Blood glucose management system

By setting signal strength and time thresholds in the blood glucose management system, the cumbersome device identifier input problem in the prior art is solved, realizing a convenient and reliable wireless communication connection and improving the user experience for patients.

WO2026107792A1PCT designated stage Publication Date: 2026-05-28MEDTRUM TECH
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
MEDTRUM TECH
Filing Date
2024-11-25
Publication Date
2026-05-28

AI Technical Summary

Technical Problem

In existing blood glucose management systems, before external devices can wirelessly connect with blood glucose testing equipment and insulin pumps, patients need to input device identifiers, which is cumbersome and unreliable.

Method used

Two selectable wireless communication connection operation modes are provided. In the first mode, the connection is automatically established by setting a preset signal strength threshold, or in the second mode, the device identifier is entered, and the connection reliability is ensured by combining a time threshold and a signal correction coefficient.

Benefits of technology

It simplifies patient procedures, improves the reliability and convenience of wireless communication connections, reduces the risk of faulty connections, and enhances the user experience.

✦ Generated by Eureka AI based on patent content.

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Abstract

A blood glucose management system, comprising: in a first operation mode, a program module (101) identifies the signal intensity of a broadcast signal; when the signal intensity of the broadcast signal is not less than a preset signal intensity threshold, the program module (101) establishes a wireless communication connection with a measurement module (100) and / or an infusion module (102) that sends the broadcast signal; in a second operation mode, a device identifier of the measurement module (100) and / or the infusion module (102) is inputted so as to establish the wireless communication connection.
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Description

Blood glucose management system Technical Field

[0001] This invention relates primarily to the field of medical devices, and in particular to a blood glucose management system. Background Technology

[0002] In healthy individuals, the pancreas automatically secretes the necessary insulin / glucagon based on blood glucose levels, thus maintaining a reasonable range of blood sugar fluctuations. However, in diabetic patients, pancreatic function is abnormal, and the pancreas is unable to secrete the required insulin normally. Diabetes is a metabolic disease and is a lifelong condition. Current medical technology cannot cure diabetes; it can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to have their blood glucose levels checked before injecting insulin. Currently, most methods involve continuous glucose monitoring using in-vitro glucose (CGM) devices. These devices use disposable percutaneous sensors inserted into the skin to measure glucose concentration in the interstitial fluid and transmit the data wirelessly to an external device for patient viewing. The external device then wirelessly transmits the required insulin dosage to the insulin pump, which delivers the insulin subcutaneously, thus forming a glucose management system.

[0004] In existing technologies, before establishing a wireless communication connection between an external device (referred to as a program module in this solution) and a blood glucose monitoring device (referred to as a monitoring module in this solution) and / or an insulin pump (referred to as an infusion module in this solution), the patient often needs to input the device identifier of the blood glucose monitoring device and / or insulin pump so that the external device can recognize the broadcast signal of the blood glucose monitoring device and / or insulin pump. The process of inputting the device identifier is cumbersome and inconvenient for the patient. Even in some existing technologies that employ solutions to establish a wireless communication connection without inputting the device identifier, the reliability of the wireless communication connection is low because it cannot effectively distinguish between the patient's own device and those of other patients.

[0005] Therefore, there is an urgent need for a highly reliable blood glucose management system that is easy for patients to operate when establishing a communication connection. Summary of the Invention

[0006] This invention discloses a blood glucose management system that provides patients with two selectable operating modes for establishing wireless communication connections. The blood glucose management system presets a signal strength threshold. In the first operating mode, the program module searches for nearby broadcast signals and identifies their signal strength. When the signal strength of the broadcast signal is not less than the preset signal strength threshold, the program module can establish a wireless communication connection with the detection module and / or infusion module that sent the broadcast signal, without needing to input the device identifier of the detection module and / or infusion module. In the second operating mode, the patient inputs the device identifier of the detection module and / or infusion module to establish a wireless communication connection, ensuring the reliability of the wireless communication connection established between the program module and the patient's own detection module and / or infusion module.

[0007] This invention discloses a blood glucose management system, including an on-body functional module, which is attached to the patient's skin and transmits broadcast signals to the outside world after being powered on. The on-body functional module includes a device identifier, which is associated with the broadcast signal; a program module, used to search for nearby broadcast signals and identify the signal strength of the broadcast signals, the signal strength of the broadcast signals being mapped to the distance between the program module and the on-body functional module; and a preset signal strength threshold in the blood glucose management system, wherein the blood glucose management system provides:

[0008] In the first operating mode, the program module compares the broadcast signal strength with a preset signal strength threshold. When the searched broadcast signal strength is not less than the preset signal strength threshold, the program module establishes a wireless communication connection with the body function module that sends the broadcast signal.

[0009] In the second operating mode, the program module acquires the device identifier, searches for broadcast signals associated with the device identifier, and establishes a wireless communication connection with the body function module of the broadcast signal.

[0010] According to one aspect of the invention, the in vivo functional module includes a detection module and / or an infusion module, wherein the detection module is used to continuously detect the patient's current blood glucose level, and the infusion module is used to infuse the patient with the currently required medication.

[0011] According to one aspect of the present invention, when the strength of the detected broadcast signal is not less than a preset signal strength threshold, the distance between the program module and the body functional module is 0-0.5m.

[0012] According to one aspect of the present invention, in a first operating mode, the broadcast signal corresponds to the device identifier, and after the program module establishes a wireless communication connection with the body function module, the program module stores the device identifier.

[0013] According to one aspect of the present invention, the program module searches for and identifies broadcast signals based on stored device identifiers, and establishes a wireless communication connection with the body function module that sends the broadcast signal corresponding to the device identifier.

[0014] According to one aspect of the invention, the blood glucose management system also includes a time threshold for timing during patient operation to establish a wireless communication connection.

[0015] According to one aspect of the present invention, if the body functional module fails to establish a wireless communication connection with the program module within a time threshold, the transmission power of the broadcast signal is reduced until the body functional module establishes a wireless communication connection with the program module.

[0016] According to one aspect of the present invention, if the body functional module fails to establish a wireless communication connection with the program module within a time threshold, the transmission time interval of the broadcast signal is increased until the body functional module establishes a wireless communication connection with the program module.

[0017] According to one aspect of the invention, if the on-body functional module fails to establish a wireless communication connection with the program module within a time threshold, the patient is prompted to execute a second operating mode to establish a wireless communication connection.

[0018] According to one aspect of the invention, the time threshold is 0-600 seconds.

[0019] According to one aspect of the invention, the time threshold is set in a body functional module or program module.

[0020] According to one aspect of the invention, a preset signal strength threshold is set in the program module.

[0021] According to one aspect of the invention, a preset signal strength threshold is set in the body functional module, and the broadcast signal includes information associated with the preset signal strength threshold.

[0022] According to one aspect of the present invention, in a first operating mode, when there is only one broadcast signal with a signal strength not less than a preset signal strength threshold, the program module establishes a wireless communication connection with the body function module that sends the broadcast signal; when there is more than one broadcast signal with a signal strength not less than the preset signal strength threshold, the program module does not establish a wireless communication connection with the body function module that sends the broadcast signal.

[0023] According to one aspect of the present invention, when the number of broadcast signals with a signal strength not less than a preset signal strength threshold exceeds one, the blood glucose management system prompts the patient to change the operating location.

[0024] According to one aspect of the invention, the program module further includes a signal correction coefficient, which is associated with the state of the program module. In a first operating mode, before the program module compares the broadcast signal strength with a preset signal strength threshold, the broadcast signal strength is corrected based on the signal correction coefficient.

[0025] According to one aspect of the present invention, patient confirmation is required before the on-body functional module and the program module establish a wireless communication connection.

[0026] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0027] The blood glucose management system disclosed in this invention provides two selectable operating modes for establishing a wireless communication connection. A preset signal strength threshold is included in the blood glucose management system. In the first mode, the program module searches for nearby broadcast signals and identifies their signal strength. When the signal strength of the broadcast signal is not less than the preset signal strength threshold, the program module can establish a wireless communication connection with the detection module and / or infusion module that sent the broadcast signal, without needing to input the device identifier of the detection module and / or infusion module. In the second operating mode, the patient inputs the device identifier of the detection module and / or infusion module to establish a wireless communication connection, ensuring the reliability of the wireless communication connection established between the program module and the patient's own detection module and / or infusion module.

[0028] Furthermore, the program module stores the device identifiers of detection modules and / or infusion modules with which wireless communication connections have been established. When the program module re-establishes a wireless communication connection with these detection modules and / or infusion modules, it can search for and identify broadcast signals based on the stored device identifiers, and establish a wireless communication connection with the detection module and / or infusion module that sent the broadcast signal corresponding to the device identifier. This eliminates the need to re-enter the device identifier or identify the signal strength, making it easier for patients to operate and improving the user experience.

[0029] Furthermore, the blood glucose management system is equipped with a time threshold. If the detection module and / or infusion module fails to establish a wireless communication connection with the program module within the time threshold period, the patient can enter the device identifier of the detection module and / or infusion module when attempting to establish a wireless communication connection. This prevents the detection module and / or infusion module from changing position when the patient fails to establish a wireless communication connection in time, which could lead to them being too close to other patients' detection modules and / or infusion modules, increasing the risk of establishing an incorrect wireless communication connection and ensuring the reliability of establishing a wireless communication connection.

[0030] Furthermore, in the first mode, the program module can also identify the number of broadcast signals whose signal strength exceeds a preset signal strength threshold. When there is only one signal, the program module establishes a wireless communication connection with the detection module and / or infusion module. When there is more than one signal, the program module does not establish a communication connection with the detection module and / or infusion module to avoid the program module establishing a communication connection with the wrong detection module and / or infusion module. At the same time, the detection module and / or infusion module can also prompt the patient to change the operation location to avoid other irrelevant broadcast signals as much as possible and improve the reliability of establishing a wireless communication connection.

[0031] Furthermore, a preset signal strength threshold can be set in the program module, detection module, or infusion module. When the preset signal strength threshold is set in the detection module or infusion module, it is transmitted along with the broadcast signal. The program module receives the broadcast signal and the preset signal strength threshold simultaneously, enabling a comparison between the broadcast signal strength and the preset signal strength threshold. This allows for the establishment of a wireless communication connection without inputting a device identifier. The preset signal strength threshold, set in the detection module or infusion module, can be associated with the state of the module. Due to differences in the hardware of different individual detection modules or infusion modules, different preset signal strength thresholds are required to facilitate the establishment of a wireless communication connection for the patient at a comfortable distance.

[0032] Furthermore, a signal correction coefficient can be set in the program module. Different individual program modules, or as the program module is used for a long time, will have different sensitivity to signal strength recognition. The signal correction coefficient can correct the signal strength recognized by the program module, thereby increasing the accuracy of the program module in recognizing signal strength and increasing the reliability of establishing a wireless communication connection. Attached Figure Description

[0033] Figure 1 is a schematic diagram of the module relationships in a general blood glucose management system;

[0034] Figure 2 is a schematic diagram of the integrated CGM according to an embodiment of the present invention;

[0035] Figure 3 is a schematic diagram of the structure of a split CGM according to an embodiment of the present invention;

[0036] Figure 4a is a schematic diagram of the structure of an integrated insulin pump according to an embodiment of the present invention;

[0037] Figure 4b is a schematic diagram of a split-type insulin pump according to an embodiment of the present invention;

[0038] Figure 5a is a schematic diagram of the main interface of the control system in the first working mode according to an embodiment of the present invention;

[0039] Figure 5b is a schematic diagram of the main interface of the control system in the second working mode according to an embodiment of the present invention;

[0040] Figures 6a-6c are schematic diagrams illustrating different operations of the control system for activating the insulin pump function according to an embodiment of the present invention.

[0041] Figures 7a-7c are schematic diagrams illustrating different operations of the automatic mode function of the control system according to an embodiment of the present invention.

[0042] Figures 8a-8b are schematic diagrams of the APP interface before and after the automatic mode function of the control system is turned on according to an embodiment of the present invention;

[0043] Figure 9a is a schematic diagram of the interface when the system activates the "Grand Meal" mode according to an embodiment of the present invention;

[0044] Figures 9b and 9c are schematic diagrams of different interfaces for selecting "regular" and "grand meal" in the system of the embodiment of the present invention.

[0045] Figure 9d is a schematic diagram of the interface when the system starts the regular meal mode according to an embodiment of the present invention;

[0046] Figure 10 is a schematic diagram of the infusion strategy for pre-infusion and supplementary infusion according to an embodiment of the present invention;

[0047] Figures 11a-11f are schematic diagrams illustrating the operation of establishing a wireless communication connection according to different embodiments of the present invention. Detailed Implementation

[0048] As mentioned earlier, in existing technologies, before establishing a wireless communication connection between an external device (referred to as a program module in this solution) and a blood glucose monitoring device (referred to as a monitoring module in this solution) and / or an insulin pump (referred to as an infusion module in this solution), the patient often needs to input the device identifier of the blood glucose monitoring device and / or insulin pump so that the external device can recognize the broadcast signal of the blood glucose monitoring device and / or insulin pump. The process of inputting the device identifier is cumbersome and inconvenient for the patient. Even in some existing technologies that employ a solution to establish a wireless communication connection without inputting the device identifier, the reliability of the wireless communication connection is low because it cannot effectively distinguish between the patient's own device and those of other patients.

[0049] To address this issue, the present invention provides a blood glucose management system that offers patients two selectable operating modes for establishing a wireless communication connection. The blood glucose management system presets a signal strength threshold. In the first operating mode, the program module searches for nearby broadcast signals and identifies their signal strength. When the signal strength of the broadcast signal is not less than the preset threshold, the program module can establish a wireless communication connection with the detection module and / or infusion module that sent the broadcast signal, without requiring the input of the device identifier of the detection module and / or infusion module. In the second operating mode, the patient inputs the device identifier of the detection module and / or infusion module to establish a wireless communication connection, ensuring the reliability of the wireless communication connection established between the program module and the patient's own detection module and / or infusion module.

[0050] 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, numerical expressions, and values ​​of the components and steps set forth in these embodiments should not be construed as limiting the scope of the invention.

[0051] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0052] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0053] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0054] Figure 1 is a schematic diagram of the module relationships in a general blood glucose management system.

[0055] The blood glucose management system disclosed in this embodiment of the invention mainly includes a detection module 100, a program module 101, and an infusion module 102.

[0056] The detection module 100 is used to continuously detect the patient's current blood glucose level. Generally, the detection module 100 is a continuous glucose monitoring (CGM) device, which can detect the patient's current blood glucose level in real time, monitor blood glucose changes, and send the current blood glucose information to the program module 101. The CGM includes an implantable sensor connected to a transmitter. The transmitter also includes a memory, processor, communication interface, etc. The transmitter is used to transmit at least the blood glucose data detected by the CGM, as well as the CGM's identifier information.

[0057] The infusion module 102 includes the necessary mechanical structures and electronic control units for infusing blood glucose regulating drugs such as insulin and glucagon, including a drug reservoir, drive structure, infusion tubing and infusion needle, power supply, and circuit board. It is controlled by the program module 101. Generally, the infusion module 102 is an insulin pump, and the electronic control unit includes a transmitter, memory, processor, and communication interface. Based on the current insulin infusion volume data issued by the program module 101, the infusion module 102 infuses the required insulin into the patient's body. Simultaneously, the infusion status of the infusion module 102 can be fed back to the program module 101 in real time.

[0058] The program module 101 controls the operation of the detection module 100 and the infusion module 102. Based on the blood glucose value detected by the detection module 100, the program module 101 generates an insulin infusion command and controls the infusion module 102 to perform the infusion. It includes a memory, a processor, a communication interface, a display, and a patient interface. The memory stores programming instructions, which the processor can execute. The program module 101 is connected to both the detection module 100 and the infusion module 102. This connection can be a conventional electrical connection or a wireless connection.

[0059] The embodiments of the present invention do not limit the specific locations 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.

[0060] In one embodiment of the invention, the three components are electrically connected to form a single integrated structure. Therefore, all three are adhered to the same location on the patient's skin. By connecting the three modules into a single unit and adhering them to the same location, the number of devices that need to be applied to the patient's skin is reduced, thereby lessening the interference with the patient's activities caused by having too many devices. Simultaneously, it effectively solves the problem of reliable wireless communication between separate devices, further enhancing the patient experience.

[0061] In another embodiment of the invention, program module 101 and infusion module 102 are interconnected to form an integral structure, while detection module 100 is separately disposed in another structure. In this case, detection module 100 and program module 101 transmit wireless signals to each other to achieve interconnection. Therefore, program module 101 and infusion module 102 are attached to one location on the patient's skin, while detection module 100 is attached to other locations on the patient's skin.

[0062] In another embodiment of the invention, program module 101 and detection module 100 are interconnected to form a single device, while infusion module 102 is disposed separately in another structure. Infusion module 102 and program module 101 transmit wireless signals to each other to achieve interconnection. Therefore, program module 101 and detection module 100 can be attached to one location on the patient's skin, while infusion module 102 can be attached to other locations on the patient's skin.

[0063] In another embodiment of the invention, the three components are disposed in different structures. Therefore, they are respectively attached to different locations on the patient's skin. At this time, the program module 101 transmits wireless signals to the detection module 100 and the infusion module 102 to achieve interconnection.

[0064] In another embodiment of the invention, the three modules are disposed in different structures. Therefore, the detection module 100 and the infusion module 102 are respectively attached to different locations on the patient's skin, while the program module 101 does not need to be attached to the skin. Control of the detection module 100 and the infusion module 102 is achieved through a handheld or portable device, such as a PDM or a smartphone. In this case, the program module 101 transmits wireless signals to both the detection module 100 and the infusion module 102 to achieve interconnection. In this embodiment of the invention, the detection module 100 and the infusion module 102 can be collectively referred to as on-body functional modules.

[0065] The wireless communication described in the foregoing embodiments can be, for example, but not limited to, radio frequency (RF) communication (e.g., 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).

[0066] Figure 2 is a schematic diagram of an integrated CGM according to an embodiment of the present invention. Figure 3 is a schematic diagram of a split CGM according to an embodiment of the present invention.

[0067] A CGM consists of a sensor and a transmitter. It is implanted under the skin of the patient using an auxiliary installer. The sensor collects and transmits the blood glucose level data. The transmitter connects to the sensor and receives the blood glucose data from the implanted sensor, converting it into a wireless signal for output. Each CGM has a unique identifier, such as a device identifier, hardware identifier, universally unique identifier, serial number, protocol-based identifier (e.g., BLE ID), or manufacturer identifier. This identifier consists of a combination of random numbers and letters and can be placed on the CGM's casing or packaging, and may vary depending on the type of CGM.

[0068] Figure 2 is a schematic diagram of an integrated CGM. The sensor and transmitter of the CGM are integrated before use, and it 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) disposed within the housing 202. The sensor 301 detects blood glucose data from the patient's body fluids and transmits this data to the transmitter via internal circuitry, which then sends it to the receiver. Identifiers can be placed on the outer casing or packaging of the CGM, or inside the CGM itself.

[0069] Figure 3 is a schematic diagram of the split-type CGM. Before use, the sensor and transmitter of the CGM are two separate components, packaged separately, and integrated together only during use. The split-type CGM includes a base shell 301 and a transmitter 302. The sensor 3011 is mounted on the base shell, and the transmitter 302 has a separate housing. The base shell 301 and the transmitter 302 housings are respectively equipped with snap-fit ​​structures 3012 and 3022. During use, the base shell 301 and the transmitter 302 are snapped together into a single unit using these snap-fit ​​structures. The sensor 3011 is electrically connected to the transmitter 302 via an electrical connector 3013. The sensor 301 detects the patient's blood glucose data and transmits this data to the transmitter 302 via the electrical connector 3013, which then sends it to the receiver.

[0070] In one embodiment of the invention, both the sensor and transmitter of the split-type CGM are single-use products, 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 invention, only the sensor of the split-type CGM is a single-use product, while the transmitter is a reusable product. Therefore, preferably, in this embodiment, the identifier is placed on the housing or outer packaging of the transmitter, which can reduce the frequency of binding patient information and identifiers and improve the patient experience. This will be described in detail below.

[0071] When the identifier is set on the housing or outer packaging of the CGM or transmitter, it can be set in the form of, but is not limited to, a QR code, barcode, or NFC tag.

[0072] Figure 4a is a schematic diagram of an integrated insulin pump according to an embodiment of the present invention; Figure 4b is a schematic diagram of a split insulin pump according to an embodiment of the present invention.

[0073] In this embodiment of the invention, the insulin pump is a patch-type insulin pump, that is, an insulin pump that does not include a long catheter. It includes an infusion structure and a control structure, and is entirely attached to the patient's skin surface by the same adhesive patch. The drug is directly infused from the reservoir along the infusion needle to the subcutaneous tissue.

[0074] Each insulin pump has a unique identifier, such as a device identifier, hardware identifier, universally unique identifier, serial number, communication protocol-based identifier, manufacturer identifier, etc. The identifier is formed by a combination of multiple random numbers and letters, which can be set on the insulin pump housing or packaging, and can also have different settings depending on the type of insulin pump.

[0075] Figure 4a is a schematic diagram of an integrated insulin pump, in which the infusion structure 410 and the control structure 400 of the insulin pump are located inside the same housing 10. The two are connected by wires and are attached to a certain position on the patient's skin by an adhesive patch 420. The whole unit is discarded after single use. The identifier can be set on the outer housing of the insulin pump, the outer packaging, or inside the insulin pump.

[0076] Figure 4b is a schematic diagram of a split-type insulin pump, in which the infusion structure 410 and the control structure 400 are respectively housed in two different housings, which are connected by a waterproof plug or directly snapped together and electrically connected to form a whole. Identifiers can be placed on the outer shell or packaging of the infusion structure and / or control structure, or inside the insulin pump.

[0077] In one embodiment of the invention, both the infusion structure and control structure of the split insulin pump are single-use products, discarded after use. Therefore, the identifier can be placed on the housing or outer packaging of the infusion structure and / or control structure. In another embodiment of the invention, only the infusion structure of the split insulin pump is a single-use product, while the control structure is a reusable product. Therefore, preferably, in this embodiment, the identifier is placed on the housing or outer packaging of the control structure, which can reduce the frequency of binding patient information and identifiers and improve the patient experience. This will be described in detail below.

[0078] When the identifier is set on the casing or outer packaging of the insulin pump or control structure, it can be set in the form of, but not limited to, a QR code, barcode, or NFC tag.

[0079] Depending on the severity of the patient's condition and their individual health status, some patients may only require continuous glucose monitoring (CGM), while others require both CGM and an insulin pump for medication infusion. When a doctor determines that a patient only needs CGM for continuous glucose monitoring, since CGM only involves monitoring the patient's blood glucose, self-use of CGM will not pose a risk to the patient's life. Therefore, the patient can purchase CGM independently. Before the CGM is installed on the patient's skin, the patient can search for and download a dedicated app for controlling the CGM from their smartphone's app store, create a new account on the app, and pair their personal information with the CGM information to achieve pairing and control between the smartphone and the CGM. In this embodiment of the invention, the CGM and insulin pump are developed and manufactured by the same manufacturer, and therefore can be controlled by the same dedicated app on the smartphone. Since not all patients need to use an insulin pump, the default home screen of the dedicated app only includes CGM-related content, as shown in Figure 5a. This simplifies the app interface, improves the patient's visual experience, and prevents patients from misoperating the insulin pump function and affecting the normal use of the CGM.

[0080] 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 doctor's request to add the patient's account to the whitelist and simultaneously sends feedback to the doctor confirming the whitelist addition is complete. Furthermore, the backend administrator directly opens the insulin pump function in the patient's app interface. At this time, the app interface changes from Figure 5a to Figure 5b, with Figure 5b adding two insulin infusion-related function keys, "Insulin Delivery" and "Easyloop," compared to Figure 5a. In another embodiment of the present invention, the backend administrator does not directly open the insulin pump function in the patient's app interface, but instead sends a security code to the patient's account. The patient can then use the security code to open the insulin pump function in the app interface when needed or convenient.

[0081] In another embodiment of the invention, when a doctor determines that a patient needs to use an insulin pump for drug infusion, as shown in Figure 6b, the patient can directly send an application to the backend administrator to enable the insulin pump function. Upon receiving the application, the backend administrator verifies whether the patient's account is on the whitelist. If the patient's account is on the whitelist, the backend administrator opens the insulin pump function on the patient's app interface, and the app interface changes from Figure 5a to Figure 5b. If the patient's account is not on the whitelist, a feedback message is sent to the patient's account, reminding the patient to ask the doctor to send an application to the backend administrator to add the patient to the whitelist. After the doctor sends the application to the backend administrator, the backend administrator can directly open the insulin pump function on the patient's app interface. If no message is received from the backend administrator within a certain time, such as 1 minute, 2 minutes, or 5 minutes, the patient can send another application to the backend administrator to enable the insulin pump function, or ask the doctor to send an application to add the patient to the whitelist. In another embodiment of the invention, the backend administrator does not directly open the insulin pump function on the patient's app interface, but instead sends a security code to the patient's account. The patient can then use the security code to open the insulin pump function on the app interface when needed or convenient.

[0082] In another 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 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 doctor's whitelist application, adds the patient's account to the whitelist, and simultaneously sends feedback to the doctor confirming the whitelist addition is complete. Furthermore, the doctor notifies the patient that they can apply to use the insulin pump function. After receiving the doctor's notification, the patient sends an application to the backend administrator to enable the insulin pump function. Upon receiving the application, the backend administrator directly opens the insulin pump function in the patient's app interface. In another embodiment of the present invention, after receiving the application, the backend administrator can first verify whether the patient's account is in the whitelist. If the patient's account is confirmed to be in the whitelist, the backend administrator opens the insulin pump function in the patient's app interface. In yet another embodiment, the backend administrator does not directly open the insulin pump function in the patient's app interface, but instead sends a security code to the patient's account. The patient can then use the security code to open the insulin pump function in the app interface when needed or convenient.

[0083] When a doctor determines that a patient no longer needs the insulin pump function, the patient can disable it themselves via the app. The app automatically sends a message to the backend administrator, who then removes the patient's account from the whitelist. Alternatively, the doctor and / or patient can submit a request to the backend administrator to disable the insulin pump function. The administrator will then disable the insulin pump function on the patient's app and remove the patient's account from the whitelist. When the patient needs to re-enable the insulin pump function, the patient's account needs to be re-added to the whitelist using one of the methods shown in Figures 6a-6c.

[0084] It's important to note that when activating the insulin pump function in the app, the insulin pump must be correctly installed on the skin, and the patient's personal information must be paired with the insulin pump's information to achieve pairing and control between the smartphone and the insulin pump. Patient personal information includes name, age, gender, and phone number. Information about the CGM and / or insulin pump includes its identifier. Simultaneously, the smartphone uploads the patient's personal information and the CGM and / or insulin pump identifier to a remote server. The remote server stores the uploaded information and verifies the validity of the CGM and / or insulin pump identifier. If an identifier already exists on the remote server, it sends a notification to the smartphone, reminding the patient that the CGM or insulin pump has been used and needs to be replaced. Once the CGM and / or insulin pump is installed on the patient's skin and successfully activated, it begins operation. The CGM's transmitter sends the detected blood glucose information to the smartphone and further uploads it to the remote server. The insulin pump's control mechanism receives the insulin infusion information and controls the infusion mechanism to deliver insulin, while simultaneously sending the infusion status to the smartphone and uploading it to the remote server.

[0085] It should be noted that the CGM and insulin pump in the embodiments of the present invention are developed and manufactured by the same manufacturer, and therefore can be controlled by the same dedicated APP in a smartphone. When a patient needs both CGM and insulin pump at the same time, even if CGM or insulin pumps are manufactured by other manufacturers, they can still be directly controlled by the dedicated APP. This avoids the inconvenience caused to patients by using different APPs to control CGM and insulin pumps separately, and improves the patient experience.

[0086] When a patient's CGM and / or insulin pump needs to be replaced due to reaching its usage period 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 via a smartphone and then uploaded to a remote server. The patient's personal information can be 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 housing or outer packaging of the CGM and / or insulin pump.

[0087] When the CGM has a split structure and the transmitter is reusable, the CGM identifier is set on the transmitter's shell or packaging. When the patient replaces the CGM, only the sensor needs to be replaced, without replacing the transmitter. The CGM identifier also remains unchanged. Therefore, there is no need to update the pairing of the CGM identifier with the patient's personal information via smartphone, nor is it necessary to upload it to a remote server. This reduces the number of steps and improves the patient experience.

[0088] When the insulin pump has a separate structure and the control structure is reusable, the insulin pump identifier is set on the outer shell or packaging of the control structure. When the patient replaces the insulin pump, only the infusion structure needs to be replaced, without replacing the control structure. The insulin pump identifier also remains unchanged. Therefore, there is no need to update the pairing of the insulin pump identifier with the patient's personal information via smartphone, nor is it necessary to upload it to a remote server. This reduces the number of operation steps and improves the patient experience.

[0089] The smartphone and CGM and / or insulin pump, as well as the remote server, communicate wirelessly. This wireless communication can be achieved through, but is not limited to, radio frequency (RF) communication (e.g., RFID, Zigbee, WiFi, infrared, USB, and UWB). Communication protocols and cellular communication, such as Code Division Multiple Access (CDMA) or Global System for Mobile Communications (GSM). Preferably, communication between the smartphone and the remote server is via WiFi and / or cellular communication, and communication between the smartphone and the CGM and / or insulin pump is via... Communication protocol communication.

[0090] When a doctor determines that a patient can activate the automatic mode, the app reads the current blood glucose level from the CGM (Continuous Glucose Measurement) and the insulin information from the insulin pump. It can then calculate future blood glucose trends and control the insulin pump's infusion based on these trends, including increasing, decreasing, or stopping the infusion to influence blood glucose levels, thus forming an automated closed-loop control. 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 whitelist request, adds the patient's account to the whitelist, and sends feedback to the doctor confirming the addition. Furthermore, the automatic mode function is directly enabled in the app interface used by the patient. At this point, the app interface changes from Figure 8a to Figure 8b. The interface in Figure 8b adds an "Auto Mode" button, a function key related to automatic mode, compared to the interface in Figure 8a. In another embodiment of the invention, the backend administrator does not directly enable the automatic mode function in the app interface used by the patient. Instead, a security code is sent to the patient's account, allowing the patient to enable the automatic mode function in the app interface when needed or convenient.

[0091] In another embodiment of the invention, when the doctor determines that the patient can enable the automatic mode, as shown in Figure 7b, the patient can directly send an application to the backend administrator to enable the automatic mode function. After receiving the application, the backend administrator will verify whether the patient's account is in the whitelist. If the patient's account is in the whitelist, the backend administrator will enable the automatic mode function of the APP interface used by the patient, and the APP interface will change from Figure 8a to Figure 8b. If the patient's account is not in the whitelist, a feedback message will be sent to the patient's account, reminding the patient to ask the doctor to send an application to the backend administrator to add the patient to the whitelist. After the doctor sends the application to the backend administrator, the backend administrator can directly enable the automatic mode function of the APP interface used by the patient. If no message is received from the backend administrator within a certain time, such as 1 minute, 2 minutes, or 5 minutes, the doctor can send another application to enable the automatic mode function, or ask the doctor to send an application to add the patient to the whitelist. In another embodiment of the 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 enable the automatic mode function of the APP interface using the security code when needed or convenient.

[0092] In another embodiment of the present invention, when a doctor determines that a patient needs to use the automatic mode, 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 request to add the patient's account to the whitelist and simultaneously sends feedback to the doctor confirming the whitelist addition is complete. Furthermore, the doctor notifies the patient that they can apply to use the automatic mode function. After receiving the doctor's notification, the patient sends a request to the backend administrator to enable the automatic mode function. Upon receiving the request, the backend administrator directly opens the automatic mode function in the patient's app interface. In another embodiment of the present invention, after receiving the patient's request to enable the automatic mode function, the backend administrator can first verify whether the patient's account exists in the whitelist. If the patient's account is confirmed to be in the whitelist, the backend administrator opens the automatic mode function in the patient's app interface. In yet another embodiment of the present invention, the backend administrator does not directly open the automatic mode function in the patient's app interface, but instead sends a security code to the patient's account. The patient can then use the security code to open the automatic mode function in the app interface when needed or convenient.

[0093] When a doctor determines that a patient no longer needs automatic mode, the patient can manually disable it on the app. The app will automatically send a message to the backend administrator, who will then remove the patient's account from the whitelist. Alternatively, the doctor and / or patient can submit a request to the backend administrator to disable automatic mode. The administrator will then disable automatic mode on the patient's app and remove the patient's account from the whitelist. When the patient needs to re-enable automatic mode, the patient's account needs to be re-added to the whitelist using one of the methods shown in Figures 7a-7c.

[0094] In this embodiment of the invention, the security code sent by the backend when requesting the insulin pump function and automatic mode function can be any number or combination of numeric characters, alphanumeric characters, and other symbols. It can also be a series of taps, a series of inputs, complex or simple gestures (e.g., swiping or other movements on a touchscreen, drawing images), etc. In some cases, the security code may also include a quiz or a set of questions. The security code sent by the backend each time is random.

[0095] Because dietary habits vary significantly across different regions and age groups, a uniform control plan may result in poor glycemic control for some individuals. Therefore, when the automatic mode function is activated, patients are required to enter a pass code to access different automatic mode interfaces. For individuals with high carbohydrate consumption, the automatic mode interface, as shown in Figure 9a, displays a "large meal" option after entering the pass code. Patients can choose whether to enable the large meal module. After enabling the large meal mode, the infusion page displays two options: "Regular" and "Large Meal," as shown in Figures 9b and 9c. When the patient selects "Regular," the insulin infusion volume corresponding to the regular carbohydrate intake will be administered; when selecting "Large Meal," the insulin infusion volume corresponding to a larger carbohydrate intake will be administered. For individuals with low carbohydrate consumption, the automatic mode interface, as shown in Figure 9d, does not have a large meal option and defaults to "Regular" mode, administering the insulin infusion volume corresponding to the regular carbohydrate intake.

[0096] In some embodiments of the invention, the access code can be a set of small questions, such as "Are you a carbohydrate enthusiast?", "Is your age within the range of A and B?", "What is your gender?", "Where do you live?", "What are your fitness hobbies?", "Do you have any special medical conditions?", "Have you used non-automatic mode before activating automatic mode?", etc. Based on the patient's answers, the system automatically determines whether the patient is a high carbohydrate consumer. In other embodiments of the invention, the access code is provided to the patient in advance by the doctor after diagnosis, or the doctor sends the patient's information regarding high carbohydrate consumption when sending an automatic mode whitelist application to the backend administrator. The backend administrator automatically assigns a corresponding access code to the patient. The access code can be any number or combination of numeric characters, alphanumeric characters, and other symbols, or it can be a series of taps, a series of inputs, complex or simple gestures (e.g., swiping or other movements on a touchscreen, drawing images), etc. The backend administrator can send the access code to the patient when activating automatic mode, or send the access code to the patient at the same time as sending the security code, or send the access code to the patient after confirming that the patient has activated the automatic mode function through the security code. In this embodiment of the invention, both the security code and the access code are generated randomly, and their generation rules can be the same or different. Preferably, the generation rules for the security code and the access code are different to avoid confusion for patients and thus avoid causing them distress.

[0097] In this embodiment of the invention, the system or doctor may make a comprehensive judgment based on multiple factors, including the patient's age, dietary habits, exercise habits, health status, and the results of using the non-automatic mode. When the patient has a record of using the non-automatic mode, the record of using the non-automatic mode shall be used as the main basis for judgment.

[0098] After the patient selects a meal, including "Regular" and "Grand Meal," the automatic mode employs a pre-infusion and supplemental infusion strategy, as shown in Figure 10. During pre-infusion and supplemental infusion, the pre-infusion and supplemental infusion volumes are categorized into different levels for both regular and grand meals, as shown in Table 1 below:

[0099] The insulin infusion volume during pre-infusion is at least related to the actual blood glucose level or rate of change of blood glucose at the time of pre-infusion, and the estimated meal intake. In other embodiments of the invention, the pre-infusion volume may also be related to the intracellular insulin content (IOB). Similarly, the insulin infusion volume during supplemental infusion is at least related to the actual blood glucose level or rate of change of blood glucose at the time of supplemental infusion, and the estimated supplemental meal intake. In other embodiments of the invention, the supplemental infusion volume may also be related to the intracellular IOB. In these embodiments, meal intake refers to the carbohydrate content of the meal.

[0100] The size of the meal intake during pre-infusion and the size of the meal intake during supplementary infusion are independent parameters. The meal intake during pre-infusion of the same level is greater than the meal intake during supplementary infusion, but there is no fixed correspondence between the two. The system can be set according to actual needs. For large meals, the minimum meal intake during pre-infusion is not less than the maximum meal intake for regular meals, and the minimum meal intake during supplementary infusion is not less than the maximum meal intake for regular meals.

[0101] Step 1001: At time T0, the patient selects the meal type and the default pre-infusion insulin volume. The default pre-infusion insulin volume can be any pre-infusion insulin volume corresponding to small, medium, or large meal sizes. Preferably, the default pre-infusion insulin volume is the insulin volume corresponding to small meal sizes. Selecting a small supplemental insulin volume can prevent excessive insulin infusion and reduce the risk of hypoglycemia.

[0102] Step 1002: At time T1, compare the current blood glucose level detected by CGM with a preset blood glucose threshold, such as 140, 150, 160, 170, 180, 190, 200 mg / mL, etc. If the current blood glucose level is greater than the preset blood glucose threshold, then administer the default supplemental insulin infusion volume; otherwise, do not administer a supplemental infusion volume. The default supplemental infusion volume can be any supplemental insulin infusion volume corresponding to a small, medium, or large meal size. Preferably, the default supplemental insulin infusion volume is the insulin infusion volume corresponding to a small meal size. Selecting a small initial supplemental insulin infusion volume can prevent excessive insulin infusion and reduce the risk of hypoglycemia. Time T1 may be 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, etc., after time T0. In other embodiments of the present invention, the blood glucose change rate at time T1 can also be used to determine whether to administer a supplemental infusion.

[0103] Step 1003: Within the ΔT0 time interval after time T0, such as 3h, 4h, 5h, if the patient experiences hyperglycemia, the next pre-infusion is upgraded, i.e., a larger insulin infusion volume corresponding to the estimated meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the next pre-infusion time; if the patient experiences hypoglycemia, the next pre-infusion is downgraded, i.e., a smaller insulin infusion volume corresponding to the estimated meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the next pre-infusion time; if the patient experiences neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, i.e., an insulin infusion volume corresponding to the same meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the next pre-infusion time.

[0104] It should be noted that, in the embodiments of the present invention, the change of infusion level means the change of the level of estimated meal intake during infusion. At the same time, the actual blood glucose value or blood glucose change rate at the time of infusion, or the in vivo IOB, are also taken into account. Therefore, in the embodiments of the present invention, the change of the estimated meal intake level also means the change of infusion level. That is, the infusion level and the estimated meal intake level can be understood as being consistent.

[0105] Step 1004: Within the ΔT1 time interval after time T1, such as 3h, 4h, 5h, etc., if the patient experiences hyperglycemia, the next supplemental infusion will be upgraded, i.e., a supplemental insulin infusion corresponding to a larger estimated meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of deficit (IOB) at the time of the next supplemental infusion. If the patient experiences hypoglycemia, the next supplemental infusion will be downgraded, i.e., a supplemental insulin infusion corresponding to a smaller estimated meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of deficit (IOB) at the time of the next supplemental infusion. If the patient experiences neither hyperglycemia nor hypoglycemia, the next supplemental infusion level will remain unchanged, i.e., a supplemental insulin infusion corresponding to the same estimated meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of deficit (IOB) at the time of the next supplemental infusion.

[0106] Step 1005: At time T2, the patient selects the type of meal and pre-infusion is performed based on the results of step 1003. This means pre-infusing a larger, smaller, or unchanged amount of insulin corresponding to the estimated meal intake, while also considering the actual blood glucose level or rate of change of blood glucose at time T2, or the intraocular insulin deficit (IOB).

[0107] Step 1006: At time T3, compare the current blood glucose level detected by CGM with a preset blood glucose threshold, such as 140, 150, 160, 170, 180, 190, 200 mg / mL, etc. If the current blood glucose level is greater than the preset blood glucose threshold, supplementary infusion is performed according to the result of step 1004. That is, a supplementary infusion of insulin corresponding to a larger, smaller, or unchanged supplementary meal intake is performed, while considering the actual blood glucose level or blood glucose change rate at time T3, or the in vivo IOB. If the current blood glucose level is not greater than the preset blood glucose threshold, no supplementary infusion is performed. In other embodiments of the present invention, the blood glucose change rate at time T3 can also be used to determine whether to perform supplementary infusion.

[0108] Step 1007: Within the ΔT0 time interval after time T2, such as 3h, 4h, 5h, if the patient experiences hyperglycemia, the next pre-infusion is upgraded, i.e., a larger insulin infusion volume corresponding to the estimated meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the time of the next pre-infusion. If the patient experiences hypoglycemia, the next pre-infusion is downgraded, i.e., a smaller insulin infusion volume corresponding to the estimated meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the time of the next pre-infusion. If the patient experiences neither hyperglycemia nor hypoglycemia, the next pre-infusion level remains unchanged, i.e., an insulin infusion volume corresponding to the same meal intake is administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the time of the next pre-infusion.

[0109] Step 1008: Within the ΔT1 timeframe after time T3, such as 3h, 4h, 5h, if the patient experiences hyperglycemia, the next supplemental infusion will be upgraded, i.e., a larger supplemental insulin infusion corresponding to the estimated meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of blood glucose (IOB) at the time of the next supplemental infusion. If the patient experiences hypoglycemia, the next supplemental infusion will be downgraded, i.e., a smaller supplemental insulin infusion corresponding to the estimated meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the IOB at the time of the next supplemental infusion. If the patient experiences neither hyperglycemia nor hypoglycemia, the next supplemental infusion level will remain unchanged, i.e., an insulin infusion corresponding to the same meal intake will be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the IOB at the time of the next supplemental infusion.

[0110] When pre-infusion and supplemental infusion are required at the next moment, repeat steps 1005-1008.

[0111] Generally, to maintain stable blood glucose levels, patients choose the same meal type at time T2 and time T0. That is, if a patient chooses a regular meal at time T0, they will also choose a regular meal at time T2; if they choose a large meal at time T0, they will also choose a large meal at time T2. Therefore, the choice of pre-infusion insulin and supplemental insulin infusion for the next time can depend on the results of the previous choice. However, if the patient's choice of meal for the next time is inconsistent with the previous choice, the patient will revert to the initial default pre-infusion and default supplemental infusion amounts at the next pre-infusion and supplemental infusion time to prevent inaccurate insulin infusion due to changes in meal patterns.

[0112] It's important to note here that if the current pre-infusion dose corresponds to the largest meal intake among the selected meal types, and hyperglycemia occurs within the ΔT0 time interval after time T0, the next pre-infusion dose will not be upgraded; the pre-infusion dose will still correspond to the larger estimated meal intake, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the next pre-infusion time. Similarly, if the current pre-infusion dose corresponds to the smallest meal intake among the selected meal types, and hypoglycemia occurs within the ΔT0 time interval after time T0, the next pre-infusion dose will not be downgraded; the pre-infusion dose will still correspond to the smaller estimated meal intake, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the next pre-infusion time.

[0113] Similarly, if the current supplemental infusion corresponds to the largest meal intake among the selected meal types, and hyperglycemia occurs within the ΔT0 time interval after time T0, the next supplemental infusion volume will not be upgraded; instead, the insulin infusion volume corresponding to the estimated large supplemental meal intake will still be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the time of the next supplemental infusion. Likewise, if the current supplemental infusion corresponds to the smallest meal intake among the selected meal types, and hypoglycemia occurs within the ΔT0 time interval after time T0, the next supplemental infusion volume will not be downgraded; instead, the insulin infusion volume corresponding to the estimated small supplemental meal intake will still be administered, while considering the actual blood glucose level or rate of change of blood glucose, or the internal rate of block (IOB) at the time of the next supplemental infusion.

[0114] In other embodiments of the present invention, the meal intake corresponding to pre-infusion and supplementary infusion is not necessarily graded. That is, the estimated meal intake during pre-infusion may only be the default amount, while the estimated meal intake during supplementary infusion may be of three different levels: large, medium, and small. Therefore, during the pre-infusion stage, each pre-infusion only infuses the insulin infusion amount corresponding to the default meal intake; or the estimated meal intake during pre-infusion may be of three different levels: large, medium, and small, while the estimated meal intake during supplementary infusion may only be the default amount. Therefore, during supplementary infusion, each supplementary infusion only infuses the insulin infusion amount corresponding to the default meal intake.

[0115] Similarly, the estimated food intake settings for pre-infusion and supplementary infusion are not necessarily the same for large meals and regular meals. That is, for each meal mode, the estimated food intake for pre-infusion and supplementary infusion can be selected as graded or not graded (default amount), which can be set according to the actual needs of the patient.

[0116] In this embodiment of the invention, the system is also equipped with a small meal mode, i.e. a snack mode. When the patient selects the snack mode, since the carbohydrate content in the snack is relatively small, the system infuses insulin based on the default estimated meal amount, while taking into account the patient's actual blood glucose level or blood glucose change rate when eating snacks, as well as the IOB in the body. Moreover, the default estimated meal amount in the snack mode is less than the lowest level of estimated meal amount in the regular mode.

[0117] Establish wireless communication connection

[0118] Figures 11a-11f are schematic diagrams illustrating the operation of establishing a wireless communication connection in different embodiments of the present invention.

[0119] In the blood glucose management system, when the program module 101 is an external device such as a smartphone, PDM, or tablet, in order to facilitate the patient's use of the artificial pancreas system, the on-body functional modules (detection module 100 and / or infusion module 102) and the program module 101 use wireless communication for data transmission and interaction. Before the formal establishment of the wireless communication connection, the detection module 100 and / or infusion module 102 send broadcast signals, and the program module 101 searches for broadcast signals and identifies the content and strength of the broadcast signals.

[0120] In existing technologies, patients need to obtain the unique device identifiers of the detection module 100 and / or infusion module 102 and input these identifiers into the program module 101 to identify the broadcast signals of the detection module 100 and / or infusion module 102 and establish a wireless communication connection. This step can be cumbersome and time-consuming for patients. Therefore, some detection modules 100 or infusion modules 102 can send broadcast signals before establishing a communication connection. When the program module 101 detects these broadcast signals, it can directly establish a communication connection with the signal source. This method eliminates the need for patients to input the device identifiers of the detection module 100 and / or infusion module 102, making it more convenient for patients to use. However, when patients are in complex environments, such as hospitals or clinics where multiple patients are likely to gather, the patient's program module 101 may search for broadcast signals from other patients' detection modules 100 and / or infusion modules 102 while searching for broadcast signals from the detection module 100 and / or infusion module 102. As a result, the patient's program module 101 may connect to the wrong detection module 100 and / or infusion module 102. This could cause the patient's program module 101 to receive blood glucose test data from other patients or send incorrect infusion instructions to other patients' infusion modules 102, while its own infusion module 102 cannot receive the correct infusion instructions. This is detrimental to the patient.

[0121] In view of the above problems, in some embodiments of the present invention, considering that when a patient establishes a wireless communication connection between their program module 101 and the detection module 100 and / or infusion module 102, they will inevitably place the program module 101 and the detection module 100 and / or infusion module 102 near themselves, that is, the distance between the patient's own detection module 100 and / or infusion module 102 and their own program module 101 is shorter than that between the detection module 100 and / or infusion module 102 of other patients and their own program module 101. Therefore, when the program module 101 searches for the broadcast signal of the patient's own detection module 100 and / or infusion module 102, the signal strength it obtains is stronger. Furthermore, if the patient intends to make their program module 101 find a stronger broadcast signal strength to distinguish it from the broadcast signals of other patients, the patient can also actively move their program module 101 closer to their own detection module 100 and / or infusion module 102. Specific implementation methods are described below.

[0122] When establishing a wireless communication connection between program module 101 and detection module 100 and / or infusion module 102, Bluetooth is generally used as the communication protocol. According to the following formula for calculating Bluetooth signal strength and distance, the distance between program module 101 and detection module 100 and / or infusion module 102 can be mapped based on the Bluetooth signal strength detected by program module 101.

[0123] In the formula:

[0124] d is the distance between program module 101 and detection module 100 and / or infusion module 102;

[0125] RSSI is the signal strength received by program module 101, and this value is negative.

[0126] A represents the signal strength received when the program module 101 is 1 meter away from the detection module 100 and / or the infusion module 102;

[0127] n is the environmental degradation factor.

[0128] According to formula (1), the distance d between program module 101 and detection module 100 and / or infusion module 102 can be determined based on the signal strength received by program module 101. The stronger the broadcast signal received by program module 101, the smaller the value of distance d, which means that the patient's program module 101 is closer to detection module 100 and / or infusion module 102. Conversely, when the patient holds program module 101 close to their own detection module 100 and / or infusion module 102, the broadcast signal strength of program module 101 searching for its own detection module 100 and / or infusion module 102 gradually increases, while the broadcast signal strength of other patients' detection modules 100 and / or infusion modules 102 gradually decreases. Based on this, program module 101 can distinguish the patient's own detection module 100 and / or infusion module 102 from other patients' detection modules 100 and / or infusion modules 102, avoiding establishing wireless communication connections with incorrect detection modules 100 and / or infusion modules 102.

[0129] Generally speaking, for the detection module 100 or the infusion module 102, as long as their model and parameters do not change, the power of the broadcast signal sent after being powered on at the factory is fixed. The signal strength of the broadcast signal decreases with distance according to the calculation formula (1). Therefore, when the program module 101 searches for the broadcast signal, it can obtain the relative distance between the program module 101 and the detection module 100 or the infusion module 102 based on the signal strength of the identified broadcast signal.

[0130] It should be noted that the above calculation formula (1) is only used as an exemplary description of signal strength and relative distance in this scheme. In actual product applications, other calculation methods may be combined or used.

[0131] Referring to Figure 11a, in some embodiments of the present invention, a signal strength threshold RSSI can be preset in program module 101. T The broadcast signal of the detection module 100 corresponds to the RSSI signal strength threshold. T100 The broadcast signal of the infusion module 102 corresponds to the signal strength threshold RSSI. T102 When the patient operates the program module 101 closes to their own detection module 100 and / or infusion module 102, the signal strength RSSI received by the program module 101 gradually increases until it is not less than the preset signal strength threshold RSSI. T100 and / or RSSI T102When the signal source is considered to be the patient's own detection module 100 and / or infusion module 102, the patient no longer needs to input the device identifier of the detection module 100 and / or infusion module 102. In this case, the program module 101 can directly establish a wireless communication connection with the detection module 100 and / or infusion module 102, which is convenient for the patient to use.

[0132] In other embodiments of the present invention, a signal strength threshold RSSI can also be preset in the detection module 100. T100 And / or a preset signal strength threshold RSSI is provided in the infusion module 102. T102 When the detection module 100 and / or the infusion module 102 send a broadcast signal, the broadcast signal carries a signal strength threshold RSSI that is equal to the preset signal strength threshold. T100 and / or RSSI T102 According to relevant information, after detecting a broadcast signal, program module 101 needs to identify the strength of the broadcast signal and, at the same time, identify the preset signal strength threshold RSSI carried in the broadcast signal. T100 and / or RSSI T102 Then the signal strength of the broadcast signal is compared with the preset signal strength threshold RSSI. T100 and / or RSSI T102 The comparison is performed; if the signal strength of the broadcast signal is not less than its preset signal strength threshold RSSI... T100 and / or RSSI T102 This indicates that the detection module 100 and / or infusion module 102 sending the broadcast signal is close to the program module 101. Therefore, the signal source can be considered to be the patient's own detection module 100 and / or infusion module 102. In this case, the patient no longer needs to input the device identifier of the detection module 100 and / or infusion module 102; a wireless communication connection can be directly established between the program module 101 and the detection module 100 and / or infusion module 102, facilitating patient use. When the detection module 100 and / or infusion module 102 are manufactured, a preset signal strength threshold RSSI is set. T100 and / or RSSI T102 The preset signal strength threshold RSSI can be set in the detection module 100 and / or the infusion module 102 according to the hardware status, type, parameters and other characteristics of each individual detection module 100 and / or infusion module 102. T100 and / or RSSI T102Different detection modules 100 and / or infusion modules 102, with varying hardware states, types, and parameters, transmit broadcast signals at different power levels. Consequently, the maximum distance between the program module 101 and the detection module 100 and / or infusion module 102 varies when the patient establishes a wireless communication connection. To enhance patient convenience and maintain consistency of habits, a preset signal strength threshold (RSSI) suitable for each individual detection module 100 and / or infusion module 102 is set. T100 and / or RSSI T102 This ensures that the distance between the program module 101 and the detection module 100 and / or the infusion module 102 is appropriate and consistent when the patient is establishing a wireless communication connection, which increases the convenience of operation for the patient and improves the patient's user experience.

[0133] In some embodiments of the present invention, the establishment of a wireless communication connection by identifying the signal strength sent by the detection module 100 and / or the infusion module 102 through the program module 101 does not necessarily mean that the blood glucose management system closes the input of the device identifiers of the detection module 100 and / or the infusion module 102 to establish a wireless communication connection. Both methods of establishing a wireless communication connection can coexist, and patients can choose the appropriate method based on their own conditions.

[0134] Referring to Figure 11b, in some embodiments of the present invention, the blood glucose management system provides the patient with two operating modes for establishing a wireless communication connection simultaneously. In the first operating mode, the patient operates the program module 101 close to the detection module 100 and / or the infusion module 102. As previously described, the program module 101 identifies the signal strength sent by the detection module 100 and / or the infusion module 102 to establish a wireless communication connection. In the second operating mode, the patient inputs the device identifier of the detection module 100 and / or the infusion module 102 into the program module 101. The device identifier contains broadcast signal information of the detection module 100 and / or the infusion module 102. Based on the device identifier, the corresponding broadcast signal can be identified to establish a wireless communication connection.

[0135] In some embodiments of the present invention, the program module 101 obtains the device identifier in ways including but not limited to manual input of characters by the patient, scanning of a QR code, Bluetooth transmission, voice recognition, etc. Any method that can input the device identifier code into the program module 101 can achieve this solution.

[0136] In some embodiments of the present invention, when a patient wishes to establish a wireless communication connection, he / she can select a first operation mode or a second operation mode in the interactive interface of the program module 101. The first operation mode and the second operation mode are displayed in parallel in the interactive interface of the program module 101.

[0137] In some embodiments of the present invention, the detection module 100 and / or the infusion module 102 may be an integrated or separate structure. When the detection module 100 is a separate structure, its transmitter is reusable. When the infusion module 102 is a separate structure, its electronic control unit, such as the control structure 100 shown in Figures 4a and 4b, is reusable. In embodiments of the present invention, the device identifier of the detection module 100 corresponds to its transmitter, and the device identifier of the infusion module 102 corresponds to its electronic control unit.

[0138] In the first operating mode, the broadcast signal carries information associated with a device identifier. The program module 101 can identify the broadcast signal and simultaneously obtain the device identifier information it carries. After the patient successfully establishes a wireless communication connection, the program module 101 generates a whitelist profile of objects that can establish wireless communication connections. The whitelist profile stores relevant information about the detection module 100 and / or infusion module 102 with which wireless communication connections have already been established, such as the device identifiers of the detection module 100 and / or infusion module 102. If the patient, without changing the transmitter or control unit, attempts to establish a wireless communication connection with the old detection module 100 and / or infusion module 102 again, the program module 101 only needs to identify the device identifier information carried in the broadcast signal. If it matches the device identifier stored in the whitelist profile, the program module 101 can directly establish a wireless communication connection with the detection module 100 and / or infusion module 102 that sent the broadcast signal, without needing to re-enter the device identifier or identify the signal strength of the broadcast signal. This simplifies patient operation and improves the user experience.

[0139] In some embodiments of the present invention, the whitelist profile of program module 101 may store one or more device identifiers.

[0140] In some embodiments of the present invention, when a patient no longer wishes to establish a wireless communication connection with an older detection module 100 and / or infusion module 102, they can choose to modify or delete the corresponding whitelist profile. This prevents the program module 101 from directly establishing a wireless communication connection with that detection module 100 and / or infusion module 102. After modifying or deleting the whitelist profile, if the patient needs to re-establish a wireless communication connection with the corresponding detection module 100 and / or infusion module 102, they need to re-enter the first operating mode or the second operating mode.

[0141] In other embodiments of the present invention, when the patient re-establishes a wireless communication connection, he / she may choose to use either the first operating mode or the second operating mode, without limiting the patient.

[0142] In some embodiments of the present invention, program module 101 just happens to find a signal strength threshold RSSI that matches the preset signal strength threshold. T100and / or RSSI T102 When broadcast signals of the same strength are used, the distance between program module 101 and detection module 100 and / or infusion module 102 is the maximum distance for establishing a wireless communication connection. If there is no change in the signal propagation medium, program module 101 can establish a wireless communication connection with detection module 100 and / or infusion module 102 at any position within this maximum distance.

[0143] In some embodiments of the present invention, the RSSI threshold value of the broadcast signal transmitted by the detection module 100 and / or the infusion module 102 is set. T100 and / or RSSI T102 The corresponding maximum distance can be set to 0.5m for the program module 101 to establish a wireless communication connection with the detection module 100 and / or the infusion module 102. That is, when the distance between the program module 101 and the detection module 100 and / or the infusion module 102 does not exceed 0.5m, the patient does not need to input the device identifier of the detection module 100 and / or the infusion module 102 to establish a wireless communication connection. Preferably, the maximum distance is 0.3m. More preferably, the maximum distance is 0.1m. In this embodiment of the invention, the smaller the distance between the program module 101 and the detection module 100 and / or the infusion module 102, the stronger the signal strength of the program module 101 in identifying the patient's own detection module 100 and / or infusion module 102, and the easier it is to distinguish the device signals from other patients. The reliability of establishing a wireless communication connection between the program module 101 and the patient's own detection module 100 and / or infusion module 102 is higher. However, if the distance between the program module 101 and the detection module 100 and / or infusion module 102 is too small, it may result in low convenience for the patient's operation. Selecting an appropriate signal strength threshold can determine the appropriate distance for establishing a wireless communication connection.

[0144] In the above embodiments, when the broadcast signal strengths sent by the detection module 100 and / or the infusion module 102 after power-on are the same, and the preset signal strength threshold RSSI in the program module 101 is... T100 and / or RSSI T102 When the condition remains unchanged, the maximum distance at which the program module 101 identifies the patient's own detection module 100 and / or infusion module 102 is also the same each time a wireless communication connection is established. In other embodiments of the present invention, the maximum distance at which the program module 101 identifies the patient's own detection module 100 and / or infusion module 102 can be adjusted.

[0145] For example, referring to FIG11c, in some embodiments of the present invention, the signal strength threshold RSSI T100 and / or RSSI T102The signal strength threshold RSSI in different program modules 101 is pre-stored in program module 101 during the manufacturing process. T100 and / or RSSI T102 The preset values ​​can be different. When the patient operates to establish a wireless communication connection, the maximum distance that the program module 101 can identify the patient's own detection module 100 and / or infusion module 102 will also be different. When the patient operates the program module 101 to approach the detection module 100 and / or infusion module 102, after entering this maximum distance, a wireless communication connection can be established between the program module 101 and the detection module 100 and / or infusion module 102.

[0146] Alternatively, in other embodiments of the invention, the available signal strength threshold RSSI T100 and / or RSSI T102 The signal strength threshold RSSI suitable for the state of the detection module 100 and / or infusion module 102 is pre-stored in the program module 101 in the form of a list profile. When the detection module 100 and / or infusion module 102 leaves the factory, the threshold is set. T100 and / or RSSI T102 The encoding is in the device identifier, and such encoding can consist of at least one digit, letter, special symbol, or other character. Before establishing a wireless communication connection, the patient can input the signal strength threshold RSSI through the interactive interface of program module 101. T100 and / or RSSI T102 The associated encoding eliminates the need to input the complete device identifiers of the detection module 100 and / or infusion module 102. Different encoding mappings correspond to different signal strength thresholds (RSSI). T100 and / or RSSI T102 When the patient inputs a code in program module 101, the corresponding signal strength threshold RSSI in the signal strength threshold list profile is called. T100 and / or RSSI T102 Furthermore, the corresponding program module 101 identifies the different maximum distances of the patient's own detection module 100 and / or infusion module 102. When the patient operates the program module 101 to approach the detection module 100 and / or infusion module 102, after entering the maximum distance corresponding to this code, the program module 101 can establish a wireless communication connection with the detection module 100 and / or infusion module 102.

[0147] In some embodiments of the present invention, the aforementioned signal strength threshold RSSI T100 and / or RSSI T102The associated encoding can be a single character, such as any Arabic numeral from 0 to 9, a Greek numeral, any letter from AZ, or any punctuation mark; there are no restrictions. In an exemplary description, the Arabic numeral 5 represents a signal strength threshold RSSI. T5 The maximum distance at which the program module 101 corresponding to this signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.5m. The Arabic numeral 3 represents another signal strength threshold, RSSI. T3 The maximum distance at which the program module 101 corresponding to this signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.3m. The letter A represents another signal strength threshold, RSSI. TA The maximum distance at which the program module 101 corresponding to the signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.05m. The above characters and their corresponding maximum distances are for illustrative purposes only.

[0148] In other embodiments of the present invention, the aforementioned signal strength threshold RSSI T100 and / or RSSI T102 The associated code can be at least two characters and can consist of any Arabic numerals, Greek numerals, letters, or punctuation marks, or a combination thereof; no restrictions are placed on this. In an exemplary description, the Arabic numeral 25 represents a signal strength threshold RSSI. T25 The maximum distance at which the program module 101 corresponding to this signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.25m. The Arabic numeral 21 represents another signal strength threshold, RSSI. T21 The maximum distance at which the program module 101 corresponding to this signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.21m. The letter 1A represents another signal strength threshold RSSI. T1A The maximum distance at which the program module 101 corresponding to the signal strength threshold establishes a wireless communication connection with the detection module 100 and / or the infusion module 102 is 0.05m.

[0149] In some embodiments of the present invention, the aforementioned signal strength threshold RSSI T100 and / or RSSI T102 The associated encoding can be a symbol at any position in the device identifier; it can be a continuous symbol encoding or a discontinuous, skipped symbol encoding, without any limitation. In an exemplary description, the encoding 1**2******** represents a signal strength threshold RSSI. T12 The asterisk (*) indicates the device identifier code, i.e., the signal strength threshold RSSI. T12The corresponding codes are located in the first and fourth positions of the device identifier. The patient only needs to input "12" in the interactive interface of the program module 101, and the program module 101 will retrieve the signal strength threshold RSSI corresponding to the code "12". T12 .

[0150] In other embodiments of the present invention, the aforementioned signal strength threshold RSSI T100 and / or RSSI T102 The associated codes are printed separately on the detection module 100 and / or the infusion module 102 or on the packaging.

[0151] After being powered on, the detection module 100 and / or infusion module 102 transmit broadcast signals at normal power, referred to here as the first power. In some existing technologies, to facilitate the establishment of wireless communication connections by patients, the first power is usually set relatively high to ensure the effective range of the broadcast signal for the program module 101 to search and identify. Transmitting broadcast signals at the first power for an extended period of time results in excessive power consumption for the detection module 100 and / or infusion module 102, affecting their service life.

[0152] Referring to Figure 11d, in some embodiments of the present invention, in order to save power consumption of the detection module 100 and / or the infusion module 102 and extend their service life, the detection module 100 and / or the infusion module 102 can reduce the broadcast signal transmission power during the broadcast signal transmission period after power-on, transmitting the broadcast signal at a second power, which is less than the first power, for example, the second power is one-half or one-third of the first power. Under this premise, such as maintaining a preset signal strength threshold RSSI... T100 and / or RSSI T102 As before, program module 101 just detected that the broadcast signal strength reached the preset signal strength threshold RSSI. T100 and / or RSSI T102 At this time, the maximum distance between the program module 101 and the detection module 100 and / or the infusion module 102 will become smaller. For example, when transmitting a broadcast signal at the first power, the maximum distance for establishing a wireless communication connection between the program module 101 and the detection module 100 and / or the infusion module 102 is 0.5m. When transmitting a broadcast signal at the second power, if the preset signal strength threshold RSSI is maintained... T100 and / or RSSI T102Without change, the maximum distance for establishing a wireless communication connection between the program module 101 and the detection module 100 and / or the infusion module 102 may be reduced to 0.3m or 0.1m. Therefore, the patient needs to operate the program module 101 closer to the detection module 100 and / or the infusion module 102. After the program module 101 establishes a wireless communication connection with the detection module 100 and / or the infusion module 102, the detection module 100 and / or the infusion module 102 will increase its signal transmission power to maintain a long-distance wireless communication connection with the program module 101 at a third power. At this time, the effective communication distance between the program module 101 and the detection module 100 and / or the infusion module 102 is 0-10m, which is convenient for the patient's daily use.

[0153] In the above embodiments, the communication distance values ​​are only used as examples and different communication distance values ​​may be applicable to different products and solutions.

[0154] After being powered on, the detection module 100 and / or infusion module 102 transmits a broadcast signal at the first power. During the establishment of a wireless communication connection between the patient operation program module and the detection module 100 and / or infusion module 102, due to improper operation or interference from other factors, the wireless communication connection between the program module 101 and the detection module 100 and / or infusion module 102 cannot be established in a timely manner. This increases the power consumption of the detection module 100 and / or infusion module 102 and reduces the service life of the detection module 100 and / or infusion module 102.

[0155] Regarding the above-mentioned problem, referring to FIG11e, in some embodiments of the present invention, a time threshold is set in the detection module 100 and / or the infusion module 102. After power-on, a broadcast signal is sent with a first parameter and timing begins. If the program module 101 fails to establish a wireless communication connection with the detection module 100 and / or the infusion module 102 within the preset time threshold, the detection module 100 and / or the infusion module 102 will decrease the broadcast signal transmission parameter and send the broadcast signal with a second parameter. In embodiments of the present invention, "parameter" can correspond to power or time interval.

[0156] When the "parameter" corresponds to the power, as mentioned above, the second power is less than the first power. For example, the second power is one-half or one-third of the first power. In this case, the patient needs to move the operating program module 101 closer to the detection module 100 and / or the infusion module 102 to establish a wireless communication connection.

[0157] In some embodiments of the present invention, the preset time threshold for the detection module 100 and / or the infusion module 102 to transmit a broadcast signal at a first power after being powered on is set by the manufacturer or the patient, and can be set to 0-600 seconds. Preferably, the above time threshold is set to 0-60 seconds. The above values ​​are for illustrative purposes only.

[0158] In other embodiments of the present invention, when the "parameter" corresponds to a time interval, if the program module 101 fails to establish a wireless communication connection with the detection module 100 and / or the infusion module 102 within a preset time threshold, the power of the broadcast signal transmitted by the detection module 100 and / or the infusion module 102 remains unchanged, but the transmission time interval of the broadcast signal is adjusted. For example, within the preset time threshold, the first time interval between two adjacent broadcast signals is 0.01-10 seconds, and after exceeding the preset time threshold, the second time interval between two adjacent broadcast signals is 1-60 seconds. Preferably, after exceeding the preset time threshold, the transmission time interval of the broadcast signal is increased, for example, before and after the preset time threshold, the transmission time interval between two adjacent broadcast signals increases from 0.1 seconds to 10 seconds. Increasing the transmission time interval of the broadcast signal reduces the number of broadcast signals transmitted per unit time, which can also reduce the power consumption of the detection module 100 and / or the infusion module 102 and extend the service life of the detection module 100 and / or the infusion module 102. Longer broadcast signal transmission intervals save more power, but also increase the waiting time for patients when establishing wireless communication connections. Choosing an appropriate broadcast signal transmission interval can reduce power consumption while also meeting the user experience needs of patients.

[0159] In some embodiments of the present invention, in order to further reduce the power consumption of the detection module 100 and / or the infusion module 102, while reducing the transmission power of the broadcast signal, the transmission time interval of the broadcast signal can also be increased.

[0160] In some embodiments of the present invention, if the patient is unable to establish a wireless communication connection between the program module 101 and the detection module 100 and / or the infusion module 102 in a timely manner, the patient's position may change during subsequent operations to establish a wireless communication connection. The patient's own detection module 100 and / or infusion module 102 may become closer to the detection modules 100 and / or infusion modules 102 of other patients, increasing the risk of establishing an incorrect wireless communication connection. This is detrimental to the patient's operation in establishing a wireless communication connection.

[0161] Regarding the above-mentioned problems, referring to FIG11f, in some embodiments of the present invention, a time threshold can be set in the detection module 100 and / or infusion module 102, and timing can begin after power-on. If the program module 101 fails to establish a wireless communication connection with the detection module 100 and / or infusion module 102 within the preset time threshold, the blood glucose management system adds a mode in which the program module 101 inputs the device identifier of the detection module 100 and / or infusion module 102 to establish a wireless communication connection. At this time, if the patient continues to operate to establish a wireless communication connection, he / she can continue to operate the program module 101 to search for broadcast signals, or he / she can input the device identifier of the detection module 100 and / or infusion module 102 in the interactive interface of the program module 101. This reduces the possibility that the program module 101 connects to the wrong detection module 100 and / or infusion module 102.

[0162] In other embodiments of the present invention, a time threshold can be set in the program module 101. After the patient powers on the detection module 100 and / or the infusion module 102, the timing starts when the operation establishes a wireless communication connection. If the program module 101 fails to establish a wireless communication connection with the detection module 100 and / or the infusion module 102 within the preset time threshold, the patient can enter the device identifier of the detection module 100 and / or the infusion module 102 in the program module 101 to establish a wireless communication connection. If the patient continues to operate to establish a wireless communication connection, they can continue to operate the program module 101 to search for broadcast signals, or they can enter the device identifier of the detection module 100 and / or the infusion module 102 in the interactive interface of the program module 101. This also reduces the possibility that the program module 101 connects to the wrong detection module 100 and / or the infusion module 102.

[0163] In some embodiments of the present invention, the preset time threshold for the device identifier is set by the manufacturer or the patient, and can be set to 0-600 seconds. Preferably, the time threshold is set to 0-60 seconds. The above values ​​are for illustrative purposes only.

[0164] In some embodiments of the present invention, in certain situations, when the operating procedure module 101 searches for broadcast signals, the patient may identify that the signal strength of multiple broadcast signals is not less than a preset signal strength threshold RSSI. T100 and / or RSSI T102 In this situation, program module 101 will be unable to select a broadcast signal to establish a wireless communication connection, and will promptly notify the patient that there are multiple connectable broadcast signals in the vicinity, requiring a change of operating location or a re-establishment of the wireless communication connection, until program module 101 identifies only one broadcast signal whose signal strength is not less than the preset signal strength threshold RSSI. T100 and / or RSSI T102Alternatively, the program module 101 may prompt the patient to enter the device identifier of the detection module 100 and / or the infusion module 102, thereby establishing a wireless communication connection between the program module 101 and the patient's own detection module 100 and / or infusion module 102.

[0165] In some embodiments of the present invention, to avoid prolonged waiting by the patient during the establishment of a wireless communication connection, the program module 101 starts timing when it begins searching for and identifying broadcast signals. For example, if the program module 101 fails to identify a broadcast signal with a signal strength not less than a preset signal strength threshold, or identifies multiple broadcast signals with a signal strength not less than the preset signal strength threshold, within 5 seconds of the program module 101 starting to search for and identify broadcast signals, the program module 101 will prompt the patient to re-establish the wireless communication connection or change the operation location. If, within the next 20 seconds, the program module 101 still fails to identify a broadcast signal with a signal strength not less than the preset signal strength threshold, or still identifies multiple broadcast signals with a signal strength not less than the preset signal strength threshold, the program module 101 will prompt the patient to enter the device identification code of the detection module 100 and / or the infusion module 102 to establish a wireless communication connection. The above time values ​​are for illustrative purposes only.

[0166] In some embodiments of the present invention, considering that the program module 101 of the signal receiving end may have different recognition of broadcast signals of the same signal strength due to individual state differences, for example, after the program module 101 leaves the factory, its hardware gradually ages over time, and its sensitivity to signal strength recognition gradually decreases. Since the program module 101 is generally a reusable device, its absolute strength recognition of the broadcast signal may change during use. When the patient establishes a wireless communication connection, the maximum distance between the program module 101 and the detection module 100 and / or the infusion module 102 may also change, which may cause inconvenience to the patient's operating habits. Therefore, a signal correction coefficient can be set in the program module 101. The broadcast signal strength searched by the program module 101 is finally determined by the arithmetic correction result of the broadcast signal strength recognized by the program module 101 and the preset signal strength threshold RSSI. T100 and / or RSSI T102 A comparison is made to determine whether a wireless communication connection should be established. The corrected broadcast signal strength ensures that the maximum distance between the program module 101 and the detection module 100 and / or the infusion module 102 does not change significantly when the patient is establishing a wireless communication connection. For example, the range of change is between -0.05m and 0.05m, which can minimize the impact on the patient's operating habits.

[0167] In some embodiments of the present invention, the signal correction coefficient can be input into the program module 101 by the patient, or the signal correction coefficient can be stored in the program module 101. As the program module 101 is used for longer periods of time, the signal correction coefficient can be adjusted over time.

[0168] In some embodiments of the present invention, the correction arithmetic of the broadcast signal strength and the signal correction coefficient is multiplication or addition, or other algorithms.

[0169] In some embodiments of the present invention, in order to further ensure the reliability of the wireless communication connection established between the program module 101 and the detection module 100 and / or the infusion module 102, the patient's confirmation instruction is required before the program module 101 establishes a wireless communication connection with the detection module 100 and / or the infusion module 102.

[0170] In summary, this invention discloses a blood glucose management system that provides patients with two selectable operating modes for establishing wireless communication connections. The blood glucose management system presets a signal strength threshold. In the first operating mode, the program module searches for nearby broadcast signals and identifies their signal strength. When the signal strength of the broadcast signal is not less than the preset signal strength threshold, the program module can establish a wireless communication connection with the detection module and / or infusion module that sent the broadcast signal, without needing to input the device identifier of the detection module and / or infusion module. In the second operating mode, the patient inputs the device identifier of the detection module and / or infusion module to establish a wireless communication connection, ensuring the reliability of the wireless communication connection established between the program module and the patient's own detection module and / or infusion module.

[0171] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A blood glucose management system, characterized in that, include: A body-mounted functional module is attached to the patient's skin surface and transmits broadcast signals to the outside world after being powered on. The body-mounted functional module includes a device identifier, which is associated with the broadcast signal. A program module is configured to search for nearby broadcast signals and identify the signal strength of the broadcast signals, wherein the signal strength of the broadcast signals is mapped to the distance between the program module and the body functional module; The blood glucose management system presets a signal strength threshold, wherein the blood glucose management system provides: In the first operating mode, the program module compares the broadcast signal strength with the preset signal strength threshold. When the searched broadcast signal strength is not less than the preset signal strength threshold, the program module establishes a wireless communication connection with the body function module that sends the broadcast signal. In the second operating mode, the program module obtains the device identifier, searches for the broadcast signal associated with the device identifier, and establishes a wireless communication connection with the body function module that sends the broadcast signal.

2. The blood glucose management system according to claim 1, characterized in that, The in vivo functional module includes a detection module and / or an infusion module. The detection module is used to continuously detect the patient's current blood glucose level, and the infusion module is used to infuse the patient with the currently required medication.

3. The blood glucose management system according to claim 1, characterized in that, In the first operating mode, when the strength of the broadcast signal found is not less than the preset signal strength threshold, the distance between the program module and the body function module is 0-0.5m.

4. The blood glucose management system according to claim 1, characterized in that, In the first operating mode, the broadcast signal corresponds to the device identifier. After the program module establishes a wireless communication connection with the body function module, the program module stores the device identifier.

5. The blood glucose management system according to claim 4, characterized in that, The program module searches for and identifies the broadcast signal based on the stored device identifier, and establishes a wireless communication connection with the body function module that sends the broadcast signal corresponding to the device identifier.

6. The blood glucose management system according to claim 1, characterized in that, The blood glucose management system also includes a time threshold for timing during the establishment of a wireless communication connection by the patient.

7. The blood glucose management system according to claim 6, characterized in that, If the body-on-the-body functional module fails to establish a wireless communication connection with the program module within the time threshold, the transmission power of the broadcast signal is reduced until the body-on-the-body functional module establishes a wireless communication connection with the program module.

8. The blood glucose management system according to claim 6, characterized in that, If the body-on-the-body functional module fails to establish a wireless communication connection with the program module within the time threshold, the transmission time interval of the broadcast signal is increased until the body-on-the-body functional module establishes a wireless communication connection with the program module.

9. The blood glucose management system according to claim 6, characterized in that, If the on-body functional module fails to establish a wireless communication connection with the program module within the time threshold, the patient is prompted to execute the second operation mode to establish a wireless communication connection.

10. The blood glucose management system according to claim 6, characterized in that, The time threshold is 0-600 seconds.

11. The blood glucose management system according to claim 6, characterized in that, The time threshold is set in the functional module or the program module of the body.

12. The blood glucose management system according to claim 1, characterized in that, The preset signal strength threshold is set in the program module.

13. The blood glucose management system according to claim 1, characterized in that, The preset signal strength threshold is set in the body functional module, and the broadcast signal includes information associated with the preset signal strength threshold.

14. The blood glucose management system according to claim 1, characterized in that, In the first operating mode, when there is only one broadcast signal with a signal strength not less than the preset signal strength threshold, the program module establishes a wireless communication connection with the body function module that sends the broadcast signal; when there is more than one broadcast signal with a signal strength not less than the preset signal strength threshold, the program module does not establish a wireless communication connection with the body function module that sends the broadcast signal.

15. The blood glucose management system according to claim 14, characterized in that, When the number of broadcast signals with a signal strength not less than the preset signal strength threshold exceeds one, the blood glucose management system prompts the patient to change the operation location or enter the device identifier of the on-body functional module.

16. The blood glucose management system according to claim 1, characterized in that, The program module also includes a signal correction coefficient, which is associated with the state of the program module. In the first operation mode, before comparing the broadcast signal strength with the preset signal strength threshold, the program module corrects the broadcast signal strength based on the signal correction coefficient.

17. The blood glucose management system according to claim 1, characterized in that, Before the on-body functional module and the program module establish a wireless communication connection, the patient's confirmation is required.

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