In vivo insulin integrated management platform system and method and computer program therefor

Abstract

An in-vivo insulin comprehensive management platform system can include a receiving module configured to receive one or more insulin injection information including past insulin injection amount and injection timing of a user through user input or through communication connection with one or more injection devices for injecting insulin to the user, and to receive injection means information for future insulin injection of the user; a management module configured to calculate in-vivo insulin of the user based on the insulin injection information, and to generate one or more management information including injection amount and injection timing of insulin for continuous management of the in-vivo insulin based on the in-vivo insulin and the injection means information; and an output module configured to provide the management information to the user.

Description

Technical Field

[0001] This patent application was filed with the support of the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Food and Drug Safety Administration, and was supported by the Cross-departmental Full-Cycle Medical Device Research and Development Project (Research Project Title: Advanced Development of Pen-Type Automated Insulin Injection Device (AID) Based on CGM (Continuous Glucose Measurement) / Motion Sensor Data Analysis Algorithm, Project Number: 1711196799).

[0002] The embodiments relate to a comprehensive insulin management platform system and method, and a computer program for use therein. More specifically, the embodiments relate to a technique that calculates and predicts in vivo insulin levels based on a user's insulin input information, and proposes future insulin input plans to the user or sets them on an infusion device based on the predicted in vivo insulin levels, thereby providing the user with an optimal insulin management method. Background Technology

[0003] With the development of modern medical technology, diabetic patients can now manage their blood sugar through insulin administration in various ways. Insulin administration methods are mainly divided into MDI (Multiple Daily Injection) therapy and CSII (Continuous Subcutaneous Insulin Infusion) therapy. MDI therapy involves injecting insulin multiple times a day using insulin pens, and it is favored by many patients due to its low initial cost and ease of use. However, if blood sugar management does not reach the target level, patients usually switch from MDI therapy to CSII therapy. CSII therapy is generally based on real-time blood glucose values ​​obtained through a continuous glucose meter, and uses an insulin pump to continuously inject the required amount of insulin subcutaneously at all times, enabling more precise blood sugar management.

[0004] Recently, systems have been introduced to calculate the optimal timing and dosage of insulin administration based on patients' blood glucose, diet, and exercise information. For example, Patent Publication No. 10-2494011 discloses a system for calculating bolus insulin based on a continuous glucose monitoring (CGM) meter. Bolus insulin refers to the extra insulin injected by diabetic patients during meals or when blood glucose rises sharply to regulate blood glucose. It is mainly a fast-acting insulin preparation used to prevent sharp rises in blood glucose and maintain blood glucose within the target range.

[0005] However, even patients using CSII therapy to manage their blood sugar may experience difficulties using the insulin pump in certain situations. For example, during strenuous exercise such as marathons, cycling, or swimming; when exposed to water (such as bathing or seawater bathing); while traveling; or when being observed by others, there may be situations where the insulin pump needs to be removed from the body and an insulin pen needs to be used for a certain period. Conversely, patients who were previously using MDI therapy with an insulin pen to manage their blood sugar may switch to CSII therapy with an insulin pump to improve their blood sugar management. In such cases, accurate blood sugar management may be difficult during the transition period of several hours to several days, but the prior art, including that disclosed in Patent Publication No. 10-2494011, does not provide comprehensive management capabilities for such changes in insulin delivery characteristics.

[0006] Due to these limitations of existing technology, problems may arise in insulin administration and blood glucose management if users cannot accurately understand the delivery device used for insulin administration and the dosage of insulin. Furthermore, since the insulin dosage before and after switching devices is entirely determined by the user, there is a high possibility of blood glucose management failure due to improper judgment. In addition, even with an insulin administration management system utilizing information and communication technology, if the history of using different insulin administration methods is not comprehensively managed, incorrect guidance on insulin dosage and timing may be provided based on erroneous information. This poses problems in reducing the level of precise blood glucose management, lowering the credibility of the entity operating the system, and potentially posing significant risks to the health of diabetic patients. Summary of the Invention

[0007] Technical issues According to one aspect of the present invention for solving such problems of the prior art, an in vivo insulin integrated management platform system, an in vivo insulin integrated management method, and a computer program for the purpose thereof are provided. This system is compatible with various insulin injection devices and, even when the user uses various delivery methods such as pumps, insulin pens, and medications, or changes the delivery method used, can calculate and predict in vivo insulin based on previous insulin delivery information, thereby achieving unified insulin delivery information management.

[0008] Technical solutions According to one aspect of the present invention, an in vivo insulin comprehensive management platform system includes: a receiving module configured to receive, via user input or via a communication connection with one or more injection devices for administering insulin to a user, one or more insulin administration information including the user's past insulin administration volume and administration timing, and to receive administration method information for the user's future insulin administration; a management module configured to calculate the user's in vivo insulin based on the insulin administration information, and to generate, based on the in vivo insulin and administration method information, one or more management information including the insulin administration volume and administration timing for continuous management of the in vivo insulin; and an output module configured to provide the management information to the user.

[0009] In one embodiment, the receiving module is further configured to receive insulin administration information from a first injection device communicatively connected to the in vivo insulin management platform system. In this case, the management module is further configured to automatically set one or more of the insulin administration amount and timing for a second injection device communicatively connected to the in vivo insulin management platform system based on the management information.

[0010] In one embodiment, the first injection device and the second injection device are devices with different insulin delivery characteristics, including one or more of the type of insulin administered, the insulin dosage, and the insulin delivery cycle. In this case, the management module is further configured to calculate the in vivo insulin based on the insulin delivery information from the first injection device, and, based on the in vivo insulin and the insulin delivery characteristics of the second injection device, determine one or more of the initial insulin dosage and the initial delivery time point from the second injection device.

[0011] In one embodiment, the administration method information includes information defining the injection device or medication used by the user for insulin administration. In this case, the management module is further configured to calculate the in vivo insulin levels and management information for the bolus or basal insulin administered by the user.

[0012] In one embodiment, the management module is further configured to calculate the in vivo insulin and the management information for each of the bolus insulin and basal insulin administered by the user.

[0013] According to one aspect of the present invention, a method for comprehensive management of in vivo insulin includes: a step of an in vivo insulin management platform system receiving, via user input or via a communication connection with one or more injection devices for administering insulin to a user, insulin administration information including one or more of the user's past insulin administration amounts and administration times; a step of the in vivo insulin management platform system calculating the user's in vivo insulin levels based on the insulin administration information; a step of the in vivo insulin management platform system receiving administration method information for the user's future insulin administration; a step of the in vivo insulin management platform system generating, based on the in vivo insulin levels and the administration method information, management information including one or more of the insulin administration amounts and administration times for continuous management of the in vivo insulin; and a step of the in vivo insulin management platform system providing the management information to the user.

[0014] In one embodiment, the step of receiving the insulin delivery information includes the step of the in vivo insulin management platform system receiving the insulin delivery information from a first injection device communicatively connected to the in vivo insulin management platform system. Furthermore, the step of providing the management information includes the step of the in vivo insulin management platform system automatically setting one or more of the insulin delivery amount and timing for a second injection device communicatively connected to the in vivo insulin management platform system based on the management information.

[0015] In one embodiment, the step of generating the management information includes the following steps: the in vivo insulin integrated management platform system calculates the in vivo insulin and the insulin delivery characteristics of the second injection device based on the insulin delivery information delivered by the first injection device, and determines one or more of the initial insulin delivery amount and the initial delivery time point delivered by the second injection device.

[0016] In one embodiment, the first injection device is an insulin pump, and the second injection device is an insulin pen.

[0017] At this time, determining one or more of the following steps—the initial insulin dosage and the initial dosage time—by the second injection device may include: the step of the in vivo insulin management platform system calculating the residual insulin in the body at the current time point of the transition to the second injection device based on the insulin dosage information from the first injection device; and the step of the in vivo insulin management platform system reflecting the residual insulin in the body at the current time point and determining the initial insulin dosage by the second injection device.

[0018] In addition, the step of generating the management information may include: the step of the in vivo insulin integrated management platform system receiving information about the time point of the transition from the first injection device to the second injection device; and the step of the in vivo insulin integrated management platform system generating the management information to suspend insulin administration by the first injection device within a preset time interval before the transition time point.

[0019] In one embodiment, the first injection device is an insulin pen, and the second injection device is an insulin pump.

[0020] At this time, determining one or more of the initial insulin dosage and initial dosage time of the second injection device may include: the step of the in vivo insulin management platform system calculating the residual insulin in the body at the current time point based on the insulin dosage information of the first injection device; and the step of the in vivo insulin management platform system reflecting the residual insulin in the body at the current time point and delaying the insulin dosage time point of the second injection device.

[0021] In addition, the steps of determining one or more of the initial insulin dosage and initial dosage time of the second injection device may include: the step of the in vivo insulin management platform system calculating the in vivo effective insulin at the current time point based on the insulin dosage information of the first injection device; and the step of the in vivo insulin management platform system determining the insulin dosage of the second injection device based on the amount obtained by subtracting the in vivo effective insulin at the current time point from the preset target basal effective insulin.

[0022] In one embodiment, the target basal-acting insulin is the convergent value of the sum of the acting insulins corresponding to the long-acting insulin injected multiple times at preset time intervals by the first injection device.

[0023] In one embodiment, the step of determining the amount of insulin administered by the second injection device includes the step of the in vivo insulin management platform system linearly increasing the amount of insulin administered by the second injection device until the in vivo acting insulin based on the insulin administered by the second injection device reaches the target basal acting insulin.

[0024] Furthermore, the insulin delivery information provided by the first injection device may include the injection time point of the long-acting insulin delivered by the first injection device. In this case, determining one or more of the initial insulin delivery amount and the initial delivery time point delivered by the second injection device may include the step of the in vivo insulin management platform system determining the insulin delivery time point delivered by the second injection device based on the duration of action of the long-acting insulin.

[0025] In one embodiment, the step of receiving the insulin administration information includes the step of the in vivo insulin management platform system receiving the insulin administration information from an injection device communicatively connected to the in vivo insulin management platform system. Furthermore, the step of providing the management information includes: the step of the in vivo insulin management platform system calculating the user's current residual insulin based on the insulin administration information; and the step of the in vivo insulin management platform determining, based on the current residual insulin, one or more of the dosage and administration time of the medication administered by the user for blood glucose regulation.

[0026] In one embodiment, the in vivo insulin and the management information are calculated for the user's administered bolus insulin or basal insulin. Alternatively, in one embodiment, the in vivo insulin and the management information may be calculated for bolus insulin and basal insulin separately.

[0027] According to another aspect of the present invention, a method for comprehensive management of insulin in vivo is provided, which is executed by a computing device communicating with one or more injection devices, thereby providing continuous management functions even when the injection device is switched.

[0028] According to one embodiment, a method for comprehensive management of in vivo insulin includes the following steps: receiving first insulin administration information, including the type, dosage, and timing of past insulin administrations, via user input or through a communication connection with a first infusion device for administering insulin to the user; calculating the user's residual insulin in vivo if the past insulin was rapid-acting, and calculating the user's active insulin in vivo if the past insulin was long-acting, based on the first insulin administration information; receiving the type of insulin corresponding to a second infusion device for future insulin administrations to the user; and automatically setting one or more of the insulin administration dosage and timing performed by the second infusion device in the second infusion device based on the user's calculated residual insulin or active insulin in vivo and the insulin type corresponding to the second infusion device.

[0029] In one embodiment, the first injection device and the second injection device are devices that use different types of insulin.

[0030] At this point, the comprehensive insulin management method further includes: receiving second insulin administration information, including the type, dosage, and timing of administration of insulin corresponding to the second injection device, either through user input or through a communication connection with the second injection device; calculating the user's residual insulin or in vivo effective insulin based on the second insulin administration information; receiving the type of insulin corresponding to a third injection device, the third injection device being used for the user's future insulin administration and having a different type of insulin than the second injection device; and automatically setting one or more of the insulin administration dosage and timing performed by the third injection device to the third injection device based on the user's residual insulin or in vivo effective insulin calculated based on the second insulin administration information and the insulin type corresponding to the third injection device.

[0031] In one embodiment, the first injection device is an insulin pump using rapid-acting insulin, the second injection device is an insulin pen using long-acting insulin, and the third injection device is an insulin pump using rapid-acting insulin.

[0032] At this time, the step of automatically setting the second injection device includes one or more steps of determining the insulin injection amount and injection timing of the second injection device based on the residual insulin in the body corresponding to the rapid-acting insulin injected into the body by the first injection device and the first insulin injection information.

[0033] In addition, the step of automatically setting the third injection device includes one or more steps of determining the insulin dosage and timing of the third injection device based on the in vivo acting insulin corresponding to the long-acting insulin injected into the body by the second injection device and the second insulin injection information.

[0034] In another embodiment, the step of automatically setting the second injection device includes one or more steps of determining the insulin dosage and timing of injection by the second injection device based on a preset target basal insulin. In this case, the target basal insulin can be the converged value of the sum of the effective insulins corresponding to long-acting insulin injected multiple times by the first injection device at preset time intervals.

[0035] Furthermore, in one embodiment, determining one or more of the steps of insulin delivery amount and delivery timing of the second injection device includes determining the insulin delivery amount of the second injection device based on the value obtained by subtracting the in vivo acting insulin at the current time point based on the long-acting insulin injected into the body by the first injection device from the target basal acting insulin.

[0036] In another embodiment, the step of determining one or more of the insulin input amount and timing of the second injection device includes linearly increasing the insulin input amount by the second injection device until the in vivo acting insulin based on the rapid-acting insulin injected into the body by the second injection device reaches the target basal acting insulin.

[0037] The in vivo insulin comprehensive management method according to one aspect of the present invention can be combined with hardware and stored in a computer-readable recording medium to perform the in vivo insulin comprehensive management method according to the above embodiments.

[0038] A computer program according to one aspect of the present invention is stored in a computer-readable recording medium to perform the in vivo insulin comprehensive management method according to the above embodiments.

[0039] The effects of the invention According to one aspect of the present invention, an insulin on board (IBO) integrated management platform system and an insulin on board integrated management method allow diabetic patients to easily manage their insulin administration records through an insulin injection device linked to their own smartphone application (app) and data manually entered in the application. This system offers the following advantages: by administering insulin according to the optimal insulin administration plan provided by the system based on IBO, blood glucose levels can be effectively regulated.

[0040] For example, when a patient switching from MDI (Multi-Injection) therapy to CSII (Continuous Serological Injection) therapy, even if the insulin pump is put on immediately after insulin is administered via insulin pen, the platform will control the insulin delivery by delaying the pump or adjusting the dosage based on previous insulin administration information. Therefore, the user does not need to worry about the conversion of administration methods. Furthermore, even when switching from CSII to MDI therapy, the platform automatically calculates and prompts the timing and dosage of insulin administration, allowing the user to administer the required amount at the appropriate time according to the application's guidance.

[0041] Brief description of the attached figures Figure 1 This is a schematic block diagram of an in vivo insulin integrated management platform system according to one embodiment.

[0042] Figure 2This is a block diagram illustrating the hardware configuration of an in vivo insulin integrated management platform system according to one embodiment.

[0043] Figure 3 This is a schematic block diagram showing the detailed configuration of the receiving module of an in vivo insulin integrated management platform system according to one embodiment.

[0044] Figure 4 This is a schematic block diagram illustrating the detailed configuration of the management module of an in vivo insulin integrated management platform system according to one embodiment.

[0045] Figure 5 It is a graph showing the decrease in active insulin and the amount of insulin acting over time after insulin administration.

[0046] Figure 6a This is a flowchart illustrating the steps of a comprehensive in vivo insulin management method according to one embodiment.

[0047] Figure 6b This is a flowchart illustrating the steps of a comprehensive in vivo insulin management method according to yet another embodiment.

[0048] Figures 7 to 9 This is a conceptual diagram illustrating an exemplary user interface (UI) provided by an in vivo insulin integrated management platform system according to one embodiment.

[0049] Figures 10a to 10d This is a conceptual diagram illustrating the adjustment of insulin delivery timing according to an embodiment of an in vivo insulin integrated management platform system.

[0050] Specific content for implementing the invention Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[0051] Figure 1 This is a schematic block diagram of an in vivo insulin integrated management platform system according to one embodiment.

[0052] Reference Figure 1 According to one embodiment, the in vivo insulin integrated management platform system 2 can communicate with the injection devices 11 to 13 used by users who need to administer insulin to themselves or others, such as diabetic patients or guardians, and / or the user devices 1 such as smartphones used by the users.

[0053] Figure 1 The number and configuration of user devices 1 shown are merely exemplary. For example, in Figure 1 The example of user device 1 is as one, but multiple examinees can also access the in vivo insulin integrated management platform system 2 through their own user devices 1. Furthermore, in Figure 1 In this embodiment, user device 1 is shown in the form of a smartphone, but in other embodiments, user device 1 may also be implemented in the form of any computing device, such as other forms of mobile communication terminals, notebook computers, personal computers, PDAs (personal digital assistants), tablets, set-top boxes for IPTV (Internet Protocol Television), etc.

[0054] In one embodiment, the in vivo insulin management platform system 2 may further communicate with one or more health management servers 3 corresponding to a user. For example, the health management server 3 may be the server of the medical institution where the user receives diagnosis and prescriptions. In this embodiment, the in vivo insulin management platform system 2 can communicate with the health management server 3 to receive information for the user's blood glucose management, or send the management information generated by the in vivo insulin management platform system 2 to the health management server 3.

[0055] Users who wish to manage their blood glucose using the In vivo Insulin Management Platform System 2 can communicatively connect one or more injection devices 11 to 13 for insulin infusion to the In vivo Insulin Management Platform System 2. For example, injection devices 11 to 13 may be capable of communicating via a short-range wireless communication network such as Bluetooth, thereby enabling them to communicatively connect (or pair) to a user device 1 such as a smartphone.

[0056] User device 1 can transmit information received from injection devices 11 to 13 to the in vivo insulin integrated management platform system 2 via a short-range or long-range communication network. In addition, user device 1 can also, based on management information received from the in vivo insulin integrated management platform system 2, communicate with injection devices 11 to 13 to set the injection time and / or injection volume of insulin by injection devices 11 to 13.

[0057] However, this is exemplary. In other embodiments, the in vivo insulin integrated management platform system 2 may be communicatively connected directly to one or more injection devices 11 to 13 without going through the user device 1, or the in vivo insulin integrated management platform system 2 itself may be configured as a software application running on the user device 1, such as a smartphone. In this case, the user device 1 may also be omitted.

[0058] According to the embodiment, the in vivo insulin integrated management platform system 2 can communicate with user device 1 and / or one or more injection devices 11 to 13 via wired and / or wireless networks, receive insulin injection information defining the type of insulin, insulin dosage, and / or injection time of the user, calculate the user's in vivo insulin based on the received information, and provide a user interface (UI) for displaying management information that allows the user's in vivo insulin to be managed at a constant level despite changes in the user's injection environment.

[0059] In this instruction manual, insulin administration means, unless otherwise specified, the act of injecting liquid insulin into the body using an injector, or the act of orally administering a drug for regulating blood sugar.

[0060] In this specification, injection devices 11 to 13 refer to any device that can be used to inject insulin into a user's body and has information communication functions with user device 1 and / or the in vivo insulin integrated management platform system 2. In this specification, injection devices 11 to 13 are described using insulin pens 12 and insulin pen caps 13 for MDI (Multiple Daily Injection) therapy and insulin pumps 11 for CSII (Continuous Subcutaneous Insulin Infusion) therapy as examples, but the types or forms of injection devices 11 to 13 that can be used with the in vivo insulin integrated management platform system 2 according to the embodiments are not limited thereto.

[0061] For example, the insulin pen described as injection devices 11 to 13 in this specification is intended to encompass, in addition to general reusable pens, disposable pens, disposable syringes, insulin pen caps, etc. Furthermore, the insulin pen 12 can be a dial-based system where the dosage is determined by rotating a dial, or other different methods. In this case, the insulin pen cap 13 is a device with wireless communication capabilities integrated into a general manual insulin pen. When the dial is rotated on the manual insulin pen 131 to set the injection volume, the pen cap 132, as an electronic device detachably integrated into the manual insulin pen 131, automatically recognizes the dial and stores the injection volume and injection time. This stored information can be transmitted wirelessly to the user device 1 and / or the in vivo insulin management platform system 2. Furthermore, if general insulin injection therapy can also manage in vivo insulin, it can be included in the injection device of the present invention.

[0062] On the other hand, the insulin pump 11, described as injection devices 11 to 13 in this specification, can be an insulin pump equipped with an algorithm that is linked to continuous blood glucose measurement to stop insulin injection when or before hypoglycemia is reached; or it can be an insulin pump that injects insulin only at a predetermined dose and cycle. Furthermore, the insulin pump can be configured to inject insulin subcutaneously in various ways, such as via needle or patch, and is not limited to having a specific hardware configuration.

[0063] In embodiments of the present invention, the insulin administered by the user through the injection devices 11 to 13 may be bolus insulin, basal insulin, or a hybrid insulin that combines these functions.

[0064] In this instruction manual, bolus insulin, used to regulate meal-related hyperglycemic spikes, refers to rapid-acting or ultra-rapid-acting insulin, typically administered immediately before or after meals. Throughout this instruction manual, any description of 'rapid-acting' refers to both 'rapid-acting insulin' and 'ultra-rapid-acting insulin'; for example, bolus insulin is a rapidly acting insulin that begins to show its effect within approximately 15 minutes after administration, reaches peak blood concentration in approximately 1 hour, and maintains its effect for approximately 2 to 4 hours. This can include, but is not limited to, insulin aspart, insulin lispro, and insulin glulisine.

[0065] Furthermore, in this instruction manual, basal insulin refers to insulin used to maintain a constant blood glucose level throughout the day. It is a type of insulin that is slowly absorbed and acts over a long period of time. Basal insulin is usually administered once or twice daily and generally provides a continuous 24-hour effect. Examples include, but are not limited to, insulin degludec, insulin glargine, and insulin detemir.

[0066] According to the embodiment, the in vivo insulin integrated management platform system 2 can calculate the in vivo insulin generated due to the past administration of each type of insulin, and manage the timing and / or amount of the same or different types of insulin to be injected in the future based on the calculated in vivo insulin.

[0067] In this specification, in vivo insulin refers to the amount of insulin remaining in the user's body and affecting the user's future blood glucose levels. In one embodiment, in vivo insulin may be defined in different forms depending on the type of insulin the user has previously injected.

[0068] For example, if a user has previously used rapid-acting insulin (including ultra-rapid-acting insulin), the user's insulin levels can be calculated as insulin on board (IOB), which represents the amount of injected insulin that has not yet been used and remains in the body. For instance, rapid-acting insulin takes effect for several hours after administration, so the amount of insulin remaining unused, i.e., IOB, can be used as information about insulin levels in the body.

[0069] Alternatively, if the user has a history of using long-acting insulin, the user's active insulin (U / min) can be used as in vivo insulin information. Long-acting insulin acts for one to several days and has a relatively constant action curve compared to rapid-acting insulin. In this case, in the embodiments, the amount of active insulin per unit time calculated from the action curve of long-acting insulin can be calculated as in vivo active insulin and used as in vivo insulin information.

[0070] According to the embodiment of the in vivo insulin integrated management platform system 2, when a user administers more than one type of insulin, it can provide management functions independently or comprehensively for each type of insulin (e.g., bolus insulin and basal insulin) injection device. Furthermore, according to the embodiment of the in vivo insulin integrated management platform system 2, it can provide in vivo insulin-based management functions in cases where a user uses more than one type of administration method (injection device or oral administration, etc.) in parallel or switches administration methods.

[0071] For example, by applying the in vivo insulin management platform system 2 according to the embodiment to situations such as when a user switches from using an insulin pump with rapid-acting insulin to using an insulin pen with long-acting insulin, or when a user switches from using an insulin pen with long-acting insulin to using an insulin pump with rapid-acting insulin, the system can determine the dosage and / or timing of future insulin injections based on the type, dosage, and / or timing of previously administered insulin. Furthermore, the in vivo insulin management platform system 2 can also automatically set the administration information determined based on in vivo insulin in the injection devices 11 to 13 through direct or indirect communication with the injection devices 11 to 13.

[0072] Users can connect the injection devices 11 to 13 to the user device 1 via pairing through a short-range communication network such as Bluetooth, and receive insulin administration information from the injection devices 11 to 13 to the user device 1. In addition, the insulin administration information received from the user device 1 can also be sent from the user device 1 to the in vivo insulin management platform system 2, either by the user's selection or automatically.

[0073] On the other hand, when the in vivo insulin management platform system 2 and the injection devices 11 to 13 are directly communicatively connected, the in vivo insulin management platform system 2 can also receive insulin administration information from the injection devices 11 to 13. Since accurate insulin administration information provided by the injection devices 11 to 13 is sent to the in vivo insulin management platform system 2, it has the advantage of preventing erroneous input that may occur when the user manually inputs the amount of insulin administered, such as bolus insulin.

[0074] However, for other delivery methods that cannot communicate with or have not established a communication connection with user device 1, the user can also directly input insulin delivery information via that delivery method into the in vivo insulin management platform system 2. For example, the user can input the insulin injection volume and injection time via another insulin pen or insulin pump not paired with user device 1 into user device 1, thereby sending the input information from user device 1 to the in vivo insulin management platform system 2. In addition, besides devices with insulin delivery functions, the user can also input information about their own medication-administered blood glucose improvers into user device 1.

[0075] To perform the above operations, the in vivo insulin management platform system 2 may include an application service server that enables a pre-defined application (or application) running on the user device 1 to run, or a web server that provides pre-defined web pages accessible via a web browser running on the user device 1. Users can use the services provided by the in vivo insulin management platform system 2 by running a specific application or accessing a specific web page on their own smartphone.

[0076] However, the illustrations in the accompanying drawings of this specification showing the in vivo insulin integrated management platform system 2 and the user device 1 as separate devices are merely exemplary. According to embodiments, the in vivo insulin integrated management platform system 2 may also be implemented, at least in part, as a software application stored and executed on the user device 1.

[0077] In one embodiment, the in vivo insulin management platform system 2 includes a receiving module 21, a management module 22, and an output module 23. Furthermore, in one embodiment, the in vivo insulin management platform system 2 may further include a database (DB) 24 for storing information such as blood glucose management records related to one or more patients using the in vivo insulin management platform system 2. Moreover, these modules 21 to 23 and DB 24 may be implemented at least partially through a combination of the hardware 200 configuration and software of the in vivo insulin management platform system 2.

[0078] That is, the apparatus described in this specification may be entirely hardware, or may have aspects that are partly hardware and partly software. For example, the in vivo insulin integrated management platform system 2 according to the embodiments, and the various systems, devices, servers communicating with it, and the units contained therein, can be collectively referred to as apparatus for sending and receiving data of a specific form and content electronically and the associated software. In this specification, terms such as “unit,” “module,” “server,” “system,” “platform,” “device,” or “terminal” are intended to refer to a combination of hardware and software driven by that hardware. For example, the hardware here may be a data processing device including a CPU or other processor. Furthermore, hardware-driven software may refer to running processes, objects, executable files, threads of execution, programs, etc.

[0079] Furthermore, the elements constituting the comprehensive insulin management platform system 2 are not necessarily intended to refer to physically distinct individual devices. That is, Figure 2 The modules and databases of the in vivo insulin integrated management platform system 2 shown are merely functional distinctions made by the hardware constituting the in vivo insulin integrated management platform system 2 according to the operations performed by that hardware; the constituent elements do not necessarily need to be independently possessed. Of course, according to the embodiments, one or more of the above-mentioned servers, units, databases, or modules can also be implemented as physically separate individual devices.

[0080] The receiving module 21 can receive information such as the type of insulin previously administered, the amount of insulin administered previously, and the timing of administration, either from information input by the user or through communication with the insulin infusion devices 11 to 13 that administer insulin to the user. For example, when the user inputs insulin administration records into the user device 1 via a smartphone application, this information can be sent to the receiving module 21.

[0081] In addition, receiving module 21 can receive information about the administration method for future insulin administrations by the user. The administration method for future insulin administrations may be information about the injection device 11 to 13 that is newly paired with user device 1 or selected by the user as the current administration method, or information defining the insulin injection device or oral medication directly specified by the user. Alternatively, receiving module 21 may also define only the type of insulin that the user will inject or administer in the future based on the information received regarding future insulin administrations.

[0082] The management module 22 can calculate the user's in-body insulin based on the insulin administration information received through the receiving module 21, and generate management information specifying the future insulin administration amount and / or administration timing based on the existing in-body insulin administration and the insulin administration methods the user will use in the future. For example, in the case of rapid-acting insulin, the management module 22 can calculate the user's residual insulin (IOB) up to the previous day and the time point of action (DIA) of the insulin in the body, thereby calculating the current or near-term insulin administration amount and administration timing for the user.

[0083] The output module 23 serves to provide the user with management information calculated by the management module 22 based on in vivo insulin levels. In one embodiment, the management information can be sent to a user device 1 capable of communicating with the in vivo insulin integrated management platform system 2, and can be conveyed to the user on the user device 1 in various ways such as digital display, notifications, and voice guidance. For example, a smartphone application can convey the user's required insulin dosage in the form of a notification.

[0084] In another embodiment, the output module 23 can directly send management information to the injection devices 11 to 13 that are communicatively connected to the in vivo insulin integrated management platform system 2, or the user device 1 that receives management information from the in vivo insulin integrated management platform system 2 can control the injection devices 11 to 13, thereby automatically setting the next insulin injection amount and timing according to the integrated management of in vivo insulin in the injection devices 11 to 13.

[0085] Through the above operations, the in vivo insulin integrated management platform system 2 can provide continuous management functions based on in vivo insulin information even if the device used by the user for insulin administration changes.

[0086] Figure 2 This is a block diagram illustrating the hardware configuration of an in vivo insulin integrated management platform system according to one embodiment.

[0087] Reference Figure 2 The hardware 200 constituting the in vivo insulin comprehensive management platform system according to the embodiment can be implemented as a computing device including one or more hardware components. In this case, the hardware 200 may include a memory 210, a processor 220, and a communication module 230. In one embodiment, the hardware 200 may further include an input / output unit 240.

[0088] The memory 210, as a non-transitory computer-readable recording medium, may include non-volatile mass storage devices such as RAM (random access memory), ROM (read only memory), disk drives, SSDs (solid state drives), and flash memory. Here, non-volatile mass storage devices such as ROM, SSDs, flash memory, and disk drives may be included in the aforementioned devices or servers as separate permanent storage devices distinct from the memory 210.

[0089] In addition, the memory 210 may store an operating system and at least one program code (e.g., code for executing an application installed and running on a server or user device). These software components may be loaded from a computer-readable recording medium separate from the memory 210. Such a separate computer-readable recording medium may include computer-readable recording media such as floppy disk drives, magnetic disks, magnetic tapes, DVD / CD-ROM drives, memory cards, etc.

[0090] In other embodiments, the software components may be loaded into memory 210 not from a computer-readable recording medium, but via communication module 230. For example, at least one program may be loaded into memory 210 based on a computer program installed via a file provided over a network by a developer or a file distribution system (e.g., a commercial application store service server) that distributes application installation files.

[0091] Processor 220 can be configured to process instructions of a computer program by performing basic arithmetic, logic, and input / output operations. Instructions can be provided to processor 220 by memory 210 or communication module 230. For example, processor 220 can be configured to execute received instructions according to program code stored in a recording device such as memory 210.

[0092] The communication module 230 provides the function of communicating with user devices, insulin injection devices, and health management servers via a network for the in vivo insulin integrated management platform system. That is, the communication module 230 achieves this function by having its function controlled by the processor 220 of the reference memory 210. Figure 2 The section on the operation of the aforementioned functional modules.

[0093] The input / output unit 240 can be a means of interfacing with an external input / output device (not shown). For example, the external input device may include devices such as a keyboard, mouse, microphone, and camera, and the external output device may include devices such as a display, speaker, and haptic feedback device. As another example, the input / output unit 240 can also be a means of interfacing with a device that integrates input and output functions, such as a touch screen.

[0094] Furthermore, in other embodiments, the hardware 200 may include more components depending on the nature of the applied device. Figure 2 The diagram shows additional components. For example, when hardware 200 is applied to a user device, it can be implemented to include at least a portion of the aforementioned input / output devices, or further include other components such as a transceiver, a GPS (Global Positioning System) module, a camera, various sensors, a database, etc. As a more specific example, when the user device is a smartphone, it can be further implemented to include various components typically included in smartphones, such as an accelerometer or gyroscope sensor, a camera module, various physical buttons, buttons using a touch panel, input / output ports, a vibrator for vibration, etc.

[0095] Figure 3 This is a schematic block diagram showing the detailed configuration of the receiving module of an in vivo insulin integrated management platform system according to one embodiment.

[0096] Reference Figure 3 In one embodiment, the receiving module 21 of the in vivo insulin management platform system may include an administration information receiving unit 211, a device information receiving unit 212, and an input unit 213. The device information receiving unit 212 receives information about the insulin administration method used by the user, such as an insulin pen or pump, which has communication capabilities. For example, it can receive information about the administration device paired with the user device 1 through communication with the user device 1, such as a smartphone. Furthermore, the device information used by the user for insulin administration can be stored and managed in the database (DB) of the in vivo insulin management platform system.

[0097] The insulin administration information receiving unit 211 can receive insulin administration information indicating the type, volume, and timing of insulin administrations previously administered by the user using an infusion device. For example, the insulin administration information can be sent from the infusion device to the paired user device, and then from the user device 1 to the receiving module 21 of the in vivo insulin integrated management platform system.

[0098] Alternatively, users can manually input the type of insulin they are using, the time of administration, and / or the dosage through their own user device 1. The input unit 213 of the in vivo insulin management platform system can also receive the information directly input by the user as insulin administration information.

[0099] Figure 4 This is a schematic block diagram illustrating the detailed configuration of the management module of an in vivo insulin integrated management platform system according to one embodiment.

[0100] Reference Figure 4 In one embodiment, the management module 22 of the in vivo insulin comprehensive management platform system may include an in vivo insulin calculation unit 221, a management information generation unit 222, and a linkage unit 223. The in vivo insulin calculation unit 221 is the part that generates in vivo insulin information based on the amount and timing of insulin input by the user in the past. At this time, the in vivo insulin calculated by the in vivo insulin calculation unit 221 may be represented as residual insulin (IOB) or active insulin in vivo, depending on the type of insulin used in the past.

[0101] In one embodiment, when a user has previously administered rapid-acting insulin, the in vivo insulin calculation unit 221 calculates the current point-of-flight (IOB) and the target basal insulin level. The current point-of-flight (IOB) refers to the residual insulin remaining in the body at the current time, which has decreased over time since the previous administration. This current point-of-flight (IOB) can be calculated using the following methods, starting from the previous administration time and following a reduction curve. Figure 5 This is a graph showing the decrease in residual insulin (IOB) and active insulin (U / min) over time after insulin administration. Figure 5 In the figure, curve 501 represents residual insulin remaining in the body, and curve 502 represents the insulin acting on the body. As shown in the figure, residual insulin 501 in the body gradually decreases over the duration of insulin activity (DIA) (Td) after insulin administration, while the insulin acting on the body 502 increases after insulin administration, reaches a peak at the peak time (tp), and then gradually decreases.

[0102] The residual IOB at the current time point in the body, when administering a mealtime insulin bolus, ensures that the calculated insulin dose is subtracted by an appropriate level from the current time point IOB, thereby preventing hypoglycemia. The percentage by which the current time point IOB is subtracted from the insulin dose can be appropriately chosen. In one embodiment of the invention, OpenAPS's IOB Calculations are used to calculate the current time point IOB. For example, the current time point IOB is calculated reflecting the following variables, but this method is not limited to.

[0103] Insulin duration of action (DIA) - Ultra-rapid-acting: 240 minutes, Rapid-acting: 360 minutes Peak time of insulin action - 75 minutes In this scenario, residual insulin 501 is represented as rapid-acting insulin with a duration of action of 360 minutes, which is completely consumed along the horizontal time axis after the initial injection. As shown in the figure, if 15U of rapid-acting insulin is injected initially, the residual insulin 501 is calculated to be 10.4U when the insulin 502 reaches its maximum effect in the body at 75 minutes, confirming that the amount of residual insulin in the body has been reduced.

[0104] Furthermore, the unit for insulin 502 in vivo is U / min, representing the amount of insulin acting per unit time. Insulin 502 in vivo increases after insulin administration, reaches a peak at the peak time (tp), and then gradually decreases. As shown in the figure, if 15U of rapid-acting insulin is injected into the body, it can be seen that the insulin 502 in vivo reaches its maximum at 75 minutes, with an action rate of 0.085U / min.

[0105] on the other hand, Figure 5 It calculates the IOB (Intake of Bounds) of rapid-acting insulin with an action time of 360 minutes and represents it as a curve. However, this calculation method can be applied not only to rapid-acting insulin, but also to the IOB calculation of long-acting insulin or the action insulin calculation of long-acting insulin.

[0106] Target basal function insulin refers to a target value used to manage the amount of basal insulin a user ingests through various means of administration. It can be a single, fixed value, or a range including upper and / or lower limits. It can be the amount ingested by dividing the total basal insulin amount determined by the time of day and activity level (diet, exercise, stress, sleep, etc.) by the number of injections, or it can be defined by combining different injection formats to match the total basal insulin amount. In particular, target basal function insulin can be used when switching from an insulin pen to an insulin pump, especially for managing the total amount of basal insulin administered at different times of the day.

[0107] The management information generation unit 222 can generate management information indicating the amount and / or timing of future insulin administrations based on the in vivo insulin calculated by the in vivo insulin calculation unit 221. If information exists regarding the insulin administration method the user will use in the future (including injection via an infusion device and / or administration via a drug, and including the type of insulin), the management information generation unit 222 can generate management information based on the administration characteristics of that administration method (e.g., dosage per administration, administration cycle, etc.).

[0108] Without specifying the input methods to be used in the future, the management information generation unit 222 can generate management information to achieve the user's target basic insulin effect, provided that the existing input methods are used continuously.

[0109] The linkage unit 223 functions as follows: it prompts the user with the management information generated by the management information generation unit 222 or sets it on the user's injection device, thereby enabling the actual implementation of in vivo insulin and blood glucose management based on the management information. For example, the linkage unit 223 can send the management information to the user device that is communicatively connected to the in vivo insulin integrated management platform system. Alternatively, the linkage unit 223 can also directly set the injection information on the injection device through communication between the in vivo insulin integrated management platform system and the injection device, or send the injection information for setting the injection device to the user device, so that the user device automatically sets the injection information to the paired injection device.

[0110] Figure 6a This is a flowchart illustrating the steps of a comprehensive in vivo insulin management method according to one embodiment.

[0111] Reference Figure 6a When a user uses an injection device 11 to 12 with network communication capabilities, the user can pair a user device 1, such as a smartphone, with the injection device 11 to 12 to receive insulin delivery information provided by the injection device 11 to 12 (S101). For example, the insulin delivery information may include data on the type of insulin injected into the body by the injection device 11 to 12, such as an insulin pen or insulin pump, the amount of insulin, and / or the timing of injection.

[0112] In one embodiment, when the infusion devices 11 to 12 are communicatively connected to the user device 1 or the in vivo insulin management platform system 2, the time of the infusion devices 11 to 12 can be synchronized with the time of the in vivo insulin management platform system 2 for consistent in vivo insulin management. Furthermore, the in vivo insulin management platform system 2 can also store information about the infusion devices 11 to 12 registered with the user, such as device identification information, battery level, insulin level, insulin usage period, insulin infusion history, and / or device status information, in its database (DB).

[0113] In parallel with or instead of the injection information received from injection devices 11 to 12, the user may also directly input the type of insulin, the amount of insulin, and / or the timing of administration to user device 1 (S102). For example, the user may also input the timing and amount of insulin administration using other injection devices not paired with user device 1, or the type, amount, and timing of the administered medication, to user device 1. Furthermore, if the user only inputs the amount of insulin or the type and amount of medication to user device 1, the timing of receiving the input may be automatically set as the administration timing and the administration information stored.

[0114] User device 1 can send insulin administration information received from the first injection device 11 previously used by the user and / or administration information directly entered by the user to the in vivo insulin integrated management platform system 2 (S103). For example, the user can send insulin administration information to the in vivo insulin integrated management platform system 2, which is equivalent to an application service server, through an application running on a smartphone.

[0115] However, this is exemplary. In other embodiments, the in vivo insulin integrated management platform system 2 may be communicatively connected to the first injection device 11, thereby receiving insulin delivery information directly from the first injection device 11 without going through a user device 1 such as a smartphone.

[0116] In addition, in one embodiment, the in vivo insulin management platform system 2 may also receive insulin input information from one or more health management servers 3 (S104). For example, the health management server 3 may be a device of a medical institution where the user with diabetes regularly receives diagnosis and prescriptions. The in vivo insulin management platform system 2 may also receive the medical institution's diagnosis and treatment records, or a portion of the diagnosis and treatment records indicating the user's insulin management status or blood glucose management status, as insulin input information from the health management server 3 (S104).

[0117] Next, the in vivo insulin management platform system 2 can calculate the user's in vivo insulin based on the received insulin input information (S105). This refers to the process of analyzing the user's past insulin input data to calculate the current amount of active insulin remaining in the body, i.e., in vivo insulin. For example, if the insulin used in the past was rapid-acting insulin, the in vivo insulin can be calculated as the current point in time (IOB); or if the insulin used in the past was long-acting insulin, the in vivo insulin can be calculated as the in vivo active insulin.

[0118] Furthermore, the in vivo insulin management platform system 2 can also calculate or adjust the user's target basal insulin level in addition to the in vivo insulin level. The target basal insulin level refers to the result of numerical calculations of the basal insulin level that the user wishes to maintain, based on the user's past meal patterns, insulin input patterns, time-of-day blood glucose fluctuation patterns, and activity-related blood glucose fluctuation patterns. It can be defined in various forms, such as a lower limit, upper limit, average value of active insulin, or a numerical range defined by upper and lower limits. This target basal insulin level can be calculated using insulin input information received from the health management server 3.

[0119] If a user of the In vivo Insulin Management Platform 2 wishes to change their method of insulin administration, the In vivo Insulin Management Platform 2 can receive information from the user device 1 regarding the method of insulin administration the user wishes to use in the future (S106). At this time, the administration method information may include the type of insulin the user will use in the future.

[0120] For example, the administration method can be an injection device such as an insulin pen or pump. Device information manually entered by the user into user device 1, or device information of injection devices 11 to 12 newly paired with user device 1, can be sent to the in vivo insulin integrated management platform system 2 as administration method information. Alternatively, when the user administers a blood glucose improver, if the user enters the medication information they wish to take into user device 1, that medication information can also be sent to the in vivo insulin integrated management platform system 2 as administration method information.

[0121] Users can directly change the injection devices 11 to 12 linked to the application by using an application that communicates with the In vivo Insulin Management Platform System 2, thereby notifying the In vivo Insulin Management Platform System 2 of the change in delivery method. Furthermore, if the communication connection between user device 1 and its existing paired injection devices 11 to 12 is lost, the application on user device 1 will automatically search for pairable injection devices 11 to 12 within the communication range. If a newly paired injection device 11 to 12 is found in the search results, the information of that injection device 11 to 12 can also be sent to the In vivo Insulin Management Platform System 2.

[0122] In the in vivo insulin comprehensive management platform system 2, when long-acting insulin is used as basal insulin via an insulin pen, comprehensive management is implemented based on received past insulin administration information and the user's intended administration method, so that the target basal insulin level can be achieved regardless of the user's chosen administration method. For example, the in vivo insulin comprehensive management platform system 2 can determine the timing and / or dosage of future insulin administration based on the intended future insulin administration method and the user's target basal insulin level (S107), and provide the determined information to the user as management information.

[0123] Management information for comprehensive management of in vivo insulin can be sent from the comprehensive in vivo insulin management platform system 2 to the user device 1 (S108). The user can administer insulin by himself while complying with the timing and / or dosage of insulin administration as defined in the management information provided by the comprehensive in vivo insulin management platform system 2, or by setting the management information to the second injection device 12 to be used in the future, so that the second injection device 12 administers insulin according to the instructions of the management information.

[0124] Alternatively, management information is sent from the in vivo insulin integrated management platform system 2 to the user device 1. The application running on the user device 1 can automatically set the injection information of the second injection device 12 paired with the user device 1 based on the received management information, so that even if the user does not take other measures, the operation of the second injection device 12 is controlled according to the integrated management of in vivo insulin.

[0125] At this time, the parameters used for operating the second injection device 12 not only set the type of insulin to be injected into the user's body via the second injection device 12, the injection time, and / or the injection volume, but also reflect the user's blood glucose level before the change in administration method, the user's insulin sensitivity, the user's past insulin administration history, and the treatment plan received from the medical institution related to the user. At this time, the in vivo insulin integrated management platform system 2 stores the aforementioned information related to the user as variables in the database of the in vivo insulin integrated management platform system 2, and can reflect the generation of management information for sending to the injection devices 11 to 12 based on these variables.

[0126] In one embodiment, the management information sent by the in vivo insulin integrated management platform system 2 may include, in addition to directly setting the operation of the injection devices 11 to 12 for user use, data instructing the user to perform corresponding operations required for continuous in vivo insulin management in preparation for switching to the use of the injection devices 11 to 12. For example, for blood glucose management during the switching of injection devices 11 to 12, management information may be generated based on data regarding the type, timing, and / or amount of insulin that the user should pre-inject before the device switching. In this case, the management information for advance response may be calculated taking into account the user's current blood glucose level, blood glucose trend, and the time required for device switching before the device switching.

[0127] Furthermore, in one embodiment, the in vivo insulin management platform system 2 can also send notification messages urging the user to perform actions to the user device 1 in order to continuously manage in vivo insulin based on insulin administration information. For example, if it is anticipated that in vivo insulin will be depleted, but the second injection device 12 is not connected to the user device 1 after the connection between the first injection device 11 and the user device 1 is broken, the in vivo insulin management platform system 2 can also generate notification messages urging the user to pair another injection device with the user device, administer insulin using another insulin injection device, or input administration information if insulin has already been administered, and send these messages to the user device 1.

[0128] Furthermore, in one embodiment, the in vivo insulin integrated management platform system 2 may also send the management information determined based on the integrated management of in vivo insulin to a health management server 3, such as a medical institution or health insurance management organization corresponding to the user (S110). The health management server 3 can, based on the management information received from the in vivo insulin integrated management platform system 2, determine the user's current blood glucose management therapy or insulin dosage and use this information for future disease or health management.

[0129] Figure 6b This is a flowchart illustrating the steps of a comprehensive in vivo insulin management method according to yet another embodiment.

[0130] Reference Figure 6b The first injection device 11 sends injection information defining the type, dosage, and / or timing of past insulin administrations to the paired user device 1 (S201), which in turn sends to the in vivo insulin management platform system 2 (S202). However, as mentioned above, in other embodiments, the in vivo insulin management platform system 2 may also be communicatively connected to the first injection device 11, thereby receiving such information directly from the first injection device 11.

[0131] The in vivo insulin management platform system 2 can calculate the in vivo insulin based on the insulin input information of the first injection device 11. In one embodiment, the in vivo insulin management platform system 2 can identify the type of insulin injected in the past (S203) and generate the value of residual insulin (IOB) or active insulin (U / min) as in vivo insulin information based on the type of insulin injected in the past (S204).

[0132] Next, the in vivo insulin management platform system 2 can receive injection device information corresponding to the second injection device 12 that the user will use in the future (S205) from the user device 1 or the second injection device 12. At this time, the injection device information received by the in vivo insulin management platform system 2 may include the type of insulin to be injected by the second injection device 12.

[0133] The in vivo insulin management platform system 2 can generate insulin delivery information defining the amount of insulin to be injected by the second injection device 12 and / or the injection time point, based on the in vivo insulin information calculated in step S204 and the injection device information received in step S205. Next, the in vivo insulin management platform system 2 can send the generated insulin delivery information to the second injection device 12, thereby automatically setting the delivery operation of the second injection device 12 (S206). However, this is exemplary; in other embodiments, the insulin delivery information may also be sent to the second injection device 12 via the user device 1.

[0134] The above-described continuous management operation based on in vivo insulin can be performed in the same manner even if the insulin delivery method used by the user is changed from the second injection device 12 to a third injection device 13.

[0135] That is, the in vivo insulin integrated management platform system 2 can receive insulin administration information from the second injection device 12 (S207), and can receive injection device information indicating that the third injection device 13 will be used for insulin administration in the future from the user device 1 or the third injection device 13 (S208). Next, the in vivo insulin integrated management platform system 2 can generate administration information indicating the amount of insulin injected by the third injection device 13 and / or the injection time point based on the in vivo insulin generated by the insulin injection of the second injection device 12 and the type of insulin injected by the third injection device 13, and send the administration information to the third injection device 13 to set the administration information (S209).

[0136] Figures 7 to 9 This is a conceptual diagram illustrating an exemplary user interface (UI) provided by an in vivo insulin integrated management platform system according to one embodiment.

[0137] Reference Figure 7 According to one embodiment, the in vivo insulin comprehensive management platform system can provide a UI element 610 that allows users to specify the date, time, period, day of the week, etc. to be queried, thereby providing users with the function of querying their own insulin input information by time.

[0138] Furthermore, according to one embodiment, the in vivo insulin comprehensive management platform system allows users to select the type of blood glucose or insulin through UI elements 620, and enables them to confirm the administration information of the selected blood glucose management or the administration information of the selected type of insulin through the screen. In this case, insulin management can be divided into mealtime insulin administration, basal insulin administration, etc., but is not limited to these.

[0139] The screen area displayed by the comprehensive insulin management platform system is allocated to insulin administration information. Figure 7 Using the dashed line representing time point 600 as a reference, this example illustrates a user switching from a first insulin delivery device to a second delivery device. Here, the first and second delivery devices refer to devices with different insulin delivery characteristics, such as the type of insulin administered, the insulin dosage, and / or the insulin delivery cycle. The device switching time point 600 can also be displayed as part of the user interface to help the user recognize the device switch.

[0140] The following description assumes that the first delivery device is a device that uses rapid-acting insulin for both mealtime insulin bolus and basal insulin (e.g., an insulin pump), and the second delivery device is a device that uses rapid-acting insulin for mealtime insulin bolus and long-acting insulin for basal insulin (e.g., an insulin pen, which can use insulin pens according to the type of insulin). The description then explains the operation of the in vivo insulin comprehensive management platform system.

[0141] For example, there may be situations where the user needs to remove the first delivery device (insulin pump) from their body and switch to an insulin pen as a second delivery device to administer insulin when the first delivery device malfunctions, the injection mechanism is blocked, the battery is depleted, or when engaging in strenuous activities such as marathons, cycling, or swimming, when in contact with water (such as bathing or seawater bathing), while traveling, or when being observed by others.

[0142] The following explanation is divided into mealtime insulin administration and basal insulin administration.

[0143] First, let's explain the management of insulin injections during meals. The bars 641 to 645 displayed on the UI screen represent the injection time and amount of rapid-acting insulin corresponding to the user's meal time. The solid lines that decrease in value from the top of each bar 641 to 645 to the right indicate that after the user's IOB increases due to the injection of rapid-acting insulin, the IOB decreases over time.

[0144] At this point, at time 600 when the delivery method is switched, the in vivo insulin management platform system 2 calculates the user's current time point IOB using the insulin delivery amount and delivery time represented by bars 641 to 645. When the delivery method switch occurs at time 600 and the current time point corresponding to the next meal time for rapid-acting insulin delivery arrives, the in vivo insulin management platform system can consider the current time point IOB calculated from previous insulin deliveries and calculate the final insulin delivery amount to be delivered via the current delivery method (i.e., insulin pen). This is in... Figure 7 As shown in bar 660, the final insulin dosage equivalent to bar 660 can be determined based on the IOB (Intake of Bile) from previous insulin administrations. For example, because the user has residual IOB due to previous insulin administrations represented by bar 645, the insulin dosage can be automatically determined based on the current IOB even at the next mealtime, instead of administering the maximum amount of rapid-acting insulin.

[0145] In detail, as described in bar 660, when the required insulin dose of 27U is calculated using the mealtime injection formula, reference bar 645 calculates the current time point IOB (Insulin Counting) at time 600 as 9U using the injection method conversion formula, and subtracts it to determine the final injection dose of 18U. The determined injection dose of 18U can be communicated to the user via user device 1 or injection devices 11 to 13 in the form of an alarm clock, or displayed on a monitor. Accordingly, by injecting the determined final injection dose of 18U, and adding it to the current time point IOB 9U before injection, the required insulin dose of 27U can be calculated. This IOB decreases again to the right from the end of bar 660.

[0146] As an example, the amount of insulin to be administered via mealtime bolus injection can be shown in Table 1 below, determined taking into account the current time point IOB.

[0147] Table 1

[0148] In Table 1 above, glucose-regulating insulin (A) is calculated based on the amount of carbohydrates consumed directly input by the user, and target glucose-regulating insulin (B) represents the amount of insulin required based on the corresponding glucose management target. Specifically, A is calculated by dividing 240g of consumed carbohydrates by the ICR (insulin-carbohydrate ratio) to obtain 24U, and B is calculated by dividing the difference between the current blood glucose and the target blood glucose by the CF (correction factor) to obtain 3U. In this embodiment of the invention, by subtracting the current time point IOB (C) from the input method conversion time 600 from the required insulin amount (A+B), the required mealtime insulin amount of 27U can be calculated.

[0149] Next, we will explain the management of basal insulin. The curve 630 displayed on the UI screen represents the amount of basal insulin administered by the user via the insulin pump. The insulin pump is configured to continuously inject small amounts of rapid-acting basal insulin in very short intervals (e.g., 1 to 3 minutes). When the insulin pump is used in conjunction with a continuous glucose meter (CGM), the basal insulin injection volume can be determined based on the average trend of the user's blood glucose levels. The graph shows increases in basal insulin levels at 3:30 AM, 5:30 AM, and 7:00 AM. Furthermore, the y-axis injection value of curve 630 represents the amount of rapid-acting insulin injected per unit time. If a point on curve 630 is displayed as 6U on the UI screen, then the total amount of rapid-acting insulin injected within one hour corresponding to that point is 6U, and the injection rate can be expressed as 6 U / hr. This can be understood as the insulin pump injecting 0.3U of basal insulin every 3 minutes, and in this case, the injection rate can also be expressed as 0.3 U / min. This is consistent with Example 3 described later. Figure 10c The units of insulin 806 with the target basal function are used in the same way.

[0150] On the other hand, basal insulin administration can be stopped during periods when hypoglycemia is detected or anticipated by a continuous glucose meter (CGM). Figure 7 The time interval represented by rectangle 670 indicates the time interval during which basal insulin administration was suspended for this reason.

[0151] In the case of insulin pens, users can typically use separate pens containing rapid-acting insulin cartridges and those containing long-acting insulin cartridges. For mealtime insulin administration, rapid-acting insulin is injected before meals as a mealtime bolus; for basal insulin administration, long-acting insulin is injected over a predetermined period, such as once daily. Figure 7 In the diagram, curve 650 represents the effect of long-acting basal insulin administered via an insulin pen, which has undergone a constant period of action.

[0152] On the other hand, long-acting insulin, used as basal insulin, is designed to act consistently over a certain period of time, aiming to maintain a constant basal insulin level for stable blood glucose management. Therefore, because the effect of insulin is highly consistent and predictable, it is primarily expressed as active insulin rather than intraocular insulin (IOB). The effect of active insulin on the body follows a normal distribution curve, and this normal distribution information can be obtained by verifying the manufacturer information of the insulin product. Furthermore, the IOB of long-acting insulin can be calculated using the duration of insulin action (DIA) and peak time of insulin action.

[0153] [Example 1] When switching from an insulin pump to an insulin pen When the device used by the user at time point 600 (represented by the dashed line) is changed from an insulin pump to an insulin pen, the in vivo insulin management platform system can take into account all parameters used to calculate the insulin injection volume, such as the user's ICR, CF, and basal insulin intake based on past insulin intake information, to determine the amount and / or timing of mealtime insulin bolus and basal insulin to be administered by the insulin pen to be used in the future.

[0154] Firstly, regarding the management of mealtime insulin injections, as mentioned above, when switching from an insulin pump using rapid-acting insulin to an insulin pen using rapid-acting insulin, the in vivo insulin integrated management platform system 2 can consider the current time point IOB calculated from the amount of insulin previously injected via the insulin pump to determine the final amount of insulin to be injected via the converted insulin pen.

[0155] In terms of basal insulin management, when using an insulin pump, basal insulin is continuously injected as a small amount of rapid-acting insulin. Therefore, once the use of the insulin pump is stopped, the rapid-acting insulin will be quickly depleted due to its characteristics, and the amount of basal insulin remaining in the body will be almost zero. Therefore, in this case, long-acting insulin can be injected as basal insulin immediately after the use of the insulin pump is stopped. Figure 7 The curve 650 shown represents the replacement of long-acting basal insulin administered via an insulin pen with active insulin that has undergone a constant period of action.

[0156] That is, in Figure 7 In the example shown, under basal insulin management, a device transition was made from an insulin pump using rapid-acting insulin to an insulin pen using long-acting insulin. Because rapid-acting insulin disappears quickly in the body, at the transition time point 600, indicated by the dashed line, the user immediately administered long-acting insulin and switched to insulin pen management.

[0157] In one embodiment, the amount of basal insulin delivered by the pump can also be adjusted at a point in time before the transition from an insulin pump to an insulin pen takes place. Figure 8 This is an exemplary curve representing the pattern of input adjustment prior to this transition point.

[0158] exist Figure 8 In the diagram, COB represents the increase in body carbohydrates through meals, curve 630 represents the basal insulin intake delivered by the insulin pump, and curve 646 represents the mealtime insulin intake delivered by the insulin pump. On the other hand, curve 661 represents the mealtime insulin intake delivered immediately after the switch from the insulin pump to the insulin pen 600.

[0159] At this point, when the user's information regarding the transition from an insulin pump to an insulin pen is received by the in vivo insulin management platform system, the system can manage the system by stopping the basal insulin delivery from the insulin pump within a predetermined time interval 692 before the transition time 600, thereby ensuring that the basal insulin delivered by the insulin pump does not remain in the body at the transition time 600. This can also be used, for example, to prevent hypoglycemia during exercise if there are upcoming plans for exercise or swimming.

[0160] Furthermore, in one embodiment, the in vivo insulin management platform system can increase the amount of basal insulin delivered by the insulin pump compared to normal (e.g., set to twice the normal amount) within a preset time interval 691 before the time interval 692 before the basal insulin injection by the insulin pump is stopped. This is to pre-inject more insulin in preparation for the possibility of future basal insulin injection being stopped, thereby preventing the user's blood glucose from rising during the time interval 692.

[0161] [Example 2] Switching from an insulin pump to an insulin pump In one embodiment, the infusion device used by the user can be switched from one insulin pump to another. For example, there may be situations where the user switches to another insulin pump due to an upgrade, malfunction, or loss of their existing insulin pump, or the user registers both insulin pumps with an in vivo insulin management platform system and switches between the pumps they use as needed.

[0162] In this case, firstly, regarding the management of mealtime insulin injections, the in vivo insulin integrated management platform system 2 can consider determining the final amount of insulin to be injected via the switched insulin pump based on the current time point IOB calculated from the amount of insulin previously injected via the insulin pump.

[0163] Next, regarding basal insulin management, since both the pre- and post-conversion administration methods involve an insulin pump that continuously delivers small amounts of rapid-acting insulin, basal insulin can be injected immediately via the new insulin pump after the existing insulin pump is discontinued, provided that the target basal insulin function is the same.

[0164] [Example 3] When switching from an insulin pen to an insulin pump On the other hand, it is also possible to switch from MDI therapy (using an insulin pen) which involves injecting (ultra)-acting insulin into mealtime bolus insulin and injecting long-acting insulin into basal insulin, to CSII therapy (using an insulin pump) which involves injecting only (ultra)-acting insulin into mealtime bolus insulin and basal insulin; at this time, the in vivo insulin integrated management platform system can also select the start time of insulin delivery by the insulin pump, which is the second delivery device, based on the IOB calculated from the insulin already injected by the insulin pen, which is the first delivery device. Figure 9 This indicates a corresponding example.

[0165] First refer to Figure 9 This section explains the management of mealtime insulin injections. The bar 740 displayed on the UI represents the timing and dosage of rapid-acting insulin injected by the insulin pen at the user's mealtime. After the user's device switching point 700, the in vivo insulin management platform system calculates the IOB (Intake of Bounds) of the rapid-acting insulin injected via the insulin pen (shown as a solid line extending from bar 740). When the next rapid-acting insulin injection time (e.g., mealtime) is approached, the current IOB is considered to determine the dosage of rapid-acting insulin delivered by the insulin pump. This... Figure 9 It is shown in bar 760.

[0166] Next, we will explain the management of basal insulin. The curve 730 displayed on the UI screen represents the amount of long-acting basal insulin administered by the user via insulin pen, and indicates the period during which the insulin's effect is maintained at a constant level. If, at the point 700 when the transition from insulin pen to insulin pump occurs, the existing basal insulin's effect has not yet ended, then, as an example, the comprehensive insulin management platform system can delay the basal insulin administration via insulin pump until the end of the basal insulin's effect based on the existing insulin administration information, thus comprehensively managing insulin levels.

[0167] exist Figure 9In the diagram, curve 750 represents the amount of basal insulin delivered by the insulin pump. There is a predetermined time interval d1 between the device switching point 700 and the point 780 where basal insulin is delivered by the insulin pump. This indicates that the in vivo insulin management platform system delays the delivery of basal insulin by the insulin pump until the end of the duration of action of the long-acting basal insulin already delivered by the insulin pen.

[0168] Figures 10a to 10d This is a conceptual diagram illustrating the adjustment of basal insulin delivery timing according to an embodiment of an in vivo insulin integrated management platform system. Figure 10a This refers to the situation where, under the current conditions without comprehensive insulin management, the user continues to use an insulin pen after switching from an insulin pump. Figure 10b and 10c This refers to a situation where, according to the embodiments, the timing and / or amount of insulin delivery by the insulin pump are adjusted to comprehensively manage insulin in the body.

[0169] On the other hand, the long-acting insulin used in this embodiment has an effect period of about 3 days, and the effect is in the form of a normal distribution curve with the peak at the front, and the effect decreases to below a certain level at the beginning and end of the effect period. As an example, insulin degludec, a long-acting basal insulin analog known by the brand name Tresiba, is a once-daily basal insulin.

[0170] Reference Figure 10a When switching from an insulin pump to an insulin pen at time point 800 (represented by the dashed line), curves 801 to 805 represent the period of action of basal insulin (i.e., long-acting insulin) administered via the insulin pen. In this case, the effective insulin tends to stabilize after several consecutive days of long-acting insulin administration. Figure 10a During the treatment, starting from the third injection of long-acting insulin 803, the insulin level remained stable with a certain effect. That is, Figure 10a This indicates the stabilization of the effect of long-acting insulin approximately 3 to 4 days after daily injection, when the insulin has a 3-day duration of action.

[0171] In this case, the user can set the stable value of the active insulin to the target basal active insulin 806. In this embodiment, the target basal active insulin 806 is set to the stable value of the active insulin based on the insulin injection. This stable value can be the stable value of the basal insulin injected according to the injection volume of long-acting insulin determined by a medical professional's prescription, or it can be the active insulin (U / day) equivalent to 40% to 60%, preferably 50%, of the daily injection volume that belongs to the patient's total daily insulin dose (TDD).

[0172] At this point, the stable value achieved by injecting basal insulin can refer to the convergent value obtained by summing the effective insulin corresponding to each injection of long-acting insulin at the current time point, when the injections are performed at multiple intervals. In this specification, convergence is not limited to the total effective insulin necessarily reaching a specific value. If the sum of effective insulin remains substantially constant within a preset error range, the in vivo insulin management platform system can also be configured to represent the stable value of effective insulin, i.e., the target basal effective insulin 806. Alternatively, the target basal effective insulin 806 can also be calculated as the average amount of basal insulin injected per unit time using the insulin pump when using CSII therapy (insulin pump).

[0173] At this time, as Figure 10b As shown, suppose we want to switch from an insulin pen to an insulin pump at time point 810, indicated by the dashed line. Figure 10b In the middle, curve 820 is... Figure 10a The superposition of the insulin action curves 801 to 805 shown is represented by a single line. In the prior art, since there is no means to manage insulin in the patient's body, switching to an insulin pump at the desired time point is not recommended. Instead, the guideline is to wait until the end of the effect of the previously injected basal insulin at time point 811 before wearing the insulin pump, as this minimizes side effects such as hypoglycemia. That is, because it is necessary to wait until time point 811 when all the IOB (Insulin Optimal Blood Pressure) generated by the insulin pen is depleted, the transition to an insulin pump is delayed and inconvenient.

[0174] Conversely, refer to Figure 10bWhen using the in vivo insulin integrated management platform system according to the embodiment, even if the basal insulin administered by the insulin pen is switched to an insulin pump at time 810 before the end of the action period of the previously administered basal insulin, the basal insulin administration by the insulin pump can be automatically delayed until time 811 when the action period of the previously administered basal insulin ends. That is, the in vivo insulin integrated management platform system can calculate the user's IOB, automatically detect the time 811 when the IOB is completely depleted, and thus provide information to the user or automatically set the injection device as shown by curve 840 so that insulin administration can be performed thereafter.

[0175] As another example, see Figure 10c Alternatively, the pump can be worn immediately from the conversion time point 810, while simultaneously calculating the target basal insulin 806 set according to the user's basal insulin settings, and controlling the amount and / or timing of basal insulin delivery by the insulin pump based on this. For example, the target basal insulin 806, as described above, can be set to a stable value of in vivo acting insulin based on long-acting insulin injections, but is not limited to this.

[0176] Figure 10c Curve 860 represents the basal insulin infusion administered by the insulin pump under this control. The hourly basal insulin infusion rate administered by the insulin pump can be determined by subtracting the in vivo in vivo in vivo infusion rate from the target basal infusion rate 806 based on the current time point of the long-acting insulin infusion.

[0177] Basal insulin infusion via an insulin pump is performed by continuously injecting small amounts of rapid-acting insulin as basal insulin in very short cycles (e.g., 1 to 3 minutes). The basal insulin infusion volume of the insulin pump considering the target basal insulin 806 is the value obtained by subtracting the effective insulin (unit: U / min) of the long-acting insulin injected via an insulin pen from the target basal insulin 806.

[0178] Alternatively, the basal insulin injection volume of the insulin pump can be calculated by multiplying the subtracted value by a predetermined parameter. In this case, the parameter can be a preset percentage, or it can include, but is not limited to, a percentage multiplied by any one of the following: the user's correction factor (CF), the insulin-carbohydrate ratio (ICR), or the user's weight.

[0179] Furthermore, in another embodiment, when the in vivo insulin comprehensive management platform system can obtain the target basal insulin 806 but cannot determine the in vivo insulin value at the current time point based on the long-acting insulin injection, it can also be done as follows: Figure 10dAs shown, the hourly basal insulin injection rate is determined as follows: during the period between the current time point (i.e., the time point when the delivery method is switched from an insulin pen to an insulin pump) and the time point 811 when all the previously injected basal insulin is depleted, the hourly basal insulin injection rate delivered by the insulin pump is linearly increased. In this case, the time point 811 when all the basal insulin is depleted can be determined as the period of action of basal insulin.

[0180] At this point, the amount of basal insulin injected by the insulin pump can be linearly increased to the maximum value of the basal insulin that corresponds to the target basal insulin level. However, when rapid-acting insulin, which acts and is depleted within a short time after injection, is used as basal insulin, the basal insulin that corresponds to the target basal insulin level injected by the insulin pump can also refer to the amount of basal insulin injected per unit time itself.

[0181] exist Figure 10d In the figure, curve 860 represents the case of switching to an insulin pump at time point 810 (shown by the dashed line), and curve 861 represents the case of switching to an insulin pump at another time point 812. As shown in the figure, the basal insulin injection volume delivered by the insulin pump can be set so that the basal insulin injection volume increases linearly from each time point of switching to the insulin pump, and reaches the target basal insulin level 806 at time point 811 when all the existing basal insulin injections are depleted.

[0182] exist Figures 8 to 1 The example in section 0 illustrates comprehensive management of in vivo insulin in cases of transitioning from an insulin pump to an insulin pen, or from an insulin pen to an insulin pump, but those skilled in the art will readily understand that the same principles can also be applied when using other forms of delivery.

[0183] For example, the following situation may exist: the user in Figure 7 and Figure 9 The administration of bolus insulin, shown by bars 641 to 645, 660, 740, and 760, uses an insulin pen, while the administration of basal insulin, shown by curves 630, 650, 730, and 750, uses an insulin pump. Alternatively, a diabetic user may use multiple insulin pens or multiple insulin pumps simultaneously to administer two or more insulins with different properties (e.g., bolus insulin and basal insulin). For example, the user can select the device to use through an application that communicates with an in vivo insulin management platform system, or the device can be automatically selected through pairing of the user device with the device.

[0184] In this case, the in vivo insulin integrated management platform system according to the embodiment can calculate the user's in vivo insulin at the current time point based on previous insulin administration information, regardless of the type of administration method used by the user, and adjust the amount of insulin to be administered next based on the calculated in vivo insulin (e.g., in the case of bolus insulin), and / or adjust the timing or amount of insulin administration next to be administered through the target basal insulin (e.g., in the case of basal insulin).

[0185] [Example 4] When switching from an insulin pen to an insulin pen In one embodiment, the injection device used by the user can be switched from one insulin pen to another. For example, there may be situations where the user switches to another insulin pen due to an upgrade, malfunction, or loss of an existing insulin pen, or the user registers both insulin pens with the in vivo insulin management platform system and switches the pen they are using as needed.

[0186] In this case, firstly, regarding the management of mealtime insulin injections, the in vivo insulin comprehensive management platform system can calculate the current in vivo insulin level based on the amount of insulin previously injected via an insulin pen. When mealtime insulin injections via a converted insulin pen are required, the final insulin injection amount is determined by subtracting the current in vivo insulin level from the amount of insulin to be injected.

[0187] At this point, the type of insulin and target insulin dose to be injected by the user can be automatically set by the in vivo insulin management platform system or directly entered by the user. The insulin injection dose calculated by subtracting the current time point IOB from this value can be determined as described above in Table 1. The calculated injection dose can be provided to the user or directly set in the insulin pen. Furthermore, the in vivo insulin management platform system can also provide information about the insulin injection time point to the user or set it in the insulin pen.

[0188] In one embodiment, the in vivo insulin management platform system can also provide users with information about the insulin pen they should use based on the determined mealtime insulin injection volume. For example, information on the types and volumes of insulin injected by various insulin pens is pre-registered in the in vivo insulin management platform system. The system can then determine the insulin pen to use based on the insulin injection volume calculated from the IOB (In vivo insulin bolus) at the current time point, such as whether the currently used insulin pen is feasible or whether other insulin pens need to be used.

[0189] Next, regarding basal insulin management, the in vivo insulin comprehensive management platform system can consider the duration of action and target insulin of long-acting insulin previously injected via insulin pens. To achieve the same target basal insulin, the system will inform the user of the same properties, injection volume, and injection time as those previously injected via insulin pens, allowing them to inject long-acting insulin via the new insulin pen. Management information including the injection time points of the new insulin pen can be provided to the user or set directly on the insulin pen.

[0190] [Example 5] Case of converting from a smart pen to a regular insulin pen In one embodiment, it is possible that after using a smart pen that can communicate with a user device 1 such as a smartphone, a user may switch the injection device to a regular manual insulin pen due to participation in sports such as swimming.

[0191] Regarding mealtime insulin administration, the in vivo insulin management platform system can calculate the current IOB (Intake Point of Birth) by using the injection volume and time point of the mealtime insulin bolus obtained from the communication between the existing smart pen and the user device. When administering mealtime insulin via a manual insulin pen, the current IOB is considered to determine the final injection volume. Since this is the same calculation process as described in Table 1 above, detailed explanation is omitted. Next, regarding basal insulin administration, the in vivo insulin management platform system can consider the duration of action of long-acting insulin administered by the existing smart pen to determine the injection volume and time point of long-acting insulin administered by the new insulin pen. At this point, the injection volume and time point of basal insulin administered by a regular insulin pen can be determined to achieve the same target basal insulin level as when using the smart pen.

[0192] However, in the case of a regular insulin pen without wireless communication capabilities, the in vivo insulin management platform system cannot obtain information. Therefore, the in vivo insulin management platform system can send management information indicating the injection time and volume of insulin to the user device. Furthermore, the in vivo insulin management platform system can send notifications to the user device urging the user to input the injection volume and time of both bolus and basal insulin administered via the insulin pen.

[0193] [Example 6] When switching from an insulin infusion device to a medication, or vice versa On the other hand, the in vivo insulin comprehensive management platform system and method according to the embodiments are also applicable when the user uses medication to administer insulin. For example, even patients who usually regulate their blood sugar with insulin pens or insulin pumps may use hypoglycemic agents such as biguanides, meglitinides, sulfonylureas, or SGLT-2 inhibitors if they need to regulate their blood sugar with medication for a short period without using an injection device. In this case, oral hypoglycemic agents have a predetermined effective period depending on the drug; for example, glimepiride, a sulfonylurea, is effective for 4 to 8.7 hours, which is equivalent to its half-life.

[0194] Therefore, the in vivo insulin integrated management platform system according to the embodiment is applicable to situations where oral medication is switched to an insulin infusion device, and to situations where oral medication is temporarily used after using an insulin infusion device such as a pump or pen. In this case, the in vivo insulin integrated management platform system can calculate the current in vivo insulin level of the user based on the user's previously administered insulin information and generate management information to administer insulin via an insulin pen, pump, or medication when the in vivo insulin is depleted. If the user has previously administered insulin via medication, the timing of future insulin administration can also be delayed based on the known effective period (e.g., half-life) of that medication.

[0195] According to the embodiments described above, the in vivo insulin comprehensive management platform system and method allow users to monitor their blood glucose levels in real time and understand their current insulin status, regardless of the type of administration method they use, enabling them to take appropriate measures when necessary. Furthermore, by managing the user's insulin dosage and administration time through the in vivo insulin comprehensive management platform system, the system can automatically set the patient's insulin administration schedule and send management information via notifications, ensuring that the patient does not miss their administration schedule.

[0196] The above management is continuous in time and can be maintained regardless of the user's insulin delivery method. Therefore, even if the user temporarily uses an insulin pen for exercise such as swimming while using an insulin pump, insulin levels can still be continuously managed. Furthermore, continuous blood glucose management can be achieved through linkage with various infusion devices. This continuous management can be implemented regardless of the manufacturer of the infusion device used or the number of infusion devices used, thus enabling continuous blood glucose management in various situations that may occur in the daily lives of diabetic patients.

[0197] Furthermore, the in vivo insulin comprehensive management platform system according to the embodiment links the insulin administration information of diabetic patients or the management information of in vivo insulin based on comprehensive management to the health management server of the corresponding medical institution, thereby helping medical experts to monitor the patient's status in real time and provide appropriate advice or medical treatment as needed. In addition, the information linked between the in vivo insulin comprehensive management platform system and medical institutions, as educational materials related to diabetes, also helps patients understand and manage their own condition.

[0198] The operation of the in vivo insulin comprehensive management method according to the embodiments described above can be at least partially implemented as a computer program and recorded on a computer-readable recording medium. The computer-readable recording medium, on which a program for implementing the operation of the method according to the embodiments is recorded, includes all types of recording devices storing data that can be read by a computer. Examples of computer-readable recording media include ROM, RAM, CD-ROM, magnetic tape, floppy disk, optical data storage devices, etc. Furthermore, the computer-readable recording medium can also be distributed across a network-connected computer system to store and execute computer-readable code in a distributed manner. Moreover, the functional programs, code, and code segments used to implement this embodiment can be readily understood by those skilled in the art to which this embodiment pertains.

[0199] Furthermore, each block or step shown in the flowcharts of this specification may represent a portion of a module, segment, or code containing one or more executable instructions for performing a specific logical function. Additionally, in several alternative embodiments, the functions mentioned in a block or step may occur out of order. For example, two blocks or steps shown consecutively may actually be executed substantially simultaneously, or these blocks or steps may sometimes be executed in reverse order according to their respective functions.

[0200] The present invention discussed above has been described with reference to the embodiments shown in the accompanying drawings, but these are merely exemplary. Those skilled in the art will understand that various modifications and variations of the embodiments can be made therefrom. However, such modifications should be considered within the scope of protection of the present invention. Therefore, the true scope of protection of the present invention should be determined by the technical concept of the appended claims.

[0201] Industrial applicability The embodiments relate to a comprehensive insulin management platform system and method, and a computer program for use therein. More specifically, the embodiments relate to a technique that calculates and predicts in vivo insulin levels based on a user's insulin input information, and proposes future insulin input plans to the user or sets them on an infusion device based on the predicted in vivo insulin levels, thereby providing the user with an optimal insulin management method.

Claims

1. An integrated in vivo insulin management platform system, comprising: include: The receiving module is configured to receive, via user input or via a communication connection with one or more injection devices for administering insulin to the user, one or more insulin administration information including the user's past insulin administration amounts and administration times, and to receive administration method information for the user's future insulin administration. The management module is configured to calculate the user's in-vivo insulin levels based on the insulin administration information, and, based on the in-vivo insulin levels and the administration method information, generate management information including one or more of the following: the amount and timing of insulin administration for continuous management of the in-vivo insulin levels; and The output module is configured to provide the management information to the user.

2. The in vivo insulin comprehensive management platform system according to claim 1, wherein, The receiving module is further configured to receive insulin administration information from a first injection device that is communicatively connected to the in vivo insulin integrated management platform system. The management module is further configured to set one or more of the insulin injection amount and injection timing of the second injection device, which is communicatively connected to the in vivo insulin integrated management platform system, based on the management information.

3. The in vivo insulin comprehensive management platform system according to claim 2, wherein, The first injection device and the second injection device are devices with different insulin delivery characteristics. The insulin delivery characteristics include one or more of the following: the type of insulin administered, the dosage of insulin administered, and the insulin administration cycle. The management module is further configured as follows: The in vivo insulin level is calculated based on the insulin delivery information provided by the first injection device. Based on the insulin in vivo and the insulin delivery characteristics of the second injection device, one or more of the initial insulin delivery amount and the initial delivery time point delivered by the second injection device are determined.

4. The in vivo insulin comprehensive management platform system according to claim 1, wherein, The administration method information includes information defining the injection device or medication used by the user for insulin administration. The management module is further configured to calculate the in vivo insulin and management information for the insulin bolus or basal insulin administered by the user.

5. The in vivo insulin comprehensive management platform system according to claim 4, wherein, The management module is further configured to calculate the in vivo insulin and management information for each of the bolus insulin and basal insulin administered by the user.

6. An in vivo insulin management method, comprising: include: The in vivo insulin integrated management platform system receives insulin administration information, including the user's past insulin administration amounts and administration times, either through user input or through a communication connection with one or more injection devices used to administer insulin to the user. The steps of the in vivo insulin comprehensive management platform system to calculate the user's in vivo insulin based on the insulin input information; The step of the in vivo insulin comprehensive management platform system receiving information on the means of insulin administration for the user's future insulin administration; The in vivo insulin comprehensive management platform system generates management information, including one or more of the insulin dosage and timing for continuous management of the in vivo insulin, based on the in vivo insulin and the administration method information; and The steps of the in vivo insulin comprehensive management platform system providing the management information to the user.

7. The method for comprehensive management of in vivo insulin according to claim 6, wherein, The step of receiving the insulin delivery information includes the step of the in vivo insulin management platform system receiving the insulin delivery information from a first injection device that is communicatively connected to the in vivo insulin management platform system. The steps of providing the management information include one or more steps of the in vivo insulin integrated management platform system automatically setting the insulin delivery amount and delivery timing of a second injection device that is communicatively connected to the in vivo insulin integrated management platform system based on the management information.

8. The method for comprehensive management of in vivo insulin according to claim 7, wherein, The first injection device and the second injection device are devices with different insulin delivery characteristics. The insulin delivery characteristics include one or more of the following: the type of insulin administered, the dosage of insulin administered, and the insulin administration cycle. The steps of generating the management information include the following steps: the in vivo insulin integrated management platform system calculates the in vivo insulin and the insulin delivery characteristics of the second injection device based on the insulin delivery information delivered by the first injection device, and determines one or more of the initial insulin delivery amount and the initial delivery time point delivered by the second injection device.

9. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The first injection device is an insulin pump. The second injection device is an insulin pen. The steps of determining one or more of the initial insulin dosage and initial administration time point administered by the second infusion device include: The system for comprehensive insulin management calculates the steps for determining the remaining insulin in the body at the current time point when the insulin is transferred to the second injection device, based on the insulin delivery information from the first injection device; and The in vivo insulin management platform system reflects the residual insulin in the body at the current time point and determines the initial insulin dosage administered by the second injection device.

10. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The first injection device is an insulin pump. The second injection device is an insulin pen. The steps for generating the management information include: The step of the in vivo insulin integrated management platform system receiving information about the timing of the transition from the first injection device to the second injection device; and The in vivo insulin integrated management platform system generates the management information to suspend the insulin delivery process performed by the first injection device within a preset time interval before the switching time point.

11. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The first injection device is an insulin pen. The second infusion device is an insulin pump. The steps of determining one or more of the initial insulin dosage and initial administration time point administered by the second infusion device include: The in vivo insulin comprehensive management platform system calculates the steps for residual insulin in the body at the current time point based on the insulin delivery information provided by the first injection device; and The in vivo insulin management platform system reflects the residual insulin in the body at the current time point and delays the insulin delivery time point performed by the second injection device.

12. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The first injection device is an insulin pen. The second infusion device is an insulin pump. The steps of determining one or more of the initial insulin dosage and initial administration time point administered by the second infusion device include: The in vivo insulin management platform system calculates the steps for the in vivo acting insulin at the current time point based on the insulin delivery information from the first injection device; and The in vivo insulin comprehensive management platform system determines the amount of insulin administered by the second injection device based on the amount obtained by subtracting the in vivo insulin at the current time point from the preset target basal insulin.

13. The method for comprehensive management of in vivo insulin according to claim 12, wherein, The target basal-acting insulin is the sum of the effective insulins corresponding to the long-acting insulin injected multiple times at preset time intervals by the first injection device.

14. The method for comprehensive management of in vivo insulin according to claim 13, wherein, The step of determining the amount of insulin administered by the second injection device includes the step of the in vivo insulin integrated management platform system linearly increasing the amount of insulin administered by the second injection device until the in vivo acting insulin based on the insulin administered by the second injection device reaches the target basal acting insulin.

15. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The first injection device is an insulin pen. The second infusion device is an insulin pump. The insulin delivery information provided by the first injection device includes the injection time points of the long-acting insulin administered by the first injection device. The steps of determining one or more of the initial insulin dosage and initial administration time point by the second injection device include the step of the in vivo insulin integrated management platform system determining the insulin administration time point by the second injection device based on the duration of action of the long-acting insulin.

16. The method for comprehensive management of in vivo insulin according to claim 8, wherein, The administration method information includes information defining the injection device or medication used by the user for insulin administration. The in vivo insulin and the management information are calculated based on the bolus insulin or basal insulin administered by the user.

17. The method for comprehensive management of in vivo insulin according to claim 16, wherein, The step of receiving the insulin delivery information includes the step of the in vivo insulin management platform system receiving the insulin delivery information from an injection device that is communicatively connected to the in vivo insulin management platform system. The steps for providing the management information include: The steps of the comprehensive insulin management platform system in calculating the user's residual insulin at the current time point based on the insulin input information; and The in vivo insulin management platform determines, based on the residual insulin in the body at the current time point, one or more steps, including the dosage and timing of medication administered by the user to regulate blood sugar.

18. The method for comprehensive management of in vivo insulin according to claim 16, wherein, The in vivo insulin and the management information are calculated separately for the bolus insulin and basal insulin administered by the user.

19. A computer program stored in a computer-readable recording medium for use in conjunction with hardware to execute the in vivo insulin comprehensive management method according to any one of claims 8 to 18.

20. A method for comprehensive management of insulin in vivo, executed by a computing device communicating with one or more infusion devices, thereby providing continuous management functionality even when the infusion device is switched, the method comprising: The step of receiving first insulin administration information, including the type, dosage, and timing of insulin administration in the past, either by user input or through a communication connection with a first insulin administration device for administering insulin to the user; Based on the first insulin input information, the steps are as follows: calculating the user's residual insulin in the body when the past insulin was rapid-acting, and calculating the user's active insulin in the body when the past insulin was long-acting. The step of receiving the type of insulin corresponding to the second infusion device used for future insulin administration to the user; as well as Based on the user's calculated residual insulin or active insulin and the type of insulin corresponding to the second injection device, the step of automatically setting one or more of the insulin injection amount and injection timing performed by the second injection device in the second injection device.

21. The method for comprehensive management of in vivo insulin according to claim 20, wherein, The first injection device and the second injection device are devices that use different types of insulin, and the method further includes: The step of receiving second insulin administration information, including the type, dosage, and timing of administration of insulin corresponding to the second injection device, through user input or through a communication connection with the second injection device; The steps for calculating the user's residual insulin or active insulin based on the second insulin input information; The step of receiving an insulin type corresponding to a third infusion device, the third infusion device being used for future insulin administration by the user and being a different insulin type than that of the second infusion device; and Based on the user's residual insulin or active insulin calculated from the second insulin input information and the type of insulin corresponding to the third injection device, the step of automatically setting one or more of the insulin input amount and timing performed by the third injection device to the third injection device.

22. The method for comprehensive management of in vivo insulin according to claim 21, wherein, The first infusion device is an insulin pump that uses rapid-acting insulin. The second injection device is an insulin pen that uses long-acting insulin. The third infusion device is an insulin pump that uses rapid-acting insulin. The step of automatically setting the second injection device includes: Based on the residual insulin in the body corresponding to the rapid-acting insulin injected into the body by the first injection device and the information on the first insulin delivery, one or more steps are taken to determine the insulin delivery amount and timing of the second injection device. The step of automatically setting the third injection device includes: Based on the in vivo acting insulin corresponding to the long-acting insulin injected into the body by the second injection device and the second insulin injection information, one or more steps are taken to determine the insulin injection amount and injection timing of the third injection device.

23. The method for comprehensive management of in vivo insulin according to claim 20, wherein, The first injection device is an insulin pen that uses long-acting insulin. The second infusion device is an insulin pump that uses rapid-acting insulin. The automatic setting process for the second injection device includes one or more steps of determining the insulin dosage and timing of injection based on a preset target basal insulin level. The target basal-acting insulin is the sum of the effective insulins corresponding to the long-acting insulin injected multiple times at preset time intervals by the first injection device.

24. The method for comprehensive management of in vivo insulin according to claim 23, wherein, Determining one or more of the steps of the second injection device in terms of insulin dosage and timing includes: The step of determining the insulin input amount of the second injection device based on the value obtained by subtracting the in vivo acting insulin at the current time point based on the long-acting insulin injected into the body by the first injection device from the target basal acting insulin.

25. The method for comprehensive management of in vivo insulin according to claim 23, wherein, Determining one or more of the steps of the second injection device in terms of insulin dosage and timing includes: The step of linearly increasing the amount of insulin administered by the second injection device until the in vivo acting insulin based on the rapid-acting insulin injected into the body by the second injection device reaches the target basal acting insulin.

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