Secure closed loop artificial pancreatic system

Abstract

The invention discloses a safe closed-loop artificial pancreas system, which is characterized in that the closed-loop artificial pancreas system enters a learning mode when the insulin infusion amount is abnormal due to abnormal real-time blood glucose value data, and in the learning mode, the insulin infusion amount required by a patient is continuously calculated based on a historical blood glucose value and a fingertip blood glucose value; the real-time blood glucose value data is abnormal, a proper amount of insulin is infused for the patient, inappropriate insulin infusion and even interruption of insulin infusion caused by abnormal real-time blood glucose value data are avoided, life danger of the patient is avoided, and treatment of the patient is facilitated.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to the following patent application: PCT patent application filed on May 27, 2024, with application number PCT / CN2024 / 095389. Technical Field

[0003] The present invention mainly relates to the field of diabetes monitoring and management, and in particular to a safe closed-loop artificial pancreas system. Background Art

[0004] The pancreas in a normal person's body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin / glucagon. However, the pancreas of diabetic patients has abnormal function and cannot normally secrete the insulin required by the human body. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function in the human body, and diabetes is a lifelong disease. At present, medical technology cannot cure diabetes, and can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar.

[0005] Diabetic patients need to monitor their blood sugar before injecting insulin into their bodies. Currently, most monitoring methods are to continuously monitor 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 blood sugar data to external devices in real time through transmitters for patients to view. This monitoring method is called continuous glucose monitoring (CGM).

[0006] When providing auxiliary treatment for diabetic patients, the closed-loop artificial pancreas system is a better choice. The closed-loop artificial pancreas system can not only monitor blood sugar in real time, but also automatically calculate and infuse insulin based on the real-time blood sugar monitoring data, which provides great convenience for the patient's diabetes treatment. However, in actual use, the sensor that monitors the real-time blood sugar data may be damaged during processing, transportation, storage and other links, resulting in abnormal real-time blood sugar data obtained by the sensor when the patient officially uses the closed-loop artificial pancreas system, and abnormal insulin infusion volume of the closed-loop artificial pancreas system, affecting the patient's treatment. The existing technology does not have an effective means to deal with such anomalies, resulting in the patient's closed-loop artificial pancreas system stopping working before replacing the sensor, or implementing insulin infusion according to abnormal real-time blood sugar data, which affects the patient's treatment.

[0007] Therefore, the existing technology urgently needs a closed-loop artificial pancreas system that can provide patients with effective insulin infusion when the real-time blood glucose data is abnormal. Summary of the invention

[0008] The present invention discloses a safe closed-loop artificial pancreas system. When the real-time blood sugar value data is abnormal and causes abnormal insulin infusion, the closed-loop artificial pancreas system enters a learning mode. In the learning mode, the closed-loop artificial pancreas system continues to calculate the insulin infusion amount required by the patient based on the historical blood sugar value and the fingertip blood sugar value, and infuses an appropriate amount of insulin into the patient. An inappropriate amount of insulin will not be infused or even the insulin infusion will not be interrupted due to the abnormal real-time blood sugar value data, thereby avoiding life-threatening situations for the patient and being beneficial to the treatment of the patient.

[0009] The embodiment of the present invention discloses a closed-loop artificial pancreas system, comprising a detection module for monitoring real-time blood sugar values; a program module for receiving real-time blood sugar values ​​from the detection module and calculating the amount of insulin infusion according to the real-time blood sugar values; and an infusion module for implementing insulin infusion; wherein, when it is determined that the real-time blood sugar value or the amount of insulin infusion is abnormal and lasts for a period of time, the system switches from a first mode to a second mode and lasts for another period of time; in the first mode, the amount of insulin infusion is calculated according to the real-time blood sugar value, and the insulin infusion is implemented based on the amount of insulin infusion; in the second mode, an estimated blood sugar value is calculated according to historical blood sugar values, an estimated insulin infusion amount is calculated according to the estimated blood sugar value, and the insulin infusion is implemented based on the estimated insulin infusion amount.

[0010] According to one aspect of the present invention, the abnormality includes that the real-time blood glucose value exceeds a preset threshold, or the infusion module infuses at a maximum insulin infusion rate, or the infusion module suspends infusion.

[0011] According to one aspect of the present invention, the preset threshold value is 3.9 mmol / L-13.9 mmol / L.

[0012] According to one aspect of the invention, the maximum insulin infusion rate is 10 U / h.

[0013] According to one aspect of the present invention, during the duration of the second mode, if the real-time blood glucose value recovers to within a preset threshold range, the system switches from the second mode back to the first mode.

[0014] According to one aspect of the present invention, the historical blood sugar value includes at least the real-time blood sugar value before the abnormality.

[0015] According to one aspect of the present invention, 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.

[0016] According to one aspect of the present invention, when the estimated blood glucose value is calculated based on the fingertip blood glucose value, the duration of the second mode may be extended.

[0017] According to one aspect of the present invention, if the fingertip blood glucose value is not provided before the end of the second mode duration, the system switches from the second mode to the third mode.

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

[0019] According to one aspect of the present invention, the fingertip blood glucose value is also used to calibrate the real-time blood glucose value.

[0020] According to one aspect of the present invention, if the real-time blood glucose value after calibration meets a predetermined condition, the system switches from the second mode back to the first mode, otherwise, the system remains in the second mode.

[0021] According to one aspect of the present invention, the predetermined condition is that when the fingertip blood glucose value is not less than 5.6 mmol / L, the difference ratio between the first real-time blood glucose value after the fingertip blood glucose value is input and the fingertip blood glucose value is less than 30%.

[0022] According to one aspect of the present invention, the predetermined condition is that when the fingertip blood glucose value is less than 5.6 mmol / L, the difference between the first real-time blood glucose value after the fingertip blood glucose value is input and the fingertip blood glucose value is less than 1.7 mmol / L.

[0023] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0024] The safe closed-loop artificial pancreas system disclosed in the present invention enters a learning mode during a period when abnormal insulin infusion volume is caused by abnormal real-time blood glucose value data. In the learning mode, the closed-loop artificial pancreas system continues to calculate the insulin infusion volume required by the patient based on historical blood glucose values ​​and fingertip blood glucose values, and infuses an appropriate amount of insulin into the patient. An inappropriate amount of insulin will not be infused or even the insulin infusion will not be interrupted due to abnormal real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and being beneficial to the patient's treatment.

[0025] Furthermore, after the closed-loop artificial pancreas system enters the learning mode, the fingertip blood glucose value is input to calibrate the real-time blood glucose value, which can extend the duration of the learning mode and provide the patient with more time to restore the blood glucose value data or replace the sensor without affecting the patient's blood glucose control, which is beneficial to the patient's treatment.

[0026] Furthermore, the calibrated real-time blood glucose value is compared with the fingertip blood glucose value. If the difference between the two is small, it can be determined that the real-time blood glucose value data of the sensor has returned to normal. At this time, the closed-loop artificial pancreas system exits the learning mode and returns to the normal closed-loop mode. In the normal closed-loop mode, the accuracy of insulin infusion is higher than that in the learning mode. Timely switching to the normal closed-loop mode can provide better treatment for patients.

[0027] Furthermore, in the learning mode, if the patient cannot provide fingertip blood sugar value data, after the learning mode continues for a period of time, the estimated blood sugar value may deviate greatly from the actual blood sugar value in the patient's body, and the estimated blood sugar value data can no longer be used to estimate the amount of insulin infusion, otherwise it will be detrimental to the patient. At this time, the closed-loop artificial pancreas system enters the safe mode. In the safe mode, insulin is infused according to a certain proportion of the basal amount, which can reduce the possibility of high blood sugar in the patient and is beneficial to the patient's treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic diagram of the relationship between modules of a universal closed-loop artificial pancreas insulin infusion control system;

[0029] Figure 2 is a schematic structural diagram of an integrated CGM according to an embodiment of the present invention;

[0030] Figure 3 is a schematic structural diagram of a split-type CGM according to an embodiment of the present invention;

[0031] Figure 4a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention;

[0032] Figure 4b A schematic diagram of the structure of a split-type insulin pump according to an embodiment of the present invention;

[0033] Figure 5a-5d A schematic diagram of the operating environment of an existing blood sugar management and insulin infusion management system;

[0034] Figure 6 A schematic diagram of an operating environment of a management system for blood sugar management and insulin infusion according to an embodiment of the present invention;

[0035] Figure 7 A schematic diagram of an operating environment of a management system for blood sugar management and insulin infusion according to another embodiment of the present invention;

[0036] Figure 8 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention;

[0037] Figure 9a and Figure 9b This is a schematic diagram of the interface when the APP is in the foreground according to an embodiment of the present invention;

[0038] Fig.9c and Figure 9d This is a schematic diagram of the interface of an APP in the background according to an embodiment of the present invention;

[0039] Fig.10 A schematic diagram of a safe infusion process of a closed-loop artificial pancreas system according to an embodiment of the present invention;

[0040] Fig.11 Schematic diagram of another safe infusion process of a closed-loop artificial pancreas system according to an embodiment of the present invention. DETAILED DESCRIPTION

[0041] As mentioned above, the existing closed-loop artificial pancreas system often has no effective means to deal with abnormalities in real-time blood glucose values ​​for a long time, causing the closed-loop artificial pancreas system to stop working, or calculating and implementing insulin infusion according to abnormal real-time blood glucose data, which affects the patient's treatment.

[0042] In order to solve this problem, an embodiment of the present invention discloses a safe closed-loop artificial pancreas system. During a period when the real-time blood glucose value data is abnormal and causes an abnormal insulin infusion amount, the closed-loop artificial pancreas system enters a learning mode. In the learning mode, the closed-loop artificial pancreas system continues to calculate the insulin infusion amount required by the patient based on the historical blood glucose value and the fingertip blood glucose value, and infuses an appropriate amount of insulin into the patient. An inappropriate amount of insulin will not be infused or even the insulin infusion will be interrupted due to abnormal real-time blood glucose value data, thereby avoiding life-threatening situations for the patient and being beneficial to the patient's treatment.

[0043] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that 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 unless otherwise specifically stated.

[0044] 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 proportions. For example, the thickness, width, length or distance of certain units may be enlarged relative to other structures.

[0045] The following description of the exemplary embodiments is merely illustrative and is not intended to limit the present invention and its application or use in any sense. Techniques, methods and devices known to ordinary technicians in the relevant field may not be discussed in detail here, but where applicable, these techniques, methods and devices should be considered as part of this specification.

[0046] It should be noted that like reference numerals and letters denote similar items in the following figures, and thus, once an item is defined or described in one figure, it will not require further discussion in the subsequent figure descriptions.

[0047] Figure 1 This is a schematic diagram of the relationship between modules of a universal closed-loop artificial pancreas insulin infusion control system.

[0048] 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 .

[0049] The detection module 100 is used to continuously detect the patient's current blood glucose level. Generally, 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 send the current blood glucose information to the program module 101. The CGM includes an implantable sensor, which is connected to a transmitter. The transmitter also includes a memory, a processor, a communication interface, etc. The transmitter is at least used to transmit the blood glucose data information monitored by the CGM, as well as the identifier information of the CGM, etc.

[0050] The infusion module 102 includes mechanical structures and electronic control units necessary for insulin infusion, such as a drug storage cartridge, a drive structure, an infusion pipeline and an infusion needle, a power supply, a circuit board, etc., and is controlled by the program module 101. Generally, the infusion module 102 is an insulin pump, and the electronic control unit includes a memory, a processor, a communication interface, etc. According to the current insulin infusion amount data sent by the program module 101, the infusion module 102 infuses the currently required insulin into the patient's body. At the same time, the infusion status of the infusion module 102 can also be fed back to the program module 101 in real time.

[0051] The program module 101 is used to control the work 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.

[0052] 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 can be met.

[0053] For example, in one embodiment of the present invention, the three are electrically connected to form an integral structure. Therefore, the three are attached to the same position on the patient's skin. The three modules are connected as a whole and attached to the same position, and the number of devices attached to the patient's skin will be reduced, thereby reducing the interference of more devices attached to the patient's activities; at the same time, it also effectively solves the problem of wireless communication reliability between separate devices, further enhancing the patient experience.

[0054] In another embodiment of the present invention, the program module 101 and the infusion module 102 are connected to each other to form an integral structure, and the detection module 100 is separately arranged 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. Therefore, the program module 101 and the infusion module 102 are attached to a certain position of the patient's skin, and the detection module 100 is attached to another position of the patient's skin.

[0055] In another embodiment of the present invention, the program module 101 and the detection module 100 are connected to each other to form the same device, and the infusion module 102 is separately arranged in another structure. The infusion module 102 and the program module 101 transmit wireless signals to each other to achieve mutual connection. Therefore, the program module 101 and the detection module 100 can be attached to a certain position of the patient's skin, and the infusion module 102 can be attached to another position of the patient's skin.

[0056] As in another embodiment of the present invention, the three are respectively arranged in different structures. Therefore, the three are respectively attached to different positions of the patient's skin. At this time, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to achieve mutual connection.

[0057] In another embodiment of the present invention, the three are respectively arranged in different structures. Therefore, the detection module 100 and the infusion module 102 are respectively attached to different positions of the patient's skin, while the program module 101 does not need to be attached to the skin, and the control of the detection module 100 and the infusion module 102 is realized through a handheld or portable device. At this time, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to realize the connection with each other.

[0058] The wireless described in the foregoing embodiments may be, 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).

[0059] 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.

[0060] CGM includes a sensor and a transmitter, which are installed on the patient through an auxiliary installation device and inserted into the subcutaneous part. 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 the 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, a hardware identifier, a universal unique identifier, a serial number, an identifier based on a communication protocol (such as a BLE ID), a manufacturer's identifier, etc. The identifier is formed by a combination of multiple randomly combined numbers and letters, which can be set on the shell or packaging of the CGM, and can also have different settings for different types of CGM.

[0061] 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 in the housing 202. The sensor 301 is used to monitor the patient's body fluid blood glucose data information, and transmits the blood glucose data information to the transmitter through an internal circuit, and then the transmitter sends it to the receiver. The identifier can be set on the outer housing or outer packaging of the CGM or inside the CGM.

[0062] Figure 3 The structure diagram of the split CGM is shown in FIG. That is, before use, the sensor and transmitter of the CGM are two different components, which are packaged separately and integrated together when in use. The split CGM includes a bottom shell 301 and a transmitter 302. The bottom shell is provided with a sensor 3011. The transmitter 302 has a separate shell. The bottom shell 301 and the shell of the transmitter 302 are provided with snap-fit ​​structures 3012 and 3022 respectively. When in use, the bottom shell 301 and the transmitter 302 are snapped into a whole through the snap-fit ​​structure. The sensor 3011 is electrically connected to the transmitter 302 through the electrical connector 3013. The sensor 301 is used to monitor the patient's blood sugar data information, and the above blood sugar data information is transmitted to the transmitter 302 through the electrical connector 3013, and then sent to the receiver by the transmitter 302.

[0063] In one embodiment of the present invention, the sensor and transmitter of the split CGM are both disposable products that are discarded after use, so the identifier can be set on the housing or outer packaging of the sensor or transmitter. In another embodiment of the present invention, only the sensor of the split CGM is a disposable product, and the transmitter is a reusable product. Therefore, preferably, in this embodiment, the identifier is set on the housing or outer packaging of the transmitter, which can reduce the binding frequency of patient information and the identifier and improve the patient experience. This will be described in detail below.

[0064] When the identifier is provided on the housing or outer packaging of the CGM or transmitter, it may be provided in a form including but not limited to a QR code, a barcode, or an NFC tag.

[0065] 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.

[0066] In some embodiments 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 with the same adhesive patch. The drug is directly infused from the drug storage cartridge along the infusion needle into the subcutaneous tissue.

[0067] 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.

[0068] Figure 4a It 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 adhered to a certain position of the patient's skin through an adhesive patch 420, and are discarded as a whole after a single use; the identifier can be set on the outer housing or outer packaging of the insulin pump or inside the insulin pump.

[0069] Figure 4b This is a schematic diagram of the structure of a split insulin pump, that is, the infusion structure 410 and the control structure 400 of the insulin pump are respectively arranged in two different housings, and the two are connected by a waterproof plug or directly snapped and electrically connected to form a whole. The identifier can be set on the outer shell or outer packaging of the infusion structure and / or the control structure or inside the insulin pump.

[0070] In one embodiment of the present invention, the infusion structure and control structure of the split-type insulin pump are both disposable products, which are discarded after use, so 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, and 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, which can reduce the binding frequency of patient information and the identifier and improve the patient experience. This will be described in detail below.

[0071] When the identifier is provided on the housing or outer packaging of the insulin pump or the control structure, it may be provided in a form including but not limited to a QR code, a barcode, or an NFC tag.

[0072] Figure 5a-5d A schematic diagram of the operating environment of an existing blood glucose management and insulin infusion management system.

[0073] The program module used to control CGM or insulin pump is generally a personal dedicated handheld device (PDM), such as Figure 5a As shown, PDM is usually designed as a low-power device that can only communicate with other devices through communication methods such as Bluetooth or NFC. Therefore, when CGM or insulin pumps need to be updated, manufacturers usually push the latest installation package to the computer through a remote server and authorize patients to manually download the update by using a computer and connect the CGM or insulin pump to the computer to start and complete the update. This process can be particularly cumbersome for patients who are unfamiliar or unaccustomed to modifying their CGM or insulin pumps. As a result, patients may avoid updates and miss important bug fixes, security updates, and new features.

[0074] Abbott has upgraded the update method of CGM. Figure 5b As shown, patients are allowed to update CGM via smartphones. Specifically, the manufacturer will push the latest installation package to personal smartphones through a remote server. The smartphone is connected to PDM, and the smartphone sends the update information to PDM, which then controls 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 CGM to complete the update. The process is still relatively cumbersome, and patients may still avoid updating, thereby missing out on important bug fixes, security updates, and new features.

[0075] At the same time, since the manufacturers of CGM and insulin pump are different, the dedicated PDMs of each are not compatible. Therefore, different PDM1 and PDM2 are usually required to control CGM and insulin pump respectively. Figure 5c As shown in the figure, it further inconveniences patients, and when the CGM or insulin pump needs to be updated with software or firmware, patients are more likely to avoid updating. Figure 5d As shown, not only is there an issue with a PDM being unable to control both a CGM and an insulin pump, but there is also the issue of requiring an intermediary to complete updates, and patients may still avoid updates and miss out on important bug fixes, security updates, and added features.

[0076] Figure 6It is a schematic diagram of the operating environment of the management system for blood glucose management and insulin infusion according to an embodiment of the present invention.

[0077] like Figure 6 As shown, the management system for blood sugar management and insulin infusion includes at least one wearable medical device, such as CGM and / or insulin pump, and a mobile device such as a smart phone. Before the CGM and / or insulin pump are respectively installed on the patient's skin surface, the patient can search and download a special APP for controlling the CGM and / or insulin pump in the application store of the smart phone. The patient creates a new account on the special APP, and pairs the patient's personal information with the CGM information and / or insulin pump information to be worn, thereby realizing the pairing of the smart phone and the medical device. The patient can be the patient himself, a medical staff or a guardian. The patient's personal information includes name, age, gender, mobile phone number, etc., and the information of the CGM and / or insulin pump worn includes the identifier information of the CGM and / or insulin pump. At the same time, the smart phone uploads the patient's personal information and the identifier information of the CGM and / or insulin pump to the remote server. The remote server can store the information uploaded by the smart phone 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 sends a prompt to the smart phone 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, and at the same time sends the infusion status to the smartphone, and further uploads it to the remote server.

[0078] 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, and the inconvenience caused to the patient by using different APPs to control the CGM and insulin pump respectively can be avoided, thereby improving the patient experience.

[0079] 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 input manually, and the identifier information of the CGM and / or insulin pump can also be input manually or by scanning the QR code, barcode, or NFC tag on the shell or outer packaging of the CGM and / or insulin pump.

[0080] 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 patient changes 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.

[0081] 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 a need to upload it to a remote server. This can reduce the number of operating steps and improve the patient experience.

[0082] The smartphone and the CGM and / or insulin pump, as well as the remote server, communicate wirelessly, which may be accomplished by, 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), 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 a wireless communication protocol and cellular communication, such as code division multiple access (CDMA) or global system for mobile communications (GSM). Communication protocol communication.

[0083] Figure 7 It is a schematic diagram of the operating environment of a management system for blood glucose management and insulin infusion according to another embodiment of the present invention.

[0084] like Figure 7As shown, the management system for blood glucose management and insulin infusion includes a dedicated handheld device PDM, which communicates with CGM and / or insulin pump and smartphone via 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 or other guardian. Preferably, in one embodiment of the present invention, the PDM and the smart phone are used by different persons respectively, such as the PDM is used by the patient himself and the smart phone 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 smart phone's 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. This can prevent the patient from misoperating the PDM, such as deleting the device, releasing the connection between the PDM and 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.

[0085] 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, thereby improving the patient experience.

[0086] Figure 8 4 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention.

[0087] After the manufacturer develops new software or firmware for CGM and / or insulin pump, it will create an update project and upload it to the remote server. The update project at least includes uploading the 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.

[0088] Step 801, the remote server pushes CGM and / or insulin pump update information to the smartphone;

[0089] Specifically, the remote server sends software or firmware update information to the smartphone that matches the CGM and / or insulin pump that needs to update the software or firmware according to the update items uploaded by the manufacturer. In one embodiment of the present invention, the update information is directly sent to the dedicated APP that controls the CGM and / or insulin pump; in another embodiment of the present invention, the update information is sent to the application store of the smartphone.

[0090] Step 802, the smartphone receives update information of the CGM and / or insulin pump;

[0091] 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 forms, such as "The CGM currently in use needs to be updated, do you want to update it?" or "The insulin pump currently in use needs to be updated, do you want to update it?" Figure 9a or Figure 9b As shown, the patient receives the update information by clicking OK; if the dedicated APP is in the background, the background notification will display "The CGM currently in use needs to be updated, do you want to update it?" or "The insulin pump currently in use needs to be updated, do you want to update it?", such as Fig.9c or Figure 9d As shown, click the notification to enter the dedicated APP, and the following Figure 9a Or the interface shown in 9b, the patient receives the update information by clicking OK. If the patient does not respond within a certain period of time, such as one minute or 30 seconds, the background will send a notification at a predetermined frequency, such as once every five minutes, or as time goes by, the interval between notifications will gradually increase until the patient responds.

[0092] When the remote server sends the update information to the application store, when the application 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.

[0093] Step 803, the smart phone enters the update step;

[0094] The update steps include but are not limited to deleting the original application, downloading and installing a new installation package, and program upgrades or downgrades, such as upgrading or downgrading to the version of the CGM and / or insulin pump software or firmware set by the manufacturer in the update project.

[0095] In one embodiment of the present invention, when the patient receives the update information through a dedicated APP or application store and clicks to confirm, the smartphone automatically starts the update step. If the update step is interrupted due to signal interruption or other reasons during the update process, the smartphone can remind the patient through text messages, vibrations, ringing, flashing lights and other visual, auditory, sensory and other means, and remind the patient whether to enter the update step again after the signal is restored or other fault reasons are resolved. After the patient clicks to confirm, the update step will be entered again until the update step is completed.

[0096] In another embodiment of the present invention, after the signal is restored or other fault causes are eliminated, the smart phone directly enters the update step again without the patient's confirmation first.

[0097] 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 other fault causes are resolved, the smartphone directly enters the update step again without the patient having to confirm first.

[0098] Step 704: The smartphone reports the update result to the remote server.

[0099] 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, and the uploaded content includes the identifier information of the CGM and / or insulin pump, the updated software version, the time of update completion, etc. If the update record is temporarily unsuccessful to the remote server due to remote communication or other reasons, the record is saved locally and uploaded to the remote server again when the 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, it means that the update has failed, and the smartphone uploads the update failure result to the remote server, and the uploaded result at least includes the identifier information of the CGM and / or insulin pump, the software version of the update level to be updated, the time of update failure, etc.

[0100] Therefore, the total number of CGMs and / or insulin pumps that need to be updated, the identifier information and number of CGMs and / or insulin pumps that have been successfully updated and those that have failed to be updated can be viewed in the update items of the remote server. For items that have already been updated, the remote server can suspend the update items, and for items that have failed to be updated, the remote server will push update notifications to the smartphone again at a certain frequency.

[0101] Reference Fig.10 and Fig.11 , Fig.10 Schematic diagram of the safe infusion process of the closed-loop artificial pancreas system according to an embodiment of the present invention. Fig.11 Schematic diagram of another safe infusion process of the closed-loop artificial pancreas system according to an embodiment of the present invention.

[0102] In some embodiments of the present invention, the program module 101 needs to continuously obtain the real-time blood glucose value of the detection module 100 before calculating the insulin infusion amount, and the infusion module 102 carries out normal insulin infusion, which is the first mode of the closed-loop artificial pancreas system, i.e., the closed-loop mode. Once the communication between the detection module 100, the program module 101, and the infusion module 102 is abnormal, or the sensor of the detection module 100 is damaged, etc., the program module 101 cannot receive the real-time blood glucose value data of the detection module 100 for a long time, or the real-time blood glucose value of the detection module 100 is abnormal, resulting in an abnormal insulin infusion amount, 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 the sensor is damaged and cannot be replaced with a new sensor, the infusion module 102 will stop the insulin infusion, which will have a serious adverse effect on the health of the diabetic patient and is not conducive to the patient's diabetes treatment.

[0103] Based on the above usage scenarios, the closed-loop artificial pancreas system also requires a safety guarantee 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, or the real-time blood glucose value data is abnormal, and the infusion module 102 completes the insulin infusion, so as to avoid adverse effects on the patient's health.

[0104] In some embodiments 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, such as 2 minutes, and 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 last blood glucose value data from the detection module 100, but such calculation cannot be sustained for a long time because the patient's blood glucose may change significantly after a long time.

[0105] In some embodiments of the present invention, when the closed-loop artificial pancreas system fails to obtain the real-time blood glucose value data of the detection module 100 for a continuous period of time t1, or when it is determined that the real-time blood glucose value data and the amount of insulin infusion are abnormal for a period of time, the closed-loop artificial pancreas system will enter the second mode, i.e., the learning mode. In the learning mode, the program module 101 predicts the estimated blood glucose value for the next period of time t2 based on the recorded historical blood glucose value, and calculates the estimated amount of insulin in the period of time t2 based on the estimated blood glucose value, and the infusion module 102 completes the insulin infusion in the period of time t2 to ensure the blood glucose safety of the patient in the period of time t2.

[0106] In some embodiments of the present invention, some standards need to be set for determining abnormal events of the closed-loop artificial pancreas system to distinguish them from normal events.

[0107] In some embodiments of the present invention, the closed-loop artificial pancreas system determines that the real-time blood glucose value data obtained by the detection module 100 continues to exceed a preset threshold, where the preset threshold can be set to 3.9mmol / L-13.9mmol / L. If the real-time blood glucose value is lower than 3.9mmol / L and continues for at least 3 hours, or the real-time blood glucose value is higher than 13.9mmol / L and continues for at least 5 hours, it can be considered that the closed-loop artificial pancreas system is abnormal.

[0108] In other embodiments of the present invention, the closed-loop artificial pancreas system determines that the infusion module 102 stops infusion and continues for at least 3 hours, or determines that the infusion module 102 infuses at the maximum insulin infusion rate and continues for at least 5 hours, and it can be considered that the closed-loop artificial pancreas system is abnormal. In the embodiment of the present invention, the "maximum insulin infusion rate" can be set by the patient, generally 10U / h, and this value can be modified in combination with the patient's treatment profile.

[0109] In some embodiments of the present invention, the average value of the period before the real-time blood glucose value data is missing or abnormal may be used, such as the average value for one hour (corresponding to 30 data points) or 50 data points (corresponding to 100 minutes), or the estimated blood glucose value may be calculated based on the speed and acceleration of change of the real-time blood glucose value, or in combination with the patient's historical data, or using a more complex prediction model.

[0110] In some embodiments of the present invention, the duration period t1 during which the closed-loop artificial pancreas system cannot receive real-time blood glucose value data and enters the learning mode can be set to 0 to 24 hours. After 24 hours, if the closed-loop artificial pancreas system still has not received the real-time blood glucose value data from the detection module 100 or the estimated blood glucose value data calculated by the program module 101, the closed-loop artificial pancreas system will stop infusing insulin, affecting the patient's treatment.

[0111] In some embodiments of the present invention, the learning mode, that is, the time period t2 for calculating the estimated blood glucose value can be set to 0 to 48 hours. Since the start time of the time period t2 is at the end of the time period t1, if the time period t2 is set too long, the estimated blood glucose value may deviate too much from the real-time blood glucose value, and the estimated insulin amount calculated based on the estimated blood glucose value may be dangerous for the patient.

[0112] In some embodiments 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:

[0113]

[0114] in:

[0115] t is the time period of each calculation cycle;

[0116] V t is the estimated infusion rate during time period t;

[0117] G t is the estimated blood glucose value in time period t;

[0118] G tar is the preset target blood sugar value;

[0119] ISF is the patient's insulin sensitivity.

[0120] 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.

[0121] In some embodiments of the present invention, if the time period t is set to be shorter, the insulin infusion rate calculation based on equation (1) can be repeated and iterated during the time period when the real-time blood glucose value data is missing. For example, if the time period t is set to 10 minutes, after 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 calculated again based on equation (1) to complete the insulin infusion until the closed-loop artificial pancreas system resumes receiving real-time blood glucose value data. When repeatedly calculating the estimated infusion rate, the estimated blood glucose value used comes from the secondary calculation of the estimated blood glucose value in the previous round of calculation, and the calculation method is consistent with the calculation method of the estimated blood glucose value in the previous round.

[0122] Obviously, such repeated iterative calculations have limitations. 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.

[0123] 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 precise insulin infusion during the period when the real-time blood glucose value data is missing or abnormal, which will still affect the patient's treatment effect.

[0124] In some embodiments of the present invention, in order to improve the accuracy of insulin infusion of the closed-loop artificial pancreas system during the period when the real-time blood glucose value data is missing or abnormal, the estimated infusion rate or estimated blood glucose value can also be calculated in combination with the patient's fingertip blood glucose value BG. t When calculating the estimated blood glucose value G, the weighted average method is used to calculate the estimated blood glucose value G by comprehensively considering the fingertip blood glucose value BG and the blood glucose value data of the previous period when the real-time blood glucose value data is missing or abnormal. 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 more trusted.

[0125] In some embodiments 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 GG. t In the calculation of the estimated blood sugar value G t The estimated insulin infusion rate V calculated in this way will become more reliable. t Each time the patient inputs the fingertip blood glucose value BG, 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 value data without affecting the patient's treatment.

[0126] In some embodiments 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 to 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, and the blood glucose value threshold includes the target blood glucose value G tar and high and low blood sugar thresholds, target blood sugar value G tar Used to distinguish the level of fingertip blood glucose value BG, by comparing the fingertip blood glucose value BG and the target blood glucose value G tar To determine the infusion strategy of the closed-loop artificial pancreas system.

[0127] In some embodiments 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. tarSet to 5.6mmol / L, 6.1mmol / L or 6.7mmol / L, etc.

[0128] In some embodiments of the present invention, after the patient inputs the fingertip blood glucose value BG, the program module 101 automatically converts the fingertip blood glucose value BG and the target blood glucose value GG into a single value. 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:

[0129]

[0130] in:

[0131] IOB is the amount of ineffective insulin in the patient's body.

[0132] In some embodiments 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 time 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:

[0133]

[0134] in:

[0135] ΔI is the reduced insulin infusion;

[0136] ΔV is the reduced infusion rate.

[0137] In some embodiments 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:

[0138]

[0139] In some embodiments of the present invention, if insulin infusion is performed at 75% of the estimated infusion rate, the reduced infusion rate ΔV may be determined as the estimated infusion rate V t This value is only for illustrative purposes.

[0140] In some embodiments 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 sDetermined by the following equation:

[0141]

[0142] 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.

[0143] In some embodiments of the present invention, in the case of abnormal real-time blood glucose value data, the patient can also use the fingertip blood glucose value BG to calibrate the abnormal real-time blood glucose value after obtaining it, and by comparing the calibrated real-time blood glucose value and the fingertip blood glucose value BG, the difference between the two is determined to determine whether the closed-loop artificial pancreas system can exit the learning mode and enter the closed-loop mode. Specifically, when the fingertip blood glucose value BG is not less than 5.6mmol / L, the difference between the first real-time blood glucose value and the fingertip blood glucose value BG after calibration is less than 30% relative to the fingertip blood glucose value BG, it can be considered that the real-time blood glucose value has returned to normal, and the closed-loop artificial pancreas system can exit the learning mode and enter the closed-loop mode. Alternatively, when the fingertip blood glucose value BG is greater than 5.6mmol / L, the difference between the first real-time blood glucose value and the fingertip blood glucose value BG after calibration is less than 1.7mmol / L, it can be considered that the real-time blood glucose value has returned to normal, and the closed-loop artificial pancreas system can exit the learning mode and enter the closed-loop mode. The above-mentioned numerical values ​​are only exemplary descriptions, and modifications to the numerical values ​​should be included in the protection scope of the present invention.

[0144] In some embodiments of the present invention, if the calibrated real-time blood glucose value fails to meet the aforementioned condition after the patient inputs the fingertip blood glucose value BG, that is, the difference between the two is large, the closed-loop artificial pancreas system will remain in the learning mode.

[0145] In some embodiments of the present invention, when the closed-loop artificial pancreas system determines that the real-time blood glucose value data is abnormal, it can also issue an alarm to the patient to prompt the patient to replace the sensor in time. When the closed-loop artificial pancreas system is in learning mode or safety mode, after the patient replaces the sensor, the system will switch to closed-loop mode by default, and re-determine whether the real-time blood glucose value or insulin infusion volume is abnormal in the closed-loop mode. Thereafter, according to the aforementioned abnormal event judgment conditions, it is determined whether the closed-loop artificial pancreas system switches to learning mode.

[0146] In some embodiments of the present invention, if the patient needs to eat during the duration of the learning mode, this will cause the patient's blood sugar to fluctuate greatly 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 dietary bolus I F .

[0147] Specifically, the patient measured fingertip blood glucose BG once 0-20 minutes before and 0-150 minutes after the meal. During this period, the infusion of a large dose of I F It can be determined by the following equation:

[0148]

[0149] in:

[0150] Carbs is the amount of carbohydrates in the meal, g;

[0151] IC is the insulin to carbohydrate ratio.

[0152] The patient's dietary bolus before and after meals was determined by fingertip blood glucose values ​​BG measured before and after meals, respectively.

[0153] In some embodiments of the present invention, after the maximum time period t2 that the learning mode can last, if the closed-loop artificial pancreas system still does not resume receiving real-time blood glucose value data, the closed-loop artificial pancreas system will enter the third mode, i.e., the safety mode, and last for a time period t3. In the safety mode, for the safety of the patient, the closed-loop artificial pancreas system automatically infuses insulin to the patient at a lower rate to maintain the basic insulin treatment level.

[0154] In some embodiments of the present invention, in the safety mode, the closed-loop artificial pancreas system infuses 0-30% of the normal dose of insulin at the estimated infusion rate. Preferably, the closed-loop artificial pancreas system infuses 0-10% of the normal dose of insulin at the estimated infusion rate.

[0155] In some embodiments of the present invention, the safe mode can be sustained for a t3 time 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 safety mode lasts too long, the blood sugar level may be too high, affecting the patient's treatment.

[0156] In some embodiments of the present invention, after the end of the time period t3 during which the safety mode can be sustained, if the closed-loop artificial pancreas system still has not resumed receiving the real-time blood glucose value, the patient will be prompted to input the fingertip blood glucose value, thereby extending the duration of the safety mode. Obviously, the duration of the safety mode cannot be repeatedly extended. At this time, the closed-loop artificial pancreas system can also be set to warn the patient, thereby urging the patient to take measures to resume receiving the real-time blood glucose value as soon as possible, or to send a help signal to his guardian, medical staff, sales consultant, manufacturer, etc.

[0157] In some embodiments of the present invention, if a patient uses a 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 missing, 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 extend the learning mode duration, but the extended duration will be shortened to 0 to 12 hours.

[0158] In some embodiments of the present invention, no matter 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.

[0159] In some embodiments 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 time delay allowed by the learning mode.

[0160] In some embodiments of the present invention, regardless of whether the closed-loop artificial pancreas system is currently in learning mode or safety mode, once the real-time blood glucose value data returns to normal, the closed-loop artificial pancreas system will return to the normal closed-loop mode, and calculate and infuse insulin based on the real-time blood glucose value data. In the closed-loop mode, the closed-loop artificial pancreas system can provide more accurate blood glucose monitoring and insulin infusion.

[0161] In summary, the embodiment of the present invention discloses a safe closed-loop artificial pancreas system. When the real-time blood glucose value data is abnormal and causes abnormal insulin infusion, the closed-loop artificial pancreas system enters a learning mode. In the learning mode, the closed-loop artificial pancreas system continues to calculate the insulin infusion amount required by the patient based on the historical blood glucose value and the fingertip blood glucose value, and infuses an appropriate amount of insulin into the patient. An inappropriate amount of insulin will not be infused due to abnormal real-time blood glucose value data, and the insulin infusion will not be interrupted, thereby avoiding life-threatening situations for the patient and being beneficial to the treatment of the patient.

[0162] Although some specific embodiments of the present invention have been described in detail by way of example, it will be appreciated 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 will be appreciated by those skilled in the art that the above embodiments may be modified 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 it is determined that the real-time blood glucose value or the insulin infusion amount is abnormal and lasts for a period of time, the system switches from the first mode to the second mode and lasts for another period of time; In the first mode, the insulin infusion amount is calculated according to the real-time blood glucose value, and insulin infusion is performed based on the insulin infusion amount; In the second mode, an estimated blood glucose value is calculated based on historical blood glucose values, an estimated insulin infusion amount is calculated based on the estimated blood glucose value, and insulin infusion is implemented based on the estimated insulin infusion amount.

2. The closed-loop artificial pancreas system according to claim 1, characterized in that: The abnormality includes that the real-time blood glucose value exceeds a preset threshold, or the infusion module infuses at a maximum insulin infusion rate, or the infusion module suspends infusion.

3. The closed-loop artificial pancreas system according to claim 2, characterized in that: The preset threshold value is 3.9mmol / L-13.9mmol / L.

4. The closed-loop artificial pancreas system according to claim 2, characterized in that: The maximum insulin infusion rate is 10 U / h.

5. The closed-loop artificial pancreas system according to claim 2, characterized in that: During the duration of the second mode, if the real-time blood glucose value recovers to within the preset threshold range, the system switches from the second mode back to the first mode.

6. The closed-loop artificial pancreas system according to claim 2, characterized in that: The historical blood sugar value at least includes the real-time blood sugar value before the abnormality.

7. The closed-loop artificial pancreas system according to claim 6, 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.

8. The closed-loop artificial pancreas system according to claim 7, characterized in that: When the estimated blood glucose level is calculated based on the fingertip blood glucose level, the second mode duration may be extended.

9. The closed-loop artificial pancreas system according to claim 7, characterized in that: At the end of the second mode duration, if the fingertip blood glucose value is not provided, the system switches from the second mode to the third mode.

10. The closed-loop artificial pancreas system according to claim 9, characterized in that: In the third mode, the insulin infusion amount is 0-30% of the estimated insulin infusion amount.

11. The closed-loop artificial pancreas system according to claim 7, characterized in that: The fingertip blood glucose value is also used to calibrate the real-time blood glucose value.

12. The closed-loop artificial pancreas system according to claim 11, characterized in that: If the real-time blood glucose value after calibration meets a predetermined condition, the system switches from the second mode back to the first mode; otherwise, the system remains in the second mode.

13. The closed-loop artificial pancreas system according to claim 12, characterized in that: The predetermined condition is that when the fingertip blood sugar value is not less than 5.6 mmol / L, the difference ratio between the first real-time blood sugar value after the fingertip blood sugar value is input and the fingertip blood sugar value is less than 30%.

14. The closed-loop artificial pancreas system according to claim 12, characterized in that: The predetermined condition is that when the fingertip blood sugar value is less than 5.6 mmol / L, the difference between the first real-time blood sugar value after the fingertip blood sugar value is input and the fingertip blood sugar value is less than 1.7 mmol / L.

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