Closed-loop artificial pancreas system for safe infusion

Abstract

The invention discloses a safe infusion closed-loop artificial pancreas system which can continuously calculate the insulin infusion amount required by a patient based on a historical blood glucose value and a fingertip blood glucose value during the long-time loss period of real-time blood glucose value data and infuse a proper amount of insulin for the patient. Infusion of inappropriate insulin and even interruption of insulin infusion due to lack of real-time blood glucose value data are avoided, life danger of a patient is avoided, and treatment of the patient is facilitated.

Description

Safe infusion closed-loop artificial pancreas system Technical Field

[0001] The present invention relates generally to the field of diabetes monitoring and management, and in particular to a closed-loop artificial pancreas system with safe infusion. Background Art

[0002] In a healthy individual, the pancreas automatically monitors blood glucose levels and secretes the necessary insulin and glucagon. However, in diabetics, the pancreas malfunctions, preventing it from producing the necessary insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; the only approach is to control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to monitor their blood sugar before injecting insulin. Currently, most monitoring methods use internal blood sugar monitoring devices to continuously monitor blood sugar. These devices use disposable transcutaneous sensors inserted into the skin to measure blood sugar concentrations in the interstitial fluid and transmit the data in real time to an external device via a transmitter for easy viewing by the patient. This monitoring method is called continuous glucose monitoring (CGM).

[0004] When providing auxiliary treatment for diabetic patients, a closed-loop artificial pancreas system is a better choice. The closed-loop artificial pancreas system can not only monitor blood glucose in real time, but also automatically calculate and infuse insulin based on the real-time blood glucose monitoring data, which provides great convenience for the patient's diabetes treatment. However, in actual use, the closed-loop artificial pancreas system may not be able to receive real-time blood glucose monitoring signals for a period of time due to reasons such as unstable signals and sensor damage. In this usage scenario, the closed-loop artificial pancreas system in the prior art often adopts the method of reducing the fixed proportion of insulin infusion or suspending insulin infusion to pass this period. These methods cannot meet the patient's diabetes treatment needs and may even put the patient's life in danger.

[0005] Therefore, the existing technology urgently needs a closed-loop artificial pancreas system that can carry out safe insulin infusion during the absence of real-time blood glucose monitoring signals.

[0006] Summary of the Invention

[0007] The present invention discloses a closed-loop artificial pancreas system with safe infusion. During a long period of missing real-time blood glucose value data, the closed-loop artificial pancreas system can enter a learning mode or a safe mode, continue to calculate the insulin infusion amount required by the patient based on historical blood glucose values ​​and fingertip blood glucose values, and infuse an appropriate amount of insulin to the patient. The system will not infuse an inappropriate amount of insulin or even interrupt the insulin infusion due to the lack of real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and benefiting the patient's treatment.

[0008] An embodiment of the present invention discloses a closed-loop artificial pancreas system, comprising a detection module for monitoring real-time blood glucose values; a program module for receiving real-time blood glucose values ​​from the monitoring module and calculating an insulin infusion amount based on the real-time blood glucose values; and an infusion module for implementing insulin infusion. When the program module fails to receive real-time blood glucose values ​​for a first period of time, the closed-loop artificial pancreas system switches from a first mode to a second mode for a second period of time. In the second mode, the closed-loop artificial pancreas system calculates an estimated blood glucose value, calculates an estimated insulin infusion amount based on the estimated blood glucose value, and completes insulin infusion based on the estimated insulin infusion amount.

[0009] According to one aspect of the present invention, the estimated blood glucose level is calculated based on the real-time blood glucose level over the last period of time.

[0010] According to one aspect of the present invention, the method further includes providing a fingertip blood glucose value, and the estimated blood glucose value is further calculated based on the fingertip blood glucose value.

[0011] According to one aspect of the present invention, when the estimated blood glucose level is calculated based on the fingertip blood glucose level, the second period of time may be extended.

[0012] According to one aspect of the present invention, a preset blood glucose threshold is further included. Based on the comparison between the fingertip blood glucose value and the blood glucose threshold, the closed-loop artificial pancreas system adopts different infusion strategies.

[0013] According to one aspect of the invention, the infusion strategy includes infusion of a correction bolus, reduction of insulin infusion, and suspension of insulin infusion.

[0014] According to one aspect of the present invention, if a meal is consumed during the second period, at least one pre-meal fingertip blood glucose value and at least one post-meal fingertip blood glucose value are provided, and the pre-meal dietary bolus is calculated based on the pre-meal fingertip blood glucose value, and the post-meal dietary bolus is calculated based on the post-meal fingertip blood glucose value.

[0015] According to one aspect of the present invention, the pre-meal fingertip blood glucose value is provided 0 to 20 minutes before the meal, and the post-meal fingertip blood glucose value is provided 0 to 150 minutes after the meal.

[0016] According to one aspect of the present invention, the calculation of the estimated blood glucose value data and the estimated insulin infusion amount data may be repeated during the second period of time.

[0017] According to one aspect of the present invention, after the second period of time ends, if the program module still does not receive the real-time blood glucose value, the closed-loop artificial pancreas system switches to the third mode for a third period of time.

[0018] According to one aspect of the present invention, in the third mode, the insulin infusion amount is 0 to 30% of the estimated insulin infusion amount.

[0019] According to one aspect of the present invention, in the third mode, the insulin infusion amount is 0-10% of the estimated insulin infusion amount.

[0020] According to one aspect of the present invention, the third period of time is 0 to 48 hours.

[0021] According to one aspect of the present invention, the first period of time is 0 to 24 hours.

[0022] According to one aspect of the present invention, the second period of time is 0 to 48 hours.

[0023] According to one aspect of the present invention, when the closed-loop artificial pancreas system is in the second mode or the third mode, if the program module resumes receiving the real-time blood glucose value, the closed-loop artificial pancreas system switches to the first mode.

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

[0025] The closed-loop artificial pancreas system with safe infusion disclosed by the present invention can continue to calculate the estimated insulin infusion amount required by the patient based on historical blood glucose values ​​and fingertip blood glucose values ​​during a long period of missing real-time blood glucose value data, and infuse the patient with an appropriate amount of insulin. It will not infuse an inappropriate amount of insulin or even interrupt the insulin infusion due to the lack of real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and benefiting the patient's treatment.

[0026] Furthermore, after inputting the fingertip blood glucose value, the duration of the learning mode can be extended, providing the patient with more time to resume receiving the real-time blood glucose value without affecting the patient's blood glucose control, which is beneficial to the patient's treatment.

[0027] Furthermore, a blood glucose threshold is preset in the closed-loop artificial pancreas system, and the input fingertip blood glucose value is compared with the blood glucose threshold. Different insulin infusion strategies are implemented according to the comparison results. The infusion strategies include infusing a correction large dose, reducing insulin infusion, and suspending insulin infusion, which can optimize blood glucose control and benefit the patient's treatment.

[0028] Furthermore, an insulin infusion plan for meals during the learning mode is provided. When meals are taken during the period when real-time blood sugar values ​​are missing, the closed-loop artificial pancreas system can also infuse the patient with an appropriate amount of insulin to avoid high blood sugar levels that affect the patient's health, thus benefiting the patient's treatment.

[0029] Furthermore, when the learning mode lasts for a long time, the closed-loop artificial pancreas system will enter the safe mode. After the real-time blood glucose value is missing for a long time, the estimated blood glucose value may deviate from the actual blood glucose value and become uncontrollable. When the deviation is too large, the estimated insulin amount calculated based on the estimated blood glucose value will not be suitable for the patient. Too much or too little estimated insulin amount may have adverse effects on the patient. After entering the safe mode, the closed-loop artificial pancreas system infuses insulin to the patient according to a predetermined ratio to ensure basic blood glucose control, which is beneficial to the patient's treatment.

[0030] Furthermore, regardless of whether the closed-loop artificial pancreas system is currently in learning mode or safety mode, once it resumes receiving real-time blood glucose values, it will enter normal closed-loop mode. In closed-loop mode, the closed-loop artificial pancreas system can provide more accurate blood glucose monitoring and insulin infusion. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system;

[0032] FIG2 is a schematic structural diagram of an integrated CGM according to an embodiment of the present invention;

[0033] FIG3 is a schematic structural diagram of a split-type CGM according to an embodiment of the present invention;

[0034] FIG4 a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention;

[0035] FIG4 b is a schematic structural diagram of a split-type insulin pump according to an embodiment of the present invention;

[0036] 5a-5d are schematic diagrams of the operating environment of existing blood glucose management and insulin infusion management systems;

[0037] 6 is a schematic diagram of an operating environment of a management system for blood glucose management and insulin infusion according to an embodiment of the present invention;

[0038] 7 is a schematic diagram of an operating environment of a blood glucose management and insulin infusion management system according to another embodiment of the present invention;

[0039] FIG8 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention;

[0040] Figures 9a and 9b are schematic diagrams of interfaces when an APP is in the foreground according to an embodiment of the present invention;

[0041] Figures 9c and 9d are schematic diagrams of interfaces of an APP in the background according to an embodiment of the present invention;

[0042] FIG10 is a schematic diagram of a safe infusion process of a closed-loop artificial pancreas system according to an embodiment of the present invention. DETAILED DESCRIPTION

[0043] As mentioned above, when real-time blood glucose values ​​are missing for a long time, existing closed-loop artificial pancreas systems often reduce the insulin infusion volume by a fixed ratio or suspend insulin infusion to pass this period. These methods cannot meet the patient's diabetes treatment needs and may even put the patient's life in danger.

[0044] To address this problem, an embodiment of the present invention discloses a closed-loop artificial pancreas system with safe infusion. During a long period of missing real-time blood glucose value data, the closed-loop artificial pancreas system can enter a learning mode or a safe mode, continue to calculate the insulin infusion amount required by the patient based on historical blood glucose values ​​and fingertip blood glucose values, and infuse the patient with an appropriate amount of insulin. The system will not infuse an inappropriate amount of insulin or even interrupt the insulin infusion due to the lack of real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and benefiting the patient's treatment.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system.

[0050] 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 .

[0051] The detection module 100 is used to continuously monitor the patient's current blood glucose level. Typically, the detection module 100 is a continuous glucose monitoring (CGM), which can detect the patient's current blood glucose level in real time, monitor blood glucose changes, and transmit the current blood glucose information to the program module 101. The CGM includes an implantable sensor connected to a transmitter. The transmitter also includes a memory, a processor, a communication interface, etc. The transmitter is used to transmit at least the blood glucose data monitored by the CGM and the CGM identifier information.

[0052] Infusion module 102 includes the necessary mechanical structures and electronic control unit for insulin infusion, such as a drug reservoir, a drive mechanism, an infusion line and needle, a power supply, and a circuit board. It is controlled by program module 101. Typically, infusion module 102 is an insulin pump, and the electronic control unit includes a memory, a processor, and a communication interface. Based on the current insulin infusion volume data transmitted by program module 101, infusion module 102 infuses the patient's body with the currently required insulin. Simultaneously, the infusion status of infusion module 102 is also fed back to program module 101 in real time.

[0053] The program module 101 is used to control the operation of the detection module 100 and the infusion module 102. Therefore, the program module 101 is connected to the detection module 100 and the infusion module 102 respectively. Here, the connection includes a conventional electrical connection or a wireless connection.

[0054] 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.

[0055] In one embodiment of the present invention, the three modules are electrically connected to form a single integrated structure. Therefore, they can be applied to the same location on the patient's skin. By connecting the three modules into a single unit and applying them to the same location, the number of devices attached to the patient's skin is reduced, thereby minimizing interference with patient activity caused by multiple devices. Furthermore, this effectively resolves the issue of wireless communication reliability between separate devices, further enhancing the patient experience.

[0056] In another embodiment of the present invention, the program module 101 and the infusion module 102 are interconnected to form an integrated structure, while the detection module 100 is separately provided in another structure. In this case, the detection module 100 and the program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, the program module 101 and the infusion module 102 are attached to a certain location on the patient's skin, while the detection module 100 is attached to another location on the patient's skin.

[0057] In another embodiment of the present invention, program module 101 and detection module 100 are interconnected to form a single device, while infusion module 102 is located in a separate structure. Infusion module 102 and program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, program module 101 and detection module 100 can be attached to a specific location on a patient's skin, while infusion module 102 can be attached to another location on the patient's skin.

[0058] In another embodiment of the present invention, the three modules are disposed in separate structures. Thus, the three modules are attached to different locations on the patient's skin. In this case, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to establish connections.

[0059] In another embodiment of the present invention, the three modules are housed in separate structures. Thus, the detection module 100 and the infusion module 102 are attached to different locations on the patient's skin, while the program module 101 is not attached to the skin. Instead, the detection module 100 and the infusion module 102 are controlled by a handheld or portable device. 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.

[0060] 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).

[0061] Figure 2 is a schematic diagram of the structure of an integrated CGM according to an embodiment of the present invention. Figure 3 is a schematic diagram of the structure of a split CGM according to an embodiment of the present invention.

[0062] CGM includes a sensor and a transmitter, which are installed on the patient through an auxiliary installation device and inserted subcutaneously. The sensor is used to collect blood sugar content in the human body and transmit the collected blood sugar content information. The transmitter is connected to the sensor and is used to receive blood sugar data information transmitted by the sensor implanted subcutaneously and convert it into a wireless signal output. Each CGM has a unique identifier, such as a device identifier, hardware identifier, universally unique identifier, serial number, communication protocol-based identifier (such as BLE ID), manufacturer's identifier, etc. The identifier is formed by a combination of multiple randomly combined numbers and letters, which can be set on the CGM shell or packaging, and can also have different settings for different types of CGM.

[0063] Figure 2 is a schematic diagram of the structure of an integrated CGM. This means that the CGM's sensor and transmitter are integrated before use. This CGM is a single-use product that is discarded after use. As shown in Figure 2, the integrated CGM includes a sensor 201, a housing 202, and a transmitter (not shown) housed within housing 202. Sensor 301 monitors the patient's blood glucose data and transmits this data to the transmitter via internal circuitry. The transmitter then transmits this data to a receiver. The identifier can be placed on the CGM's outer housing, packaging, or within the CGM.

[0064] Figure 3 is a schematic diagram of the structure of a split-type CGM. Prior to use, the CGM's sensor and transmitter are two separate components, packaged separately. They are integrated together during use. The split-type CGM includes a base housing 301 and a transmitter 302. The base housing is provided with a sensor 3011, while the transmitter 302 has a separate housing. The base housing 301 and transmitter 302 are provided with snap-fit ​​structures 3012 and 3022, respectively. During use, the base housing 301 and transmitter 302 are snapped together into a single unit via the snap-fit ​​structures. The sensor 3011 is electrically connected to the transmitter 302 via an electrical connector 3013. The sensor 301 monitors a patient's blood glucose data and transmits this data to the transmitter 302 via the electrical connector 3013. The transmitter 302 then transmits this data to the receiver.

[0065] In one embodiment of the present invention, both the sensor and transmitter of a split-type CGM are disposable products that are discarded after use. Therefore, the identifier can be placed on the housing or outer packaging of the sensor or transmitter. In another embodiment of the present invention, only the sensor of the split-type CGM is a disposable product, while the transmitter is a reusable product. Therefore, in this embodiment, preferably, the identifier is placed on the housing or outer packaging of the transmitter. This can reduce the frequency of binding patient information and the identifier, thereby improving the patient experience. This will be described in detail below.

[0066] 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.

[0067] FIG4 a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention; FIG4 b is a schematic structural diagram of a split insulin pump according to an embodiment of the present invention.

[0068] In an embodiment of the present invention, the insulin pump is a patch-type insulin pump, that is, an insulin pump that does not include a long catheter, includes an infusion structure and a control structure, and is adhered as a whole to the patient's skin surface by a same adhesive patch. The drug is directly infused from the drug storage cartridge along the infusion needle into the subcutaneous tissue.

[0069] 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.

[0070] Figure 4a is a schematic diagram of the structure of an integrated insulin pump, that is, the infusion structure 410 and the control structure 400 of the insulin pump are arranged inside the same housing 10, the two are connected by a wire, and are affixed to a certain position on the patient's skin through an adhesive patch 420, and are discarded as a whole after one-time use; the identifier can be set on the outer housing or outer packaging of the insulin pump or inside the insulin pump.

[0071] Figure 4b is a schematic diagram of the structure of a split-type insulin pump, in which the infusion mechanism 410 and control mechanism 400 of the insulin pump are housed in separate housings, connected by a waterproof plug or directly snapped together and electrically connected to form a single unit. The identifier can be placed on the outer housing, packaging, or inside the insulin pump itself.

[0072] In one embodiment of the present invention, both the infusion structure and the control structure of a split-type insulin pump are disposable products that are discarded after use. Therefore, the identifier can be set on the housing or outer packaging of the infusion structure and / or the control structure. In another embodiment of the present invention, only the infusion structure of the split-type insulin pump is a disposable product, while the control structure is a reusable product. Therefore, preferably, in this embodiment, the identifier is set on the housing or outer packaging of the control structure. This can reduce the frequency of binding patient information and the identifier, thereby improving the patient experience. This will be described in detail below.

[0073] 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.

[0074] 5a-5d are schematic diagrams of the operating environment of existing blood glucose management and insulin infusion management systems.

[0075] The program module used to control a CGM or insulin pump is typically a personal dedicated device (PDM), as shown in Figure 5a. PDMs are typically designed as low-power devices that can only communicate with other devices via methods such as Bluetooth or NFC. Therefore, when a CGM or insulin pump requires an update, the manufacturer typically pushes the latest installation package to a computer via a remote server and authorizes the patient to manually download the update using a computer and connect the CGM or insulin pump to the computer to initiate and complete the update. This process can be particularly cumbersome for patients who are unfamiliar or unaccustomed to modifying their CGM or insulin pump. As a result, patients may avoid updates and miss out on important bug fixes, security updates, and new features.

[0076] Currently, Abbott has upgraded the update method of CGM, as shown in Figure 5b, allowing patients to update CGM through smartphones. Specifically, the manufacturer will push the latest installation package to personal smartphones through a remote server. The smartphone is connected to the PDM, and the smartphone sends the update information to the PDM, which then controls the CGM to complete the update. Although this method can simplify the update process to a certain extent and does not require a computer to complete the update, it still requires an intermediary, the smartphone, to connect to the remote server and PDM, and then control the CGM to complete the update. The process is still relatively cumbersome, and patients may still avoid updating, thereby missing important bug fixes, security updates, and new features.

[0077] Furthermore, because CGMs and insulin pumps are manufactured by different manufacturers, their respective dedicated PDMs are incompatible. Consequently, separate PDMs 1 and 2 are typically required to control the CGM and insulin pump, respectively, as shown in Figure 5c. This further inconveniences patients and makes them more likely to avoid updating when the CGM or insulin pump software or firmware requires updating. If updates are performed through Abbott's method, as shown in Figure 5d, not only does a single PDM not have the ability to control both the CGM and insulin pump simultaneously, but an intermediary is also required to complete the update. This further increases the risk of patients avoiding updates and missing out on important bug fixes, security updates, and new features.

[0078] FIG6 is a schematic diagram of an operating environment of a management system for blood glucose management and insulin infusion according to an embodiment of the present invention.

[0079] As shown in Figure 6, the management system for blood glucose management and insulin infusion includes at least one wearable medical device, such as a CGM and / or insulin pump, and a mobile device, such as a smartphone. Before the CGM and / or insulin pump are installed on the patient's skin, the patient can search and download a dedicated app for controlling the CGM and / or insulin pump from the smartphone's app store. The patient creates a new account on the dedicated app and pairs the patient's personal information with the CGM and / or insulin pump information to be worn, thereby achieving pairing between the smartphone and the medical device. The patient can be the patient himself, a medical staff member, or a guardian. The patient's personal information includes name, age, gender, mobile phone number, etc. The information of the CGM and / or insulin pump worn includes the identifier information of the CGM and / or insulin pump. At the same time, the smartphone uploads the patient's personal information and the identifier information of the CGM and / or insulin pump to a remote server. The remote server can store the information uploaded by the smartphone and verify whether the identifier information of the CGM and / or insulin pump is valid. If a certain identifier information already exists in the remote server, the remote server will send a prompt to the smartphone to remind the patient that the CGM or insulin pump has been used and needs to be replaced. When the CGM and / or insulin pump is installed on the patient's skin and successfully activated, the CGM and / or insulin pump starts working. The CGM transmitter sends the monitored blood sugar information to the smartphone and further uploads it to the remote server. The control structure of the insulin pump receives the insulin infusion information and controls the infusion structure to infuse insulin. At the same time, the infusion status is sent to the smartphone and further uploaded to the remote server.

[0080] It should be noted that the CGM and insulin pump in the embodiment of the present invention are developed and produced by the same manufacturer, and therefore can be controlled by the same dedicated APP in the smartphone. Even if it is assumed that the CGM or insulin pump is produced by other manufacturers, the CGM or insulin pump can be directly controlled by the dedicated APP, which can also avoid the inconvenience caused to the patient by using different APPs to control the CGM and insulin pump respectively, thereby improving the patient experience.

[0081] When the CGM and / or insulin pump worn by the patient needs to be replaced due to reaching the usage cycle or failure, the unique identifier information of the new CGM and / or insulin pump also needs to be paired and updated with the patient's personal information through the smartphone and further uploaded to the remote server. The patient's personal information is entered manually, and the identifier information of the CGM and / or insulin pump can also be entered manually or by scanning the QR code, barcode, or NFC tag on the shell or outer packaging of the CGM and / or insulin pump.

[0082] When the CGM has a split structure and the transmitter is reusable, the CGM identifier is set on the transmitter's outer shell or packaging. When the patient replaces the CGM, he only needs to replace the sensor without replacing the transmitter. The CGM identifier also remains unchanged. Therefore, there is no need to update the pairing of the CGM identifier and the patient's personal information through a smartphone, nor is there any need to upload it to a remote server. This can reduce the number of operating steps and improve the patient experience.

[0083] When the insulin pump has a split structure and the control structure is reusable, the identifier of the insulin pump is set on the outer shell or packaging of the control structure. When the patient replaces the insulin pump, he only needs to replace the infusion structure without replacing the control structure. The identifier of the insulin pump also remains unchanged. Therefore, there is no need to update the pairing of the insulin pump identifier and the patient's personal information through a smartphone, nor is there any need to upload it to a remote server. This can reduce the number of operating steps and improve the patient experience.

[0084] 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.

[0085] FIG7 is a schematic diagram of an operating environment of a blood glucose management and insulin infusion management system according to another embodiment of the present invention.

[0086] As shown in Figure 7, the management system for blood glucose management and insulin infusion includes a dedicated handheld device PDM. PDM communicates with CGM and / or insulin pump and smartphone through short-range communication such as Bluetooth. The pairing method of PDM and CGM and / or insulin pump is similar to the pairing method of the aforementioned smartphone and CGM and / or insulin pump. The patient creates a new account on PDM and pairs the patient's personal information with the identifier information of the CGM and / or insulin pump to be worn. The patient may also be the patient himself, a medical staff or a guardian, etc. Preferably, in one embodiment of the present invention, the PDM and the smartphone are used by different persons respectively, such as the PDM is used by the patient himself and the smartphone is used by the guardian. When the patient is an elderly person or a young child, or a diabetic patient with special diseases who is unable to perform self-blood glucose monitoring and / or insulin infusion, the guardian can limit the patient's operations on the PDM through the lock mode on the smartphone dedicated APP, such as preventing the patient from viewing real-time blood glucose data information on the PDM, receiving blood glucose alarms, changing alarm settings, modifying the insulin infusion settings of the insulin pump, pausing or stopping insulin infusion, etc., which can prevent the patient from misoperating the PDM, such as deleting the device, disconnecting the PDM from the CGM, and the insulin pump, thereby affecting the normal blood glucose monitoring and insulin infusion of the CGM; not accepting blood glucose alarms can also avoid interference or impact of blood glucose alarms on the patient.

[0087] 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 PDM, which can avoid the inconvenience caused to the patient by using different PDMs to control the CGM and insulin pump respectively, and improve the patient experience.

[0088] FIG8 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention.

[0089] After the manufacturer develops new software or firmware for the CGM and / or insulin pump, it will create an update project and upload it to the remote server. The update project at least includes the uploaded new software or firmware installation package, the identifier information of the CGM and / or insulin pump that needs to update the software or firmware, the updated software or firmware version, whether the update is mandatory, and other information.

[0090] Step 801: The remote server pushes CGM and / or insulin pump update information to the smartphone;

[0091] Specifically, the remote server sends software or firmware update information based on the manufacturer's uploaded update items to smartphones compatible with the CGM and / or insulin pump that requires the software or firmware update. In one embodiment of the present invention, the update information is sent directly to a dedicated app that controls the CGM and / or insulin pump; in another embodiment, the update information is sent to the smartphone's app store.

[0092] Step 802 , the smartphone receives updated information about the CGM and / or insulin pump;

[0093] When the remote server sends the update information to the dedicated app, if the dedicated app is in the foreground, the update information will be displayed in text or other form, such as "The current CGM needs to be updated. Do you want to update?" or "The current insulin pump needs to be updated. Do you want to update?", as shown in Figure 9a or Figure 9b. The patient can click OK to receive the update information. If the dedicated app is in the background, a background notification will be displayed, such as "The current CGM needs to be updated. Do you want to update?" or "The current insulin pump needs to be updated. Do you want to update?", as shown in Figure 9c or Figure 9d. Clicking the notification will enter the dedicated app, displaying the interface shown in Figure 9a or 9b. The patient can click OK to receive the update information. If the patient does not respond within a certain period of time, such as one minute or 30 seconds, the background will send notifications at a predetermined frequency, such as once every five minutes, or the interval between notifications will gradually increase over time until the patient responds.

[0094] When the remote server sends the update information to the App Store, when the App Store is in the foreground or background, the update information is displayed in a manner similar to that displayed by the dedicated APP, which will not be repeated here.

[0095] Step 803, the smartphone enters the update step;

[0096] The update steps include but are not limited to deleting the original application, downloading and installing a new installation package, and upgrading or downgrading the program, such as upgrading or downgrading to the software or firmware version of the CGM and / or insulin pump set by the manufacturer in the update project.

[0097] In one embodiment of the present invention, after a patient receives an update message via a dedicated app or app store and clicks "Confirm," the smartphone automatically begins the update process. If the update process is interrupted due to signal loss or other reasons, the smartphone can alert the patient through visual, auditory, or sensory means such as text messages, vibration, ringing, or flashing lights. Once the signal is restored or the cause of the problem is resolved, the smartphone can prompt the patient to re-enter the update process. After the patient clicks "Confirm," the update process will resume until the update process is complete.

[0098] In another embodiment of the present invention, after the signal is restored or other fault causes are eliminated, the smartphone directly enters the update step again without the patient's confirmation first.

[0099] In another embodiment of the present invention, when the update items uploaded by the manufacturer include items that are mandatory updates, when the patient receives the update information through a dedicated APP or application store, the smartphone automatically starts the update step without the patient having to click to confirm first; similarly, when the update step is interrupted due to signal interruption or other reasons, the smartphone can remind the patient through text messages, vibrations, ringing, flashing lights and other visual, auditory, and sensory methods, and after the signal is restored or the cause of other faults is resolved, the smartphone directly enters the update step again without the patient having to confirm first.

[0100] Step 704: The smartphone reports the update result to the remote server.

[0101] After the patient completes the update, the smartphone connects to the CGM and / or insulin pump via wireless communication. If the connection is successful within a certain period of time, such as within 2 minutes, the smartphone uploads the update success result to the remote server. The uploaded content includes the CGM and / or insulin pump identifier, the updated software version, and the time the update was completed. If the update record is temporarily unsuccessful due to remote communication issues, the record is saved locally and uploaded to the remote server again when remote communication is restored until the upload is successful. If the connection is not successful within a certain period of time, such as within 2 minutes, the update fails, and the smartphone uploads the update failure result to the remote server. The uploaded result includes at least the CGM and / or insulin pump identifier, the software version to be updated, and the time the update failed.

[0102] Therefore, the remote server can view the total number of CGMs and / or insulin pumps that need to be updated, as well as the identifiers and number of CGMs and / or insulin pumps that have successfully and failed to update. For items that have already been updated, the remote server can pause the update. For items that have failed to update, the remote server will push update notifications to the smartphone again at a certain frequency.

[0103] 10 , which is a schematic diagram of a safe infusion process of a closed-loop artificial pancreas system according to an embodiment of the present invention.

[0104] In an embodiment of the present invention, program module 101 needs to continuously obtain real-time blood glucose values ​​from detection module 100 before calculating the insulin infusion amount, and infusion module 102 will carry out normal insulin infusion. This is the first mode of the closed-loop artificial pancreas system, namely the closed-loop mode. If communication between detection module 100, program module 101, and infusion module 102 is abnormal, or if the sensor of detection module 100 is damaged, program module 101 will be unable to receive real-time blood glucose value data from detection module 100 for a long time, and the closed-loop artificial pancreas system will exit the closed-loop mode. If the patient does not know how to set the insulin infusion rate, or if the sensor is damaged and cannot be replaced with a new one, infusion module 102 will stop insulin infusion, which will have a serious adverse impact on the health of the diabetic patient and is not conducive to the patient's diabetes treatment.

[0105] Based on the above usage scenarios, the closed-loop artificial pancreas system also requires a safety assurance plan in which the program module 101 can accurately calculate the amount of insulin infusion when the real-time blood glucose value data of the detection module 100 cannot be obtained for a long time, and the infusion module 102 completes the insulin infusion, so as to avoid adverse effects on the patient's health.

[0106] In an embodiment of the present invention, under normal circumstances, the program module 101 continuously receives the patient's blood glucose value data from the detection module 100 at fixed time intervals, for example, 2 minutes. The program module 101 calculates the insulin infusion amount and the infusion module 102 completes the infusion. If the program module 101 accidentally fails to receive the real-time blood glucose value data from the detection module 100 for one or several time intervals, the program module 101 can continue to calculate the insulin infusion amount based on the most recent blood glucose value data from the detection module 100. However, such calculation cannot be continued for a long time because the patient's blood glucose may change significantly after a long period of time.

[0107] In this embodiment of the present invention, if the closed-loop artificial pancreas system fails to obtain real-time blood glucose data from the detection module 100 for a period of time t1, it enters a second mode, namely, learning mode. In learning mode, the program module 101 predicts an estimated blood glucose level for the next period t2 based on recorded historical blood glucose values. Based on this estimated blood glucose level, the program module 101 calculates an estimated insulin dose for the period t2. The insulin infusion module 102 then delivers the insulin for the period t2, ensuring the patient's blood glucose safety during the period t2.

[0108] In an embodiment of the present invention, the average value of the period before the real-time blood glucose value data is missing, such as the average value of 50 data points (corresponding to 100 minutes), or the estimated blood glucose value can be calculated based on the change rate and acceleration of the real-time blood glucose value, or in combination with the patient's historical data, or using a more complex prediction model.

[0109] In an embodiment of the present invention, the duration t1 during which the closed-loop artificial pancreas system cannot receive real-time blood glucose data and enters the learning mode can be set to 0 to 24 hours. If, after 24 hours, the closed-loop artificial pancreas system still does not receive the real-time blood glucose data from the detection module 100 or the estimated blood glucose data calculated by the program module 101, the closed-loop artificial pancreas system will stop infusing insulin, affecting the patient's treatment.

[0110] In the embodiment of the present invention, the learning mode, i.e., the time period t2 for calculating the estimated blood glucose value, can be set to 0 to 48 hours. Since the start time of time period t2 is at the end of time period t1, if time period t2 is set too long, the estimated blood glucose value may deviate too much from the real-time blood glucose value. In this case, the estimated insulin amount calculated based on the estimated blood glucose value may be dangerous for the patient.

[0111] In the embodiment of the present invention, during the time period t2, the estimated infusion rate V of the infusion module 102 is t It can be obtained by the following calculation formula:

[0112] in:

[0113] t is the time period of each calculation cycle;

[0114] V t is the estimated infusion rate during time period t;

[0115] G t is the estimated blood glucose value during time period t;

[0116] G tar is the preset target blood glucose value;

[0117] ISF is the patient's insulin sensitivity.

[0118] During the time period t2 of the learning mode, the above calculations are completed in the program module 101, and the infusion module 102 performs insulin infusion according to the estimated infusion rate.

[0119] In the embodiment of the present invention, if the time period t is set to be short, the insulin infusion rate calculation based on equation (1) can be repeated during the period when the real-time blood glucose value data is missing. For example, if the time period t is set to 10 minutes, after the insulin is infused at the estimated infusion rate for 10 minutes, the estimated blood glucose value G can be re-determined. t, and the estimated infusion rate for the next 10 minutes is recalculated based on equation (1) to complete insulin infusion until the closed-loop artificial pancreas system resumes receiving real-time blood glucose data. When recalculating the estimated infusion rate, the estimated blood glucose value used is derived from the second calculation of the estimated blood glucose value in the previous round of calculation, and the calculation method is consistent with the previous round of estimated blood glucose value calculation.

[0120] Obviously, such repeated calculations have limits. As time goes by, the deviation between the estimated infusion rate and the infusion rate actually required by the patient gradually becomes uncontrollable. When the deviation is too large, too much or too little insulin infusion is dangerous for the patient.

[0121] In addition, if only the estimated blood glucose value is used to calculate the estimated infusion rate, it may not be sufficient to meet the requirements of accurate insulin infusion during the period when the real-time blood glucose value data is missing, which will still affect the patient's treatment effect.

[0122] In the embodiment of the present invention, in order to improve the insulin infusion accuracy of the closed-loop artificial pancreas system during the period when the real-time blood glucose value data is missing, the patient's fingertip blood glucose value BG can also be combined to calculate the estimated infusion rate or estimated blood glucose value. t When the fingertip blood glucose value BG and the blood glucose value data before the real-time blood glucose value data is lost are comprehensively considered, and the weighted average method is used to calculate the estimated blood glucose value G t ,As the calculation time increases, the weight of the fingertip blood glucose value BG can be ,dynamically increased, and the fingertip blood glucose value BG can be ,trusted more.

[0123] In the embodiment of the present invention, after the patient measures the fingertip blood glucose value BG and inputs it into the closed-loop artificial pancreas system, the duration of the learning mode can be extended because the fingertip blood glucose value BG is added to the estimated blood glucose value G t In the calculation of the estimated blood glucose value G t The estimated insulin infusion rate V calculated in this way will become more reliable. t Each time a patient enters their fingertip blood glucose value, the learning mode can be extended by 0 to 48 hours, which provides more time for the patient to take measures to resume receiving real-time blood glucose data without affecting their treatment.

[0124] In the embodiment of the present invention, when the patient's fingertip blood glucose value BG is at different levels, the closed-loop artificial pancreas system can adopt different infusion strategies to achieve higher accuracy and more adaptable infusion mode for the patient. In equation (1), during the learning mode, the estimated infusion rate needs to be calculated in combination with the patient's preset blood glucose value threshold, which includes the target blood glucose value G tar and high and low blood sugar thresholds, target blood sugar value G tarUsed as a level distinction for fingertip blood glucose value BG, by comparing fingertip blood glucose value BG with target blood glucose value G tar To determine the infusion strategy of the closed-loop artificial pancreas system.

[0125] In the embodiment of the present invention, the target blood glucose value G tar The target blood glucose value G can be determined by the patient or his / her healthcare provider, entered and stored in the closed-loop artificial pancreas system. tar It can be dynamically adjusted according to the patient's treatment status to achieve the best treatment effect for the patient. In the descriptive embodiment of this solution, the target blood glucose value G tar Set to 5.6mmol / L, 6.1mmol / L or 6.7mmol / L, etc.

[0126] In the embodiment of the present invention, after the patient inputs the fingertip blood glucose value BG, the program module 101 automatically compares the fingertip blood glucose value BG with the target blood glucose value GG. tar If the fingertip blood glucose value BG is greater than the target blood glucose value G tar , the closed-loop artificial pancreas system requires the infusion of a correction large dose of I C , the corrected bolus dose for infusion is determined by the following formula:

[0127] in:

[0128] IOB is the amount of unresponsive insulin in the patient's body.

[0129] In an embodiment of the present invention, if the fingertip blood glucose value BG is less than the target blood glucose value but greater than or equal to 3.9mmol / L, the closed-loop artificial pancreas system needs to reduce the amount of insulin infusion for a period of time. The reduced infusion amount can be achieved by reducing the infusion rate. The insulin infusion rate after the reduction in infusion amount is 60% to 95% of the estimated infusion rate. Preferably, insulin is infused at 75% of the estimated infusion rate. During the learning mode period, the duration of reducing the insulin infusion rate is 10 to 120 minutes. Specifically, the time t for reducing the infusion rate is t d It can be determined by the following formula:

[0130] in:

[0131] ΔI is the reduced insulin infusion;

[0132] ΔV is the reduced infusion rate.

[0133] In the embodiment of the present invention, after the fingertip blood glucose value BG is input, the reduced insulin infusion amount ΔI can be determined by the following formula:

[0134] In an embodiment of the present invention, if insulin infusion is carried out at 75% of the estimated infusion rate, the reduced infusion rate ΔV can be determined as the estimated infusion rate V t This value is only for illustrative purposes.

[0135] In the embodiment of the present invention, if the fingertip blood glucose value BG is less than 3.9mmol / L, the closed-loop artificial pancreas system suspends insulin infusion for a period of time t s Determined by the following equation:

[0136] After the pause in infusion ends, the closed-loop artificial pancreas system resumes infusion at the estimated infusion rate, or prompts the patient to re-measure fingerstick blood sugar and then determines the next infusion strategy based on the re-measured fingerstick blood sugar value.

[0137] In some embodiments of the present invention, if the patient needs to eat during the learning mode, this will cause the patient's blood sugar to fluctuate significantly for a period of time after the meal. Therefore, the patient is required to input the fingertip blood sugar value BG at least once before and after the meal for the program module 101 to calculate the maximum meal dose I F .

[0138] Specifically, the patient measured the fingertip blood glucose value BG once 0-20 minutes before the expected meal and 0-150 minutes after the meal. During this period, the infusion of a large dose of dietary I F It can be determined by the following equation:

[0139] in:

[0140] Carbs is the amount of carbohydrates in the meal, g;

[0141] IC is the insulin to carbohydrate ratio.

[0142] The patient's dietary bolus before and after meals was determined by fingertip blood glucose values ​​(BG) measured before and after meals, respectively.

[0143] In this embodiment of the present invention, after the maximum duration t2 of the learning mode, if the closed-loop artificial pancreas system still has not resumed receiving real-time blood glucose data, the closed-loop artificial pancreas system will enter a third mode, or safety mode, for a period of time t3. In safety mode, for patient safety, the closed-loop artificial pancreas system automatically delivers insulin at a lower rate to maintain basal insulin therapy levels.

[0144] In an embodiment of the present invention, in the safety mode, the closed-loop artificial pancreas system infuses an amount of insulin of 0 to 30% of a normal dose at an estimated infusion rate. Preferably, the closed-loop artificial pancreas system infuses an amount of insulin of 0 to 10% of a normal dose at an estimated infusion rate.

[0145] In an embodiment of the present invention, the safe mode can last for a t3 period of 0 to 48 hours. In the safe mode, the amount of insulin infused by the closed-loop artificial pancreas system is small. During this period, the patient may eat and sleep multiple times. If the duration is too long, the blood sugar level may be too high, affecting the patient's treatment.

[0146] In this embodiment of the present invention, if the closed-loop artificial pancreas system still has not resumed receiving real-time blood glucose values ​​after the end of the safe mode duration t3, the patient will be prompted to enter a fingertip blood glucose value, thereby extending the duration of safe mode. Obviously, the duration of safe mode cannot be repeatedly extended. In this case, the closed-loop artificial pancreas system can also be configured to issue an alert to the patient, urging them to take steps to resume receiving real-time blood glucose values ​​as soon as possible, or to send a call for help to their caregiver, medical staff, sales consultant, manufacturer, etc.

[0147] In an embodiment of the present invention, if a patient uses the closed-loop artificial pancreas system for less than 7 days, the system cannot record sufficient patient historical data. After the real-time blood glucose value data is lost, the maximum time period t2 for the closed-loop artificial pancreas system to enter the learning mode will be shortened, for example, from 24 hours to 12 hours. In this scenario, the patient can still be allowed to input fingertip blood glucose value data and the learning mode duration can be extended, but the extended duration will be shortened to 0 to 12 hours.

[0148] In the embodiment of the present invention, regardless of when the closed-loop artificial pancreas system enters the learning mode, after the learning mode ends, if the real-time blood glucose value data received from the detection module 100 has not been restored and the fingertip blood glucose value data has not been input, the closed-loop artificial pancreas system will enter the safe mode.

[0149] In the embodiment of the present invention, in the learning mode, even if the patient inputs fingertip blood glucose value data, the closed-loop artificial pancreas system will enter the safety mode after exceeding the allowed time delay.

[0150] In an embodiment of the present invention, regardless of whether the closed-loop artificial pancreas system is currently in learning mode or safe mode, once the real-time blood glucose value data resumes normal reception, the closed-loop artificial pancreas system will return to normal closed-loop mode and calculate and infuse insulin based on the real-time blood glucose value data. In closed-loop mode, the closed-loop artificial pancreas system can provide more accurate blood glucose monitoring and insulin infusion.

[0151] In summary, the embodiments of the present invention disclose a closed-loop artificial pancreas system with safe infusion. During a long period of missing real-time blood glucose value data, the closed-loop artificial pancreas system can continue to calculate the patient's required insulin infusion amount based on historical blood glucose values ​​and fingertip blood glucose values, and infuse the patient with an appropriate amount of insulin. The system will not infuse an inappropriate amount of insulin or even interrupt insulin infusion due to the lack of real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and benefiting the patient's treatment.

[0152] 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 closed-loop artificial pancreas system, comprising: A detection module, the detection module is used to monitor the real-time blood sugar value; A program module, the program module is used to receive the real-time blood sugar value from the detection module and calculate the insulin infusion amount according to the real-time blood sugar value; and an infusion module, wherein the infusion module is used to implement insulin infusion; When the program module fails to receive the real-time blood glucose value for a first period of time, the closed-loop artificial pancreas system switches from the first mode to the second mode for a second period of time. In the second mode, the closed-loop artificial pancreas system calculates an estimated blood glucose value, calculates an estimated insulin infusion amount based on the estimated blood glucose value, and implements insulin infusion based on the estimated insulin infusion amount.

2. The closed-loop artificial pancreas system according to claim 1, characterized in that: The estimated blood glucose value is calculated based on the real-time blood glucose value of the last period of time.

3. The closed-loop artificial pancreas system according to claim 2, characterized in that: It also includes providing a fingertip blood glucose value, and the estimated blood glucose value is also calculated based on the fingertip blood glucose value.

4. The closed-loop artificial pancreas system according to claim 3, characterized in that: When the estimated blood glucose level is calculated based on the fingertip blood glucose level, the second period of time may be extended.

5. The closed-loop artificial pancreas system according to claim 3, characterized in that: It also includes a preset blood sugar value threshold. Based on the comparison relationship between the fingertip blood sugar value and the blood sugar value threshold, the closed-loop artificial pancreas system adopts different infusion strategies.

6. The closed-loop artificial pancreas system according to claim 5, characterized in that: The infusion strategies include infusion of a correction bolus, reduction of insulin infusion, and suspension of insulin infusion.

7. The closed-loop artificial pancreas system according to claim 3, characterized in that: If a meal is taken within the second period of time, at least one pre-meal fingertip blood glucose value and at least one post-meal fingertip blood glucose value are provided, and the pre-meal dietary bolus is calculated based on the pre-meal fingertip blood glucose value, and the post-meal dietary bolus is calculated based on the post-meal fingertip blood glucose value.

8. The closed-loop artificial pancreas system according to claim 7, characterized in that: The pre-meal fingertip blood glucose value is provided 0 to 20 minutes before a meal, and the post-meal fingertip blood glucose value is provided 0 to 150 minutes after a meal.

9. The closed-loop artificial pancreas system according to claim 1, characterized in that: During the second period of time, the calculation of the estimated blood sugar value data and the estimated insulin infusion amount data may be repeated.

10. The closed-loop artificial pancreas system according to claim 1, characterized in that: After the second period of time ends, if the program module still has not received the real-time blood glucose value, the closed-loop artificial pancreas system switches to a third mode for a third period of time.

11. The closed-loop artificial pancreas system according to claim 10, characterized in that: In the third mode, the insulin infusion amount is 0-30% of the estimated insulin infusion amount.

12. The closed-loop artificial pancreas system according to claim 11, characterized in that: In the third mode, the insulin infusion amount is 0-10% of the estimated insulin infusion amount.

13. The closed-loop artificial pancreas system according to claim 10, characterized in that: The third period of time is 0 to 48 hours.

14. The closed-loop artificial pancreas system according to claim 1, characterized in that: The first period of time is 0 to 24 hours.

15. The closed-loop artificial pancreas system according to claim 1, characterized in that: The second period of time is 0 to 48 hours.

16. The closed-loop artificial pancreas system according to any one of claims 1 to 15, characterized in that: When the closed-loop artificial pancreas system is in the second mode or the third mode, if the program module resumes receiving the real-time blood glucose value, the closed-loop artificial pancreas system switches to the first mode.

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