Control system for blood glucose monitoring and management

Abstract

A control system for blood glucose monitoring and management. A first working mode of the control system is to control a blood glucose monitoring device to perform real-time blood glucose monitoring. The control system enters a second working mode on the basis of a trigger condition, and the second working mode at least comprises controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling an insulin infusion device to perform insulin infusion. By means of the trigger condition, the control system enters the second working mode of at least controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion from the first working mode of controlling the blood glucose monitoring device to perform real-time blood glucose monitoring, so that a patient is prevented from accidentally entering unnecessary or unauthorized working modes, and the safety of blood glucose monitoring and management of the patient is improved.

Description

A control system for blood sugar monitoring and management Technical Field

[0001] The present invention relates generally to the field of medical devices, and in particular to a control system for blood sugar monitoring and management. Background Art

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

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

[0004] Doctors will give different recommendations based on the severity of the patient's illness and their individual health conditions. For example, patients with very mild symptoms may only need to regularly measure a small amount of fingertip blood for testing. General diabetics can achieve self-monitoring and management of their blood sugar through continuous blood glucose monitoring. For more severe diabetics, a doctor's intervention is required to adopt a targeted insulin infusion plan to restore the diabetic's blood sugar level to a relatively stable state. At the same time, personalized diet and exercise plans are provided to enable patients to achieve self-monitoring and management of their blood sugar. The device for continuous blood glucose monitoring is generally a CGM, and the device for drug infusion is generally an insulin pump. Because inaccuracies in insulin infusion can pose risks of high and low blood sugar to patients, patients must first be evaluated by a doctor before using an insulin pump to confirm that their physical condition is suitable for the use of an insulin pump, and at the same time, they must follow the insulin infusion plan prescribed by the doctor.

[0005] Currently, major manufacturers of blood glucose monitoring devices and insulin infusion devices, such as Abbott and Dexcom, which produce blood glucose monitoring devices (CGMs), and FactorWright, which produce insulin infusion devices (insulin pumps), all use their own dedicated handheld devices to control the corresponding CGM or insulin pump. When using the CGM and / or insulin pump, they need to use the corresponding control devices separately. However, Yiyu Technology produces both CGM and insulin pumps. When producing the corresponding control devices, it considers the compatibility of the control of CGM and insulin pumps, so that the CGM and / or insulin pump can be controlled simultaneously with a single control device. As mentioned above, since not all patients need to use CGM and insulin pumps at the same time, if the user interface of the control device displays both CGM and insulin pump related functions, for patients who do not need the insulin pump function, displaying both CGM and insulin pump related functions in the user interface will not only make the interface display more complicated and affect the user's visual experience, but also may affect the normal use of the CGM function due to patients' misoperation of the insulin pump function.

[0006] Therefore, the prior art urgently needs a control system that can achieve safe control of CGM and insulin pump according to different situations through simple operation.

[0007] Summary of the Invention

[0008] An embodiment of the present invention discloses a control system for blood glucose monitoring and management. The first working mode of the control system is to control a blood glucose monitoring device to perform real-time blood glucose monitoring. Based on a trigger condition, the control system enters a second working mode. The second working mode at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling an insulin infusion device to perform insulin infusion. Through the trigger condition, the control system enters from the first working mode of controlling the blood glucose monitoring device to perform real-time blood glucose monitoring to the second working mode of at least controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion, thereby preventing the patient from mistakenly entering an unnecessary or unauthorized working mode and improving the safety of the patient's blood glucose monitoring and management.

[0009] The present invention discloses a control system for blood glucose monitoring and management, comprising a processor and a memory, wherein programming instructions are stored in the memory, and the processor executes the programming instructions to perform the following operations: the control system includes at least a first working mode, wherein the first working mode is to control a blood glucose monitoring device to perform real-time blood glucose monitoring; based on a trigger condition, the control system enters a second working mode, wherein the second working mode at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling an insulin infusion device to perform insulin infusion.

[0010] According to one aspect of the present invention, the triggering condition at least includes that the patient account for which the second working mode needs to be enabled exists in the whitelist of the background administrator.

[0011] According to one aspect of the present invention, the whitelist is generated by medical staff sending a whitelist addition application to a backend administrator.

[0012] According to one aspect of the present invention, the backend administrator directly controls the control system to enter the second working mode after adding the whitelist.

[0013] According to one aspect of the present invention, the backend administrator sends a security code to the patient account after adding the whitelist, and the patient controls the control system to enter the second working mode through the security code.

[0014] According to one aspect of the present invention, the patient reminds the medical staff to send a whitelist addition application to the backend management.

[0015] According to one aspect of the present invention, after receiving the whitelist application, the backstage administrator sends feedback to the medical staff, and after receiving the feedback, the medical staff notifies the patient to send an application to the backstage administrator.

[0016] According to one aspect of the present invention, the backend administrator directly controls the control system to enter the second working mode after receiving the application.

[0017] According to one aspect of the present invention, after receiving the application, the backend administrator sends a security code to the patient's account, and the patient controls the system to enter the second working mode through the security code.

[0018] According to one aspect of the present invention, the second working mode further includes an automatic mode.

[0019] According to one aspect of the present invention, the triggering condition of the automatic mode at least includes that the patient account for which the automatic mode needs to be enabled exists in the whitelist of the backend administrator.

[0020] According to one aspect of the present invention, the whitelist is generated by medical staff sending a whitelist addition application to a backend administrator.

[0021] According to one aspect of the present invention, the backend administrator directly controls the control system to enter the automatic mode after adding the whitelist.

[0022] According to one aspect of the present invention, the backend administrator sends a security code to the patient account after adding the patient to the whitelist, and the patient controls the system to enter automatic mode through the security code.

[0023] According to one aspect of the present invention, the patient reminds the medical staff to send a whitelist addition application to the backend management.

[0024] According to one aspect of the present invention, after receiving the whitelist application, the backstage administrator sends feedback to the medical staff, and after receiving the feedback, the medical staff notifies the patient to send an application to the backstage administrator.

[0025] According to one aspect of the present invention, the backend administrator directly controls the control system to enter the automatic mode after receiving the application.

[0026] According to one aspect of the present invention, after receiving the application, the backend administrator sends a security code to the patient's account, and the patient controls the control system to enter the automatic mode through the security code.

[0027] According to one aspect of the present invention, the control system is a smart phone.

[0028] According to one aspect of the present invention, the control system is an APP installed in a smart phone.

[0029] According to one aspect of the present invention, after the control system enters the second working mode, the APP main interface displays insulin infusion related functions.

[0030] According to one aspect of the present invention, when the patient account is deleted from the whitelist, the control system exits the second working mode.

[0031] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0032] In the control system for blood glucose monitoring and management disclosed in the present invention, the first working mode of the control system is to control the blood glucose monitoring device to perform real-time blood glucose monitoring. Based on the trigger condition, the control system enters the second working mode. The second working mode at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion. Through the trigger condition, the control system enters from the first working mode of controlling the blood glucose monitoring device to perform real-time blood glucose monitoring to the second working mode of at least controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion, thereby preventing the patient from mistakenly entering an unnecessary or unauthorized working mode, thereby improving the safety of the patient's blood glucose monitoring and management.

[0033] Furthermore, the triggering condition is at least based on a whitelist list existing in the background administrator account, further improving the security of the patient's blood glucose monitoring and management.

[0034] Furthermore, the whitelist application is sent by medical staff to the backend administrator, indicating that after the evaluation of medical staff, the patient can indeed enter the second working mode to ensure the safety of the patient's blood sugar monitoring and management.

[0035] Furthermore, the patient can send an application to the backend administrator to enable the insulin pump function. The backend administrator will verify whether the patient's account exists in the whitelist bill. If so, the insulin pump function will be turned on to ensure the security of the patient's blood sugar monitoring and management. If not, feedback will be sent to the patient, asking the medical staff to send a whitelist application, and the medical staff will further confirm whether the patient can enter the second working mode. On the one hand, it ensures the safety of the patient's blood sugar monitoring and management, and on the other hand, it reminds the medical staff to send an application to add to the whitelist, so that the medical staff will not be too busy and forget to send an application to add certain patient accounts to the whitelist list of the backend administrator.

[0036] Furthermore, after adding the whitelist, the backend administrator can directly control the control system to enter the second working mode, simplifying the patient's operation, or send a security code to the patient's account, and the patient can control the control system to enter the second working mode through the security code. The patient can decide when to enter the second working mode according to the actual situation, providing a better user experience.

[0037] Furthermore, the second operating mode also includes an automatic mode. Automatic mode is entered upon triggering conditions and can be accessed at will by non-patients, ensuring the safety of automatic mode. The triggering conditions are based on at least a whitelist stored in the backend administrator account, further enhancing the security of patient blood sugar monitoring and management.

[0038] Furthermore, the whitelist application is sent by medical staff to the backend administrator, indicating that after the medical staff's evaluation, the patient can indeed enter the automatic mode and the patient's blood sugar monitoring and management are safe.

[0039] Furthermore, the patient can send an application to the backend administrator to enable the automatic mode. The backend administrator will verify whether the patient's account exists in the whitelist bill. If so, the automatic mode function will be turned on to ensure the security of the patient's blood glucose monitoring and management. If not, feedback will be sent to the patient, asking the medical staff to send a whitelist application, and the medical staff will further confirm whether the patient can enter the automatic mode. On the one hand, it ensures the safety of the patient's blood glucose monitoring and management, and on the other hand, it reminds the medical staff to send an application to add to the whitelist, so that the medical staff will not be too busy and forget to send an application to add certain patient accounts to the whitelist list of the backend administrator.

[0040] Furthermore, after adding the whitelist, the backend administrator can directly control the control system to enter automatic mode, simplifying the patient's operation, or send a security code to the patient's account, and the patient can control the control system to enter automatic mode through the security code. The patient can decide when to enter automatic mode based on actual conditions, providing a better user experience.

[0041] Furthermore, the control system is the same APP in the smartphone, which makes it convenient for patients to use one APP to control blood glucose monitoring and insulin infusion at the same time, providing convenience for patients.

[0042] Furthermore, after the control system enters the second working mode from the first working mode, the insulin infusion-related functions are displayed on the main interface of the APP, so that the patient can keep the interface simple when only the first working mode is needed, and the notification prevents the patient from misoperating the insulin pump function and affecting the normal use of the first working mode.

[0043] Furthermore, when the patient no longer needs to use the second working mode, the patient can turn off the second working mode by himself, or the doctor and / or patient can send a closing application to the backend administrator. After the backend administrator accepts the application, the second working mode will be closed and the patient account will be removed from the whitelist. The various methods are convenient for patients to choose and improve the patient user experience.

[0044] Furthermore, after the system is controlled in automatic mode, the functions related to the automatic mode are displayed on the APP interface, so that the patient can keep the interface simple when the automatic mode is not needed, and the notification prevents the patient from misoperating the automatic mode and affecting the normal use of other working modes.

[0045] Furthermore, when the automatic mode is no longer needed, the patient can turn it off by himself, or the doctor and / or patient can send a shutdown application to the backend administrator. After the backend administrator accepts the application, the automatic mode is turned off and the patient account is removed from the whitelist. The various methods are convenient for patients to choose and improve the patient user experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system;

[0047] FIG2 is a schematic structural diagram of an integrated CGM according to an embodiment of the present invention;

[0048] FIG3 is a schematic structural diagram of a split-type CGM according to an embodiment of the present invention;

[0049] FIG4 a is a schematic structural diagram of an integrated insulin pump according to an embodiment of the present invention;

[0050] FIG4 b is a schematic structural diagram of a split-type insulin pump according to an embodiment of the present invention;

[0051] FIG5a is a schematic diagram of a main interface of a control system in a first working mode according to an embodiment of the present invention;

[0052] FIG5 b is a schematic diagram of the main interface of the control system according to an embodiment of the present invention when the control system is in the second working mode;

[0053] 6a-6c are schematic diagrams of different operations of enabling the insulin pump function of a control system according to an embodiment of the present invention;

[0054] 7a-7c are schematic diagrams of different operations of turning on the automatic mode function of a control system according to an embodiment of the present invention;

[0055] 8a-8b are schematic diagrams of an APP interface before and after the automatic mode function is turned on in a control system according to an embodiment of the present invention. DETAILED DESCRIPTION

[0056] As mentioned above, due to the different severity of diabetes patients, not all patients need CGM monitoring of blood sugar and insulin pump infusion of insulin at the same time. The existing control system separately controls CGM monitoring of blood sugar and insulin pump infusion of insulin. Therefore, a simple control system is needed that can simultaneously control CGM monitoring of blood sugar and / or insulin pump infusion of insulin, and can conveniently switch between controlling CGM monitoring of blood sugar and / or insulin pump infusion of insulin according to the patient's severity of illness.

[0057] In order to solve this problem, the present invention provides a control system for blood glucose monitoring and management. The first working mode of the control system is to control the blood glucose monitoring device to perform real-time blood glucose monitoring. Based on the trigger condition, the control system enters the second working mode. The second working mode at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion. Through the trigger condition, the control system enters from the first working mode of controlling the blood glucose monitoring device to perform real-time blood glucose monitoring to the second working mode of at least controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion, thereby preventing the patient from mistakenly entering an unnecessary or unauthorized working mode, thereby improving the safety of the patient's blood glucose monitoring and management.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] FIG1 is a schematic diagram showing the relationship between modules of a general closed-loop artificial pancreas insulin infusion control system.

[0063] 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 .

[0064] 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.

[0065] 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.

[0066] Program module 101 controls the operation of detection module 100 and infusion module 102 and includes memory, a processor, a communication interface, a display, a user interface, and the like. The memory stores programming instructions, and the processor executes the programming instructions. Program module 101 is connected to detection module 100 and infusion module 102, respectively. This connection can include conventional electrical or wireless connections.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] In another embodiment of the present invention, the three modules are arranged in separate structures. Thus, the detection module 100 and the infusion module 102 are attached to different locations on the user's skin, while the program module 101 does not need to be attached to the skin. Instead, the detection module 100 and the infusion module 102 are controlled by a handheld or portable device, such as a PDM or a smartphone. In this case, the program module 101 transmits wireless signals to and from the detection module 100 and the infusion module 102, respectively, to establish a connection between them.

[0073] 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).

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] As mentioned above, depending on the severity of the patient's illness and their individual health conditions, some patients may only need CGM for continuous blood glucose monitoring, while others may need not only CGM for continuous blood glucose monitoring but also an insulin pump for drug infusion. When a doctor determines that a patient only needs to use CGM for continuous blood glucose monitoring, since CGM only involves monitoring the patient's blood glucose, the user's own use of CGM will not pose a risk to the user's life safety. Therefore, the user can purchase CGM on their own. Before the CGM is installed on the user's skin surface, the user can search and download a dedicated APP for controlling CGM in the smartphone's app store, create a new account on the dedicated APP, pair the patient's personal information with the CGM information to be worn, and thus achieve pairing and control of the smartphone and CGM. The CGM and insulin pump in the embodiment of the present invention are developed and produced by the same manufacturer and can therefore be controlled by the same dedicated APP in the smartphone. Since not all patients need to use an insulin pump, the default home screen of the dedicated APP only involves CGM-related content, as shown in Figure 5a. On the one hand, this can simplify the APP interface and provide a better visual experience for the user, and on the other hand, prevent the user from misoperating the insulin pump function and affecting the normal use of the CGM function.

[0088] In one embodiment of the present invention, when a doctor determines that a patient needs to use an insulin pump for drug infusion, as shown in Figure 6a, the doctor sends a request to the backend administrator to add the patient's account to the whitelist, allowing the patient to use the insulin pump function. The backend administrator receives the whitelist addition request sent by the doctor, adds the patient's account to the whitelist, and sends feedback to the doctor that the whitelist addition has been completed. Furthermore, the backend administrator directly opens the insulin pump function on the APP interface used by the patient. At this time, the APP interface changes from Figure 5a to Figure 5b. Compared with the interface of Figure 5a, the interface of Figure 5b adds two function keys related to insulin infusion, "Insulin Delivery" and "Easyloop". In another embodiment of the present invention, the backend administrator does not directly open the insulin pump function on the APP interface used by the patient, but instead sends a security code to the patient's account. The patient can use the security code to open the insulin pump function on the APP interface when needed or convenient.

[0089] In another embodiment of the present invention, when a doctor determines that a patient requires an insulin pump for medication infusion, as shown in Figure 6b, the patient can directly submit a request to enable the insulin pump function to the backend administrator. Upon receiving the request, the backend administrator will verify whether the patient's account is on a whitelist. If the patient's account is on the whitelist, the backend administrator will enable the insulin pump function in the patient's app interface, and the app interface will change from Figure 5a to Figure 5b. If the patient's account is not on the whitelist, the backend administrator will send a feedback message to the patient's account, reminding the patient to ask the doctor to submit a request to add the patient to the whitelist. After the doctor sends the whitelist request to the backend administrator, the backend administrator can directly enable the insulin pump function in the patient's app interface. If the doctor does not receive a response from the backend administrator within a certain period of time (e.g., 1 minute, 2 minutes, or 5 minutes), the backend administrator can submit another request to enable the insulin pump function to the backend administrator, or ask the doctor to submit a whitelist request to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly enable the insulin pump function in the patient's app interface. Instead, the backend administrator sends a security code to the patient's account, which the patient can use to enable the insulin pump function in the app interface when needed or convenient.

[0090] In another embodiment of the present invention, when the doctor determines that the patient needs to use an insulin pump for drug infusion, as shown in Figure 6c, the doctor sends an application to the backend administrator, requesting that the patient's account be added to the whitelist, allowing the patient to use the insulin pump function. The backend administrator receives the whitelist addition application sent by the doctor and adds the patient's account to the whitelist list. At the same time, feedback is sent to the doctor that the whitelist addition has been completed. Further, the doctor notifies the patient that he or she can apply to use the insulin pump function; after receiving the doctor's notification, the patient sends an application to open the insulin pump function to the backend administrator. After the backend administrator receives the application to open the insulin pump function sent by the patient, the backend administrator directly opens the insulin pump function on the APP interface used by the patient. In another embodiment of the present invention, after the backend administrator receives the application to open the insulin pump function sent by the patient, it can also first verify whether the patient's account exists in the whitelist. If it is determined that the patient's account is in the whitelist list, the backend administrator opens the insulin pump function on the APP interface used by the patient. In another embodiment of the present invention, the backend administrator does not directly open the insulin pump function on the APP interface used by the patient, but sends a security code to the patient's account. The patient can use the security code to open the insulin pump function on the APP interface when needed or convenient.

[0091] When the doctor determines that the patient no longer needs to have the insulin pump function enabled, the patient can disable the insulin pump function on the app. The app will automatically send a message to the backend administrator, who will then delete the patient account from the whitelist. The doctor and / or patient can also send a request to the backend administrator to disable the insulin pump function. The backend administrator will disable the insulin pump function on the patient's app and delete the patient account from the whitelist. If the patient needs to re-enable the insulin pump function, the patient account will need to be re-added to the whitelist using one of the methods described in Figures 6a-6c.

[0092] It should be noted that when turning on the insulin pump function of the app, it is necessary to ensure that the insulin pump is correctly installed on the skin and to pair the patient's personal information with the insulin pump information, thereby achieving pairing and control of the smartphone and the insulin pump. The patient's personal information includes name, age, gender, mobile phone number, etc., and the information of the CGM and / or insulin pump worn includes the identifier information of the CGM and / or insulin pump. At the same time, the smartphone uploads the patient's personal information and the identifier information of the CGM and / or insulin pump to a remote server. The remote server can store the information uploaded by the smartphone and verify whether the identifier information of the CGM and / or insulin pump is valid. If a certain identifier information already exists in the remote server, the remote server will send a prompt to the smartphone to remind the 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 begins to work. The CGM transmitter sends the monitored blood sugar information to the smartphone and further uploads it to the remote server. The control structure of the insulin pump receives the insulin infusion information and controls the infusion structure to infuse insulin. At the same time, the infusion status is sent to the smartphone and further uploaded to the remote server.

[0093] It should be noted that the CGM and insulin pump in the embodiment of the present invention are developed and produced by the same manufacturer, and therefore can be controlled by the same dedicated APP in the smartphone. When the patient needs both CGM and insulin pump and CGM at the same time, even if the CGM or insulin pump is produced by other manufacturers, the CGM or insulin pump can be directly controlled by the dedicated APP, which can also avoid the inconvenience caused to the user by using different APPs to control the CGM and insulin pump respectively, thereby improving the user experience.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] When the doctor determines that the patient can enable automatic mode, the app reads the current blood glucose level monitored by the CGM and the insulin information infused by the insulin pump, calculates the future blood glucose trend, and controls the insulin pump infusion based on the calculated blood glucose trend, including increasing, decreasing, or stopping insulin infusion, to achieve the purpose of influencing the blood glucose level, forming an automated closed-loop control cycle. As shown in Figure 7a, the doctor sends a request to the backend administrator to add the patient's account to the whitelist, allowing the patient to use the automatic mode function. The backend administrator receives the doctor's whitelist addition request and adds the patient's account to the whitelist list. At the same time, it sends feedback to the doctor that the whitelist addition has been completed. Furthermore, the automatic mode function of the app interface used by the patient is directly enabled. At this time, the app interface changes from Figure 8a to Figure 8b. The interface of Figure 8b has an "Auto Mode" function key associated with the automatic mode compared to the interface of Figure 8a. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function of the app interface used by the patient, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function of the app interface when needed or convenient.

[0099] In another embodiment of the present invention, when a doctor determines that a patient requires an insulin pump for drug infusion, as shown in Figure 7b, the patient can directly send a request to enable the automatic mode function to the backend administrator. Upon receiving the request, the backend administrator will verify whether the patient's account is on a whitelist. If the patient's account is on the whitelist, the backend administrator will enable the automatic mode function on the patient's app interface, and the app interface will change from Figure 8a to Figure 8b. If the patient's account is not on the whitelist, the backend administrator will send a feedback message to the patient's account, reminding the patient to ask the doctor to send a whitelist addition request to the backend administrator. After the doctor sends the whitelist addition request to the backend administrator, the backend administrator can directly enable the automatic mode function on the patient's app interface. If no message is received from the backend administrator within a certain period of time (e.g., 1 minute, 2 minutes, or 5 minutes), the backend administrator can send another request to enable the insulin pump function to the backend administrator, or ask the doctor to send a whitelist addition request to the backend administrator. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function on the patient's app interface, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function on the app interface when needed or convenient.

[0100] In another embodiment of the present invention, when the doctor determines that the patient needs to use an insulin pump for drug infusion, as shown in Figure 7c, the doctor sends a request to the backend administrator to add the patient's account to the whitelist, allowing the patient to use the automatic mode function. The backend administrator receives the doctor's whitelist addition request and adds the patient's account to the whitelist list. At the same time, it sends feedback to the doctor that the whitelist addition has been completed. Further, the doctor notifies the patient that he or she can apply to use the automatic mode function. After receiving the doctor's notification, the patient sends a request to enable the automatic mode function to the backend administrator. After receiving the patient's request to enable the automatic mode function, the backend administrator directly enables the automatic mode function on the APP interface used by the patient. In another embodiment of the present invention, after the backend administrator receives the patient's request to enable the automatic mode function, it can also first verify whether the patient's account is on the whitelist. If it is determined that the patient's account is on the whitelist, the backend administrator enables the automatic mode function on the APP interface used by the patient. In another embodiment of the present invention, the backend administrator does not directly enable the automatic mode function on the APP interface used by the patient, but instead sends a security code to the patient's account. The patient can use the security code to enable the automatic mode function on the APP interface when needed or convenient.

[0101] When the doctor determines that the patient no longer needs automatic mode, the patient can turn it off on the app. The app will automatically send a message to the backend administrator, who will then remove the patient account from the whitelist. The doctor and / or patient can also send a request to the backend administrator to turn off automatic mode. The backend administrator will turn off automatic mode on the patient's app and remove the patient account from the whitelist. If the patient needs to turn automatic mode back on, the patient account will need to be re-added to the whitelist using one of the methods shown in Figures 7a-7c.

[0102] In summary, the present invention discloses a control system for blood glucose monitoring and management. The first working mode of the control system is to control the blood glucose monitoring device to perform real-time blood glucose monitoring. Based on the trigger condition, the control system enters the second working mode. The second working mode at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion. Through the trigger condition, the control system enters from the first working mode of controlling the blood glucose monitoring device to perform real-time blood glucose monitoring to the second working mode of at least controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion, thereby preventing the patient from mistakenly entering an unnecessary or unauthorized working mode, thereby improving the safety of the patient's blood glucose monitoring and management.

[0103] 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 control system for blood glucose monitoring and management, comprising a processor and a memory, wherein the memory stores programming instructions, and the processor executes the programming instructions to perform the following operations: The control system includes at least a first working mode, wherein the first working mode is to control the blood glucose monitoring device to perform real-time blood glucose monitoring, and is characterized in that: Based on the trigger condition, the control system enters a second working mode, which at least includes controlling the blood glucose monitoring device to perform real-time blood glucose monitoring and controlling the insulin infusion device to perform insulin infusion.

2. The control system for blood sugar monitoring and management according to claim 1, characterized in that: The trigger condition at least includes that the patient account that needs to enable the second working mode exists in the whitelist list of the background administrator.

3. The control system for blood sugar monitoring and management according to claim 2, characterized in that: The whitelist is generated by medical staff sending a whitelist addition application to the backend administrator.

4. The control system for blood sugar monitoring and management according to claim 3, characterized in that: After adding the whitelist, the backend administrator directly controls the control system to enter the second working mode.

5. The control system for blood sugar monitoring and management according to claim 3, characterized in that: The backend administrator sends a security code to the patient account after adding the whitelist, and the patient controls the control system to enter the second working mode through the security code.

6. The control system for blood sugar monitoring and management according to claim 3, characterized in that: The patient reminds the medical staff to send the whitelist addition application to the backend management.

7. The control system for blood sugar monitoring and management according to claim 3, characterized in that: After receiving the whitelist application, the backstage administrator sends feedback to the medical staff, and after receiving the feedback, the medical staff informs the patient to send an application to the backstage administrator.

8. The control system for blood sugar monitoring and management according to claim 7, characterized in that: After receiving the application, the backend administrator directly controls the control system to enter the second working mode.

9. The control system for blood sugar monitoring and management according to claim 7, characterized in that: After receiving the application, the backend administrator sends a security code to the patient account, and the patient controls the control system to enter the second working mode through the security code.

10. The control system for blood sugar monitoring and management according to claim 1, characterized in that: The second working mode also includes an automatic mode.

11. The control system for blood sugar monitoring and management according to claim 10, characterized in that: The triggering condition of the automatic mode at least includes that the patient account for which the automatic mode needs to be enabled exists in the whitelist of the backend administrator.

12. The control system for blood sugar monitoring and management according to claim 11, characterized in that: The whitelist is generated by medical staff sending a whitelist addition application to the backend administrator.

13. The control system for blood sugar monitoring and management according to claim 12, characterized in that: After adding the whitelist, the backend administrator directly controls the control system to enter the automatic mode.

14. The control system for blood sugar monitoring and management according to claim 12, characterized in that: The backend administrator sends a security code to the patient account after adding the whitelist, and the patient controls the control system to enter the automatic mode through the security code.

15. The control system for blood glucose monitoring and management according to claim 12, characterized in that: The patient reminds the medical staff to send the whitelist addition application to the backend management.

16. The control system for blood sugar monitoring and management according to claim 12, characterized in that: After receiving the whitelist application, the backstage administrator sends feedback to the medical staff, and after receiving the feedback, the medical staff informs the patient to send an application to the backstage administrator.

17. The control system for blood sugar monitoring and management according to claim 16, characterized in that: After receiving the application, the backend administrator directly controls the control system to enter the automatic mode.

18. The control system for blood glucose monitoring and management according to claim 16, characterized in that: After receiving the application, the backend administrator sends a security code to the patient's account, and the patient controls the control system to enter the automatic mode through the security code.

19. The control system for blood glucose monitoring and management according to claim 1, characterized in that: The control system is a smart phone.

20. The control system for blood glucose monitoring and management according to claim 19, characterized in that: The control system is an APP installed in a smart phone.

21. The control system for blood glucose monitoring and management according to claim 20, characterized in that: After the control system enters the second working mode, the APP main interface displays the insulin infusion related functions.

22. The control system for blood glucose monitoring and management according to claim 2, characterized in that: When the patient account is deleted from the white list, the control system exits the second working mode.

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