of the on-body functional device and the personal management device; the subscription service is at least a service related to the insulin infusion function or the blood glucose monitoring function that can be selected by the user to activate; wherein, when the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication.

[0008] According to one aspect of the present invention, the triggering of the subscription service indication includes active triggering and passive triggering.

[0009] According to one aspect of the present invention, the active trigger indication includes at least:

[0010] ① The functional device on the body is activated or stopped;

[0011] ② Push, update or close subscription services;

[0012] ③The subscription service is about to expire or has expired;

[0013] ④Changes in the user's subscription service permissions;

[0014] ⑤ Software or hardware updates related to subscription services;

[0015] ⑥User’s account information indication;

[0016] Passive triggering instructions include at least:

[0017] ①User query and change subscription services;

[0018] ②Users query and change account information;

[0019] ③Users update software or hardware related to the subscription service.

[0020] According to one aspect of the present invention, the subscription service rights include at least the usage type, usage period and user authority level of the subscription service.

[0021] According to one aspect of the present invention, the account information includes at least account status, subscription service status and account balance.

[0022] According to one aspect of the present invention, the account status includes at least a general user account status, a clinical user account status, a guardian account status, a trial account status, and a doctor account status.

[0023] According to one aspect of the present invention, the account information indication includes at least account status change, subscription service status change, account balance change and insufficient account balance.

[0024] According to one aspect of the present invention, the subscription service status change includes purchasing, renewing, and canceling the subscription service.

[0025] According to one aspect of the present invention, the subscription service management system further includes a cloud server, the personal management device is communicatively connected to the cloud server, and the subscription service indication is at least derived from the cloud server.

[0026] According to one aspect of the present invention, the cloud server stores exogenous data, and triggers a subscription service indication based on the exogenous data. The exogenous data includes at least the doctor's treatment opinion on the user, the user's physical condition, daily habits, living environment and consumption records.

[0027] According to one aspect of the present invention, the cloud server analyzes external data in combination with algorithms or artificial intelligence to obtain subscription services suitable for the user and trigger the subscription service indication.

[0028] According to one aspect of the present invention, the cloud server is managed and operated by a backend administrator, and the backend administrator triggers a subscription service instruction through the cloud server.

[0029] According to one aspect of the present invention, a whitelist is provided in the cloud server, and the whitelist records information related to the on-body functional devices and the personal management devices.

[0030] According to one aspect of the present invention, only the on-body function devices and personal management devices recorded in the whitelist can perform operations corresponding to the subscription service indication.

[0031] According to one aspect of the present invention, only users recorded in the whitelist can query or change subscription service permissions.

[0032] According to one aspect of the present invention, a user sends a service subscription instruction to a personal management device or a cloud server. In response to the user's instruction, the personal management device or the cloud server triggers a service subscription indication.

[0033] According to one aspect of the present invention, data related to the subscription service is stored in a cloud server.

[0034] According to one aspect of the present invention, a subscription service indication is triggered based on preset rules, where the preset rules include:

[0035] ① Trigger the subscription service indication at the preset time interval, and do not trigger the subscription service indication within the preset time interval;

[0036] ② Adjust the time interval for triggering the subscription service indication according to the expiration date of the subscription service.

[0037] According to one aspect of the present invention, the closer to the expiration date of the subscription service, the shorter the time interval for triggering the subscription service indication.

[0038] According to one aspect of the present invention, the subscription service management system triggers a subscription service indication based on the operating status of the on-body functional device and the personal management device:

[0039] ① When the on-body function device or personal management device is no longer in use, the subscription service instruction will not be triggered;

[0040] ② When the on-body function device or personal management device is in dormant state, increase the time interval for triggering the subscription service indication;

[0041] ③ When the on-body functional device or personal management device is in working state, the subscription service indication is triggered according to the preset time interval.

[0042] According to one aspect of the present invention, the personal management device further includes a user interaction unit, which is at least configured to prompt the user with a subscription service indication, and the user interacts with the user interaction unit to respond to the subscription service indication.

[0043] According to one aspect of the present invention, the prompt of the user interaction unit includes image display, vibration, sound or optical prompt.

[0044] According to one aspect of the present invention, the user's response to the user interaction unit includes confirming, canceling, viewing or ignoring the subscription service indication.

[0045] According to one aspect of the present invention, the user's response to the user interaction unit includes at least body movements, facial expressions or voice movements.

[0046] According to one aspect of the present invention, before the subscription service management unit and the device management unit implement the operation corresponding to the subscription service indication, a confirmation response from the user is required.

[0047] According to one aspect of the present invention, the personal management device further includes a storage unit, and data related to the subscription service is stored in the storage unit.

[0048] According to one aspect of the present invention, the on-body function device and the personal management device further include software or hardware related to the subscription service.

[0049] According to one aspect of the present invention, software or hardware related to the subscription service is pre-installed in the on-body function device or the personal management device when leaving the factory.

[0050] According to one aspect of the present invention, software or hardware related to the subscription service is installed in the on-body function device or the personal management device when the subscription service is used.

[0051] According to one aspect of the present invention, subscription services include at least first-category services, second-category services, and third-category services. First-category services are services that users can activate on their own without the need for doctor's confirmation. Second-category services are services that users can choose to activate only after doctor's confirmation. Third-category services are services that doctors have the authority to activate but users do not.

[0052] According to one aspect of the present invention, the subscription service includes basic services and advanced services related to the insulin infusion function or the blood glucose monitoring function.

[0053] According to one aspect of the present invention, it also includes a security device, which is communicatively connected to the on-body functional device and the personal management device. Before the subscription service management unit and the device management unit implement operations corresponding to the subscription service instructions, they need to be confirmed by the security device.

[0054] According to one aspect of the present invention, the subscription service indication includes first encryption information, and the security device includes second encryption information paired with the first encryption information. Only after the first encryption information and the second encryption information are successfully paired, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication.

[0055] According to one aspect of the present invention, the first encrypted information and the second encrypted information are paired on a security device, an on-body functional device, or a personal management device.

[0056] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0057] The present invention discloses a subscription service management system for on-body functional devices, including on-body functional devices and personal management devices. The personal management device includes a subscription service management unit and a device management unit. When the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication. The functional services of the device are no longer sold in conjunction with the device, which reduces the user's initial costs. The user can also choose applicable subscription services according to their own needs. Device manufacturers can also better understand user needs, provide users with more abundant subscription service options, improve user experience, and optimize costs for both supply and demand sides. When the user uses the subscription service, the subscription service management system provides a subscription service indication and implements operations related to the subscription service to avoid users falling into blind operations. At the same time, it can also guide users to use the subscription service and improve user experience.

[0058] Furthermore, the subscription service indication can be actively triggered by the subscription service management system, or it can be passively triggered by the subscription service management system to promptly remind users of information and status changes related to the subscription service. Users can perform operations in response to the subscription service indication, such as purchasing, renewing, canceling, viewing details and ignoring subscription services, etc., so that users can clearly participate in subscription service operations and users can purchase, renew and cancel subscription services in a timely manner to avoid unnecessary expenses and affect the user's treatment.

[0059] Furthermore, the subscription service management system provides users with a detailed subscription service list and account information, so that users can fully understand the subscription service and account usage details, such as the user's account information, purchased subscription services, subscription service purchase records, consumption records of purchased subscription services, a list of purchasable subscription services, a list of upgradeable subscription services, a detailed introduction to the subscription services, and subscription service precautions, thereby improving the user experience.

[0060] Furthermore, the subscription service management system can also be connected to the cloud server, and with the help of the powerful computing and storage capabilities of the cloud server, it can provide users with better subscription service management. Users can understand and obtain subscription services suitable for themselves through the cloud server. With the help of some external data of the user, the artificial intelligence or algorithm built into the cloud server and the back-end administrator of the cloud server can provide users with subscription service suggestions and optimize the user's subscription service, which can not only improve the user's treatment effect, but also reduce the user's unnecessary expenses and enhance the user experience.

[0061] Furthermore, a whitelist is set up in the cloud server. Only the body function devices and personal management devices recorded in the whitelist can perform operations corresponding to the subscription service instructions. Only users recorded in the whitelist can query or change subscription service permissions, which fully ensures the security of the subscription service management system, allowing users to use the subscription service with peace of mind and improve the user experience.

[0062] Furthermore, the triggering of the subscription service indication can be adaptively and intelligently adjusted according to the user's habits to avoid excessive and frequent impact on the user's daily life and improve the user's usage experience.

[0063] Furthermore, subscription service indications can be triggered in a variety of forms, including but not limited to image display, vibration, sound or optical prompts. Users' responses to subscription service indications also have a variety of forms, including but not limited to body movements, facial expressions or voice movements. The rich subscription service triggering and response forms can provide users with sufficient convenience and fun, and enhance the user experience.

[0064] Furthermore, subscription services can be classified according to the degree of their impact on the user's treatment. The first type of service can be purchased and activated by the user himself. The second type of service requires the user to obtain advice from a doctor or equipment manufacturer before he can purchase and activate it himself. The third type of service requires the doctor or equipment manufacturer to give the user permission before the user can purchase and activate it, or the user still needs the doctor or equipment manufacturer to activate it on the user's behalf after purchase. This can prevent users from activating some unnecessary subscription services, or prevent users from activating some subscription services that have an adverse effect on the treatment process and effect, thereby protecting the user's interests and physical health and improving the user's usage experience.

[0065] Furthermore, the subscription service management system may also include security devices. Before implementing operations corresponding to the subscription service, they must be confirmed by the security devices. This can prevent others from maliciously invading the subscription service management system, changing the user's subscription service permissions and confirming subscription service instructions on behalf of the user, thereby damaging the user's interests and even threatening the user's treatment process and physical health, further increasing the security of the subscription service management system. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Figure 1 This is a schematic diagram of the relationship between modules of a universal closed-loop artificial pancreas insulin infusion control system;

[0067] Figure 2 2 is a schematic structural diagram of an integrated CGM according to an embodiment of the present invention;

[0068] Figure 3 Schematic diagram of the structure of a split-type CGM according to an embodiment of the present invention;

[0069] Figure 4a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention;

[0070] Figure 4b A schematic structural diagram of a split-type insulin pump according to an embodiment of the present invention;

[0071] Figure 5a is a schematic diagram of the main interface when the control system according to an embodiment of the present invention is in the first working mode;

[0072] Figure 5b is a schematic diagram of the main interface when the control system according to an embodiment of the present invention is in the second working mode;

[0073] Figures 6a-6c Schematic diagram of different operations of turning on the insulin pump function of the control system according to an embodiment of the present invention;

[0074] Figures 7a-7c Schematic diagram of different operations for turning on the automatic mode function of a control system according to an embodiment of the present invention;

[0075] Figures 8a-8b This is a schematic diagram 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;

[0076] Figure 9a This is a schematic diagram of the interface when the system according to an embodiment of the present invention turns on the feast mode;

[0077] Figure 9b and 9c Schematic diagram of different interfaces for selecting regular and feast in the feast mode of the system in an embodiment of the present invention;

[0078] Figure 9d This is a schematic diagram of the interface when the system according to an embodiment of the present invention opens the regular meal mode;

[0079] Figure 10 A schematic diagram of the process of the infusion strategy of pre-infusion and supplementary infusion according to an embodiment of the present invention;

[0080] Figure 11a Schematic diagram of a closed-loop infusion system based on food image recognition according to an embodiment of the present invention;

[0081] Figure 11b Schematic diagram of a closed-loop infusion method based on food image recognition according to one embodiment of the present invention;

[0082] Figure 11c Schematic diagram of a closed-loop infusion method based on food image recognition according to another embodiment of the present invention;

[0083] Figure 12Schematic diagram of another closed-loop infusion method based on food image recognition according to an embodiment of the present invention;

[0084] Figures 13a-13c Schematic diagram of a subscription service management system for on-body functional devices according to an embodiment of the present invention. DETAILED DESCRIPTION

[0085] As mentioned above, currently in the field of CGM and insulin pumps, most of the functional services that CGM and insulin pumps can provide are sold on a traditional buyout basis. The functional services are bundled with CGM and insulin pumps and sold. The initial costs for users are too high, which affects the sales of CGM and insulin pumps and is also not conducive to the treatment of diabetic users.

[0086] In order to solve this problem, the present invention provides a subscription service management system for on-body functional devices, including on-body functional devices and personal management devices. The personal management device includes a subscription service management unit and a device management unit. When the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication. The functional services of the device are no longer bundled with the device for sale, which reduces the user's initial costs. In addition, the user can choose applicable subscription services according to their own needs. Device manufacturers can also better understand user needs, provide users with more abundant subscription service options, improve user experience, and optimize the costs of both supply and demand sides. When the user uses the subscription service, the subscription service management system provides a subscription service indication and implements operations related to the subscription service to avoid the user from falling into blind operation. At the same time, it can also guide the user to use the subscription service and improve the user experience.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] Figure 1 This is a schematic diagram of the module relationship of a universal closed-loop artificial pancreas insulin infusion control system.

[0092] 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 .

[0093] The detection module 100 is used to continuously monitor the user's current blood glucose level. Typically, the detection module 100 is a continuous glucose monitoring (CGM), which can detect the user's current blood glucose level in real time, monitor blood glucose changes, and send 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.

[0094] The 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. These components are controlled by the program module 101. Typically, the 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 the program module 101, the infusion module 102 delivers the currently required insulin to the user's body. Simultaneously, the infusion status of the infusion module 102 is also fed back to the program module 101 in real time.

[0095] 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 user 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 includes conventional electrical or wireless connections.

[0096] 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.

[0097] In one embodiment of the present invention, the three modules are electrically connected to form a single integrated structure. Therefore, they are applied to the same location on the user's skin. By connecting the three modules as a single unit and applying them to the same location, the number of devices attached to the user's skin is reduced, thereby minimizing interference with user activities caused by multiple devices being attached. Furthermore, this effectively resolves the issue of wireless communication reliability between separate devices, further enhancing the user experience.

[0098] 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 user's skin, while the detection module 100 is attached to another location on the user's skin.

[0099] 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 the user's skin, while infusion module 102 can be attached to another location on the user's skin.

[0100] In another embodiment of the present invention, the three modules are disposed in different structures. Thus, the three modules are attached to different locations on the user'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.

[0101] 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 user'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.

[0102] 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).

[0103] Figure 2 Schematic diagram of the structure of an integrated CGM according to an embodiment of the present invention. Figure 3 Schematic diagram of the structure of a split-type CGM according to an embodiment of the present invention.

[0104] CGM includes a sensor and a transmitter, which are installed on the user 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.

[0105] Figure 2 This is a schematic diagram of the structure of an integrated CGM. That is, the sensor and transmitter of the CGM are already integrated before use, and it is a disposable product that is discarded after use. Figure 2 As shown, the integrated CGM includes a sensor 201, a housing 202, and a transmitter (not shown) disposed within the housing 202. The sensor 301 is used to monitor the user's body fluid blood glucose data and transmits the blood glucose data to the transmitter via internal circuitry, which then transmits the data to the receiver. The identifier can be placed on the CGM's outer housing, packaging, or within the CGM.

[0106] Figure 3 This is a schematic diagram of the structure of a split-type CGM. That is, before 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 bottom shell 301 and a transmitter 302. The bottom shell is provided with a sensor 3011, while the transmitter 302 has a separate housing. The bottom shell 301 and the transmitter 302 housings are provided with snap-fit structures 3012 and 3022, respectively. During use, the bottom shell 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 is used to monitor the user's blood sugar data and transmits this blood sugar data to the transmitter 302 via the electrical connector 3013. The transmitter 302 then sends this data to the receiver.

[0107] 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 user information and the identifier, thereby improving the user experience. This will be described in detail below.

[0108] 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.

[0109] Figure 4a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention; Figure 4b Schematic diagram of the structure of a split-type insulin pump according to an embodiment of the present invention.

[0110] 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 user'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.

[0111] 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.

[0112] Figure 4a This is a structural diagram of an integrated insulin pump, i.e., 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 user'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.

[0113] Figure 4b This is a schematic diagram of a split-body insulin pump. The insulin pump's infusion mechanism 410 and control mechanism 400 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.

[0114] 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 user information and the identifier, thereby improving the user experience. This will be described in detail below.

[0115] 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.

[0116] Depending on the different levels of illness of the users and their personal health conditions, some users may only need CGM for continuous blood glucose monitoring, some users may not only need CGM for continuous blood glucose monitoring, but also need insulin pumps for drug infusion, and some users choose to use insulin pumps for drug infusion, but do not use CGM for continuous blood glucose monitoring, but use methods such as fingertip blood to intermittently obtain blood glucose values. When the doctor determines that the user only needs to use CGM for continuous blood glucose monitoring, since CGM only involves monitoring the user's blood glucose, the user's self-use of CGM will not pose a risk to the user's life safety. Therefore, the user can purchase CGM by himself. Before the CGM is installed on the user's skin surface, the user can search and download the APP for controlling CGM in the smartphone's application store, and create a new account on the APP, and pair the user'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 APP in the smartphone. Since not all users need to use the insulin pump, the default home screen of the APP only involves CGM-related content, such as Figure 5a As shown, on the one hand, it can simplify the interface of the APP and provide users with a better visual experience, and on the other hand, it can prevent users from misoperating the insulin pump function and affecting the normal use of the CGM function.

[0117] In one embodiment of the present invention, when a doctor determines that a user needs to use an insulin pump for drug infusion, such as Figure 6a As shown, the doctor sends an application to the backend administrator, requesting that the user account be added to the whitelist, allowing the user to use the insulin pump function. The backend administrator receives the whitelist addition application sent by the doctor, adds the user account to the whitelist, 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 user. At this time, the APP interface changes from Figure 5a become Figure 5b , Figure 5b Compared with the interface Figure 5a The interface has added two function keys related to insulin infusion, "InsulinDelivery" and "Easyloop". In another embodiment of the present invention, the backend administrator does not directly activate the insulin pump function of the app interface used by the user. Instead, a security code is sent to the user account. The user can use the security code to activate the insulin pump function of the app interface when needed or convenient.

[0118] In another embodiment of the present invention, when the doctor determines that the user needs to use an insulin pump for drug infusion, such as Figure 6b As shown, the user can directly send an application to the backend administrator to enable the insulin pump function. After receiving the application from the user, the backend administrator will verify whether the user account is in the whitelist. If the user account is in the whitelist, the backend administrator will turn on the insulin pump function of the APP interface used by the user. The APP interface will be changed from Figure 5a become Figure 5b ; If the user account is not in the whitelist, feedback information is sent to the user account, reminding the user to ask the doctor to send an application to add to the whitelist to the backend administrator. After the doctor sends the application to add to the whitelist to the backend administrator, the backend administrator can directly turn on the insulin pump function of the APP interface used by the user. If no information from the backend administrator is received within a certain period of time, such as 1min, 2min, 5min, the application to turn on the insulin pump function can be sent to the backend administrator again, or the doctor can be asked to send an application to add to the whitelist to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly turn on the insulin pump function of the APP interface used by the user, but sends a security code to the user account, and the user can turn on the insulin pump function of the APP interface through the security code when needed or convenient.

[0119] In another embodiment of the present invention, when the doctor determines that the user needs to use an insulin pump for drug infusion, Figure 6cAs shown, the doctor sends an application to the backend administrator, requesting that the user account be added to the whitelist, allowing the user to use the insulin pump function. The backend administrator receives the whitelist addition application sent by the doctor and adds the user 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 user that he can apply to use the insulin pump function; after receiving the doctor's notification, the user sends an application to the backend administrator to turn on the insulin pump function. After the backend administrator receives the application to turn on the insulin pump function sent by the user, the backend administrator directly turns on the insulin pump function of the APP interface used by the user. In another embodiment of the present invention, after the backend administrator receives the application to turn on the insulin pump function sent by the user, it can also first verify whether the user account exists in the whitelist. If it is determined that the user account is in the whitelist list, the backend administrator turns on the insulin pump function of the APP interface used by the user. In another embodiment of the present invention, the backend administrator does not directly turn on the insulin pump function of the APP interface used by the user, but sends a security code to the user account. The user can turn on the insulin pump function of the APP interface through the security code when needed or convenient.

[0120] When the doctor determines that the user no longer needs to turn on the insulin pump function, the user can turn off the insulin pump function on the APP by himself. The APP automatically sends a message to the backend administrator, and the backend administrator deletes the user account from the whitelist. The doctor and / or the user can also send an application to the backend administrator to request to turn off the insulin pump function. The backend administrator turns off the insulin pump function on the user account APP and deletes the user account from the whitelist. When the user needs to turn on the insulin pump function again, the user account needs to refer to Figures 6a-6c One of the ways to add the whitelist again.

[0121] When only the insulin pump function is used, the user can turn off the CGM function on the app. Therefore, the app interface will no longer display blood sugar-related content. The app interface will prompt that the CGM system has been turned off.

[0122] 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 user's personal information with the information of the insulin pump, thereby achieving pairing and control of the smartphone and the insulin pump. The user'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 user'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 user 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 user's skin and successfully activated, the CGM and / or insulin pump starts working. The CGM's 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.

[0123] 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 APP in the smartphone. When the user needs both CGM and insulin pump 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 APP, which can avoid the inconvenience caused to the user by using different APPs to control the CGM and insulin pump respectively, thereby improving the user experience.

[0124] When the CGM and / or insulin pump worn by the user 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 user's personal information through the smartphone and further uploaded to the remote server. The user'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.

[0125] When the CGM has a split structure and the transmitter is reusable, the CGM identifier is set on the outer shell or packaging of the transmitter. When the user replaces the CGM, he only needs to replace the sensor without replacing the transmitter, and the CGM identifier remains unchanged. Therefore, there is no need to update the pairing of the CGM identifier and the user's personal information through the smartphone, nor is there any need to upload it to the remote server. This can reduce the operation steps and improve the user experience.

[0126] 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 user 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 user's personal information through the smartphone, nor is there any need to upload it to a remote server. This can reduce the number of operating steps and improve the user experience.

[0127] 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.

[0128] When the doctor determines that the user can turn on the automatic mode, the APP reads the current blood sugar value monitored by the CGM and the insulin information infused by the insulin pump, and can calculate the future blood sugar trend. It can control the infusion of the insulin pump based on the calculated blood sugar trend, including increasing, decreasing, or stopping insulin infusion, in order to achieve the purpose of influencing the blood sugar value, forming an automatic closed-loop control over and over again. Figure 7a As shown, the doctor sends an application to the backend administrator, requesting to add the user account to the whitelist and allow the user to use the automatic mode function. The backend administrator receives the whitelist addition application sent by the doctor and adds the user account to the whitelist list. At the same time, it sends feedback to the doctor that the whitelist addition has been completed. Further, the automatic mode function of the APP interface used by the user is directly turned on. At this time, the APP interface changes from Figure 8a become Figure 8b , Figure 8b Compared with the interface Figure 8a The interface has been updated to include an "Auto Mode" function key, which is associated with automatic mode. 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 user. Instead, the administrator sends a security code to the user account, allowing the user to enable the automatic mode function on the app interface when needed or convenient. The artificial pancreas in which automatic mode is not enabled is considered to be in normal mode.

[0129] In another embodiment of the present invention, when the doctor determines that the user can turn on the automatic mode, such as Figure 7b As shown, the user can directly send an application to the backend administrator to enable the automatic mode function. After receiving the application from the user, the backend administrator will verify whether the user account is in the whitelist. If the user account is in the whitelist, the backend administrator will turn on the automatic mode function of the APP interface used by the user. The APP interface will be changed from Figure 8a become Figure 8b ; If the user account is not in the whitelist, feedback information is sent to the user account to remind the user to ask the doctor to send an application to add to the whitelist to the backend administrator. After the doctor sends the application to add to the whitelist to the backend administrator, the backend administrator can directly turn on the automatic mode function of the APP interface used by the user. If no information from the backend administrator is received within a certain period of time, such as 1min, 2min, 5min, you can send an application to turn on the automatic mode function to the backend administrator again, or ask the doctor to send an application to add to the whitelist to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly turn on the automatic mode function of the APP interface used by the user, but sends a security code to the user account. The user can use the security code to turn on the automatic mode function of the APP interface when needed or convenient.

[0130] In another embodiment of the present invention, when the doctor determines that the user needs to use the automatic mode, such as Figure 7cAs shown, the doctor sends an application to the backend administrator, requesting that the user account be added to the whitelist, allowing the user to use the automatic mode function. The backend administrator receives the whitelist addition application sent by the doctor, and adds the user account to the whitelist list, and sends feedback to the doctor that the whitelist addition has been completed. Further, the doctor notifies the user that he can apply to use the automatic mode function; after receiving the doctor's notification, the user sends an application to turn on the automatic mode function to the backend administrator. After the backend administrator receives the application sent by the user to turn on the automatic mode function, the backend administrator directly turns on the automatic mode function of the APP interface used by the user. In another embodiment of the present invention, after the backend administrator receives the application sent by the user to turn on the automatic mode function, it can also first verify whether the user account exists in the whitelist. If it is determined that the user account is in the whitelist list, the backend administrator turns on the automatic mode function of the APP interface used by the user. In another embodiment of the present invention, the backend administrator does not directly turn on the automatic mode function of the APP interface used by the user, but sends a security code to the user account. The user can turn on the automatic mode function of the APP interface through the security code when needed or convenient. When the doctor determines that the user no longer needs to turn on the automatic mode, that is, to restore to the normal artificial pancreas mode, the user can turn off the automatic mode on the APP by himself, and the APP will automatically send a message to the backend administrator, who will delete the user account from the whitelist. The doctor and / or the user can also send an application to the backend administrator to request to turn off the automatic mode. The backend administrator will turn off the automatic mode on the user account APP and delete the user account from the whitelist. When the user needs to turn on the automatic mode again, the user account needs to refer to Figures 7a-7c In some embodiments of the present invention, the automatic mode may include a first automatic mode and a second automatic mode, the second automatic mode being an advanced automatic mode. In the first automatic mode, the user needs to set the parameters for calculating the bolus, such as the insulin-to-food ratio, insulin sensitivity, and target blood glucose level. The user may choose to set the default values or input the parameter values determined by a doctor or other professional. The user also needs to input the weight and the total daily infusion amount. Before a meal, the system automatically calculates and infuses the corresponding bolus based on the meal information input by the user or recognized by the system. The method for the system to recognize meal information will be described in detail later. In the second automatic mode, the user does not need to set the parameters for calculating the bolus, such as the insulin-to-food ratio, insulin sensitivity, and target blood glucose level. The user only needs to input the weight and / or the total daily infusion amount. Preferably, the user only needs to input the weight, and the system can calculate the total daily infusion amount based on the user's weight. At the same time, the system automatically sets the parameters for calculating the bolus and automatically adjusts the parameters based on the control effect of the user's blood glucose level, thereby greatly reducing the user's operations and improving the user experience.

[0131] In one embodiment of the present invention, Figure 7a-7c The default setting for the automatic mode described in the is to enable the first automatic mode. When you need to enable the second automatic mode, you can refer to Figure 7a-7c The method of turning it off can also refer to the first automatic mode, where the user can turn it off on their own in the APP, or the doctor and / or the user can send an application to the backend administrator, who can then turn off the user's second automatic mode.

[0132] In an embodiment of the present invention, the security code sent by the backend when applying for insulin pump functions, namely, the normal artificial pancreas mode and the automatic mode functions, 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 movement 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.

[0133] Since people in different regions or at different age groups have different eating habits, adopting a unified control plan may lead to poor blood sugar control for some people. Therefore, when the user's automatic mode function is turned on, the user is required to enter a pass code to enter the automatic mode interface containing different carbohydrate modes. For people who consume a lot of carbohydrates, after entering the pass code, they enter the high carbohydrate mode. The automatic mode interface is as follows: Figure 9a As shown, the automatic mode interface appears with a large meal option, and the user can choose whether to turn on the large meal module function. After the user turns on the large meal mode function, the infusion page will appear with two options, "Regular" and "Large Meal", as shown. Figure 9b and 9c As shown in the figure, when the user selects "Regular", the insulin infusion amount corresponding to the normal carbohydrate amount will be infused; when selecting "Big Meal", the insulin infusion amount corresponding to the larger carbohydrate amount will be infused. For people who consume less carbohydrates, after entering the pass code, they will enter the normal carbohydrate mode. The interface of the automatic mode is as follows Figure 9d As shown, the interface does not have a large meal option and defaults to "regular" mode, infusing the insulin infusion amount corresponding to the regular carbohydrate amount.

[0134] 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 user's answers, the system automatically determines whether the user is a high carb consumer. In other embodiments of the present invention, the passcode is notified to the user in advance by a doctor after diagnosing the patient, or the doctor sends information indicating whether the user is a high carb consumer when sending an automatic mode whitelist request to a backend administrator. The backend administrator automatically assigns the corresponding passcode to the user. 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 user when helping the user turn on automatic mode, send the passcode to the user at the same time as sending the security code, or send the passcode to the user after confirming that the user has turned on the automatic mode function using the security code. In the 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 user confusion and thus trouble to the user.

[0135] In an embodiment of the present invention, the system or doctor may determine whether the user is a high carbohydrate consumer based on a comprehensive judgment of multiple factors including the user's age, diet, exercise habits, health status, and non-automatic mode usage results. When the user has a non-automatic mode usage record, the non-automatic mode usage record is used as the main basis for judgment.

[0136] After the user selects a meal, the meal type includes "regular" and "big meal", and the automatic mode adopts the drug infusion strategy of pre-infusion and supplementary infusion, such as Figure 10 In the case of pre-infusion and supplementary infusion, for regular meals and large meals, the pre-infusion amount and supplementary infusion amount are divided into different levels, as shown in the following Table 1:

[0137]

[0138] The amount of insulin infused 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 infused 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.

[0139] The large, medium and small meal sizes corresponding to pre-infusion and the large, medium and small meal sizes corresponding to supplementary infusion are all independent parameters. The meal size corresponding to pre-infusion of the same level is larger than the 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 meal size corresponding to pre-infusion is not less than the maximum meal size corresponding to regular meals, and the minimum meal size corresponding to supplementary infusion is not less than the maximum meal size corresponding to regular meals.

[0140] In step 1001, the user selects the meal type at time T0 and pre-infuses a default insulin infusion amount. The default pre-infusion insulin infusion amount can be the pre-infusion insulin infusion amount corresponding to any small, medium or large meal size. Preferably, the default pre-infusion insulin infusion amount is the insulin infusion amount corresponding to a small meal size. Selecting a small amount of supplementary insulin infusion amount can prevent excessive insulin infusion and reduce the risk of hypoglycemia.

[0141] Step 1002, at time T1, compare the current blood glucose value monitored by the CGM with a preset blood glucose threshold value, 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 value, the default supplementary insulin infusion amount is infused; otherwise, no supplementary infusion amount is infused, wherein the default supplementary infusion amount is the supplementary insulin infusion amount corresponding to any small, medium or large meal size. Preferably, the default supplementary infusion amount is the insulin infusion amount corresponding to a small meal size. Selecting a small initial supplementary 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 after time T0, etc. In other embodiments of the present invention, it can also be determined whether to perform supplementary infusion in conjunction with the blood glucose change rate at time T1.

[0142] Step 1003, within the △T0 time after the T0 moment, such as 3h, 4h, 5h, etc., if the user has hyperglycemia, the next pre-infusion is upgraded, that is, the insulin infusion amount corresponding to the larger estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion moment is taken into consideration; if the user has hypoglycemia, the next pre-infusion is downgraded, that is, the insulin infusion amount corresponding to the smaller estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion moment is taken into consideration; if the user has neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, that is, the insulin infusion amount corresponding to the same meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion moment is taken into consideration.

[0143] 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.

[0144] Step 1004: within the ΔT1 time after time T1, such as 3h, 4h, 5h, etc., if the user has hyperglycemia, the next supplementary infusion is upgraded, that is, the supplementary insulin infusion amount corresponding to the larger estimated meal amount is infused, while considering the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion; if the user has hypoglycemia, the next supplementary infusion is downgraded, that is, the insulin infusion amount corresponding to the smaller estimated supplementary meal amount is infused, while considering the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion; if the user has neither hyperglycemia nor hypoglycemia, the next supplementary infusion level remains unchanged, that is, the insulin infusion amount corresponding to the same supplementary estimated meal amount is infused, while considering the actual blood glucose value or blood glucose change rate, or the IOB in the body at the time of the next supplementary infusion.

[0145] In step 1005, the user 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 insulin infusion amount 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.

[0146] At step 1006, at time T3, the current blood glucose level monitored by the CGM is compared with a preset blood glucose threshold, such as 140, 150, 160, 170, 180, 190, 200 mg / mL, etc. 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 amount corresponding to the supplemental meal size is increased, decreased, or maintained, while also 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 in conjunction with the blood glucose rate of change at time T3.

[0147] Step 1007, within the △T0 time after time T2, such as 3h, 4h, 5h, etc., if the user has hyperglycemia, the next pre-infusion is upgraded, that is, the insulin infusion amount corresponding to the larger estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion time is taken into consideration; if the user has hypoglycemia, the next pre-infusion is downgraded, that is, the insulin infusion amount corresponding to the smaller estimated meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion time is taken into consideration; if the user has neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, that is, the insulin infusion amount corresponding to the same meal size is infused, and the actual blood glucose value or blood glucose change rate, or the IOB in the body at the next pre-infusion time is taken into consideration.

[0148] Step 1008, within the ΔT1 time after time T3, such as 3h, 4h, 5h, etc., if the user has hyperglycemia, the next supplementary infusion is upgraded, that is, a larger supplementary insulin infusion amount corresponding to the 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 user has hypoglycemia, the next supplementary infusion is downgraded, that is, a smaller supplementary insulin infusion amount corresponding to the 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 user has neither hyperglycemia nor hypoglycemia, the next supplementary infusion level remains unchanged, that is, the insulin infusion amount corresponding to the same 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.

[0149] When pre-infusion and supplemental infusion are required at the next moment, steps 1005-1008 are repeated.

[0150] Generally, in order to maintain the stability of the user's blood sugar level, the meal type selected by the user at time T2 and time T0 is consistent, that is, if the user selects a regular meal at time T0, then the regular meal will also be selected at time T2. If the user selects a large meal at time T0, then the large meal will also be selected at time T2. Therefore, the next pre-infusion insulin selection and supplementary insulin infusion selection can both depend on the results of the previous pre-infusion insulin selection and supplementary insulin infusion selection. However, if the user's next meal selection is inconsistent with the previous meal selection, the patient will restore to the initial default pre-infusion amount and default supplementary infusion amount at the next pre-infusion and supplementary infusion time to prevent inaccurate insulin infusion amount due to changes in meal patterns.

[0151] It should be noted here that if the meal size corresponding to the current pre-infusion amount is already the largest meal size in the selected meal type, if hyperglycemia still occurs within the △T0 time after T0, the next pre-infusion amount will not be upgraded, and the insulin infusion 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 in-vivo IOB. 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, the next pre-infusion amount will not be downgraded, and the insulin infusion 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 in-vivo IOB.

[0152] Similarly, if the meal size corresponding to the current supplementary infusion amount is already the largest meal size in the selected meal type, if hyperglycemia still occurs within the △T0 time after T0, the next supplementary infusion amount will not be upgraded, and the insulin infusion 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 in the selected meal type, if hypoglycemia still occurs within the △T0 time after T0, the next supplementary infusion amount will not be downgraded, and the insulin infusion 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.

[0153] In other embodiments of the present invention, the meal sizes corresponding to pre-infusion and supplementary infusion are not necessarily graded, that is, the estimated meal size during pre-infusion may be only a default size, while during supplementary infusion, the estimated meal size may be at three different levels: large, medium, and small. Therefore, during the pre-infusion stage, only the insulin infusion amount corresponding to the default meal size is infused for each pre-infusion; or the estimated meal size during pre-infusion may be at three different levels: large, medium, and small, while during supplementary infusion, only the estimated meal size may be at the default size. Therefore, during supplementary infusion, only the insulin infusion amount corresponding to the default meal size is infused for each supplementary infusion.

[0154] Similarly, the settings for the estimated meal sizes 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 sizes corresponding to pre-infusion and supplementary infusion can be selected as graded or ungraded (default amount), and can be set according to the user's actual needs.

[0155] In other embodiments of the present invention, after selecting the meal type, it is also possible to not adopt the pre-infusion and supplementary infusion strategies, and directly perform insulin infusion based on the default estimated meal amount of the selected regular meal or large meal, while taking into account the user's actual blood sugar value or blood sugar change rate during the meal, as well as the IOB in the body.

[0156] In an embodiment of the present invention, a small meal mode, i.e., a snack mode, is also provided in the system. When the user selects the snack mode, since the carbohydrate content range in snacks is relatively small, the system performs insulin infusion based on the default estimated meal amount, while taking into account the user's actual blood sugar value or blood sugar change rate when eating snacks, as well as the IOB in the body. Moreover, the default estimated meal amount in the snack mode is smaller than the lowest level estimated meal amount in the regular mode.

[0157] Figure 11a Schematic diagram of a closed-loop infusion system based on food image recognition according to an embodiment of the present invention. Figure 11b Schematic diagram of a closed-loop infusion method based on food image recognition according to an embodiment of the present invention. Figure 11c This is a schematic diagram of a closed-loop infusion method based on food image recognition according to another embodiment of the present invention.

[0158] In other embodiments of the present invention, quantitative analysis of food is performed to determine the content of nutrients such as carbohydrates, fats, and proteins in the food, which can further optimize the amount of insulin infusion required during meals and obtain a more accurate insulin infusion amount.

[0159] In an embodiment of the present invention, an imaging module 103 is incorporated into the system. This imaging module 103 can be used to capture food images, which are then input into the program module 101 or the cloud server 104. The food images are then quantitatively analyzed to determine the type and weight of the food, for example, 500g potatoes, 340g pasta, 220g beef, and 450g milk. The nutritional composition of the food is then determined based on the type of food, and the nutritional content of each food item is determined based on its weight. The cloud server 104 can be a large server located on a public network for storing and computing data.

[0160] Specifically, in some embodiments of the present invention, the imaging module 103 is an image acquisition device independent of the closed-loop artificial pancreas. With the development and popularization of closed-loop artificial pancreas technology, smart devices can be connected to the closed-loop artificial pancreas to assist in completing the user's blood sugar testing and insulin infusion. Smart devices such as mobile phones, tablets, head-mounted augmented reality devices, etc. generally have camera functions. Users can use the camera function of the smart device to take pictures of food before meals to obtain food images. Since smart devices can be iterated frequently, their image acquisition software and hardware meet the needs of daily food image acquisition, have superior performance, and the captured food images are clear, which is conducive to quantitative analysis of food images.

[0161] In other embodiments of the present invention, the imaging module 103 may be a submodule of the closed-loop artificial pancreas. For example, a camera function may be added to the PDM to obtain food images, thereby eliminating the need for additional image acquisition equipment and saving usage costs for users.

[0162] Regardless of which device is used to photograph food, it is referred to as an imaging module 103 in the embodiment of the present invention.

[0163] In an embodiment of the present invention, the imaging module 103 is connected to the closed-loop artificial pancreas system via a wired or wireless method, and performs data interaction with at least one of the detection module 100, the program module 101, and the infusion module 102 to transmit food image data to the closed-loop artificial pancreas. Alternatively, after acquiring the food image, the imaging module 103 directly performs data analysis on the food image to determine the type and weight of the food, and then transmits the type and weight data of the food to the closed-loop artificial pancreas to determine the nutrient content. The system determines the amount of insulin infusion based on the blood glucose data and infuses it. Alternatively, after acquiring the food image, the imaging module 103 performs data analysis on the food image to determine the type and weight of the food, and then determines the nutrient content based on the type and weight of the food, and then transmits the nutrient data to the closed-loop artificial pancreas. The system determines the amount of insulin infusion based on the blood glucose data and infuses it. Alternatively, after acquiring the food image, the imaging module 103 performs data analysis on the food image to determine the type and weight of the food, and then determines the nutrient content based on the type and weight of the food, and determines the insulin infusion amount in combination with the blood glucose data, and then transmits the insulin infusion amount data to the closed-loop artificial pancreas, and the system infuses according to the insulin infusion amount data.

[0164] In an embodiment of the present invention, after acquiring the food image, the imaging module 103 can directly perform quantitative analysis on the food image in the imaging module 103, or transmit the food image to the closed-loop artificial pancreas, and the system can perform quantitative analysis on the food image, or transmit the food image to the cloud server 104, and the cloud server 104 can perform quantitative analysis on the food image.

[0165] In an embodiment of the present invention, a food image recognition model based on deep learning can be used to quantitatively analyze food images. For example, the color (R\G\B channels), shape, layer, texture, projection and other features in the food image can be identified, and the type and weight of the food can be determined by combining the shooting distance characteristics of the imaging module 103 relative to the food. In order to more accurately identify food images, a food image library can be accessed, and each food in the food image can be extracted into the food image library, and compared with the images in the food image library to determine the type of food. After determining the type and weight of the food, the type and weight data of the food are transmitted to the food nutrition library to determine the nutrients and content of the food.

[0166] In an embodiment of the present invention, the food nutrition library can only record the nutritional content of various foods, as shown in Table 2.1. After identifying the type and weight of the food in the food image, the nutritional content of each nutrient can be calculated by reading the nutritional content of the food in the food nutrition library. The food nutrition library can also record the nutritional content of each nutrient contained in a specified weight of food, as shown in Table 2.2. After identifying the type and weight of the food in the food image, the nutritional content of each food in the food image can be obtained by directly reading the food nutrition library.

[0167] Table 2.1 Food Nutrition Database

[0168]

[0169] In an embodiment of the present invention, 500g of potatoes are identified in a food image, and the food nutrient database records the potato's carbohydrate content as α, fat content as β, and protein content as γ. Therefore, the potato in the food image provides 500g*α of carbohydrates, 500g*β of fat, and 500g*γ of protein. If 250g of beef is also identified in the same food image, and the food nutrient database records the beef's carbohydrate content as α', fat content as β', and protein content as γ', then the beef in the food image provides 250g*α' of carbohydrates, 250g*β' of fat, and 250g*γ' of protein. The total carbohydrates identified in the food image are 500g*α+250g*α', the total fat is 500g*β+250g*β', and the total protein is 500g*γ+250g*γ'. Based on these identified total nutrient contents, a simulated blood sugar curve for the user is predicted, the postprandial insulin infusion amount is calculated, and the corresponding insulin infusion is completed. The above data is for illustrative purposes only. When calculating the amount of insulin infusion, algorithms such as PID, MPC, and neural networks can be used to predict the user's simulated blood glucose curve.

[0170] Table 2.2 Food Nutrition Database

[0171]

[0172] In an embodiment of the present invention, 400g of potatoes and 200g of beef are identified in the food image, and recording the carbon water content of potatoes in the food nutrition library is a (mg), and fat content is b (mg), and protein content is c (mg), recording the carbon water content of beef is d (mg), and fat content is e (mg), and protein content is f (mg), so the total carbon water content finally identified in the food image is a+d (mg), and fat content is b+e (mg), and protein content is c+f (mg). According to these total nutrient content predictions identified, the user simulated blood glucose curve is used, and the insulin infusion amount after the meal is calculated, and corresponding insulin infusion is completed. The above data are only described as an example. When calculating the insulin infusion amount, insulin algorithms such as PID, MPC, neural networks are used to predict the user simulated blood glucose curve.

[0173] In an embodiment of the present invention, the food nutrition library can be stored in a smart device, a closed-loop artificial pancreas, or a cloud server 104, without limitation. Due to the limited storage space of the readable storage device, the food nutrition library will not record the nutritional content of all foods of a specified weight and all types. The system can display the closest food column and its corresponding nutritional content for the user to confirm. When the user or his / her medical guardian is able to provide more accurate nutritional content of the food, it can be input into the system and stored through the interactive interface of the smart device or PDM to update the original data recorded in the food nutrition library, or to add unrecorded raw data to the food nutrition library, where the unrecorded raw data includes food type, weight, and nutrient content.

[0174] In an embodiment of the present invention, the food nutrition library can record not only the nutritional content of carbohydrates, fats and proteins, but also the content of nutrients such as cholesterol, vitamins, trace elements, such as vitamin B, vitamin B, vitamin C, vitamin D, calcium, magnesium, iron, zinc, sodium, potassium, etc.

[0175] In the embodiment of the present invention, after identifying the nutritional content in the food image, the simulated blood glucose curve corresponding to each nutrient is calculated according to the total carbohydrate, total fat and total protein, that is, the carbohydrate blood glucose curve l α , fat and blood sugar curve β and protein blood glucose curve γ , Carbohydrate Blood Sugar Curve α , fat and blood sugar curve β and protein blood glucose curve γ It can reflect the effects of post-meal carbohydrates, fats and proteins on the user's blood sugar. When calculating the simulated blood sugar curve, historical data and IOB can be combined. α , fat and blood sugar curve β and protein blood glucose curve γAfter that, the three curves are fitted to obtain the simulated blood glucose curve l1. The simulated blood glucose curve l1 can be obtained by the carbohydrate blood glucose curve l α , fat and blood sugar curve β and protein blood glucose curve γ Obtained by linear fitting:

[0176] l1=g*l α +*l β +i*l γ (1) Where g, h, and i are the fitting coefficients of the blood glucose curves of each nutrient.

[0177] The simulated blood glucose curve l1 reflects the theoretical blood glucose change after the nutrient content in the food image is identified by the food image recognition model, the insulin infusion amount is calculated and then infused into the user.

[0178] In the embodiment of the present invention, the fitting of the simulated blood glucose curve l1 lasts for a period of time, for example, 2 to 5 hours. During this period, the detection module 100 obtains the user's actual blood glucose curve l2 in real time. By comparing the simulated blood glucose curve l1 data with the actual blood glucose curve l2 data, the simulated blood glucose curve l1 can be optimized to improve the carbohydrate blood glucose curve l2. α , fat and blood sugar curve β and protein blood glucose curve γ This allows the food image recognition model to learn further and adjust the parameters of the food image recognition algorithm and the insulin algorithm to improve the accuracy of food image recognition and the accuracy of insulin infusion calculation. Specifically, after the fitting duration of the simulated blood glucose curve l1 ends, by comparing the difference between the simulated blood glucose curve l1 and the actual blood glucose curve l2 during this period, the carbohydrate blood glucose curve l2 is adjusted and optimized. α , fat and blood sugar curve β and protein blood glucose curve γ This means that the total carbohydrate, total fat and total protein contents identified by the food image recognition model before the meal are adjusted and optimized, and then the insulin algorithm parameters are corrected to improve the accuracy and applicability of the insulin algorithm parameters. Similarly, based on the aforementioned comparison differences, the food image recognition algorithm parameters in the food image recognition model can also be corrected so that the next food image recognition result will be more accurately corrected. The correction procedure for the food image recognition model algorithm parameters and the insulin algorithm parameters is repeatable, and such a correction procedure can be repeated to continuously iterate the food image recognition model algorithm and the insulin algorithm. This continuous iterative process is the deep learning process of the food image recognition model and the insulin algorithm.

[0179] In an embodiment of the present invention, the iterative correction of the food image recognition model algorithm and the insulin algorithm is completed based on the user's actual blood glucose curve l2. When infusing insulin, since the physiological characteristics and living habits of different users may not be the same, in the initial state, even if the food image recognition model recognizes exactly the same nutrient content and completes the corresponding insulin infusion, the actual blood glucose curve l2 finally detected by the detection module 100 will not be exactly the same. This will make the correction results of the food image recognition model parameters and the insulin algorithm parameters different. Moreover, with the repeated iterations of the correction program, the parameters of the food image recognition model will become more accurate, and the insulin algorithm parameters will gradually become the user's unique parameters and will no longer be applicable to other users. After repeated iterations of the parameters, the insulin algorithm also changes from the broad insulin algorithm at the factory to the user's narrow insulin algorithm.

[0180] In this embodiment of the present invention, the user can choose whether to upload the food image recognition model and insulin algorithm after repeated parameter iterations to the cloud server 104. Alternatively, the user can consent to the system automatically uploading the iterated food image recognition model and insulin algorithm to the cloud server 104. Alternatively, the food image recognition model and insulin algorithm are running on the cloud server 104, and the user can consent to their disclosure to the server backend. After obtaining a sufficient number of narrow insulin algorithms, they can be aggregated to form a narrow insulin algorithm cluster. Within a cluster, users can be categorized into different groups based on identifiable features such as physiological characteristics and lifestyle habits derived from the model. These groups share common identifiable features. For example, users can be divided into multiple groups based on age or age ranges, such as 0-10, 10-15, 15-18, and 18-20. Alternatively, male and female users can be divided into two groups based on gender, with female users further divided into two groups based on whether they are pregnant. Alternatively, users can be divided into multiple groups based on their habitual daily exercise duration, such as 0-10 minutes, 10-30 minutes, or 30-60 minutes. Alternatively, groups can be formed based on a combination of multiple common identifiable features, such as "users aged 10-15 with a daily exercise duration of 10-30 minutes," "male users aged 15-18," and "pregnant users aged 20-22." Identifiable features can also include individual insulin resistance, weight, genetic disease history, medical history, nationality, and job type. Since the users from which the models in each group come have one or more common identifiable features, any algorithm in the group can be applied to other users with the same identifiable features to a certain extent. This provides convenience for users with the identifiable features. Before eating, these users can choose whether to use the food image recognition model and narrow insulin algorithm of other users with the same identifiable features. This has higher accuracy and applicability than directly using the broad insulin algorithm, and does not require multiple corrections of the insulin algorithm parameters and image recognition model. It has higher accuracy in recognizing food images and improves the therapeutic effect of the closed-loop artificial pancreas system.

[0181] In an embodiment of the present invention, after using the group's food image recognition model and narrow insulin algorithm, a group of users iterates the food image recognition model and narrow insulin algorithm after one or several meals. The iterated food image recognition model and narrow insulin algorithm parameters can also be fed back into the user's identifiable feature group. For example, a user with the identifiable feature of "16-year-old male user" uses the food image recognition model to identify food images before a meal, and then uses the narrow insulin algorithm to complete insulin infusion. Five hours after the meal, the food image recognition model and narrow insulin algorithm he used complete the iteration. The user chooses to disclose the iterated food image recognition model and narrow insulin algorithm parameters to the backend. In this case, these parameters can be fed back to the group of "16-year-old users", the group of "male users", and the group of "16-year-old male users".

[0182] In an embodiment of the present invention, identifiable feature groups exist in a parallel form independent of each other. For example, "16-year-old male user" and "16-year-old user" are two independent groups, and applicable food image recognition models and narrow insulin algorithm parameters are stored in both groups. In these independent groups, the more identifiable features there are, the more accurate the food image recognition model and narrow insulin algorithm in the group, and the more suitable its parameters are for the user. For example, a person whose identifiable feature is "16-year-old male user" can find a food image recognition model and narrow insulin algorithm that are suitable for him in either the "16-year-old user" or "16-year-old male user" groups. Obviously, the food image recognition model and narrow insulin algorithm he finds in the "16-year-old male user" group are more suitable for him because the food image recognition model and narrow insulin algorithm in the "16-year-old user" group have also been learned from user-source data of "female users", which does not match the physiological state of this user. This will obviously affect the calculation of the insulin infusion amount for the "male user".

[0183] In other embodiments of the present invention, the identifiable feature group is stored in the system or cloud server 104 in the form of a subset. For example, "16-year-old male users" is a subordinate subset of "16-year-old users". When searching for the "16-year-old male users" group, it is necessary to first retrieve the "16-year-old users" group, and then search for the "male users" group in the "16-year-old users" group. Obviously, among the identifiable features, age and gender are two independent features, and both can be used as subordinate subsets. When searching for the "16-year-old male users" group, it is also possible to first retrieve the "male users" group, and then search for the "16-year-old users" group in the "male users" group. Both of the above methods can ultimately point to the group of "16-year-old male users", that is, "16-year-old users" and "male users" can be subsets of each other.

[0184] In an embodiment of the present invention, the identifiable feature subset is tailored to individual users or user groups, and its directory is editable. It is impossible for a manufacturer to pre-store all identifiable features in the system or cloud server 104 in an exhaustive manner for user selection. Therefore, a user may not be able to retrieve the identifiable features that apply to them. In this case, the user can edit the identifiable feature subset to add, modify, or delete the identifiable feature subset, or request the server to add, modify, or delete the identifiable feature subset.

[0185] In this embodiment of the present invention, due to the objective determinability of the nutritional content in food images, the parameters of the food image recognition model will tend to be consistent after multiple iterations. The parameters of the food image recognition model provided by each user can be used to improve the food image recognition model and the food nutrient library. By leveraging big data and deep learning to improve the food image recognition model, the accuracy of food image recognition can be improved, which is beneficial for the development of closed-loop artificial pancreas systems.

[0186] Reference Figure 11a and Figure 11b In an embodiment of the present invention, in step 2001, when using a closed-loop artificial pancreas system with food image recognition, the user must first use the imaging module 103 of the smart device to capture an image of the food currently being consumed. Considering that food may be spread across multiple tableware during consumption, the user can capture one or more images of the food in each tableware. When capturing multiple food images, the user can select different angles to capture images that may be obscured. The food image recognition model can identify foods that the user has repeatedly captured by the user by evaluating factors such as color, shadow, shape, and size in the food images, and eliminate redundant images of the food when calculating the nutritional content of the food.

[0187] In step 2002, after the user takes a food image, if the food image recognition model is set on the smart device, the food image can be directly transmitted to the food image recognition application (hereinafter referred to as the application) where the food image recognition model is located. The application can be downloaded to the smart device by the user or his / her guardian, or the application is a subroutine of the closed-loop artificial pancreas program, and the recognition of the food image can be completed in the closed-loop artificial pancreas program.

[0188] In step 2003, after the application completes the recognition of the food image, it can obtain the nutrient content (mainly including carbohydrate, fat and protein content) in the food image and display it to the user through the interactive interface. The display content includes the recognized food type, weight, corresponding nutrient content and total nutrient content. The interactive interface can also prompt the user whether to confirm the display content. If the user confirms the food type, weight, corresponding nutrient content and total nutrient content obtained by the food image recognition model, it can be used to calculate the insulin infusion amount. If the user believes that there is an obvious deviation in the food type, weight, corresponding nutrient content and total nutrient content obtained by the food image recognition model, the user can choose to re-recognize the food image, or re-photograph the food and recognize it again until the recognition result of the food image recognition model is confirmed by the user.

[0189] In step 2004, the application transmits the total nutrient content to the closed-loop artificial pancreas. Based on the total nutrient content, the insulin algorithm is invoked to calculate and administer the insulin infusion amount. The postprandial insulin infusion amount includes a basal dose and a bolus dose. Simultaneously, the system simulates the user's blood glucose curve l1 for a period of time after eating based on the calculated insulin infusion amount. In this step, it is assumed that the insulin algorithm is stored in the closed-loop artificial pancreas. The insulin algorithm can also be stored in the application. After the application recognizes the food image, it can directly calculate the postprandial insulin infusion amount locally. The postprandial insulin infusion amount data is then transmitted to the closed-loop artificial pancreas, which then administers the infusion. In this step, the insulin algorithm invoked can be an insulin algorithm stored in the application or the closed-loop artificial pancreas, or an algorithm from a narrow insulin algorithm cluster. Invoking an algorithm from a narrow insulin algorithm cluster requires the user to first identify their own identifiable features. Based on these features, a suitable insulin algorithm is retrieved. The more identifiable features a user has, the more suitable the retrieved insulin algorithm is for the user, and the more accurate the calculated postprandial insulin infusion amount is.

[0190] In step 2005, when the postprandial insulin infusion starts, the detection module 100 detects and records the user's actual postprandial blood glucose data to form the user's actual blood glucose curve l2, which lasts for a period of time, such as 2 to 5 hours, which coincides with the duration of the simulated blood glucose curve l1.

[0191] In step 2006, after the detection module 100 has recorded blood glucose data for a preset period of time, the system compares the data of the simulated blood glucose curve l1 with the data of the actual blood glucose curve l2. Based on the comparison results, the insulin algorithm parameters are modified to gradually bring the simulated blood glucose curve l1 and the actual blood glucose curve l2 into closer alignment. The narrow insulin algorithm with the modified parameters is more suitable for the user and can therefore be referred to as the narrow insulin algorithm. Simultaneously, the system transmits the comparison results back to the application, which can modify the parameters of the food image recognition model to optimize the food image recognition model. The parameter-modified insulin algorithm and food image recognition model will be used for food image recognition and insulin calculation during the next meal. Furthermore, with the user's consent, the parameter-modified insulin algorithm can be aggregated into a narrow insulin algorithm cluster and categorized into corresponding groups based on the user's identifiable features, allowing the user or other users with the same identifiable features to access it before a meal.

[0192] In some embodiments of the present invention, due to the limited computing power and storage capacity of smart devices or closed-loop artificial pancreas, they may not be able to support complex image recognition and insulin infusion amount calculations, may not be able to store enough narrow insulin algorithms, and may not be able to store a sufficiently rich food nutrient library. Considering this practical problem, the cloud server 104 can be connected to the closed-loop artificial pancreas system. The cloud server 104 can establish communication with the smart device or closed-loop artificial pancreas via wired or wireless means to achieve data exchange. After connecting to the cloud server 104, the cloud server 104 can provide powerful computing power and storage capacity support for the closed-loop artificial pancreas and smart device. The image recognition model, narrow insulin algorithm cluster, or food nutrient library can be stored in the cloud server 104. The cloud server 104 can also complete the recognition of food images or the calculation of insulin infusion amount, or complete the comparison of simulated blood glucose data with actual blood glucose data, and even complete the correction of insulin algorithm or image recognition model parameters. In this way, food recognition and insulin infusion amount calculation during meals can be completed without using a high-performance closed-loop artificial pancreas and smart device, saving the user's usage costs.

[0193] After accessing the cloud server 104, the method of using the closed-loop artificial pancreas system will change. Figure 11c , the specific steps are as follows:

[0194] In step 3001, a user uses a smart device to take a food image, and a food image recognition model recognizes the food image.

[0195] In step 3002, a food image recognition model is set in the cloud server 104. After taking a food image, the user uploads the food image to the cloud server 104 via a smart device and completes food image recognition.

[0196] In step 3003, the cloud server 104 transmits the identified food type, weight, corresponding nutrient content and total nutrient content data back to the smart device, and displays it to the user through an interactive interface. If the user confirms the food type, weight, corresponding nutrient content and total nutrient content obtained by the food image recognition model, it can be used to calculate the post-meal insulin infusion amount. If the user believes that there is an obvious deviation in the food type, weight, corresponding nutrient content and total nutrient content obtained by the food image recognition model, the user can choose to re-identify the food image, or re-photograph the food and identify it until the recognition result of the food image recognition model is confirmed by the user.

[0197] In step 3004, the user calls the insulin algorithm, or retrieves an insulin algorithm with the same identifiable features as the user from the narrow insulin algorithm cluster. Based on the determined insulin algorithm and nutrient content, the cloud server 104 calculates the user's postprandial insulin infusion amount, simulates the user's postprandial blood sugar changes, obtains simulated blood sugar data, and forms a simulated blood sugar curve l1. The cloud server 104 sends the postprandial insulin infusion amount data to the closed-loop artificial pancreas and completes the infusion. The postprandial insulin infusion amount includes a basal amount and a large dose.

[0198] In step 3005, when insulin infusion begins, the detection module 100 detects and records the user's actual blood glucose data to form an actual blood glucose curve l2 for a period of time, such as 2 to 5 hours, which coincides with the duration of the simulated blood glucose curve l1, and transmits the actual blood glucose data during this period to the cloud server 104.

[0199] In step 3006, cloud server 104 compares the simulated blood glucose curve l1 data with the actual blood glucose curve l2 data. Based on the comparison results, it modifies the insulin algorithm parameters so that the simulated blood glucose curve l1 gradually converges with the actual blood glucose curve l2. The modified insulin algorithm is more suitable for the user and is therefore referred to as the narrow insulin algorithm. Simultaneously, cloud server 104 uses the comparison results and the modified insulin algorithm parameters to adjust the parameters of the food image recognition model to optimize the food image recognition model. The narrow insulin algorithm and food image recognition model will be used for food image recognition and insulin calculation during the next meal. Furthermore, with the user's consent, the narrow insulin algorithm can be aggregated into a narrow insulin algorithm cluster and categorized into corresponding groups based on the user's identifiable features. This algorithm will replace the pre-modified insulin algorithm and be available for use by the user or other users with the same identifiable features before meals.

[0200] In the embodiment of the present invention, the calculation of the insulin infusion amount can be completed in the closed-loop artificial pancreas, or the smart device, or the cloud server 104, and the specific implementation process will not be repeated here.

[0201] In the embodiment of the present invention, the recognition of food images can be completed in a closed-loop artificial pancreas, or an intelligent device, or a cloud server 104, and the specific implementation process will not be repeated here.

[0202] In the embodiment of the present invention, the simulation calculation of the simulated blood glucose curve l1 can be completed in a closed-loop artificial pancreas, or an intelligent device, or a cloud server 104, and the specific implementation process will not be repeated here.

[0203] Reference Figure 12 , Figure 12 This figure is a schematic diagram of another closed-loop infusion method based on food image recognition according to an embodiment of the present invention. The insulin algorithm can be integrated into the food image recognition model. Once the food image recognition model identifies the type and weight of the food, the insulin algorithm can directly determine the postprandial insulin infusion dose without having to identify the nutritional content of the food. This is described in detail below. The model resulting from the normalization of the food image recognition model and the insulin algorithm is referred to as the "large model" in this invention.

[0204] In the embodiment of the present invention, the insulin algorithm can be divided into two modes: logical operation and lookup table, which are described in detail below.

[0205] In an embodiment of the present invention, the large model can be stored in a smart device, a closed-loop artificial pancreas system or a cloud server 104. After receiving the food image input, the postprandial insulin infusion amount can be directly output, and the closed-loop artificial pancreas can complete the postprandial insulin infusion.

[0206] Taking the large model stored in a smart device as an example, in an embodiment of the present invention, in step 4001, the large model still needs to use the imaging module 103 of the smart device to obtain food images. The steps of obtaining food images are consistent with the previous text and will not be repeated here.

[0207] In step 4002, the food image is transmitted to a food image recognition application, and a large model in the application recognizes the type and weight of food in the food image.

[0208] In step 4003, after the large model identifies the food type and weight in the food image, it displays the information to the user through the interactive interface of the smart device and prompts them to confirm. If the user confirms the food type and weight displayed on the interactive interface, the pre-set insulin algorithm will output the post-meal insulin infusion amount. If the user believes that the identified food type and weight are significantly different, the user can choose to re-identify the food image or take a photo of the food and identify it again until the large model's recognition result is confirmed by the user.

[0209] In step 4004, after the user confirms the type and weight of the food, the large model calculates the user's post-meal insulin infusion amount based on the type and weight of the food using a preset insulin algorithm. The preset insulin algorithm can be one or more logical operations such as a neural network, PID, and MPC, which can calculate the post-meal insulin infusion amount based on the type and weight of the food. After recognizing the food image, the large model calculates the post-meal insulin infusion amount for each food, and then adds up the post-meal insulin infusion amounts of all foods to obtain the total post-meal insulin infusion amount. For example, the large model identifies 500g of potatoes, 250g of pasta, and 250g of beef in the food image provided by the user. Using the preset insulin algorithm, it is calculated that the post-meal insulin infusion amount corresponding to 500g of potatoes is I1, the post-meal insulin infusion amount corresponding to 250g of pasta is I2, and the post-meal insulin infusion amount corresponding to 250g of beef is I3. Then, the user's total post-meal insulin infusion amount is I1+I2+I3. The above is only a schematic description.

[0210] The preset insulin algorithm can also be a query table. Based on the query table, the postprandial insulin infusion amount is retrieved according to the type and weight of the food. The postprandial insulin infusion amount of each food and its corresponding weight is stored in the large model in the form of a query table, as shown in Table 3.1. For example, the large model identifies 300g of potatoes, 200g of pasta and 200g of beef for the food image provided by the user. By searching the query table, it is found that the postprandial insulin infusion amount corresponding to 300g of potatoes is I4, the postprandial insulin infusion amount corresponding to 200g of pasta is I5, and the postprandial insulin infusion amount corresponding to 200g of beef is I6. Then the total postprandial insulin infusion amount of the user is I4+I5+I6. The above is only a schematic description.

[0211] Table 3.1 Food-Insulin Lookup Table

[0212]

[0213]

[0214] Table 3.1 is a representation of a query table, which includes at least columns for "Food Type," "Food Weight," and "Insulin Infusion Amount." More detailed query tables may also include additional food information, such as "Food Origin," "Cooking Method," and "Food Storage Time." After capturing a food image, the user can select this additional food-related information on the smart device's interactive interface to help the food image recognition model better identify the food image. This additional food information is critical for influencing the nutrient content of the food. This information may be difficult for the food image recognition model to identify, which can affect the quantitative analysis of nutrients in the food. Therefore, before the food image is recognized, the user must input or select information related to the food as additional information.

[0215] In the large model, whether logical operations or lookup tables are used to determine the amount of post-meal insulin infusion, commonly used empirical parameters are initially used. The same food may have different effects on the blood sugar of different users due to factors such as meal time, user's digestion level, cooking method, etc. The insulin algorithm cannot take all influencing factors into account in an exhaustive way, so the insulin algorithm can be modified.

[0216] After obtaining the user's postprandial insulin infusion amount, the large model simulates the user's postprandial blood glucose data based on the postprandial insulin infusion amount to form a simulated blood glucose curve l3. The simulation process lasts for a period of time, such as 2 to 5 hours.

[0217] In step 4005, the application transmits the user's postprandial insulin infusion data to the closed-loop artificial pancreas, and the system starts postprandial insulin infusion. At the same time, the system records the actual blood glucose data detected by the detection module 100 to form an actual blood glucose curve l4. The duration of the actual blood glucose curve l4 coincides with the duration of the simulated blood glucose curve l3.

[0218] In step 4006, the system transmits the actual blood glucose data to the smart device. The large model compares the difference between the simulated blood glucose curve l3 data and the actual blood glucose curve l4 data, and corrects the simulated blood glucose curve until it is consistent with the actual blood glucose curve. The comparison result is used to correct the preset insulin logic operation parameters or query table data in the large model, and can even be used to correct the image recognition model parameters.

[0219] In an embodiment of the present invention, the insulin logic operation parameters or query table data will gradually adapt to the user's eating habits after each correction. Therefore, the correction process of the insulin algorithm parameters in this solution is a learning process. The insulin algorithm becomes more and more suitable for the user's physiological characteristics and living habits during the learning process. The post-meal insulin infusion amount calculated in this way will be more accurate, which will help the user's diabetes treatment.

[0220] In this embodiment of the present invention, when modifying a query table, the data in the "Insulin Infusion Amount" column can be modified, and data in the "Type" and "Weight" columns can also be added, modified, or deleted. The modified query table can still be aggregated and grouped according to user-identifiable characteristics for easy access by other users. As previously mentioned, the modified query table can be referred to as a narrow query table to distinguish it from the unmodified query table.

[0221] In some embodiments of the present invention, the food image recognition model and the insulin algorithm can be separated and stored in different modules. For example, the food image recognition model is stored in an intelligent device, and the insulin algorithm is stored in one of the detection module 100, program module 101, or infusion module 102 of the closed-loop artificial pancreas system. After the intelligent device completes food image recognition, the food type and weight data are transmitted to the closed-loop artificial pancreas, and the system calculates or queries the amount of insulin and completes insulin infusion. For another example, the food image recognition model is stored in a cloud server, and the insulin algorithm is stored in the intelligent device. For another example, the food image recognition model is stored in a cloud server, and the insulin algorithm is stored in one of the detection module 100, program module 101, or infusion module 102 of the closed-loop artificial pancreas system.

[0222] In an embodiment of the present invention, the order of some of the above steps can be interchanged. For example, the step of calculating the simulated blood glucose data can be set before the step of obtaining the actual blood glucose data, or it can be set after the step of obtaining the actual blood glucose data. This does not affect the calculation and infusion of the user's postprandial insulin, nor does it affect the comparison of the simulated blood glucose data with the actual blood glucose data to correct the narrow insulin algorithm parameters.

[0223] It can be understood by those skilled in the art that any step exchange that does not affect the implementation of this solution, the solution before the step exchange and the solution after the step exchange should be included in the scope of protection of the present invention. At the same time, no matter whether the food image recognition model and the insulin algorithm are normalized or separated, or how the storage location is changed, they should be included in the scope of protection of the present invention.

[0224] Figure 13a Schematic diagram of a subscription service management system according to an embodiment of the present invention.

[0225] Currently, the CGM device 200 (detection module) and personal management device (PDM) 203, or the insulin pump device 20 (infusion module, including the control unit 201 and the infusion unit 202) and the personal management device (PDM) 203, or the closed-loop artificial pancreas system composed of the CGM device 200, the insulin pump device 20 and the personal management device 203, which are sold on the market, are often bundled with all the services related to the blood glucose monitoring function and the insulin infusion function on the device by the device manufacturers for the convenience of sales. The R&D and manufacturing costs of these functional services are also all added to the CGM device 200 and the insulin pump device 20. The sales costs of the pump device 20 and the personal management device 203, however, not all of these functional services are applicable to all users. For example, the food image recognition function mentioned above, some users may not need this functional service, or may not need this function within a specific time period. However, when users purchase and use the CGM device 200, the insulin pump device 20 and the personal management device 203, they need to pay for the food image recognition function, which increases the user's purchase and use costs, reduces the user's use experience, and therefore affects the manufacturer's equipment sales, which is not good for both the supply and demand sides.

[0226] Obviously, there are other functional services in the CGM device 200, the insulin pump device 20 and the personal management device 203 that also have the above problems, not limited to the food image recognition function.

[0227] Based on the above problems, refer to Figure 13a The present invention proposes a subscription service management system in which services related to blood glucose monitoring and insulin infusion are no longer bundled with the CGM device 200, insulin pump device 20, and personal management device 203. Users can choose to activate desired services based on their needs, such as automatic mode, food image recognition, bolus, temporary basal, exercise mode, extended bolus, report statistics, event logging, reminders, online doctor, and third-party guardian services. When users purchase a CGM device 200, insulin pump device 20, or personal management device 203, unnecessary services are no longer bundled by default, significantly reducing their purchase costs. Manufacturers can even offer free CGM devices 200, insulin pumps, and personal management devices 203 to promote their own services. This increases user willingness to purchase and boosts sales of manufacturers' devices and services, optimizing costs for both supply and demand.

[0228] In the field of blood glucose monitoring and insulin infusion, adopting the above-mentioned subscription service model may be a new development direction. This requires a comprehensive subscription service management system to enable users, manufacturers, and even hospitals to use subscription services. The subscription service management system is described in detail below.

[0229] In some embodiments of the present invention, a subscription service management system includes at least a CGM device 200 and / or an insulin pump device 20 and a personal management device 203. Since both the CGM device 200 and the insulin pump device 20 are attached to the user's body surface, they can be collectively referred to as on-body functional devices. The personal management device 203 is wirelessly connected to the CGM device 200 and the insulin pump device 20. The personal management device 203 includes at least a subscription service management unit and a device management unit. The subscription service management unit is used to manage subscription services, and the device management unit is used to manage the operating status of the on-body functional devices and the personal management device.

[0230] In some embodiments of the present invention, when a user purchases a CGM device 200, an insulin pump device 20, and a personal management device 203, these devices may not have any available services. The user can choose to activate appropriate services based on their own circumstances. A dedicated application (APP, hereinafter referred to as APP) is provided in the subscription service management unit. The user registers a personal account and fills in personal account information through the APP. Each user has a unique account ID to avoid confusion with other users. When a user wishes to subscribe to certain services, he or she needs to enter the APP from the personal management device 203. The APP displays the subscription services that can be activated and their corresponding usage periods and prices in the form of lists, charts, etc. to the user, forming a subscription service list. After the user selects a subscription service, the subscription service instructions related to the subscription service will be triggered, such as "View details", "Subscribe to service", "Insufficient account balance", etc. The user can first choose to view the details, fully understand the service content, choose to purchase the subscription service, and pay for these subscription services through the personal account, or cancel the subscription service and exit. If a user chooses to purchase the subscription service, the subscription service management unit will deduct the balance corresponding to the subscription service from the user's account. After payment is completed, the subscription service permission is activated, and the user can use the subscription service. Accordingly, the subscription service management unit will associate the subscription service permission with the user's account. The device management unit will control the CGM device 200, insulin pump device 20, and personal management device 203 to perform actions related to the subscription service, such as activating the CGM device 200, insulin pump device 20, or activating the automatic mode permission in the personal management device 203. After the user's account is associated with the subscription service permission, the user can view and adjust the corresponding subscription service permission through the account to facilitate the user's use of the subscription service.

[0231] In some embodiments of the present invention, the manufacturers of the CGM device 200 and the insulin pump device 20 may also create a website specifically for selling subscription services, or post a list of subscription service sales and its prices on their official website. Users only need to log in to the website with their account registered in the APP. After purchasing any subscription service, it will be synchronized to the APP. Or after the user logs in to other accounts to purchase the subscription service, the website generates a serial number corresponding to the subscription service, and the user can activate the subscription service by entering the serial number through the personal management device 203.

[0232] In some embodiments of the present invention, in addition to deducting the account balance as described above, users can also purchase subscription services by directly paying through channels such as bank cards, credit cards, payment software, etc. associated with the account, or after purchasing a physical card or digital card associated with the subscription service, the user enters the card account and password into the subscription service management unit to obtain the corresponding subscription service rights, or after purchasing the subscription service through an authenticated third-party sales channel, the user obtains a serial number associated with the subscription service, and then enters the serial number into the subscription service management unit to obtain the corresponding subscription service rights.

[0233] In some embodiments of the present invention, it is necessary for the subscription service management system to trigger a subscription service indication when the user is operating the subscription service. The subscription service indication is used to prompt the user with information related to the subscription service, and can guide the user to complete the corresponding device usage operations and subscription operations, thereby facilitating user use and avoiding blind operations.

[0234] In some embodiments of the present invention, the subscription service indication can be actively triggered by the subscription service management system. For example, when a user obtains a new CGM device 200 or insulin pump device 20, the CGM device 200 or insulin pump device 20 is in an unactivated state and cannot start using the CGM device 200 or insulin pump device 20. The user also needs to obtain an activation device subscription service to activate the device. Since users need to spend additional money to obtain an activation device subscription service before they can use the CGM device 200 or insulin pump device 20, device manufacturers can reduce the sales price of the CGM device 200 or insulin pump device 20, or even give it to users for free, to increase the sales of the CGM device 200 or insulin pump device 20, which can optimize the costs of both the supply and demand sides. After the user obtains the activation device subscription service, the personal management device 203 triggers the device subscription service indication to prompt and guide the user to activate the CGM device 200 and the insulin pump device 20. During this period, the device management unit implements the operation of establishing wireless communication between the personal management device 203 and the CGM device 200 and the insulin pump device 20. After the wireless communication connection is established, the device management unit continues to operate to activate the CGM device 200 and the insulin pump device 20. After the CGM device 200 and the insulin pump device 20 are activated, the personal management device 203, the CGM device 200, and the insulin pump device 20 trigger the subscription service indication that the CGM device 200 and the insulin pump device 20 have been activated to prompt the user to start using the CGM device 200 and the insulin pump device 20. The CGM device 200 and the insulin pump device 20 enter the working state and start continuously monitoring blood sugar and infusing insulin.

[0235] In some embodiments of the present invention, after the user obtains the activation device subscription service, the device manufacturer sends the activation key to the personal management device 203 through the network, or the subscription service management unit generates an activation key and wirelessly transmits the key to the CGM device 200 and the insulin pump device 20 through the device management unit. The CGM device 200 and the insulin pump device 20 are activated after obtaining the key.

[0236] In some embodiments of the present invention, after the user obtains the activation device subscription service, the device manufacturer sends the activation serial number to the mobile communication device associated with the user account, such as a smartphone, or to the user's email address via the network. The user enters the activation serial number on the personal management device 203, and the device management unit can also implement the operation of activating the CGM device 200 and the insulin pump device 20.

[0237] Of course, after a wireless communication connection is established between the personal management device 203 and the CGM device 200 and the insulin pump device 20, the personal management device 203, the CGM device 200 and the insulin pump device 20 can also trigger a communication connected subscription service indication to prompt the user that the wireless communication connection has been established and the device management unit will continue with the activation operation.

[0238] In some embodiments of the present invention, the way in which a user obtains the activation device subscription service is not limited. For example, a user can directly purchase the activation device subscription service in the subscription service management unit, or the user can obtain the serial number of the activation subscription service after purchasing the activation subscription service from a third-party channel, and obtain the activation device subscription service after entering the serial number on the personal management device 203, or automatically obtain the activation device subscription service permission after opening a premium account, or the activation device subscription service can be purchased by others and given to the user.

[0239] In some embodiments of the present invention, the period for users to obtain the activated device subscription service can be permanent, with no usage time limit. After the user activates the CGM device 200 or insulin pump device 20, he or she can continue to use it until the end of the design life of the device.

[0240] In other embodiments of the present invention, the period for a user to obtain the activation device subscription service is time-limited, such as 5 days or 10 days. This period is generally not allowed to exceed the design life of the device, otherwise the extra activation device subscription service time will be wasted. Alternatively, the user can purchase multiple devices to continue using the activation device subscription service. After the personal management device 203 is connected to the new CGM device 200 or insulin pump device 20, as long as the account logged into the APP has not changed, the user can operate to activate the new CGM device 200 or insulin pump device 20 to continue using it until the remaining period of the activation device subscription service expires. After the user activates the CGM device 200 or insulin pump device 20, it can only be used within the corresponding period. After the period expires, the user's device usage rights will be revoked. After the CGM device 200 or insulin pump device 20 is activated, the user can use some non-subscription service related functions, such as viewing information about the CGM device 200 or insulin pump device 20 through the personal management device 203, including the place of manufacture, remaining life, and usage instructions. It should be pointed out that the device manufacturer also provides users with premium accounts. Users need to spend money to upgrade their ordinary accounts to premium accounts. When the user opens a premium account, he or she will automatically obtain the right to activate the device subscription service and some other subscription service rights bound to the premium account. After activating the CGM device 200 and the insulin pump device 20, these subscription services can be used directly, but the usage period is the same as the duration of the user's premium account. When the user's premium account expires, the user's subscription service rights will be closed, and the device usage rights will also be closed.

[0241] In some embodiments of the present invention, the subscription service purchased by the user is bound to the user's account. The user logs in to his or her account on other personal management devices 203. After the other personal management devices 203 establish a communication connection with the user's CGM device 200 and insulin pump device 20, the user can continue to use the CGM device 200 and insulin pump device 20.

[0242] In some embodiments of the present invention, when the personal management device 203 triggers the subscription service indication for activating the device, the user is also required to perform a confirmation operation. Only after the user's confirmation can the device management unit continue to operate and activate the CGM device 200 and the insulin pump device 20.

[0243] In the above embodiment, the subscription service indication can be actively triggered on the personal management device 203, and the triggering form can be a pop-up box, an icon, or light emission displayed on the user interaction unit of the personal management device 203, or the personal management device 203 generates vibrations, emits sounds, etc., which are not limited here. It should be noted that the subscription service indication can be set to a variety of styles, and each style of subscription service indication can convey different information to the user, allowing the user to easily know the status of the current subscription service operation. It can be understood by those skilled in the art that the various subscription service indications involved in the present invention can all be triggered in the above-mentioned different forms, which will be described in detail later.

[0244] In other embodiments of the present invention, when the device management unit monitors that the CGM device 200 and the insulin pump device 20 stop working due to reasons such as the user canceling the device usage subscription service, the personal management device 203 actively triggers the subscription service indication of the CGM device cessation and the insulin pump device cessation to remind the user that the on-body functional device has stopped being used, so as to avoid the user worrying about being charged for continuing to use the on-body functional device.

[0245] In other embodiments of the present invention, the backend administrator of the subscription service management system (hereinafter referred to as the backend administrator), such as the manufacturer of the CGM device 200 or the insulin pump device 20, can push, update, or close some subscription services to users through the subscription service management system to provide users with a better user experience. For example, if the device manufacturer launches a new automatic mode subscription service that includes a newly developed automatic mode algorithm, which can provide users with a better insulin infusion experience and better treatment effects, the backend administrator can push the automatic mode subscription service to its user group through the subscription service management system, and the user's subscription service management unit will trigger a subscription service push indication, prompting the user that the new automatic mode subscription service is available for purchase.

[0246] For another example, if the manufacturer of the CGM device 200 or insulin pump device 20 upgrades the automatic mode to optimize the expected blood glucose profile during insulin infusion, the subscription service management system proactively triggers an indication to update the automatic mode subscription service. After receiving the indication to trigger the automatic mode subscription service update, the user can choose to view details, update the automatic mode subscription service, or not update the automatic mode subscription service. After the user chooses to update the automatic mode subscription service, the subscription service management unit controls the personal management device 203 to update the automatic mode application, and the device management unit controls the CGM device 200, insulin pump device 20, and personal management device 203 to implement the updated automatic mode.

[0247] For another example, due to changes in local policies and regulations, the launch of more optimized subscription services, certain subscription services failing to achieve the expected results, or users actively canceling subscriptions, backend administrators can disable certain subscription services through the subscription service management system, and the user's personal device will automatically trigger a subscription service indication indicating "**Subscription service disabled." When a subscription service is disabled, the subscription service management unit cancels the subscription service's usage rights, and the CGM device 200, insulin pump device 20, and personal management device 203 are no longer able to use the subscription service.

[0248] In some embodiments of the present invention, a user's subscription service permissions include at least the type of subscription service usage, the duration of the usage, and the user permission level. Users in different regions and with different diabetes types may purchase different types of subscription services. For example, some local regulations strictly protect user privacy and prohibit hospital doctors from using the report and statistics subscription service. Doctors in these regions do not have the permission to purchase the report and statistics subscription service. However, doctors in other regions do allow hospital doctors to use the report and statistics subscription service and have the permission to purchase the report and statistics subscription service.

[0249] In some embodiments of the present invention, the user's usage period includes the start time and end time of the subscription service. Considering that the user cannot be sure whether the purchased subscription service is suitable for him or her, some subscription services are sold to users for a fixed period rather than permanently, such as one week or one month, which can reduce the user's initial purchase cost. The user can fully use the subscription service within the fixed period of the subscription service.

[0250] In some embodiments of the present invention, user permissions can be divided into two or more levels according to the subscription service level purchased by the user. For example, if a user purchases the basic version of the automatic mode subscription service, he or she can use the functions of the basic version of the automatic mode subscription service, and if a user purchases the advanced automatic mode subscription service, he or she can use the functions of the advanced automatic mode subscription service. Compared with the basic version of the automatic mode, the blood glucose monitoring algorithm and insulin infusion algorithm in the advanced automatic mode subscription service are more intelligent, or a dietary large dose optimization algorithm is added, etc., which can provide users with a better quality blood glucose monitoring and insulin infusion experience.

[0251] In some embodiments of the present invention, different subscription service permissions may result in different sales prices for subscription services. For example, a 30-day Basic Edition Automatic Mode subscription service is more expensive than a 7-day Basic Edition Automatic Mode subscription service, and a 30-day Advanced Automatic Mode subscription service is more expensive than a 30-day Basic Edition Automatic Mode subscription service. Of course, the price of a report statistics subscription service and a Basic Edition Automatic Mode subscription service may also be different. The specific sales price can be determined based on a combination of factors such as the market environment, regional policies, R&D costs, and user demand. This is only an example description.

[0252] In some embodiments of the present invention, the usage period of the subscription service sold by the manufacturer may be fixed, such as 3 days, 7 days, 30 days, 180 days or permanent, but the user may often not know how long they will need to use a certain subscription service. Therefore, the usage period of the subscription service may also be not fixed. For example, the subscription service management unit may deduct the balance of the day from the user's account with 1 day as a unit of time, and the user can use the subscription service corresponding to 1 day. The subscription service management unit may even deduct the corresponding balance from the user's account every hour with 1 hour as a unit of time, and the user can use the subscription service corresponding to 1 hour.

[0253] In some embodiments of the present invention, the subscription service management system can also monitor and manage the expiration period of a user's subscribed services in real time. When a user purchases a fixed-term subscription service, they may not remember the expiration date of the subscription service. If the user misses the expiration date and does not continue to purchase the subscription service, the subscription service will be terminated, affecting the user's user experience and, in serious cases, potentially endangering the user's life. Therefore, when the subscription service purchased by the user is about to expire, the subscription service management system will proactively trigger a subscription service indication indicating that the subscription service is about to expire, prompting the user to decide whether to continue purchasing the subscription service. If the user chooses to continue purchasing the subscription service, the subscription service management unit will implement the operation of extending the subscription service period.

[0254] In some embodiments of the present invention, when a subscription service expires, the user chooses not to continue purchasing the subscription service, or the user's account balance is insufficient to renew the subscription service, the subscription service management system will actively trigger a subscription service indication that the subscription service has expired, prompting the user that the subscription service has been discontinued and no further fees will be deducted from the account balance, and the subscription service management unit will implement the operation of canceling the user's subscription service rights.

[0255] In some embodiments of the present invention, a user may purchase a basic automatic mode subscription service. After using the basic automatic mode subscription service for a period of time, they may decide that the treatment effects of the basic automatic mode subscription service do not meet their needs. The user may choose to upgrade to an advanced automatic mode subscription service. Therefore, the user's subscription service permissions are changed. The subscription service management system proactively triggers a subscription service instruction indicating a subscription service permission change. The subscription service management unit controls the personal management device 203 to implement the automatic mode subscription service upgrade operation. Accordingly, the device management unit controls the CGM device 200 and the insulin pump device 20 to implement the advanced automatic mode. Alternatively, if the user changes the subscription service type, such as switching from a purchased dietary bolus subscription service to a combined bolus subscription service, the subscription service management system proactively triggers a subscription service instruction indicating a subscription service change. The subscription service management unit controls the personal management device 203 to cancel the dietary bolus subscription service permission and activate the combined bolus subscription service permission. Alternatively, if the user changes the subscription service usage period, such as if the user has purchased a three-month dietary bolus subscription service and wishes to extend or shorten the period, the subscription service management system proactively triggers a subscription service instruction indicating an extension or shortening of the subscription service period. The subscription service management unit implements the extension or shortening of the subscription service period.

[0256] In some embodiments of the present invention, the APP in the personal management device 203 needs to be updated regularly or irregularly to optimize the APP subscription service functions or resolve some subscription service vulnerabilities (BUGs), thereby providing a better basic framework for the subscription service management system. When the APP is updated, the subscription service management system proactively triggers the subscription service indication of the APP update. The user can choose to view details or update the APP, and the subscription service management unit implements the APP update operation.

[0257] In some embodiments of the present invention, some hardware related to the subscription service also needs to be updated regularly or irregularly. For example, the food image recognition function described above requires a matching imaging module to realize the complete subscription service. As the imaging module becomes unclear or choppy over time, it is necessary to replace it with a new imaging module to obtain a better subscription service experience. When the imaging module needs to be replaced, the subscription service management system actively triggers the subscription service instruction to replace the imaging module to prompt the user that the imaging module needs to be replaced. If the user agrees to replace the imaging module, the subscription service management unit will suspend the permission of the food image recognition function. During this period, the user cannot use the food image recognition function. After the imaging module is replaced, the subscription service management unit will enable the permission of the food image recognition function, and the user can use the food image recognition function again.

[0258] In some embodiments of the present invention, after a user registers a personal account in the APP and logs in to the personal account, the user's account information is recorded in the APP. The user's account information includes at least the user's account status, subscription service status and account balance.

[0259] In some embodiments of the present invention, users may have different account statuses depending on their user roles. For example, a user may use a regular account when acting as a patient, a guardian account when acting as a patient guardian, a clinical user account when acting as a clinical medical trial patient, a trial account when experiencing the CGM device 200 or insulin pump device 20, and a doctor account when acting as a doctor. Different account statuses give users different subscription service permissions. For example, a regular account can purchase and activate all basic subscription services, a guardian account can purchase and activate advanced subscription services or premium subscription services for a regular account, a clinical user account can only use subscription services opened by the hospital for the account, a trial account can only use a few basic subscription services, and a doctor account can be associated with other regular accounts or clinical user accounts to view the subscription service details, insulin infusion data, and blood glucose monitoring data of other accounts. After a user applies for a trial account, experiences the CGM device 200 or insulin pump device 20, and tries out some subscription services, and feels that the CGM device 200 or insulin pump device 20 is effective for their diabetes treatment, they can change the trial account to a regular account to experience more subscription services. When a user changes his account status, the subscription service management system passively triggers an account status change indication, and the subscription service management unit provides the user with available and purchasable subscription services based on the changed account status.

[0260] In some embodiments of the present invention, device manufacturers can provide subscription service trials for users with ordinary accounts. For example, after purchasing or obtaining a CGM device 200, an insulin pump device 20, or a personal management device 203, a user with an ordinary account can experience all or part of the subscription services for free for a period of time, such as 3 days or 7 days. During this period, the user can have access to all or part of the subscription services without having to top up the account balance or purchase a premium account. This allows the user to understand which subscription services are applicable to them and which are not, thereby improving the user experience. After the free trial period, the user needs to top up the account balance or purchase a premium account to continue using the subscription services that are applicable to them.

[0261] In some embodiments of the present invention, a doctor using a doctor account wishes to regularly view the patient user's blood glucose monitoring data and insulin infusion data over the past period of time, as well as statistical analysis of these data. In this case, the doctor will push a "report statistics" subscription service to the patient user and actively trigger an instruction to push the subscription service on the patient user's personal management device 203. The push subscription service instruction may include a link to guide the patient user to subscribe to the report statistics, or prompt the patient user why the patient user needs to subscribe to the service, or prompt the patient user how to subscribe to the service. The patient user may choose to view the push subscription service details or choose to purchase the push subscription service. After the patient user purchases the report statistics subscription service, the subscription service management unit implements an operation to activate the report statistics permission. The patient user or personal doctor may enter the "report statistics" module to view the patient user's blood glucose monitoring data and insulin infusion data over the past period of time, as well as statistical analysis of these data.

[0262] In some embodiments of the present invention, doctors using doctor accounts can also purchase report statistics subscription services and associate the patient user's ordinary account with the doctor account. The ordinary account associated with the doctor account can authorize the sharing of subscription service details, insulin infusion data and blood glucose monitoring data with the doctor for viewing. Users no longer need to spend extra money to purchase report statistics subscription services.

[0263] In some embodiments of the present invention, a user's subscription service permissions can be changed either by the user themselves or by someone else on their behalf. For example, after a user's personal doctor account is linked to their regular account, if the doctor finds that the user's blood sugar is well controlled after reviewing the user's historical insulin infusion and blood glucose monitoring records and no longer needs to review the user's historical insulin infusion and blood glucose monitoring records, the doctor can use the doctor account to disable the report statistics subscription service on the user's behalf, saving the user money.

[0264] In some embodiments of the present invention, users can also view subscription service details in their personal accounts, such as the type of subscription service, the remaining term of the subscription service, the rights of the subscription service, the cost of the subscription service, the usage record of the subscription service, and the history of the subscription service, making it easier for users to understand the usage of the subscription service. Based on the user's viewing operation, the subscription service management system passively triggers a trigger instruction corresponding to the viewed content, such as providing viewing details of the subscription service type, including the subscription service name, usage instructions, precautions, whether there is an advanced or premium version, purchase price, start date and expiration date, etc.

[0265] In some embodiments of the present invention, subscription service statuses include "unpurchased," "in use," and "expired." The "unpurchased" subscription service status includes subscription services that the current account has permission to purchase but has not yet purchased, and subscription services that the current account does not have permission to purchase. The "in use" subscription service status includes subscription services that the current account has purchased and is currently using. The "expired" subscription service status includes subscription services that the current account has purchased but not renewed or canceled. When the subscription service status changes, such as after a user purchases, renews, or cancels some subscription services, the subscription service management system passively triggers an indication of the subscription service status change. The user can view the subscription service status change details according to the indication to fully understand the subscription service status.

[0266] In some embodiments of the present invention, users can also view their account balances in their personal accounts, and their account balances can be used to purchase new subscription services or renew already subscribed services. Users can directly pay for recharges by binding a bank card, credit card, payment software, etc. through the personal management device 203, or fill in the card number and password to recharge after purchasing a recharge card, or purchase a recharge limit through an authenticated third-party channel, obtain a recharge serial number, and then fill in the recharge serial number on the personal management device 203 to increase their account balances, without any restrictions. The user's account balance can be recharged by the user himself or given to the user by others, without any restrictions. When the user's account balance changes, for example, the balance increases after recharging, or the balance decreases after purchasing or renewing a subscription service, the subscription service management system passively triggers a subscription service indication of the account balance change, and the user can view the account balance details or the subscription service details according to the indication.

[0267] In some embodiments of the present invention, when a subscription service with a predetermined period is about to expire, for example, 24 hours or 12 hours before the expiration of the subscription service, the subscription service management system proactively triggers a subscription service expiration renewal indication to prompt the user whether to choose to renew the subscription service. If the user chooses to renew the subscription service, the subscription service management unit deducts the corresponding fee for the subscription service from the account balance and adds a corresponding period to the subscription service. If the user chooses not to renew the subscription service, the subscription service management unit cancels the right to use the subscription service after the subscription service expires.

[0268] In some embodiments of the present invention, the subscription service does not grant the user usage rights by deducting the user account balance regularly or irregularly. Instead, the user opens a premium account for the subscription service and, after a one-time payment, obtains the right to use some or all subscription services. The usage period of these subscription services is consistent with the term of the premium account for the subscription service. When the user cancels the premium account for the subscription service, the corresponding right to use the subscription service is also cancelled.

[0269] In some embodiments of the present invention, users can choose to use subscription services by periodically or irregularly deducting the user account balance and opening a premium account for subscription services. There is no restriction here. For example, device manufacturers can set some subscription services not to be bound to premium accounts. Even if the user opens a premium account, the account balance still needs to be deducted to use these subscription services.

[0270] In some embodiments of the present invention, users can also actively update or replace some software or hardware related to the subscription service. For example, after purchasing the food image recognition function, the user is not satisfied with the clarity of the existing imaging module, and the food image recognition function cannot reach the optimal operating state. The user can replace the imaging module with one with better quality and performance. Based on the user's operation of replacing the imaging module, the subscription service management system passively triggers the subscription service instruction to update the imaging module. During the replacement of the imaging module, the subscription service management unit implements the operation of suspending the permission of the food image recognition function. During this period, the user cannot use the food image recognition function. After the imaging module is replaced, the subscription service management unit implements the operation of enabling the permission of the food image recognition function, and the user can use the food image recognition function again. For another example, after the user purchases the food image recognition function, the algorithm of the food image recognition function module in the APP has not been updated for a long time. As the user's eating habits change, the original food image recognition algorithm may no longer be applicable to the current user, and the user needs to update the food image recognition algorithm. Based on the user's instruction to update the food image recognition algorithm, the subscription service management system passively triggers the subscription service instruction to update the food image recognition algorithm, and guides the user to perform the algorithm update operation. During the update of the food image recognition algorithm, the subscription service management unit implements the operation of suspending the food image recognition function permission. During this period, the user cannot use the food image recognition function. After the food image recognition algorithm is updated, the subscription service management unit implements the operation of enabling the food image recognition function permission, and the user can use the updated food image recognition function.

[0271] Figure 13b Schematic diagram of a subscription service management system including a cloud server in an embodiment of the present invention.

[0272] In some embodiments of the present invention, the subscription service management system may further include a cloud server 204. As previously mentioned, cloud server 204 is a large server located on a public network for storing and computing data. Due to its advantages of fast data processing, large data storage capacity, and good compatibility, it is widely used in data processing systems. Cloud server 204 establishes a communication connection with personal management device 203 via a network (Internet), 5G, Wi-Fi, cellular data, or other means, accesses the subscription service management system, and exchanges data with personal management device 203.

[0273] In some embodiments of the present invention, the cloud server 204 is primarily managed and maintained by a backend administrator. The backend administrator can access the subscription service management system through the cloud server 204 to view, update, and push subscription services. After accessing the subscription service management system, the backend administrator can also track and determine the operating status of the CGM device 200 and the insulin pump device 20 by obtaining the operating data of the device management unit. When the CGM device 200 or the insulin pump device 20 fails, the administrator can promptly detect and alert the user. The backend administrator can also obtain some external data of the user through the user's personal management device 203, such as the user's physical condition, daily habits, living environment, and consumption records.

[0274] In some embodiments of the present invention, a user's external data is acquired through the personal management device 203 and then transmitted to and stored in the cloud server 204. The user or backend administrator can access the cloud server 204 to learn about the external data. The personal management device 203 can analyze and acquire the external data by tracking the user's body movements, device operation records, location trajectory, meal content, cash flow, etc. The user can also actively input the external data into the personal management device 203 and upload it to the cloud server 204.

[0275] In some embodiments of the present invention, after the cloud server 204 is connected to the subscription service management system, it can participate in the management of the subscription service. Some subscription service instructions originate from the cloud server 204. For example, after a doctor issues a treatment opinion for a user and a backend administrator understands external data such as the user's physical condition, daily habits, living environment, and consumption history, the backend administrator can combine this external data to push subscription services applicable to the user to the user. In response to the backend administrator's push on the cloud server 204, the subscription service management system proactively triggers the push of the subscription service instruction. The user can view the details of the pushed subscription service instruction through the personal management device 203 and decide whether to purchase the subscription service. For another example, the cloud server 204 discovers through the personal management device 203 that the user's location has changed to another country or region. These countries or regions may have different regulations governing the operation of the CGM device 200, insulin pump device 20, or personal management device 203, or applicable regulations for subscription services. The cloud server 204 prompts the subscription service management system to proactively trigger a subscription service change instruction to make regulatory adaptation adjustments to the operation of the CGM device 200, insulin pump device 20, or personal management device 203, or to the content of the subscription service. For another example, the cloud server 204 discovers through the personal management device 203 that the user's recent carbohydrate intake is significantly higher, and that the expected blood glucose model in the basic version of the automatic mode subscription service needs to be adjusted, or that the basic version of the automatic mode subscription service needs to be upgraded to an advanced automatic mode subscription service to use a more intelligent insulin infusion algorithm. The cloud server 204 prompts the subscription service management system to actively trigger a subscription service change instruction to adapt to the user's recent increase in carbohydrate intake.

[0276] In some embodiments of the present invention, cloud server 204 may also include large-scale model algorithms or artificial intelligence (AI) to conduct in-depth analysis of user exogenous data to obtain subscription services suitable for the user. For example, the large-scale model algorithm or AI in cloud server 204 may analyze a user's subscription service expenditures and usage over the past year and discover that a user has spent a significant amount on the food image recognition function. However, this user's frequency of use of the food image recognition function is significantly lower than the average frequency of use for all users, and may even have not used the food image recognition function for a long period of time. Therefore, the cloud server 204 recommends that the user reduce their spending on the food image recognition function, such as by reducing the duration of each subscription or increasing the interval between subscriptions. In response to the algorithm or AI recommendation, cloud server 204 prompts the subscription service management system to proactively trigger a subscription service instruction to change the permissions for the food image recognition function, suggesting that the user adjust their subscription method for the food image recognition function to reduce unnecessary user expenses. The user may choose to adjust their subscription method for the food image recognition function as recommended, or not.

[0277] In some embodiments of the present invention, a whitelist may also be provided in the cloud server 204, which records relevant information of users who use the subscription service. For example, after a user purchases and obtains information about a CGM device 200, an insulin pump device 20, and a personal management device 203, and registers an account on the APP, the device codes of the CGM device 200, the insulin pump device 20, and the personal management device 203 are associated with the user's account ID and stored together in the whitelist of the cloud server 204. Only the CGM device 200, the insulin pump device 20, and the personal management device 203 recorded in the whitelist have the authority to trigger subscription service instructions and implement operations corresponding to subscription service instructions. This is to take into account that the subscription service management system may be interfered with by external factors. For example, when the user's personal management device 203 is mistakenly connected to someone else's CGM device 200 or insulin pump device 20, when the user purchases the subscription service through the APP, since the device code of the CGM device 200 or insulin pump device 20 cannot match the device code recorded in the whitelist, the cloud server 204 can prompt the user through the personal management device 203 and trigger the indication of device connection error, so that the user can check whether the CGM device 200 and insulin pump device 20 with which the communication connection has been established are the devices purchased by the user, and re-establish the communication connection between the personal management device 203 and the CGM device 200 and insulin pump device 20. Otherwise, the user cannot successfully purchase the subscription service.

[0278] In some embodiments of the present invention, if a user has purchased a subscription service before establishing a communication connection between the personal management device 203 and the CGM device 200 or insulin pump device 20, but the user's personal management device 203 establishes a communication connection with the wrong CGM device 200 or insulin pump device 20, when the user executes the subscription service, the device code of the CGM device 200 or insulin pump device 20 does not match the device code recorded in the whitelist, and the CGM device 200 or insulin pump device 20 will not be able to perform operations corresponding to the subscription service. The cloud server 204 can prompt the user through the personal management device 203 and trigger an indication of a device connection error, so that the user can check whether the CGM device 200 or insulin pump device 20 with which the communication connection has been established is the device they purchased, and re-establish the communication connection between the personal management device 203 and the CGM device 200 or insulin pump device 20. Otherwise, the user will not be able to successfully use the subscription service, thereby avoiding adverse effects on the user or others. In some embodiments of the present invention, after a user logs in to a personal account in an APP, the user's account ID is bound to the APP or the personal management device 203. The user can only access the subscription service function module through the personal management device 203 bound to the account ID. After the user's account is logged in from other personal management devices 203, the user cannot access the subscription service function module, cannot query or change the user's subscription service permissions, and cannot renew, cancel, or purchase new subscription services. This is to prevent others from maliciously logging into the user's account and performing operations that are detrimental to the user's account. If the user wishes to access the subscription service function module after logging in to the personal account from other personal management devices 203, further verification is required, such as confirming the login on the original personal management device 203, or answering account security questions on other personal management devices 203, etc. The user can obtain temporary access to the subscription service function module on other personal management devices 203 through verification, or change the binding between the personal management device 203 and the account ID.

[0279] In some embodiments of the present invention, only when a user purchases or obtains a CGM device 200, insulin pump device 20, or personal management device 203 through a formal channel will the device manufacturer's personnel record the user's account ID or the device code of the CGM device 200, insulin pump device 20, or personal management device 203 in a whitelist. If the user does not purchase or obtain a CGM device 200, insulin pump device 20, or personal management device 203 through a formal channel, the user's account ID or the device code of the CGM device 200, insulin pump device 20, or personal management device 203 cannot be recorded in the whitelist, and the cloud server 204 will not exchange data with these devices. Therefore, an account ID not recorded in the whitelist cannot access the subscription service function module through the personal management device 203, or an account ID not recorded in the whitelist cannot change subscription service permissions. Moreover, a CGM device 200, insulin pump device 20, or personal management device 203 not recorded in the whitelist cannot trigger a subscription service instruction or perform operations related to the subscription service instruction.

[0280] By setting up a whitelist on the cloud server 204, it is possible to prevent others from maliciously changing the user's subscription service permissions and damaging the user's rights and interests, and to prevent the user from performing incorrect subscription service operations after connecting to the wrong device. It can also restrict users from purchasing and obtaining devices through informal channels, guide users to purchase and obtain devices through formal channels, and safeguard the interests of users and device manufacturers.

[0281] In some embodiments of the present invention, the user may also send some instructions to the subscription service management system to trigger the corresponding subscription service instructions on the personal management device 203 or the cloud server 204. For example, when a user purchases a new CGM device 200, insulin pump device 20, and personal management device 203, they may not know which subscription service is applicable to them. Or, after using the CGM device 200, insulin pump device 20, and personal management device 203 for a period of time, the user may not know whether they should purchase premium subscription services or whether they can turn off some subscription services. Based on this, the user may send instructions to the cloud server 204 through the personal management device 203, so that the cloud server 204 can push subscription service recommendations to the user. In response to the user's instructions, the backend administrator of the cloud server 204, or the large model algorithm or artificial intelligence in the cloud server 204, after obtaining the user's external data, helps the user analyze and obtain applicable subscription services, and then triggers the subscription service indication. The user obtains the subscription service indication through the personal management device 203, and can view the subscription services applicable to the user to add or renew, or close the subscription services that are no longer applicable to the user. The user's addition, renewal or closure of subscription services will trigger the corresponding subscription service indication, which will not be repeated here.

[0282] In some embodiments of the present invention, the cloud server 204 is connected to the subscription service management system not only because of its powerful and fast computing power, but also has a huge storage space, which can store the user's account information, subscription service-related data and device usage data, such as the user's account balance, subscription service purchase record, subscription service list, blood glucose monitoring data, insulin infusion data, device replacement record, etc. in the cloud server 204. When the user wants to obtain this information, he can send a data acquisition instruction to the cloud server 204 through the personal management device 203. In response to the user's instruction, the cloud server 204 retrieves the relevant data and transmits it to the personal management device 203, so that the user can quickly obtain the required data.

[0283] In some embodiments of the present invention, if the subscription service management system frequently and actively triggers subscription service indications, it may affect the user's daily use and reduce the user's experience. Based on this problem, the user can set trigger rules for some subscription service indications that do not need to be processed by the user in a timely manner, and preset the trigger interval time of the subscription service indication, such as 2 hours, 12 hours, or 24 hours, or even an interval of infinite length. The subscription service management system triggers the subscription service indication according to the time interval preset by the user, and does not actively trigger the subscription service indication within the preset time interval. After the preset time interval is reached, the subscription service indications within the time period are postponed and triggered in batches, so that the user can obtain the subscription service indication and avoid omissions. When the user sets an infinite interval for a subscription service, it can be understood that the user does not want the relevant subscription service indications of the subscription service to appear, and the subscription service management system will not trigger the subscription service indications related to the subscription service.

[0284] In some embodiments of the present invention, subscription service indications can be divided into subscription service indications that require timely user processing and subscription service indications that do not require timely user processing based on their processing urgency. Subscription service indications that do not require timely user processing include, but are not limited to, push subscription service indications, update subscription service indications, close subscription service indications, subscription service expiration indications, subscription service expiration indications, subscription service permission change indications, software (hardware) update indications, account information indications, etc. When such subscription service information or status changes, the triggering of the relevant subscription service indications can be delayed without affecting the user's normal use of the subscription service functions. Of course, if the user needs to pay special attention to certain subscription service indications, such as subscription service permission change indications, these subscription service indications that do not require timely processing by the user can also be changed to subscription service indications that require timely processing by the user. When the subscription service management system triggers a subscription service indication that requires timely processing by the user, it can not postpone the trigger according to the trigger interval set by the user, but trigger in real time to prompt the user to handle it in time. For example, when activating the device subscription service, during the process of activating the CGM device 200 and the insulin pump device 20, the user needs to pay attention to whether the device establishes a communication connection, whether the device establishing the communication connection is correct, whether the device is activated, and whether the device works normally after activation. Therefore, the activation device subscription service indication needs to be triggered in time and does not belong to the subscription service indication triggered according to the preset time interval.

[0285] In some embodiments of the present invention, if a user wishes the subscription service management system to trigger certain subscription service indications, the user may issue instructions to the subscription service management system. In response to the user's instructions, the subscription service management system may trigger the corresponding subscription service indications in real time without waiting for a preset time interval.

[0286] In some embodiments of the present invention, the user can set a unified trigger time interval for all subscription service indications to simplify user operations. The user can also set an independent trigger preset time interval for certain subscription services that need to be focused on. For example, the user may need to focus on the report statistics subscription service, but not on other subscription services. The user can set the trigger preset time interval for other subscription services to 12 hours, and set the trigger preset time interval for the report statistics subscription service that needs to be focused on to 2 hours. In this way, the report statistics subscription service is triggered more frequently, and the user can understand the blood glucose monitoring data and insulin infusion data more intensively. The above preset time intervals are only described as examples, and users can set them according to actual needs.

[0287] In some embodiments of the present invention, after purchasing certain subscription services with time limits, users need to regularly monitor the expiration dates of these subscription services and promptly decide whether to renew. Otherwise, the subscription services may be closed upon expiration, or not automatically renewed upon expiration, impacting the user's user experience and, in serious cases, even their physical health. Therefore, the subscription service management system needs to promptly remind users of expiring subscription services and proactively trigger expiration indications. Once the number of subscription services purchased by a user increases, these expiration indications will become too frequent, potentially impacting the user's daily use and reducing their user experience. To address this issue, the subscription service management system needs to adaptively and intelligently adjust the subscription indication triggering interval. It can adjust the interval for triggering the subscription service expiration indication based on the subscription service expiration date. For example, if a user purchases the food image recognition feature, which is valid for 30 days, the subscription service management system will not actively trigger the subscription service expiration indication for the first 23 days of using the feature. It will then actively trigger the subscription service expiration indication once seven days and three days before the subscription service expires. It will also actively trigger the subscription service expiration indication once every 12 hours two days before the subscription service expires, once every three hours one day before the subscription service expires, and once every one hour on the day the subscription service expires. The above time intervals are for illustrative purposes only, and users can adjust them based on their preferences. Regardless of the time remaining until the subscription service expiration date, once the user decides to renew or not renew the subscription service, the subscription service expiration indication will be canceled and will no longer be triggered until the next renewal period of the subscription service is about to expire, or the user repurchases the subscription service and the expiration period is about to expire. If the user is unsure whether to renew the subscription service, the subscription service management system will proactively trigger an indication of expiration of the subscription service when the subscription service expires, prompting the user that the subscription service has expired and allowing the user to decide whether to continue purchasing. If the user still cannot decide whether to renew the subscription service, the subscription service management system will increase the time interval for proactively triggering the indication of expiration as the time approaches the expiration date. For example, on the day the subscription service expires, the subscription service expiration indication will be proactively triggered every hour. One day after the subscription service expires, the subscription service expiration indication will be proactively triggered every three hours. Two days after the subscription service expires, the subscription service expiration indication will be proactively triggered every twelve hours. Three days and seven days after the subscription service expires, the subscription service expiration indication will be proactively triggered each time. After seven days from the subscription service expiration, the subscription service expiration indication will no longer be proactively triggered.

[0288] In some embodiments of the present invention, since the device management unit continuously monitors the operating status of the CGM device 200, the insulin pump device 20 and the personal management device 203, the subscription service management system can also adjust the triggering of the subscription service indication according to the operating status of the device to optimize the triggering time interval of the subscription service indication and improve the user experience.

[0289] In some embodiments of the present invention, when the CGM device 200, insulin pump device 20, or personal management device 203 is detected and determined by the device management unit to be out of service due to a malfunction, power outage, or poor communication, the subscription service management system will not trigger a subscription service instruction related to the CGM device 200, insulin pump device 20, or personal management device 203, but will prompt the user to resolve the issue of the CGM device 200, insulin pump device 20, or personal management device 203 being out of service. For example, if the CGM device is experiencing poor communication with the insulin pump device 20, or personal management device 203, and the user wishes to purchase an automatic mode subscription service, the subscription service management unit will not trigger an instruction to purchase the automatic mode subscription service, and the user will not be able to enter the automatic mode purchase process. At the same time, the subscription service management system will prompt the user to first resolve the poor communication issue between the CGM device, insulin pump device 20, and personal management device 203 before purchasing the automatic mode subscription service. This can avoid the problem of users purchasing a subscription service but not being able to use it, thereby improving the user experience.

[0290] In some embodiments of the present invention, if the CGM device 200, insulin pump device 20, or personal management device 203 itself is functioning normally and communicating well, and the device management unit determines that the CGM device 200, insulin pump device 20, or personal management device 203 is in a dormant or low-power state, or if the device management unit determines based on external user data that the user is sleeping or exercising, and is unable to promptly process subscription service instructions, the subscription service management system may increase the triggering interval for subscription service instructions during this period, for example, from the user's preset 12-hour interval to 13 hours, 18 hours, or 24 hours, etc. Subscription service instructions that should have been triggered within the original preset interval will need to wait until the extended interval expires before being collectively triggered, thereby reducing the disruption to the user by the subscription service management system and improving the user experience. When the device management unit detects that the CGM device 200, insulin pump device 20, or personal management device 203 exits the dormant or low-power state, or determines that the user has finished sleeping or exercising, the subscription service management system will immediately collectively trigger the subscription service instructions that were not triggered during the extended period, allowing the user to obtain subscription service instructions and avoid missing them. During the time extension period, if the user issues a subscription service-related instruction to the subscription service management system, the subscription service management system triggers the subscription service indication in a timely manner in response to the instruction.

[0291] In some embodiments of the present invention, when the device management unit determines that the CGM device 200, insulin pump device 20, or personal management device 203 is in normal working order, the subscription service management system triggers a subscription service indication at a user-preset time interval. If the user issues a subscription service-related instruction to the subscription service management system, the subscription service management system promptly triggers the subscription service indication in response to the instruction.

[0292] In some embodiments of the present invention, the personal management device 203 also includes a user interaction unit, such as a touch screen display, an optical interaction element, an acoustic interaction element, a motion interaction element, etc. The user interaction unit can prompt the user with a subscription service indication, and the user can also respond to the subscription service indication through the user interaction unit, or send instructions to the subscription service management system. For example, when the user interaction unit is a touch screen display, the subscription service indication is displayed as a pop-up window or icon on the screen. The user can directly click with a finger, or slide the pop-up window or icon on the screen to respond to the subscription service indication. The user's response operation includes confirming, canceling, viewing or ignoring the subscription service indication. Different clicks and different sliding actions of the user on the touch screen correspond to different response operations, which can be customized by the user. For another example, when the user interaction unit is a motion interaction element, the motion interaction element includes a vibration motor and a motion sensor. When the subscription service management system triggers a subscription service indication, the vibration generated by the vibration motor prompts the user of the subscription service indication. Different vibration frequencies, vibration durations, vibration intervals, and their combinations correspond to different subscription service indications. The user can respond to the subscription service indication through body movements. The motion sensor senses the user's body movements, such as shaking hands, jumping, waving arms, turning in circles, etc. Different body movements or combinations of body movements correspond to different response operations, which can be customized by the user. For another example, when the user interaction unit is an acoustic interaction element, the subscription service indication is transmitted to the user through different music or simulated human voices, and the user can respond to the subscription service indication through different voice motion commands. For another example, when the user interaction unit is an optical interactive element, including a light source, a light sensor, or a camera, the subscription service indication is conveyed to the user through the color, duration, and interval of light emitted by the light source. The user can respond to the subscription service indication by blocking the duration and interval of natural light shining on the light sensor. Alternatively, the user can make different facial expressions towards the camera, such as blinking, opening the mouth, frowning, etc., to respond to different subscription service indications. The above description is merely an example, and the specific implementation is not limited here.

[0293] In some embodiments of the present invention, the user interaction unit can also be a combination of multiple elements, such as a combination of a touch screen and a motion interaction element. The subscription service indication is displayed through a pop-up window or icon on the touch screen, and the user can respond to the subscription service indication through body movements, which is consistent with the effect of the user clicking or sliding on the touch screen. The user can also click or slide on the touch screen to respond to the subscription service indication without using body movements. Of course, there can also be other combinations of elements to form the user interaction unit, such as a combination of a touch screen and an acoustic interaction element, or a combination of an acoustic interaction element and a motion interaction element, which are not limited here.

[0294] In some embodiments of the present invention, after a user responds to a subscription service instruction, the subscription service management unit and the device management unit may still require a confirmation response from the user before they begin implementing operations corresponding to the subscription service. For example, after a user purchases a premium automatic mode subscription service, before the app begins upgrading to automatic mode, the personal management device 203 prompts the user to confirm whether to upgrade to automatic mode. The user must confirm the upgrade before the app can begin upgrading to automatic mode, and the subscription service management system deducts the fee required for the upgrade. This is to prevent users from making mistakes and purchasing unnecessary subscription services, thereby harming their interests.

[0295] In some embodiments of the present invention, the personal management device 203 further includes a storage unit for storing information related to subscription services, such as user account information, purchased subscription services, subscription service purchase records, consumption records of purchased subscription services, a list of purchasable subscription services, a list of upgradeable subscription services, detailed descriptions of subscription services, and subscription service precautions. Users can quickly access this information on the personal management device 203, allowing them to fully understand the subscription services without having to connect to the internet. When the personal management device 203 is connected to the internet, the subscription service-related information can be automatically updated and stored in the storage unit, overwriting or not overwriting the old subscription service-related information.

[0296] In some embodiments of the present invention, some subscription services require supporting software or hardware to achieve their intended functions. For example, the food image recognition function requires the support of a supporting camera module (hardware) and a food image recognition algorithm (software). After a user purchases the food image recognition subscription service, if the personal management device 203 does not have a camera module, the user must purchase an additional camera module and connect the personal management device 203 to the Internet to download the food image recognition algorithm in order to properly use the food image recognition function.

[0297] In other embodiments of the present invention, the software or hardware supporting the subscription service is pre-installed on the CGM device 200, insulin pump device 20, or personal management device 203. For example, when a user purchases the CGM device 200, insulin pump device 20, and personal management device 203, the food image recognition algorithm is already stored in the personal management device 203, and the personal management device 203 also has a built-in camera module. Before purchasing the food image recognition function, the user does not have permission to use the food image recognition algorithm and camera module. Only after purchasing the food image recognition function will the subscription service management system grant the user permission to use the food image recognition algorithm and camera module, and the device management unit will enable the camera module's capture function.

[0298] In some embodiments of the present invention, since some subscription services are related to the life and health of users, and affect the process and effect of users' diabetes treatment to a certain extent, it is also possible to consider classifying the types of subscription services used according to the degree of their impact on the user's treatment. For example, subscription services such as activation equipment, report statistics, and event records are classified as first-category services. This type of service has little impact on the user's physical health and treatment effect, and can be purchased and activated by the user without the need for doctors or manufacturers to give advice or permission. Subscription services such as basic version automatic mode, normal large dose, temporary basal amount, etc. are classified as second-category services. This type of service has a certain impact on the user's physical health and treatment effect, and is a commonly used or indispensable subscription service when the user uses a closed-loop artificial pancreas. The user needs to obtain advice from a doctor or manufacturer before purchasing and activating it on his own. If necessary, the user is also required to provide a certificate of advice from a doctor or manufacturer. Subscription services such as food image recognition, extended bolus, combined bolus, and preset bolus are classified as Category 3 services. These services have a significant impact on the user's health and treatment outcomes, and are optional when using a closed-loop human pancreas. Only doctors or manufacturer personnel have the authority to activate Category 3 services, and this requires a doctor or manufacturer's personnel to grant the user permission before the user can purchase and activate them. Alternatively, after the user purchases, a doctor or manufacturer's personnel will be required to activate the service on the user's behalf. This prevents users from activating unnecessary subscription services or services that may adversely affect the treatment process and outcomes, thereby protecting the user's interests and health.

[0299] In the above embodiment, the classification of each subscription service may be determined by local doctors or manufacturer personnel, because it is also necessary to consider that different subscription services may have significantly different therapeutic effects on different populations, and that the supervision and regulations for subscription services may vary from region to region. Therefore, the classification of subscription services in the above embodiment is only described as an example.

[0300] Figure 13cA schematic diagram of a subscription service management system including security devices according to an embodiment of the present invention.

[0301] Reference Figure 13c In some embodiments of the present invention, the subscription service management system may further include a security device 205. The security device 205 is a secure component independent of the CGM device 200, insulin pump device 20, and personal management device 203 and may be an electronic watch, wristband, secure physical key, or the like. The security device 205 can establish a wireless or wired communication connection with the CGM device 200, insulin pump device 20, and personal management device 203, such as a short-range Bluetooth connection, a local area network, or a wired connection via a cable or optical cable. However, the security device 205 does not exchange data with external devices, such as the cloud server 204, to ensure the communication independence of the security device 205. The communication connection between the security device 205 and the CGM device 200, insulin pump device 20, and personal management device 203 can be instantaneous; the security device 205 does not establish a communication connection with any other device. Before the subscription service management system performs operations related to the subscription service indication, the user must first establish a communication connection between the security device 205 and the CGM device 200, insulin pump device 20, and personal management device 203.

[0302] In general, the security device 205 establishes a wireless communication connection with the CGM device 200, the insulin pump device 20 and the personal management device 203, which can reduce the user's operation steps and provide convenience for the user.

[0303] In some embodiments of the present invention, after the security device 205 establishes a communication connection with the personal management device 203 and the subscription service management system triggers a subscription service indication, confirmation from the security device 205 is still required before the subscription service management unit and the device management unit can perform operations corresponding to the subscription service. For example, after a user purchases the premium automatic mode subscription service, the APP must also receive a confirmation instruction from the security device 205 before it can begin upgrading to the basic automatic mode. Only after the personal management device 203 receives the instruction from the security device 205 can the APP begin upgrading to the automatic mode. Alternatively, after a user cancels the food image recognition function, confirmation from the security device 205 is still required before the subscription service management unit can cancel the user's permission to use the food image recognition function.

[0304] In some embodiments of the present invention, the confirmation instruction of the security device 205 may come from the user or may be automatically generated by the security device 205. For example, after the user receives the subscription service instruction and confirms it on the personal management device 203, the user still needs to confirm it again through the security device 205. For another example, after the personal management device 203 and the security device 205 establish short-range communication, the personal management device 203 will automatically generate first encrypted information at regular intervals, and the security device 205 will automatically generate second encrypted information at the same time. The first encrypted information matches the second encrypted information. When the subscription service management system triggers the subscription service indication, the subscription service indication data carries the first encrypted information. At the same time, the personal management device 203 sends a confirmation instruction inquiry to the security device 205. The user sends the second encrypted information to the personal management device 203 through the security device 205. Only after the personal management device 203 receives the second encrypted information from the security device 205 and the second encrypted information is successfully paired with the first encrypted information in the personal management device 203, can the subscription service management unit and the device management unit implement operations corresponding to the subscription service. This can prevent others from maliciously invading the subscription service management system, changing the user's subscription service permissions and confirming the subscription service indication on the personal management device 203 on behalf of the user, thereby damaging the user's interests and even threatening the user's treatment process and physical health. When someone maliciously invades the subscription service management system and triggers the subscription service indication, since the security device is not connected to the external network, others cannot know the second encrypted information paired with the first encrypted information, and cannot perform operations corresponding to the subscription service. This greatly improves the security of the subscription service management system.

[0305] In some embodiments of the present invention, the first encrypted information and the second encrypted information may be pairing information automatically generated by the personal management device 203 and the security device 205, respectively, or may be pairing information set by the user on the personal management device 203 and the security device 205, respectively, such as questions and answers, numbers with certain logic, letter arrangements, etc.

[0306] In other embodiments of the present invention, since the security device 205, the CGM device 200 or the insulin pump device 20 can establish a wireless communication connection with the personal management device 203, the first encrypted information and the second encrypted information can be transmitted to the CGM device 200 or the insulin pump device 20 through the personal management device 203. The pairing of the first encrypted information and the second encrypted information can be completed on the personal management device 203, or on the security device 205, the CGM device 200 or the insulin pump device 20, which is not limited here.

[0307] In summary, the present invention discloses a subscription service management system for on-body functional devices, including on-body functional devices and personal management devices. The personal management device includes a subscription service management unit and a device management unit. When the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication. The functional services of the device are no longer bundled with the device for sale, which reduces the user's initial costs. In addition, the user can choose applicable subscription services according to their own needs. Device manufacturers can also better understand user needs, provide users with richer subscription service options, improve user experience, and optimize the costs of both supply and demand parties. When the user uses the subscription service, the subscription service management system provides a subscription service indication and implements operations related to the subscription service to avoid the user from falling into blind operation. At the same time, it can also guide the user to use the subscription service and improve the user experience.

[0308] 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 subscription service management system for on-body functional devices, characterized in that: include: An on-body functional device, the on-body functional device comprising an insulin infusion module and / or a blood glucose monitoring module, the insulin infusion module being configured to perform an insulin infusion function, the blood glucose monitoring module being configured to perform a blood glucose monitoring function; and a personal management device, the personal management device being wirelessly connected to the on-body functional device, the personal management device comprising a subscription service management unit and a device management unit, the subscription service management unit being configured to manage the subscription service; The device management unit is used to manage the operating status of the on-body functional device and the personal management device; The subscription service is at least a service related to the insulin infusion function or the blood glucose monitoring function that the user can choose to activate; When the subscription service management system triggers a subscription service indication, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication.

2. The subscription service management system according to claim 1, characterized in that: The triggering of the subscription service indication includes active triggering and passive triggering.

3. The subscription service management system according to claim 2, characterized in that: The active trigger indication includes at least: ① The functional device on the body is activated or stopped; ② Push, update or close the subscription service; ③The subscription service is about to expire or has expired; ④Changes in the user's subscription service permissions; ⑤ Software or hardware updates related to the subscription service; ⑥User’s account information indication; The passive trigger indication includes at least: ①Users query or change the subscription services; ② The user queries or changes the account information; ③ The User updates the software or hardware related to the Subscription Service.

4. The subscription service management system according to claim 3, characterized in that: The subscription service rights include at least the usage type, usage period and user permission level of the subscription service.

5. The subscription service management system according to claim 3, characterized in that: The account information includes at least account status, subscription service status and account balance.

6. The subscription service management system according to claim 5, characterized in that: The account status includes at least a general user account status, a clinical user account status, a guardian account status, a trial account status and a doctor account status.

7. The subscription service management system according to claim 5, characterized in that: The account information indication includes at least the account status change, the subscription service status change, the account balance change, and insufficient account balance.

8. The subscription service management system according to claim 7, characterized in that: The subscription service status change includes purchasing, renewing and canceling the subscription service.

9. The subscription service management system according to claim 3, characterized in that: The subscription service management system further includes a cloud server, the personal management device is in communication with the cloud server, and the subscription service indication is at least derived from the cloud server.

10. The subscription service management system according to claim 9, characterized in that: The cloud server stores exogenous data, and the subscription service indication is triggered based on the exogenous data. The exogenous data at least includes the doctor's treatment opinion on the user, the user's physical condition, daily habits, living environment and consumption records.

11. The subscription service management system according to claim 10, wherein: The cloud server analyzes the external data in combination with an algorithm or artificial intelligence, obtains the subscription service applicable to the user and triggers the subscription service indication.

12. The subscription service management system according to claim 9, wherein: The cloud server is managed and operated by a backend administrator, and the backend administrator triggers the subscription service instruction through the cloud server.

13. The subscription service management system according to claim 9, characterized in that: A whitelist is set in the cloud server, and the whitelist records information related to the on-body functional device and the personal management device.

14. The subscription service management system according to claim 13, wherein: Only the on-body function devices and the personal management devices recorded in the whitelist can perform operations corresponding to the subscription service indication.

15. The subscription service management system according to claim 13, wherein: Only users recorded in the whitelist can query or change the subscription service permissions.

16. The subscription service management system according to claim 9, wherein: The user sends an instruction for subscribing to the service to the personal management device or the cloud server. In response to the instruction of the user, the personal management device or the cloud server triggers the subscription service indication.

17. The subscription service management system according to claim 9, wherein: Data related to the subscription service is stored in the cloud server.

18. The subscription service management system according to claim 1, wherein: The subscription service indication is triggered based on a preset rule, where the preset rule includes: ① triggering the subscription service indication according to a preset time interval, and not triggering the subscription service indication within the preset time interval; ② Adjust the time interval for triggering the subscription service indication according to the expiration date of the subscription service.

19. The subscription service management system according to claim 18, wherein: The closer to the expiration date of the subscription service, the shorter the time interval for triggering the subscription service indication.

20. The subscription service management system according to claim 18, wherein: Further based on the operating status of the on-body function device and the personal management device, the subscription service management system triggers the subscription service indication: ① When the on-body functional device or the personal management device stops being used, the subscription service indication is not triggered; ② When the on-body function device or the personal management device is in a dormant state, increasing the time interval for triggering the subscription service indication; ③ When the on-body functional device or the personal management device is in working state, the subscription service indication is triggered according to the preset time interval.

21. The subscription service management system according to claim 1, wherein: The personal management device further includes a user interaction unit, which is configured to at least prompt the user with the subscription service indication, and the user interacts with the user interaction unit to respond to the subscription service indication.

22. The subscription service management system according to claim 21, wherein: The prompt of the user interaction unit includes image display, vibration, sound or optical prompt.

23. The subscription service management system according to claim 21, wherein: The user's response to the user interaction unit includes confirming, canceling, viewing or ignoring the subscription service indication.

24. The subscription service management system according to claim 21, wherein: The user's response to the user interaction unit includes at least body movements, facial expressions or voice movements.

25. The subscription service management system according to claim 21, wherein: Before the subscription service management unit and the device management unit implement the operation corresponding to the subscription service indication, a confirmation response from the user is required.

26. The subscription service management system according to claim 1, wherein: The personal management device further includes a storage unit in which data related to the subscription service is stored.

27. The subscription service management system according to claim 1, wherein: The on-body function device and the personal management device also include software or hardware related to the subscription service.

28. The subscription service management system according to claim 27, wherein: The software or hardware related to the subscription service is pre-installed in the on-body function device or the personal management device when leaving the factory.

29. The subscription service management system according to claim 27, wherein: Software or hardware related to the subscription service is installed in the on-body function device or the personal management device when the subscription service is used.

30. The subscription service management system according to claim 1, wherein: The subscription service includes at least the first category of services, the second category of services and the third category of services. The first category of services are services that users can activate on their own without the need for doctor's confirmation. The second category of services are services that users can choose to activate only after doctor's confirmation. The third category of services are services that doctors have the authority to activate but users do not have the authority to activate.

31. The subscription service management system according to claim 1, wherein: The subscription service includes basic services and advanced services related to the insulin infusion function or the blood glucose monitoring function.

32. The subscription service management system according to claim 1, wherein: It also includes a security device, which is communicatively connected to the on-body functional device and the personal management device. Before the subscription service management unit and the device management unit implement operations corresponding to the subscription service instructions, they need to be confirmed by the security device.

33. The subscription service management system according to claim 32, wherein: The subscription service indication includes first encryption information, and the security device includes second encryption information paired with the first encryption information. Only after the first encryption information and the second encryption information are successfully paired, the subscription service management unit and the device management unit implement operations corresponding to the subscription service indication.

34. The subscription service management system according to claim 33, wherein: The first encrypted information and the second encrypted information are paired on the security device, the on-body functional device, or the personal management device.

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