Management system for blood glucose monitoring and insulin infusion

Abstract

The invention discloses a blood glucose monitoring and insulin infusion management system which comprises at least one wearable medical device, a smart phone provided with a special APP for controlling the medical device, and a remote server. The smart phone controls the wearable medical equipment to update software or firmware, and the update of the medical equipment does not need to be completed through more intermedia, so that the update mode of the medical equipment is more convenient and quicker.

Description

Management system for blood glucose monitoring and insulin infusion Technical Field

[0001] The present invention mainly relates to the field of diabetes monitoring and management, and in particular to a management system for blood sugar monitoring and insulin 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] Diabetics typically monitor their blood sugar and take insulin to maintain a relatively stable blood sugar level. Currently, major manufacturers of blood glucose monitors and insulin pumps, such as Abbott and Dexcom, and FactorLite, all use dedicated handheld devices (PDMs) to control their CGMs or insulin pumps. Because PDMs are typically designed as low-power devices that communicate only with other devices via Bluetooth or NFC, when a CGM or insulin pump update is needed, the manufacturer typically pushes the latest installation package to a computer via a remote server and authorizes the user to manually download the update using a computer and connect the CGM and / or insulin pump to the computer to initiate and complete the update. This process can be particularly cumbersome for users who are unfamiliar or unaccustomed to modifying their CGM and / or insulin pumps. Consequently, users may avoid updates, missing out on important bug fixes, security updates, and new features. On this basis, Abbott has upgraded the update method of CGM, allowing users 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 finally the PDM controls the CGM to complete the update. The process is still relatively cumbersome, and users may still avoid updating, thereby missing important bug fixes, security updates, and new features.

[0005] Therefore, the prior art urgently needs a system that can conveniently and quickly complete the update of the software or firmware of the CGM and / or insulin pump.

[0006] Summary of the Invention

[0007] The present invention discloses a management system for blood glucose monitoring and insulin infusion, which includes at least one wearable medical device, a smartphone installed with a dedicated APP for controlling the medical device, and a remote server. When the remote server pushes update information to the smartphone, the smartphone controls the wearable medical device to update the software or firmware without the need for more intermediaries to complete the update of the medical device, making the update method of the medical device more convenient and quick.

[0008] An embodiment of the present invention discloses a system comprising at least one wearable medical device; a smartphone installed with a dedicated APP for controlling the at least one wearable medical device; and a remote server that communicates with the smartphone via remote communication. When the remote server pushes update information to the smartphone, the smartphone controls the at least one wearable medical device to update software or firmware.

[0009] According to one aspect of the present invention, the at least one wearable medical device includes a CGM and / or an insulin pump.

[0010] According to one aspect of the present invention, the CGM and / or insulin pump are controlled by the same dedicated APP installed in the smartphone.

[0011] According to one aspect of the present invention, update information is pushed to a dedicated APP or application store of the smartphone.

[0012] According to one aspect of the present invention, after receiving the update information, the smart phone needs user confirmation before entering the update step.

[0013] According to one aspect of the present invention, if the updating step is interrupted, the updating step can be entered again after the cause of the interruption is eliminated and user confirmation is required.

[0014] According to one aspect of the present invention, if the updating step is interrupted, the updating step is directly entered again after the interruption cause is eliminated.

[0015] According to one aspect of the present invention, the smart phone directly enters the updating step after receiving the updating information without user confirmation.

[0016] According to one aspect of the present invention, if the updating step is interrupted, the updating step is directly entered again without user confirmation after the interruption cause is eliminated.

[0017] According to one aspect of the present invention, after the updating step is completed, the smart phone reports the updating result to the remote server, where the updating result includes whether the updating is successful or failed.

[0018] According to one aspect of the present invention, at least one wearable medical device is paired with patient personal information in a smartphone via identifier information.

[0019] According to one aspect of the present invention, the identifier is provided on an outer packaging or housing of at least one wearable medical device.

[0020] According to one aspect of the present invention, at least one wearable medical device includes a reusable portion, and the identifier is provided on an outer packaging or housing of the reusable portion.

[0021] According to one aspect of the present invention, the identifier is provided in the form of a QR code, a barcode, or an NFC tag.

[0022] According to one aspect of the present invention, the present invention includes a personal dedicated handheld device, which communicates with at least one wearable medical device and a smart phone via Bluetooth.

[0023] According to one aspect of the present invention, the CGM and / or insulin pump can be controlled by the same dedicated handheld device.

[0024] According to one aspect of the present invention, the smart phone and the dedicated handheld device are used by a guardian and the patient respectively, and the guardian can limit the patient's operations through a lock mode.

[0025] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0026] The blood glucose monitoring and insulin infusion management system disclosed in the present invention comprises at least one wearable medical device, a smartphone equipped with a dedicated APP for controlling the medical device, and a remote server. When the remote server pushes update information to the smartphone, the smartphone controls the wearable medical device to update the software or firmware without the need for further intermediaries to complete the update of the medical device, making the updating of the medical device more convenient and quick.

[0027] Furthermore, the CGM and / or insulin pump are controlled by the same dedicated APP in the smartphone, avoiding the inconvenience in the use and update of the CGM and insulin pump caused by the fact that CGM and insulin pumps produced by different manufacturers require their own dedicated APP control, thereby improving the user experience.

[0028] Furthermore, for mandatory update items, the smartphone automatically enters the update step after receiving the update information. Even if the process is interrupted, it will automatically enter the update step again after the cause of the interruption is eliminated without the need for user confirmation first. On the one hand, it can simplify the update process, and on the other hand, it can prevent users from forgetting to confirm after the interruption is resumed and missing important bug fixes, security updates and new features.

[0029] Furthermore, for non-mandatory update items, after receiving the update information, the smartphone requires the user to confirm before entering the update step. When the process is interrupted and the cause of the interruption is eliminated, the user is required to confirm again before entering the update step, giving the user sufficient choices and improving the user experience.

[0030] Furthermore, for non-mandatory update items, the smartphone enters the update step after receiving the update information and the user confirms the update. If the process is interrupted, it automatically enters the update step after the cause of the interruption is eliminated. Since the user has confirmed the update, it indicates that the user has chosen to update. Automatically entering the update step after the interruption is restored can also reduce the user's operations and enable the update to be completed smoothly.

[0031] Furthermore, it also includes a personal dedicated handheld device (PDM), and the user can control the CGM and / or insulin pump through the PDM and / or smart phone, which is convenient for the user.

[0032] Furthermore, the CGM and / or insulin pump can be controlled through the same PDM and / or smartphone, further facilitating user use.

[0033] Furthermore, PDM and smartphones can be used by different people respectively. For example, the patient himself uses PDM, and the guardian or medical staff uses smartphones. The guardian can also limit the patient's operations on PDM through the lock mode. For the elderly, young children and other people who need special care, the lock mode can prevent patients from operating incorrectly and improve safety of use. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

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

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

[0039] 5a-5d are schematic diagrams of the operating environment of existing blood glucose management and insulin infusion management systems;

[0040] 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;

[0041] 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;

[0042] FIG8 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention;

[0043] Figures 9a and 9b are schematic diagrams of interfaces when an APP is in the foreground according to an embodiment of the present invention;

[0044] FIG9c and FIG9d are schematic diagrams of interfaces of an APP in the background according to an embodiment of the present invention. DETAILED DESCRIPTION

[0045] As mentioned above, when software or firmware of existing medical devices needs to be updated, an intermediate medium such as a computer or smartphone is required to send the update information to the PDM, and then the medical device is updated through the PDM. Since the process is relatively cumbersome, users may avoid updating and miss out on important bug fixes, security updates and new features.

[0046] In order to solve this problem, an embodiment of the present invention discloses a management system for blood glucose monitoring and insulin infusion, which includes at least one wearable medical device, a smartphone installed with a dedicated APP for controlling the medical device, and a remote server. When the remote server pushes update information to the smartphone, the smartphone controls the wearable medical device to update the software or firmware without the need for more intermediaries to complete the update of the medical device, making the update method of the medical device more convenient and quick.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system.

[0052] 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 .

[0053] The detection module 100 is used to continuously monitor the user's current blood glucose level. Typically, the detection module 100 is a continuous glucose monitoring (CGM), which can detect the user's current blood glucose level in real time, monitor blood glucose changes, and send the current blood glucose information to the program module 101. The CGM includes an implantable sensor connected to a transmitter. The transmitter also includes a memory, a processor, a communication interface, etc. The transmitter is used to transmit at least the blood glucose data monitored by the CGM and the CGM identifier information.

[0054] The infusion module 102 includes the necessary mechanical structures and electronic control unit for insulin infusion, such as a drug reservoir, a drive mechanism, an infusion line and needle, a power supply, and a circuit board. These components are controlled by the program module 101. Typically, the infusion module 102 is an insulin pump, and the electronic control unit includes a memory, a processor, and a communication interface. Based on the current insulin infusion volume data transmitted by the program module 101, the infusion module 102 delivers the currently required insulin to the user's body. Simultaneously, the infusion status of the infusion module 102 is also fed back to the program module 101 in real time.

[0055] 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.

[0056] 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.

[0057] In one embodiment of the present invention, the three modules are electrically connected to form a single integrated structure. Therefore, they are applied to the same location on the user's skin. By connecting the three modules as a single unit and applying them to the same location, the number of devices attached to the user's skin is reduced, thereby minimizing interference with user activities caused by multiple devices being attached. Furthermore, this effectively resolves the issue of wireless communication reliability between separate devices, further enhancing the user experience.

[0058] In another embodiment of the present invention, the program module 101 and the infusion module 102 are interconnected to form an integrated structure, while the detection module 100 is separately provided in another structure. In this case, the detection module 100 and the program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, the program module 101 and the infusion module 102 are attached to a certain location on the user's skin, while the detection module 100 is attached to another location on the user's skin.

[0059] In another embodiment of the present invention, program module 101 and detection module 100 are interconnected to form a single device, while infusion module 102 is located in a separate structure. Infusion module 102 and program module 101 transmit wireless signals to each other to achieve mutual connection. Thus, program module 101 and detection module 100 can be attached to a specific location on the user's skin, while infusion module 102 can be attached to another location on the user's skin.

[0060] In another embodiment of the present invention, the three modules are disposed in different structures. Thus, the three modules are attached to different locations on the user's skin. In this case, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to establish connections.

[0061] 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 user'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.

[0062] 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).

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] In an embodiment of the present invention, the insulin pump is a patch-type insulin pump, that is, an insulin pump that does not include a long catheter, includes an infusion structure and a control structure, and is adhered as a whole to the user's skin surface by a same adhesive patch. The drug is directly infused from the drug storage cartridge along the infusion needle into the subcutaneous tissue.

[0071] 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.

[0072] 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 adhered to a certain position on the user's skin through an adhesive patch 420, and are discarded as a whole after one-time use; the identifier can be set on the outer housing or outer packaging of the insulin pump or inside the insulin pump.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 5a-5d are schematic diagrams of the operating environment of existing blood glucose management and insulin infusion management systems.

[0077] 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 communicate only with other devices via methods like 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 user 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 users who are unfamiliar or unaccustomed to modifying their CGM or insulin pump. Consequently, users may avoid updates, missing out on important bug fixes, security updates, and new features.

[0078] Currently, Abbott has upgraded the update method of CGM, as shown in Figure 5b, allowing users 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, and then the PDM controls the CGM to complete the update. Although this method can simplify the update process to a certain extent and does not require the update to be completed through a computer, it still requires an intermediary, the smartphone, to connect to the remote server and PDM, and then the PDM controls the CGM to complete the update. The process is still relatively cumbersome, and users may still avoid updating, thereby missing important bug fixes, security updates and new features.

[0079] 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 users 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 it also requires multiple intermediaries to complete the update. This further increases the risk of users avoiding updates and missing out on important bug fixes, security updates, and new features.

[0080] 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.

[0081] 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 user's skin surface, the user can search and download a dedicated app for controlling the CGM and / or insulin pump in the smartphone's app store. The user 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 user 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., and the information of the CGM and / or insulin pump worn includes the identifier information of the CGM and / or insulin pump. At the same time, the smartphone uploads the patient's personal information and the identifier information of the CGM and / or insulin pump to a remote server. The remote server can store the information uploaded by the smartphone and verify whether the identifier information of the CGM and / or insulin pump is valid. If a certain identifier information already exists in the remote server, the remote server will send a prompt to the smartphone to remind the user that the CGM or insulin pump has been used and needs to be replaced. When the CGM and / or insulin pump is installed on the 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.

[0082] 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 avoid the inconvenience caused to the user by using different APPs to control the CGM and insulin pump respectively, thereby improving the user experience.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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 between PDM and CGM and / or insulin pump is similar to the pairing method between smartphone and CGM and / or insulin pump mentioned above. The user 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 user can also be the patient himself, medical staff or guardians. Preferably, in one embodiment of the present invention, the PDM and the smartphone are used by different persons respectively. For example, 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. This 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.

[0089] 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 user by using different PDMs to control the CGM and insulin pump respectively, and improve the user experience.

[0090] FIG8 is a flowchart of software or firmware update on a medical device according to an embodiment of the present invention.

[0091] 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.

[0092] Step 801: The remote server pushes CGM and / or insulin pump update information to the smartphone;

[0093] 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.

[0094] Step 802 , the smartphone receives updated information about the CGM and / or insulin pump;

[0095] When the remote server sends 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 user 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 user can click OK to receive the update information. If the user 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 at a gradually longer interval over time, until the user responds.

[0096] 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.

[0097] Step 803, the smartphone enters the update step;

[0098] 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.

[0099] In one embodiment of the present invention, after a user 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 user 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 will prompt the user to re-enter the update process. After the user clicks "Confirm," the update process will resume until the update process is complete.

[0100] In another embodiment of the present invention, after the signal is restored or other fault causes are resolved, the smart phone directly enters the update step again without the need for user confirmation first.

[0101] In another embodiment of the present invention, when the update items uploaded by the manufacturer include items that are mandatory updates, when the user receives the update information through a dedicated APP or application store, the smartphone automatically starts the update step without the user 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 user through visual, auditory, or sensory methods such as text messages, vibrations, ringing, and flashing lights, and after the signal is restored or the cause of the other fault is resolved, the smartphone directly enters the update step again without the user having to confirm first.

[0102] Step 704: The smartphone reports the update result to the remote server.

[0103] After the user 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.

[0104] 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.

[0105] In summary, an embodiment of the present invention discloses a management system for blood glucose monitoring and insulin infusion, which includes at least one wearable medical device, a smartphone installed with a dedicated APP for controlling the medical device, and a remote server. When the remote server pushes update information to the smartphone, the smartphone controls the wearable medical device to update the software or firmware without the need for more intermediaries to complete the update of the medical device, making the update method of the medical device more convenient and quick.

[0106] 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 system comprising: At least one wearable medical device; A smart phone with a dedicated APP installed for controlling the at least one wearable medical device; A remote server communicates with the smart phone via remote communication; characterized in that: After the remote server pushes the update information to the smart phone, the smart phone controls the at least one wearable medical device to update the software or firmware.

2. The system according to claim 1, characterized in that The at least one wearable medical device includes a CGM and / or an insulin pump.

3. The system according to claim 2, characterized in that The CGM and / or the insulin pump are controlled by the same dedicated APP installed in the smartphone.

4. The system according to claim 3, characterized in that The update information is pushed to the dedicated APP or application store of the smartphone.

5. The system according to claim 4, characterized in that After receiving the update information, the smart phone needs user confirmation before entering the update step.

6. The system according to claim 5, characterized in that If the updating step is interrupted, the updating step can be entered again after the interruption cause is eliminated and the user confirms.

7. The system according to claim 5, characterized in that If the updating step is interrupted, the updating step is directly entered again after the interruption cause is eliminated.

8. The system according to claim 4, characterized in that After receiving the update information, the smart phone directly enters the update step without user confirmation.

9. The system according to claim 8, characterized in that If the updating step is interrupted, the updating step is directly entered again without the user's confirmation after the interruption cause is eliminated.

10. The system according to claim 5 or 8, characterized in that: After the updating step is completed, the smart phone reports the updating result to the remote server, where the updating result includes updating success or updating failure.

11. The system according to claim 1, characterized in that The at least one wearable medical device is paired with the patient's personal information in the smartphone through identifier information.

12. The system according to claim 11, characterized in that The identifier is disposed on an outer packaging or housing of the at least one wearable medical device.

13. The system according to claim 12, characterized in that The at least one wearable medical device includes a reusable portion, and the identifier is disposed on an outer packaging or housing of the reusable portion.

14. The blood sugar management system for use in a hospital according to claim 13, characterized in that: The identifier is provided in the form of a QR code, a barcode, or an NFC tag.

15. The system according to claim 2, characterized in that Also included is a personal dedicated handheld device, which communicates with the at least one wearable medical device and the smart phone via Bluetooth.

16. The system according to claim 15, characterized in that The CGM and / or the insulin pump may be controlled by the same dedicated handheld device.

17. The system according to claim 16, characterized in that The smart phone and the dedicated handheld device are used by a guardian and the patient himself respectively, and the guardian can limit the operation of the patient himself through a locking mode.

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