Platform system and method for integrated management of insulin in body, and computer program for same

Abstract

This platform system for integrated management of insulin in the body may comprise: a receiving module configured to receive insulin administration information including at least one of a past insulin administration amount or administration time of a user through a user input or a communication connection with one or more injection devices used to inject insulin into the user, and to receive administration means information to be used for future insulin administration of the user; a management module configured to calculate the insulin in the body of the user on the basis of the insulin administration information, and to generate management information including at least one of an insulin administration amount or administration time for continuous management of the insulin in the body on the basis of the insulin in the body and the administration means information; and an output module configured to provide the user with the management information.

Description

In vivo insulin integrated management platform system and method and computer program for the same

[0001] This patent was filed with the support of the Pan-Governmental Full-Cycle Medical Device Research and Development Project (Research Project Name: Advanced Development of Pen-Type Automatic Insulin Injection Device (AID) Based on CGM (Continuous Glucose Monitoring) / Motion Sensor Data Analysis Algorithm, Project No.: 1711196799), which is supported by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety, and supported by the Pan-Governmental Full-Cycle Medical Device Research and Development Foundation (Research Project Name: : Advanced Development of Pen-Type Automatic Insulin Injection Device (AID) Based on Motion Sensor Data Analysis Algorithm, Project No.: 1711196799).

[0002] The embodiments relate to an integrated intracellular insulin management platform system and method and a computer program for the same. More specifically, the embodiments relate to a technology that calculates and predicts intracellular insulin based on a user's insulin injection information, and provides an optimal insulin management method to a user by proposing a future insulin injection plan to the user or setting it in an infusion device based on the predicted intracellular insulin.

[0003] Due to advancements in modern medical technology, diabetic patients can now manage their blood sugar levels through various insulin administration methods. Insulin administration methods are primarily classified into Multiple Daily Injection (MDI) and Continuous Subcutaneous Insulin Infusion (CSII) regimens. MDI therapy involves injecting insulin multiple times a day using devices such as an insulin pen; it is preferred by many patients due to its low initial cost and ease of use. However, if blood sugar levels do not reach target levels, it is common practice to switch from MDI therapy to CSII therapy. CSII therapy generally enables more precise blood sugar management by continuously injecting the necessary amount of insulin subcutaneously using an insulin pump, based on real-time blood glucose readings from a continuous glucose monitor.

[0004] Recently, systems that calculate the optimal timing and dosage of insulin administration based on information such as a patient's blood glucose, diet, and exercise are being introduced. For example, Registered Patent Publication No. 10-2494011 discloses a system for calculating bolus insulin based on Continuous Glucose Monitoring (CGM). Bolus insulin refers to insulin that is additionally injected by diabetic patients to control blood glucose levels during meal times or when blood glucose rises rapidly. It is primarily a fast-acting insulin preparation used to prevent a rapid rise in blood glucose and to maintain it within a target blood glucose range.

[0005] However, even for patients managing their blood sugar with CSII therapy, there may be situations where using an insulin pump becomes difficult in specific circumstances. For instance, situations may arise where the insulin pump must be removed from the body and an insulin pen used for a certain period, such as during strenuous exercise like marathon running, cycling, or swimming; when exposed to water like bathing or swimming in the sea; or while traveling or when attracting the attention of others. Conversely, there may also be cases where a patient managing blood sugar with MDI therapy using an insulin pen switches to CSII therapy using an insulin pump to improve their blood sugar control. In such cases, accurate blood sugar management may become difficult during the transition period, which can last from several hours to several days; however, conventional technologies, including those disclosed in Registered Patent Publication No. 10-2494011, do not provide integrated management functions for situations where changes in insulin delivery characteristics occur.

[0006] Due to these limitations of conventional technology, if a user does not accurately recognize the injection device used for insulin administration and the amount of insulin to be administered, problems may arise in insulin administration and blood glucose management. Furthermore, since the user must entirely decide the insulin dosage before and after switching devices, there is a high likelihood of failure in blood glucose management due to inappropriate judgment. Additionally, even if an insulin dosage management system utilizing information and communication technology is used, if the history of using different insulin administration methods is not integrated and managed, the insulin dosage and timing may be incorrectly guided based on erroneous information. This is problematic in that it lowers the level of sophisticated blood glucose management, reduces the credibility of the system operator, and can pose a significant risk to the health of diabetic patients.

[0007] According to one aspect of the present invention for solving the problems of the prior art, a platform system for integrated management of insulin on board, a method for integrated management of insulin on board, and a computer program for the same can be provided, which is compatible with various insulin injection devices and, even when a user uses various injection means such as a pump, insulin pen, or medication, or changes the injection means used, calculates and predicts insulin on board based on previous insulin injection information, thereby enabling unified management of insulin injection information based thereon.

[0008] A system for an integrated intracellular insulin management platform according to one aspect of the present invention comprises: a receiving module configured to receive insulin injection information, including one or more of a user's past insulin injection amount and injection timing, and to receive information on an injection means to be used for future insulin injection of the user, through user input or a communication connection with one or more injection devices used to inject insulin into the user; a management module configured to calculate the user's intracellular insulin based on the insulin injection information and to generate management information, including one or more of an insulin injection amount and injection timing for continuous management of the intracellular insulin based on the intracellular insulin and the injection means information; 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 injection information from a first injection device that is communically connected to the in vivo insulin integrated management platform system. At this time, the management module is further configured to automatically set one or more of the insulin injection amount and injection timing of a second injection device that is communically connected to the in vivo insulin integrated 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 injection characteristics, and the insulin injection characteristics include one or more of the type of insulin to be injected, the amount of insulin injected, and the insulin injection cycle. In this case, the management module is further configured to calculate the insulin in the body based on the insulin injection information by the first injection device, and to determine one or more of the initial amount of insulin injected by the second injection device and the initial injection time based on the insulin in the body and the insulin injection characteristics of the second injection device.

[0011] In one embodiment, the input means information includes information defining the infusion device or drug for the user to use for insulin administration. In this case, the management module is further configured to calculate the in vivo insulin and the management information regarding the bolus insulin 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] A method for integrated management of insulin in the body according to one aspect of the present invention comprises: a step in which an integrated insulin management platform system receives insulin injection information including one or more of a user's past insulin injection amount and injection time through user input or a communication connection with one or more injection devices used to inject insulin into the user; a step in which the integrated insulin management platform system calculates the user's insulin in the body based on the insulin injection information; a step in which the integrated insulin management platform system receives information on an injection means to be used for future insulin injection of the user; a step in which the integrated insulin management platform system generates management information including one or more of an insulin injection amount and injection time for continuous management of the insulin in the body based on the insulin in the body and the injection means information; and a step in which the integrated insulin management platform system provides the management information to the user.

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

[0015] In one embodiment, the step of generating the management information includes the step of the in vivo insulin integrated management platform system determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration based on the in vivo insulin calculated based on the insulin administration information by the first injection device and the insulin administration characteristics of 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, the step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration may include: the step of the in vivo insulin integrated management platform system calculating the residual insulin in the body at the current time of switching to the second injection device based on the insulin administration information by the first injection device; and the step of the in vivo insulin integrated management platform system determining the initial amount of insulin administered by the second injection device by reflecting the residual insulin in the body at the current time.

[0018] Additionally, the step of generating the management information may include: the step of the in vivo insulin integrated management platform system receiving information regarding the time of switching 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 stop insulin administration by the first injection device during a preset time interval prior to the time of switching.

[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, the step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration may include: the step of the in vivo insulin integrated management platform system calculating the remaining insulin in the body at a current time based on the insulin administration information by the first injection device; and the step of the in vivo insulin integrated management platform system delaying the time of administration of insulin by the second injection device by reflecting the remaining insulin in the body at a current time.

[0021] Additionally, the step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration may include: the step of the in vivo insulin integrated management platform system calculating the in vivo acting insulin at the current time based on the insulin administration information by the first injection device; and the step of the in vivo insulin integrated management platform system determining the amount of insulin administered by the second injection device based on the amount obtained by subtracting the in vivo acting insulin at the current time from a preset target basal acting insulin.

[0022] In one embodiment, the target basal action insulin is a value at which the sum of the action insulin corresponding to the sustained-release insulin injected multiple times at preset time intervals by the first injection device converges.

[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 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 into the body by the second injection device reaches the target basal acting insulin.

[0024] Additionally, the insulin injection information by the first injection device may include the timing of the injection of sustained-release insulin by the first injection device. At this time, the step of determining one or more of the initial injection amount and the initial injection time of insulin by the second injection device may include the step of the in vivo insulin integrated management platform system determining the timing of the insulin injection by the second injection device based on the duration of action of the sustained-release insulin.

[0025] In one embodiment, the step of receiving the insulin injection information includes the step of the in vivo insulin integrated management platform system receiving the insulin injection information from an infusion device that is communically connected to the in vivo insulin integrated management platform system. Additionally, the step of providing the management information includes the step of the in vivo insulin integrated management platform system calculating the user's current residual insulin based on the insulin injection information; and the step of the in vivo insulin integrated management platform determining one or more of the dosage and timing of administration of a drug administered by the user for blood glucose control based on the current residual insulin.

[0026] In one embodiment, the body insulin and the management information are calculated for the bolus insulin or basal insulin administered by the user. In another embodiment, the body insulin and the management information may be calculated for the bolus insulin and basal insulin, respectively.

[0027] According to another aspect of the present invention, an in vivo insulin integrated management method is provided, which is performed by a computing device communicating with one or more infusion devices to provide a continuous management function even when the infusion device is switched.

[0028] A method for integrated management of insulin in the body according to one embodiment comprises: receiving first insulin injection information including the type, amount, and timing of past insulin injections of the user by means of user input or a communication connection with a first injection device used to inject insulin into the user; calculating the user's residual insulin in the body based on the first insulin injection information if the past insulin was rapid-acting, and calculating the user's insulin acting in the body if the past insulin was sustained-acting; receiving a type of insulin corresponding to a second injection device to be used for future insulin injection of the user; and automatically setting one or more of the insulin injection amount and timing by the second injection device to the second injection device based on the user's calculated residual insulin or insulin acting in the body and the type of insulin corresponding to the second injection device.

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

[0030] At this time, the method for integrated management of insulin in the body further comprises: receiving second insulin injection information including the type, amount, and timing of insulin corresponding to the second injection device through user input or communication connection with the second injection device; calculating the user's remaining insulin or body-acting insulin based on the second insulin injection information; receiving a type of insulin corresponding to a third injection device, which has a different type of insulin from the second injection device, to be used for the user's future insulin injection; and, based on the user's remaining insulin or body-acting insulin calculated based on the second insulin injection information and the type of insulin corresponding to the third injection device, automatically setting one or more of the insulin amount and timing of insulin injection by the third injection device 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 determining one or more of the insulin injection amount and the injection timing of the second injection device based on the residual insulin in the body based on the rapid-acting insulin injected into the body by the first injection device and the first insulin injection information.

[0033] Additionally, the step of automatically setting the third injection device includes determining one or more of the insulin dosage and the timing of administration of the third injection device based on the intracellularly acting insulin based on the sustained-release insulin injected into the body by the second injection device and the second insulin administration information.

[0034] In another embodiment, the step of automatically setting the second injection device includes determining one or more of the insulin dosage and the timing of administration of the second injection device based on a preset target basal action insulin. In this case, the target basal action insulin may be a value at which the sum of the action insulins corresponding to the sustained-release insulin injected multiple times at preset time intervals by the first injection device converges.

[0035] In addition, in one embodiment, the step of determining one or more of the insulin dosage and the timing of administration of the second injection device includes the step of determining the insulin dosage of the second injection device based on the value obtained by subtracting the current in vivo-acting insulin based on the sustained-release 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 dosage and the timing of administration of the second injection device includes the step of linearly increasing the insulin dosage by the second injection device until the body-acting insulin based on rapid-acting insulin injected into the body by the second injection device reaches the target basal-acting insulin.

[0037] A method for integrated in vivo insulin management according to one aspect of the present invention may be stored in a computer-readable recording medium to be combined with hardware and to execute the method for integrated in vivo insulin management according to the embodiments described above.

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

[0039] According to an Insulin On Board integrated management platform system and an Insulin On Board integrated management method according to one aspect of the present invention, a diabetic patient can easily manage their insulin injection records through an insulin injection device linked to their smartphone app and data manually entered into the app, and has the advantage of effectively controlling blood sugar by administering insulin according to an optimal insulin injection plan provided by the system based on insulin on board.

[0040] For example, when a patient managing blood sugar with MDI therapy switches to CSII therapy, even if the patient puts on an insulin pump immediately after injecting insulin through an insulin pen, the platform controls the pump by delaying insulin injection or adjusting the dosage based on previous insulin injection information, so the user does not need to pay attention to the switch injection method. In addition, when switching from CSII therapy to MDI therapy, the platform automatically calculates and suggests the timing and dosage required for insulin injection, so the user has the advantage of being able to inject the necessary amount at the appropriate time according to the app's guidance.

[0041] FIG. 1 is a schematic block diagram of an in vivo insulin integrated management platform system according to one embodiment.

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

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

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

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

[0046] FIG. 6a is a flowchart showing each step of an in vivo insulin integrated management method according to one embodiment.

[0047] FIG. 6b is a flowchart illustrating each step of an in vivo insulin integrated management method according to another embodiment.

[0048] FIGS. 7 to 9 are conceptual diagrams illustrating exemplary user interfaces (UI) provided by an in vivo insulin integrated management platform system according to one embodiment.

[0049] FIGS. 10a to 10d are conceptual diagrams for explaining the control of the timing of insulin administration by an in vivo insulin integrated management platform system according to one embodiment.

[0050] Hereinafter, embodiments of the present invention will be examined in detail with reference to the drawings.

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

[0052] Referring to FIG. 1, an in vivo insulin integrated management platform system (2) according to one embodiment can communicate and operate with an infusion device (11 to 13) used by a user who needs to administer insulin to their own body or another person's body, such as a diabetic patient or a caregiver, and / or a user device (1) such as a smartphone used by the user.

[0053] The number and form of the user device (1) shown in FIG. 1 are merely exemplary. For example, although the user device (1) is exemplified as one in FIG. 1, multiple examiners may each access the in vivo insulin integrated management platform system (2) through their own user device (1). Additionally, although the user device (1) is shown in FIG. 1 in the form of a smartphone, in other embodiments, the user device (1) may be implemented in the form of any computing device, such as a mobile communication terminal, a notebook computer, a personal computer, a PDA (personal digital assistant), a tablet, or a set-top box for IPTV (Internet Protocol Television).

[0054] In one embodiment, the in vivo insulin integrated management platform system (2) may further communicate and operate with one or more health management servers (3) corresponding to the user. For example, the health management server (3) may be a server of a medical institution where the user is receiving medical treatment and prescriptions, and in this embodiment, the in vivo insulin integrated management platform system (2) may communicate with the health management server (3) to receive information for the user's blood sugar management from the health management server (3) or transmit management information generated by the in vivo insulin integrated management platform system (2) to the health management server (3).

[0055] A user who wishes to perform blood sugar management using the in vivo insulin integrated management platform system (2) may connect one or more injection devices (11 to 13) used for insulin injection to communicate with the in vivo insulin integrated management platform system (2). For example, the injection devices (11 to 13) may be equipped with a communication function through a short-range wireless communication network such as Bluetooth, and may be connected (or paired) to a user device (1), such as a smartphone, to communicate.

[0056] The user device (1) can transmit information received from the injection devices (11 to 13) to the in vivo insulin integrated management platform system (2) via a short-range or long-range communication network. Additionally, the user device (1) may operate to set the timing and / or amount of insulin injection by the injection devices (11 to 13) by communicating with the injection devices (11 to 13) based on the management information received from the in vivo insulin integrated management platform system (2).

[0057] However, this is exemplary, and in other embodiments, the in vivo insulin integrated management platform system (2) may be directly connected to one or more injection devices (11 to 13) for communication without passing through the user device (1), or the in vivo insulin integrated management platform system (2) itself may be configured in the form of a software application running within a user device (1), such as a smartphone, in which case the user device (1) may be omitted.

[0058] The in vivo insulin integrated management platform system (2) according to the embodiments can receive insulin injection information defining the type of insulin, the amount of insulin to be injected, and / or the timing of injection by communicating with a user device (1) and / or one or more injection devices (11 to 13) via a wired and / or wireless network, calculate the insulin in the user's body based on the received information, and provide a user interface (UI) for displaying management information that allows the insulin in the user's body to be managed at a constant level despite changes in the user's injection environment.

[0059] In this specification, the term "infusion of insulin" is intended to encompass the act of injecting liquid insulin into the body using an injector or the act of orally administering a drug for blood sugar control, unless otherwise specified.

[0060] In this specification, the term "injection device (11 to 13)" refers to any device that can be used to inject insulin into a user's body and is equipped with information communication functions with a user device (1) and / or an in vivo insulin integrated management platform system (2). In this specification, the injection device (11 to 13) is described by exemplifying an insulin pen (12) and an insulin pen cap (13) for use in MDI (Multiple Daily Injection) therapy, and an insulin pump (11) for use in CSII (Continuous Subcutaneous Insulin Infusion) therapy, but the types or forms of the injection device (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 in this specification as an injection device (11 to 13) is intended to include not only a general reusable pen but also a disposable pen, a disposable syringe, an insulin pen cap, etc. Additionally, the insulin pen (12) may be a dial type that determines the dosage by turning a dial, or it may be of a different type. In this case, the insulin pen cap (13) is a device equipped with wireless communication capabilities that is coupled to a general manual insulin pen. When the dial is turned to set the injection amount on the manual insulin pen (131), the pen cap (132), which is an electronic device detachably coupled to the manual insulin pen (131), automatically recognizes the dial, stores the injection amount and the injection time, and can transmit this stored information to a user device (1) and / or an in vivo insulin integrated management platform system (2) via wireless communication. Additionally, a general insulin injection regimen may also be included in the injection device of the present invention if the insulin in the body can be managed.

[0062] Meanwhile, the insulin pump (11), described as an injection device (11 to 13) in this specification, may be equipped with an algorithm that stops insulin injection when or before reaching hypoglycemia in conjunction with continuous glucose monitoring, or it may simply inject insulin at a predetermined dose and frequency. Additionally, the insulin pump may be configured to inject insulin subcutaneously in various ways, such as a needle type or a patch type, and is not limited to having a specific hardware configuration.

[0063] In the embodiments of the present invention, the insulin administered by the user through the injection device (11 to 13) may be bolus insulin, basal insulin, or a mixed insulin having a combination of the functions thereof.

[0064] In this specification, bolus insulin refers to rapid-acting or ultra-rapid-acting insulin used to control blood glucose spikes associated with meals, usually administered immediately before or immediately after a meal. Throughout this specification, when the term "rapid-acting" is used, it refers to both "rapid-acting insulin" and "ultra-rapid-acting insulin." For example, bolus insulin is an insulin that acts rapidly, begins to show effect within about 15 minutes after administration, reaches a peak blood concentration after about 1 hour, and lasts for about 2 to 4 hours. It may be, but is not limited to, insulin aspart, insulin lispro, insulin glulisine, etc.

[0065] In addition, as specified herein, basal insulin refers to insulin used to maintain a constant blood glucose level throughout the day, and means a type of insulin that is slowly absorbed and acts over a long period of time. Basal insulin is usually administered once or twice a day and typically provides an effect lasting for 24 hours, such as insulin degludec, insulin glargine, and insulin determir, but is not limited thereto.

[0066] The in vivo insulin integrated management platform system (2) according to the embodiments can calculate the insulin in the body resulting from the past administration of the corresponding insulin for each type of insulin, and manage the timing and / or amount of insulin of the same or different type to be injected in the future based on the calculated insulin in the body.

[0067] In this specification, "intrinsic in the body" refers to the amount of insulin remaining in the user's body that affects the user's future blood glucose levels. In one embodiment, intravenous 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 in the body can be calculated as Insulin on Board (IOB), which refers to the amount of insulin administered that remains in the body. For instance, since rapid-acting insulin acts for several hours after administration, the IOB—the amount of insulin remaining unacted—can be utilized as information regarding insulin in the body.

[0069] Alternatively, if the user has previously used long-acting insulin, the user's active insulin (U / min) can be used as the body's insulin information. Long-acting insulin acts for about one day to several days and has a relatively constant action profile compared to rapid-acting insulin. In this case, in the embodiments, the amount of active insulin per hour calculated through the action profile of long-acting insulin can be calculated as the body's active insulin and utilized as the body's insulin information.

[0070] The in vivo insulin integrated management platform system (2) according to the embodiments can provide management functions independently or in combination for each type of insulin (e.g., bolus insulin and basal insulin) injection device when a user administers one or more types of insulin. Additionally, the in vivo insulin integrated management platform system (2) according to the embodiments can provide management functions based on in vivo insulin in response to cases where a user uses one or more types of injection means (injection device or oral administration, etc.) in parallel or switches injection means.

[0071] For example, when a user switches from using an insulin pump that uses rapid-acting insulin to an insulin pen that uses long-acting insulin, or when a user switches from using an insulin pen that uses long-acting insulin to an insulin pump that uses rapid-acting insulin, the in vivo insulin integrated management platform system (2) according to the embodiments is applied, thereby allowing the amount and / or timing of insulin to be injected in the future to be determined based on the type, amount, and / or timing of insulin injected in the past. In addition, the in vivo insulin integrated management platform system (2) may automatically set the injection information determined based on the in vivo insulin to the injection devices (11 to 13) through direct or indirect communication with the injection devices (11 to 13).

[0072] The user can communicate with the injection device (11 to 13) and the user device (1) by pairing via a short-range communication network such as Bluetooth, and receive insulin injection information via the injection device (11 to 13) on the user device (1). Additionally, the insulin injection information received on the user device (1) may be transmitted from the user device (1) to the in vivo insulin integrated management platform system (2) either by the user's selection or automatically.

[0073] Meanwhile, when the in vivo insulin integrated management platform system (2) is connected to the direct injection device (11 to 13) for communication, the in vivo insulin integrated management platform system (2) may receive insulin injection information from the injection device (11 to 13). Since accurate insulin injection information by the injection device (11 to 13) is transmitted to the in vivo insulin integrated management platform system (2), there is an advantage in preventing errors that may occur when a user manually inputs the amount of insulin, such as bolus insulin.

[0074] However, in the case of other injection means for which communication with the user device (1) is impossible or a communication connection has not been established, the user may directly input information regarding insulin injection through such injection means into the in vivo insulin integrated management platform system (2). For example, the user may input the amount and timing of insulin injection through another insulin pen or insulin pump that is not paired with the user device (1) into the user device (1), thereby allowing the input information to be transmitted from the user device (1) to the in vivo insulin integrated management platform system (2). Additionally, the user may input information regarding a blood glucose improving agent administered by the user via medication, in addition to the device equipped with the insulin injection function, into the user device (1).

[0075] For the above operation, the in vivo insulin integrated management platform system (2) may include an application service server that enables the operation of a specific application (or app) running on a user device (1), or a web server that provides a specific web page accessible through a web browser running on the user device (1). The user may use the services provided by the in vivo insulin integrated management platform system (2) by running a specific app on their smartphone or accessing a specific web page.

[0076] However, in the drawings attached to this specification, the in vivo insulin integrated management platform system (2) and the user device (1) are depicted as separate devices merely as examples, and according to the embodiment, the in vivo insulin integrated management platform system (2) may be implemented in the form of a software application that is stored and executed at least partially on the user device (1).

[0077] In one embodiment, the in vivo insulin integrated management platform system (2) includes a receiving module (21), a management module (22), and an output module (23). In addition, in one embodiment, the in vivo insulin integrated 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 integrated management platform system (2). Furthermore, each of these modules (21-23) and the DB (24) may be realized at least partially through the combination of the hardware (200) configuration and software of the in vivo insulin integrated management platform system (2).

[0078] That is, the devices described in this specification may be entirely hardware or have aspects that are partially hardware and partially software. For example, the in vivo insulin integrated management platform system (2) according to the embodiments and each system, device, server, and each unit included therein that communicates with it may collectively refer to devices and related software for exchanging data of a specific format and content via electronic communication. 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 said hardware. For example, the hardware here may be a data processing device including a CPU or other processor. Additionally, the software driven by the hardware may refer to a running process, object, executable file, thread of execution, program, etc.

[0079] In addition, each element constituting the in vivo insulin integrated management platform system (2) is not intended to refer to a separate device that is physically separated from one another. That is, each module and DB of the in vivo insulin integrated management platform system (2) illustrated in FIG. 2 is merely a functional classification of the hardware constituting the in vivo insulin integrated management platform system (2) according to the operation performed by the said hardware, and each component does not necessarily have to be provided independently of each other. Of course, depending on the embodiment, it is also possible for one or more of the aforementioned servers, units, DBs, or modules to be implemented as separate devices that are physically separated from one another.

[0080] The receiving module (21) can receive information such as the type of insulin administered in the past, the amount of insulin administered in the past, and the timing of administration through information input by the user or through communication with the injection device (11 to 13) that administers insulin to the user. For example, if the user inputs an insulin administration record to the user device (1) through a smartphone app, this information can be transmitted to the receiving module (21).

[0081] Additionally, the receiving module (21) may receive information on the means of administration to be used for the user's future insulin administration. The means of administration to be used for the user's future insulin administration may be information on an injection device (11 to 13) that has been newly paired with the user device (1) or selected as a means currently used by the user, or information defining an insulin injection device or an orally administered drug directly designated by the user. Alternatively, the information received by the receiving module (21) regarding future insulin administration may only define the type of insulin to be injected or administered by the user in the future.

[0082] The management module (22) can calculate the insulin in the user's body based on insulin injection information received through the receiving module (21), and generate management information that specifies the amount of insulin to be injected and / or the timing of injection based on the insulin in the body according to the previously injected insulin and the information on the insulin injection method the user will use in the future. For example, in the case of rapid-acting insulin, the management module (22) can calculate the remaining insulin in the body (IOB) of the insulin injected by the user up to the previous day and the time at which the insulin acts in the body (DIA), and calculate the amount of insulin to be injected and the timing of injection that the user must inject at the present or near time.

[0083] The output module (23) serves to provide management information calculated based on insulin in the body by the management module (22) to the user. In one embodiment, the management information can be transmitted to a user device (1) capable of communicating with the body insulin integrated management platform system (2), and can be delivered to the user in various ways, such as digital display, notification, or voice guidance, on the user device (1). For example, a smartphone app can deliver the amount of insulin required by the user as a notification.

[0084] In another embodiment, the output module (23) may directly transmit management information to an injection device (11 to 13) that is communically connected to the in vivo insulin integrated management platform system (2), or a user device (1) that receives management information from the in vivo insulin integrated management platform system (2) may control the injection device (11 to 13) so that the next insulin injection amount and injection timing according to the in vivo insulin being integratedly managed are automatically set in the injection device (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 when the device used by the user for insulin administration is changed.

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

[0087] Referring to FIG. 2, the hardware (200) constituting the in vivo insulin integrated management platform system according to the embodiments may be implemented as a computing device comprising 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) is a non-transient computer-readable recording medium and may include a permanent mass storage device such as RAM (random access memory), ROM (read only memory), disk drive, SSD (solid state drive), flash memory, etc. Here, the permanent mass storage device such as ROM, SSD, flash memory, disk drive, etc. may be included in the device or server described above as a separate permanent storage device distinct from the memory (210).

[0089] Additionally, 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). This separate computer-readable recording medium may include computer-readable recording media such as a floppy drive, disk, tape, DVD / CD-ROM drive, or memory card.

[0090] In another embodiment, software components may be loaded into memory (210) via a communication module (230) rather than a computer-readable recording medium. For example, at least one program may be loaded into memory (210) based on a computer program installed by files provided over a network by developers or a file distribution system (e.g., a commercial application store service server) that distributes installation files for applications.

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

[0092] The communication module (230) can provide a function for the in vivo insulin integrated management platform system to communicate with a user device, an insulin injection device, a health management server, etc., through a network. That is, the communication module (230) is a part for realizing the operation of each function module described above with reference to FIG. 2, by controlling its function by a processor (220) that references memory (210).

[0093] The input / output unit (240) may be a means for interfacing with an external input / output device (not shown). For example, the external input device may include devices such as a keyboard, mouse, microphone, camera, etc., and the external output device may include devices such as a display, speaker, haptic feedback device, etc. As another example, the input / output unit (240) may be a means for interfacing with a device in which the functions for input and output are integrated into one, such as a touchscreen.

[0094] Additionally, in other embodiments, the hardware (200) may include more components than those shown in FIG. 2 depending on the nature of the device to which it is applied. For example, when the hardware (200) is applied to a user device, it may be implemented to include at least some of the input / output devices described above, or it may include additional 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 may be implemented to include various additional components such as an accelerometer or gyroscope sensor, a camera module, various physical buttons, buttons using a touch panel, input / output ports, and a vibrator for vibration, which are generally included in smartphones.

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

[0096] Referring to FIG. 3, in one embodiment, the receiving module (21) of the in vivo insulin integrated management platform system may include an injection information receiving unit (211), a device information receiving unit (212), and an input unit (213). The device information receiving unit (212) is a part that receives information about an insulin injection means equipped with a communication function, such as an insulin pen or pump used by a user, and can receive information about an injection device paired with a user device (1), such as a user's smartphone, through communication with the user device (1). In addition, information about the device used by the user for insulin injection may be stored and managed in the DB of the in vivo insulin integrated management platform system.

[0097] The injection information receiving unit (211) can receive insulin injection information indicating the type of insulin, the amount of insulin injected, and the time of injection that the user has previously injected using an injection device. For example, the insulin injection information can be transmitted from the injection device to a paired user device, and then transmitted from the user device (1) to the receiving module (21) of the in vivo insulin integrated management platform system.

[0098] Alternatively, the user may manually input the type of insulin administered, the time and / or amount administered through their user device (1), and the input unit (213) of the in vivo insulin integrated management platform system may receive the information directly entered by the user as insulin administration information.

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

[0100] Referring to FIG. 4, in one embodiment, the management module (22) of the in vivo insulin integrated management platform system may include an in vivo insulin calculation unit (221), a management information generation unit (222), and an interlocking unit (223). The in vivo insulin calculation unit (221) is a part that generates in vivo insulin information based on the amount and timing of insulin administration that the user has previously administered. At this time, the in vivo insulin calculated by the in vivo insulin calculation unit (221) may differ as residual insulin (IOB) or in vivo acting insulin depending on the type of insulin used in the past.

[0101] In one embodiment, when a user has previously administered rapid-acting insulin, the body insulin calculation unit (221) calculates the current time point IOB and the target basal-acting insulin. The current time point IOB refers to the residual insulin remaining in the body at the current time, which has decreased over time since the previous time point of administration. This current time point IOB can be calculated as a decrease curve starting from the previous time point of administration with the following details, and FIG. 5 is a graph showing the decrease in residual insulin (IOB) and active insulin (U / min) over time after insulin administration. In FIG. 5, the first graph (501) represents the residual insulin remaining in the body, and the second graph (502) represents the insulin acting on the body. As illustrated, the residual insulin (501) in the body [is the Duration of Insulin Activity; DIA) (T d It gradually decreases over ), and the insulin (502) acting in the body increases after insulin administration, reaching a peak time of action (Peak Time) (t p It forms a peak at ) and then gradually decreases.

[0102] The current time point IOB remaining in the body is used to prevent hypoglycemia by subtracting an appropriate amount from the calculated insulin injection amount when administering mealtime bolus insulin. At this time, the ratio for subtracting the current time point IOB from the insulin injection amount can be appropriately selected. In one embodiment of the present invention, OPENAPS's IOB Calculations were used to calculate the current time point IOB. For example, the current time point IOB was calculated by reflecting the following variables, but the method of calculation is not limited to this.

[0103] Insulin Duration of Action (DIA) - Ultra-short-acting: 240 minutes, Short-acting: 360 minutes

[0104] Insulin Peak Time - 75 minutes

[0105] In this case, the remaining insulin (501) in the body is a rapid-acting insulin with an insulin action time of 360 minutes, and it is shown that it was completely depleted at 360 minutes along the horizontal time axis after the initial injection. As shown, if 15U of rapid-acting insulin is initially injected into the body, at 75 minutes when the insulin (502) in the body is at its maximum, the remaining insulin (501) in the body is calculated to be 10.4U, confirming that the amount of insulin remaining in the body has decreased.

[0106] In addition, the body-acting insulin (502) represents the amount of insulin acting per hour in units of U / min. The body-acting insulin (502) increases after insulin administration, forms a peak at the peak time of action (Peak Time) (tp), and then gradually decreases. As illustrated, if 15 U of rapid-acting insulin is injected into the body, it can be seen that the body-acting insulin (502) acts at 0.085 U / min at 75 minutes, when it is at its maximum.

[0107] Meanwhile, Figure 5 shows the calculated IOB of rapid-acting insulin with an insulin action time of 360 minutes, but this calculation method can be applied in the same way to the calculation of IOB of long-acting insulin or the calculation of the action insulin of long-acting insulin, not just rapid-acting insulin.

[0108] Target basal insulin refers to a target value for managing the amount of basal insulin administered by a user through various delivery methods. It may be a single fixed value, a numerical range including upper and / or lower limits, an injection amount calculated by dividing the total range of basal insulin—which can be determined based on time of day and activity status (diet, exercise, stress, sleep, etc.)—by the number of injections, or a combination of different injection amounts designed to match the total basal insulin amount. In particular, target basal insulin can be utilized when switching from an insulin pen to an insulin pump, and specifically for managing the total amount of basal insulin over time.

[0109] The management information generation unit (222) can generate management information that indicates the amount of insulin to be administered and / or the time of administration of insulin to be administered by the user in the future, based on the insulin in the body calculated by the insulin calculation unit (221). If there is information received regarding the insulin administration means to be used by the user in the future (including administration 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 the administration means (e.g., amount administered per dose, administration cycle, etc.).

[0110] If the means of administration to be used in the future is not separately specified, the management information generation unit (222) can generate management information to achieve the user's target basal action insulin on the premise that the means of administration used previously will continue to be used.

[0111] The linkage unit (223) plays a role in enabling the actual realization of in vivo insulin and blood sugar management based on management information by presenting management information generated through the management information generation unit (222) to the user or setting it on the infusion device used by the user. For example, the linkage unit (223) can transmit management information to a user device that is connected to communicate with the in vivo insulin integrated management platform system. Alternatively, the linkage unit (223) may set the injection information directly on the infusion device through communication between the in vivo insulin integrated management platform system and the infusion device, or transmit the injection information for setting the infusion device to the user device, thereby allowing the user device to automatically set the injection information on the infusion device paired with it.

[0112] FIG. 6a is a flowchart showing each step of an in vivo insulin integrated management method according to one embodiment.

[0113] Referring to FIG. 6a, when a user uses an injection device (11 to 12) equipped with a communication function through a network, the user can receive insulin injection information by the injection device (11 to 12) on the user device (1) by pairing the user device (1), such as a smartphone, with the injection device (11 to 12) (S101). For example, the insulin injection 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 an insulin pump, the amount of insulin, and / or the timing of the injection.

[0114] In one embodiment, when the injection devices (11 to 12) are connected to communicate with the user device (1) or the in vivo insulin integrated management platform system (2), the time of the injection devices (11 to 12) can be synchronized with the time of the in vivo insulin integrated management platform system (2) for consistent in vivo insulin management. Additionally, the in vivo insulin integrated management platform system (2) may store information of the injection devices (11 to 12) registered in relation to the user, such as device identification information, battery level, insulin level, insulin expiration date, insulin injection history and / or device status information, etc., in the DB of the in vivo insulin integrated management platform system (2).

[0115] In parallel with or as an alternative to the injection information received from the injection devices (11 to 12), the user may directly input the type of insulin, the amount of insulin, and / or the timing of administration into the user device (1) (S102). For example, the user may input the timing and amount of insulin injection using another injection device that is not paired with the user device (1), or the type, amount, and timing of administration of the administered drug, etc., into the user device (1). Additionally, if the user inputs only the amount of insulin or the type and amount of the drug into the user device (1), the time at which the input is received may be automatically set as the timing of administration and the administration information may be stored.

[0116] The user device (1) can transmit injection information received from the first injection device (11) used by the user in the past and / or injection information directly entered by the user to the in vivo insulin integrated management platform system (2) (S103). For example, the user can transmit insulin injection information to the in vivo insulin integrated management platform system (2) corresponding to the application service server through an app running on a smartphone.

[0117] However, this is exemplary, and in another embodiment, the in vivo insulin integrated management platform system (2) may be communicated with the first injection device (11) and may receive insulin injection information directly from the first injection device (11) without going through a user device (1), such as a smartphone.

[0118] In addition, in one embodiment, the in vivo insulin integrated management platform system (2) may receive insulin injection 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 a diabetic patient receives periodic medical treatment and prescriptions, and the in vivo insulin integrated management platform system (2) may receive the medical records of the medical institution or some content indicating the user's insulin management status or blood sugar management status from the health management server (3) as insulin injection information (S104).

[0119] Next, the body insulin integrated management platform system (2) can calculate the user's body insulin based on the received insulin injection information (S105). This may refer to a process of calculating the body insulin, which is the amount of active insulin remaining in the body at present, by analyzing the user's past insulin injection data. For example, if the insulin used in the past was rapid-acting insulin, the body insulin can be calculated as the current IOB, or if the insulin used in the past was long-acting insulin, the body insulin can be calculated as the body-acting insulin.

[0120] In addition, the body insulin integrated management platform system (2) may further calculate or adjust the user's target basal-acting insulin along with the body insulin. Target basal-acting insulin refers to the basal insulin that the user wishes to maintain, calculated numerically based on the user's past eating patterns, insulin injection patterns, blood glucose fluctuation patterns by time of day, and blood glucose fluctuation patterns by activity situation. It can be defined in various forms, such as a lower limit, upper limit, average value, or a numerical range defined by upper and lower limits of the amount of active insulin. This target basal-acting insulin can be calculated using insulin injection information received from the health management server (3).

[0121] When a user who has been using the in vivo insulin integrated management platform system (2) wishes to change the means of administering insulin, the in vivo insulin integrated management platform system (2) may receive information from the user device (1) regarding the means of administration that the user wishes to use for future insulin administration (S106). At this time, the information regarding the means of administration may include the type of insulin that the user will use in the future.

[0122] For example, the injection means may be an injection device such as an insulin pen or a pump, and device information entered manually by the user into the user device (1) or device information of an injection device (11 to 12) newly paired with the user device (1) may be transmitted to the in vivo insulin integrated management platform system (2) as injection means information. Alternatively, when the user administers a blood sugar improvement agent, if the user enters information about the medication they wish to take into the user device (1), such medication information may be transmitted to the in vivo insulin integrated management platform system (2) as injection means information.

[0123] The user can notify the in vivo insulin integrated management platform system (2) of the switch of the injection means by directly changing the injection devices (11 to 12) linked to the app by using an app that communicates with the in vivo insulin integrated management platform system (2). In addition, if the communication connection between the user device (1) and the previously paired injection devices (11 to 12) is disconnected, the app on the user device (1) automatically searches for pairable injection devices (11 to 12) within the communication range, and if there is a newly paired injection device (11 to 12) as a result of the search, information of the injection device (11 to 12) may be transmitted to the in vivo insulin integrated management platform system (2).

[0124] In the in vivo insulin integrated management platform system (2), when long-acting insulin is used as basal insulin through an insulin pen, integrated management is performed based on received past insulin injection information and information on the injection method the user intends to use, so that the target basal-acting insulin can be achieved regardless of which insulin injection method the user uses. For example, the in vivo insulin integrated management platform system (2) determines the timing and / or amount of future insulin injection based on the insulin injection method the user intends to use in the future and the user's target basal-acting insulin (S107), and can provide the determined information to the user as management information.

[0125] Management information for the integrated management of insulin in the body can be transmitted from the body insulin integrated management platform system (2) to the user device (1) (S108). The user can directly administer insulin while complying with the insulin administration timing and / or amount defined in the management information provided from the body insulin integrated management platform system (2), or can set the management information in the second injection device (12) to be used in the future so that the second injection device (12) administers insulin as instructed in the management information.

[0126] Alternatively, management information is transmitted from the internal insulin integrated management platform system (2) to the user device (1), and an app 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 the operation of the second injection device (12) is controlled according to the internal insulin that is integratedly managed, even if the user does not take separate action.

[0127] At this time, the parameters for the operation of the second injection device (12) may not only set the type of insulin to be injected into the user's body through the second injection device (12), the injection time and / or the injection amount, but may also be determined by reflecting the user's blood glucose level before switching the injection means, the user's insulin sensitivity, the user's past insulin injection history, and a treatment plan received from a medical institution regarding 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 DB of the in vivo insulin integrated management platform system (2), and can generate management information to be transmitted to the injection device (11 to 12) by reflecting the variables.

[0128] In one embodiment, the management information transmitted by the in vivo insulin integrated management platform system (2) may include, in addition to directly setting the operation of the infusion device (11 to 12) to be used by the user, data instructing the user to perform corresponding actions necessary for continuous management of insulin in the body in preparation for switching to the infusion device (11 to 12). For example, to manage blood sugar levels during the switching of the infusion device (11 to 12), data regarding the type of insulin, the timing of administration, and / or the amount of administration that the user must inject in advance before switching devices may be generated as management information. In this case, the management information for pre-response may be calculated by taking into account the user's current blood sugar value, blood sugar trend, and the time required for switching devices before switching devices.

[0129] In addition, in one embodiment, the in vivo insulin integrated management platform system (2) may further transmit notification information to the user device (1) to urge the user to perform actions for the continuous management of insulin in the body calculated based on insulin injection information. For example, if insulin depletion in the body is expected but the connection between the first injection device (11) and the user device (1) is disconnected and the second injection device (12) is not connected to the user device (1), the in vivo insulin integrated management platform system (2) may generate and transmit notification information to the user device (1) urging the user to pair another injection device with the user device, administer insulin using a separate insulin injection device, or input injection information if insulin has already been administered.

[0130] In addition, in one embodiment, the in vivo insulin integrated management platform system (2) may further transmit management information determined based on the in vivo insulin being integratedly managed to a health management server (3), such as a medical institution or a health insurance management corporation corresponding to the user (S110). The health management server (3) can identify the management therapy or insulin dosage currently being applied by the user for blood sugar management based on the management information received from the in vivo insulin integrated management platform system (2) and use this for future disease or health management.

[0131] FIG. 6b is a flowchart illustrating each step of an in vivo insulin integrated management method according to another embodiment.

[0132] Referring to FIG. 6b, the first injection device (11) transmits injection information defining the type of insulin, the amount of insulin, and / or the time of injection to a paired user device (1) (S201), and the user device (1) can transmit this to an in vivo insulin integrated management platform system (2) (S202). However, as described above, in other embodiments, the in vivo insulin integrated management platform system (2) may be communicably connected to the first injection device (11) to receive this information directly from the first injection device (11).

[0133] The body insulin integrated management platform system (2) can calculate body insulin based on insulin injection information from the first injection device (11). In one embodiment, the body insulin integrated management platform system (2) may identify the type of insulin injected in the past (S203) and, depending on the type of insulin injected in the past, generate body insulin information such as the value of residual insulin (IOB) or body-acting insulin (U / min) (S204).

[0134] Next, the in vivo insulin integrated management platform system (2) can receive injection device information corresponding to the second injection device (12) that the user will use in the future from the user device (1) or the second injection device (12) (S205). At this time, the injection device information received by the in vivo insulin integrated management platform system (2) may include the type of insulin to be injected by the second injection device (12).

[0135] The in vivo insulin integrated management platform system (2) can generate insulin injection information that defines the amount of insulin to be injected by the second injection device (12) and / or the timing of insulin injection, 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 integrated management platform system (2) can transmit the generated insulin injection information to the second injection device (12) to automatically set the injection operation of the second injection device (12) (S206). However, this is exemplary, and in other embodiments, the insulin injection information may be transmitted to the second injection device (12) via the user device (1).

[0136] The continuous management operation based on insulin in the body as described above can be performed in the same manner even when the insulin delivery means used by the user is changed from the second injection device (12) to another third injection device (13).

[0137] That is, the in vivo insulin integrated management platform system (2) receives insulin injection information from the second injection device (12) (S207), and can receive injection device information from the user device (1) or the third injection device (13) indicating that the third injection device (13) will be used for insulin injection in the future (S208). Next, the in vivo insulin integrated management platform system (2) can generate injection information indicating the amount of insulin injected by the third injection device (13) and / or the timing of injection based on the type of insulin injected by the second injection device (12) and the insulin injected by the third injection device (13), and can set the injection information by transmitting the injection information to the third injection device (13) (S209).

[0138] FIGS. 7 to 9 are conceptual diagrams illustrating exemplary user interfaces (UI) provided by an in vivo insulin integrated management platform system according to one embodiment.

[0139] Referring to FIG. 7, an in vivo insulin integrated management platform system according to one embodiment can provide a UI element (610) that allows the user to specify the date, time, period, day of the week, etc. to be viewed, thereby providing a function that allows the user to view their insulin injection information by time.

[0140] In addition, the in vivo insulin integrated management platform system according to one embodiment allows a user to select a type of blood glucose or insulin through UI elements (620), and allows the user to check the insulin injection information for managing the selected blood glucose or the insulin injection information for the selected type through a screen. At this time, insulin management may be classified into meal bolus insulin management, basal insulin management, etc., but is not limited thereto.

[0141] The screen area displayed by the in vivo insulin integrated management platform system is assigned to insulin injection information, and FIG. 7 exemplarily illustrates a case where the injection device used by the user for insulin injection is switched from the first injection device to the second injection device based on the distinction point (600) indicated by the dotted line. At this time, the first injection device and the second injection device refer to devices with different insulin injection characteristics, such as the type of insulin to be injected, the amount of insulin injected, and / or the insulin injection cycle. The device switching point (600) may be displayed to the user as part of the UI screen so that the user recognizes the device switching.

[0142] In the following, the operation of integrated in vivo insulin management by an integrated in vivo insulin management platform system is described by assuming a case where the first delivery device is a delivery device that uses both mealtime bolus insulin and basal insulin as rapid-acting insulin (e.g., an insulin pump), and the second delivery device is a delivery device that uses the mealtime bolus as rapid-acting insulin and the basal insulin as long-acting insulin (e.g., an insulin pen, or an insulin pen according to the type of insulin can be used, respectively).

[0143] For example, there may be cases where the user needs to remove the first delivery device from their body and switch to the second delivery device, the insulin pen, to administer insulin, such as when the first delivery device, the insulin pump, is malfunctioning, the injection mechanism is clogged, or the battery is depleted; when engaging in strenuous exercise such as marathon running, cycling, or swimming; when being exposed to water such as bathing or swimming in the sea; or when traveling or being watched by others.

[0144] The following explanation will be divided into mealtime bolus insulin management and basal insulin management.

[0145] First, regarding the management of meal bolus insulin, each bar (641 to 645) displayed on the UI screen indicates the timing and amount of rapid-acting insulin injected in response to the user's meal time, and the solid line extending from the top to the right of each bar (641 to 645) with decreasing values ​​indicates that the user's IOB increases due to the injection of rapid-acting insulin and then decreases over time.

[0146] At the point in time (600) when the switching of the injection means occurs, the in vivo insulin integrated management platform system (2) calculates the user's current point in time IOB through the amount of insulin injected and the time of injection, each represented by bars (641 to 645). When the current time arrives to inject rapid-acting insulin corresponding to the next meal time after the switching of the injection means (600), the in vivo insulin integrated management platform system can calculate the final amount of insulin to be injected through the current injection means (i.e., insulin pen) by considering the current point in time IOB calculated through the previous insulin injection. This is illustrated as a bar (660) in FIG. 7, and the final amount of insulin to be injected corresponding to the bar (660) can be determined based on the calculation of the IOB through the previous insulin injection. For example, since the IOB remains in the user's body due to the previous insulin injection represented by the bar (645), the amount of insulin to be injected can be automatically determined based on the current point in time IOB instead of injecting the maximum amount of rapid-acting insulin even when the next meal time arrives.

[0147] More specifically, as shown in the bar (660) above, when a total required insulin amount of 27U is calculated through the meal bolus calculation formula, the current IOB at the time of switching the injection means (600) is estimated to be 9U by referring to the bar (645) through the calculation formula, and these are subtracted to determine the final injection amount of 18U. The determined injection amount of 18U can be delivered to the user as an alarm through the user device (1) or injection device (11 to 13) or displayed on the display. Accordingly, by injecting the determined final injection amount of 18U, the total required insulin amount of 27U can be calculated by adding it to the current IOB of 9U before injection. This IOB decreases again to the right from the shortest point of the bar (660).

[0148] For example, the amount of meal bolus insulin to be administered can be determined by considering the current time point IOB as shown in Table 1 below.

[0149] Carbohydrate Intake Glucose Regulating Insulin (A) Meal Classification 240g ICR(g / U) 10A: Calculated Amount (U) 24U Target Blood Glucose Regulating Insulin (B) CF(mg / dL / U) 35 Target Blood Glucose (mg / dL) 105 Current Blood Glucose (mg / dL) 210B: Calculated Amount (U) 3 Current Time Point IOB(C) C: Calculated Amount (U) 9 Final Result (A + B - C) (Meal Insulin to be Injected) 27U

[0150] In Table 1 above, the intake carbohydrate glucose-regulating insulin (A) is calculated based on the amount of meal carbohydrates directly entered by the user, and the target blood glucose-regulating insulin (B) represents the amount of necessary insulin calculated based on the corresponding blood glucose management target. That is, A is calculated as 24U by dividing 240g of meal carbohydrates by the Insulin-Carbohydrate Ratio (ICR), and B is calculated as 3U by dividing the difference between the current blood glucose and the target blood glucose by the Correction Factor (CF). In this embodiment of the present invention, the amount of meal insulin to be administered, 27U, can be calculated by subtracting the current time point IOB (C) at the time of switching the administration means (600) from the amount of necessary insulin (A+B).

[0151] Next, regarding the management of basal insulin, the graph (630) displayed on the UI screen represents the amount of basal insulin administered by the user through the insulin pump. The insulin pump is configured to continuously infuse a small amount of rapid-acting basal insulin in very short cycles (e.g., 1 to 3 minutes). When a continuous glucose monitor (CGM) is used in conjunction with the insulin pump, the amount of basal insulin administered can be determined based on the average trend of the user's blood glucose fluctuations, and in the drawing, it can be seen that the amount of basal insulin increased at 3:30 AM, 5:30 AM, and 7:00 AM. Additionally, the bolus value on the y-axis of the graph (630) represents the amount of rapid-acting insulin administered per hour. If a specific point in time on the graph (630) is displayed at 6U on the UI screen, the total amount of rapid-acting insulin administered during the corresponding hour is 6U, and the unit of the infusion rate can be expressed as 6 U / hr. This can be understood as injecting 0.3 U of basal insulin every 3 minutes from an insulin pump, and in this case, the unit of the infusion rate can likewise be expressed as 0.3 U / min. This is used identically to the unit of the target basal action insulin (806) in Example 3 and FIG. 10c to be described later.

[0152] Meanwhile, the administration of basal insulin may be stopped during periods when the user's hypoglycemia is detected or expected through a continuous glucose monitor (CGM), and the time interval indicated by the square (670) in FIG. 7 represents the time interval during which the administration of basal insulin is stopped for this reason.

[0153] In the case of insulin pens, users can generally use insulin pens containing rapid-acting insulin cartridges and insulin pens containing long-acting insulin cartridges, respectively. Meal bolus insulin management involves injecting rapid-acting insulin into the body before meals, and basal insulin management involves injecting long-acting insulin into the body for a set period, for example, once a day. In FIG. 7, the graph (650) indicates the action insulin that acts consistently over its duration of action when administered through the insulin pen.

[0154] On the other hand, long-acting insulin is used as basal insulin and is designed to act consistently over a set period of time. Its purpose is to stably manage blood glucose by maintaining a constant basal insulin level. Consequently, since the action of insulin is highly consistent and predictable, it is not expressed as IOB but is primarily referred to as "active insulin." The effect of such active insulin on the body follows the shape of a normal distribution curve, and information regarding this normal distribution can be obtained by checking the manufacturer's specifications for the insulin product. Furthermore, the IOB of the corresponding long-acting insulin can also be calculated using its Insulin-Induced Action (DIA) and Peak Time.

[0155]

[0156] [Example 1] When switching from an insulin pump to an insulin pen

[0157] When the device used by the user is switched from an insulin pump to an insulin pen at the time (600) indicated by the dotted line, the in vivo insulin integrated management platform system can determine the amount and / or timing of the administration of meal bolus insulin and basal insulin by the insulin pen to be used in the future by considering all parameters for calculating the insulin injection amount, such as the user's ICR, CF, and the amount of basal insulin based on past insulin administration information.

[0158] First, regarding the management of meal bolus insulin, as described 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 determine the final amount of insulin to be administered through the switching insulin pen by considering the current time point IOB calculated through the amount of insulin administered through the previous insulin pump.

[0159] In terms of basal insulin management, since the insulin pump continuously infuses basal insulin as a small amount of rapid-acting insulin, if the use of the insulin pump is stopped, the rapid-acting insulin is quickly depleted, leaving almost no basal insulin remaining in the body. Therefore, in this case, long-acting insulin can be injected as basal insulin using an insulin pen immediately after stopping the use of the insulin pump. The graph (650) shown in FIG. 7 is a representation of the long-acting basal insulin injected through the insulin pen acting as a constant-acting insulin over its duration of action.

[0160] That is, in the example illustrated in FIG. 7, for basal insulin management, the device was switched from an insulin pump using rapid-acting insulin to an insulin pen using long-acting insulin, and since rapid-acting insulin is rapidly consumed in the body, at the switching point (600) indicated by the dotted line, the user immediately administered long-acting insulin and switched to insulin pen management.

[0161] In one embodiment, the amount of basal insulin administered by the pump may be controlled at a time prior to the transition from the insulin pump to the insulin pen, and FIG. 8 is an exemplary graph showing the form of dosage control prior to such transition.

[0162] In FIG. 8, COB represents the amount of carbohydrates in the body that increase through a meal, graph (630) represents the amount of basal insulin administered by the insulin pump, and graph (646) represents the amount of meal bolus insulin administered by the insulin pump. Meanwhile, graph (661) represents the amount of meal bolus insulin administered through the insulin pen immediately after the switch (600) from the insulin pump to the insulin pen.

[0163] At this time, when the system receives information that the user intends to switch the device from an insulin pump to an insulin pen, the system can manage the basal insulin injected by the insulin pump so that it does not remain in the body at the time of switching (600) by stopping the injection of basal insulin by the insulin pump for a predetermined time interval (692) before the time of switching the injection means (600). This can also be used, for example, to prevent blood sugar levels from dropping too low during exercise if there is a plan to exercise or swim in the near future.

[0164] In addition, in one embodiment, the in vivo insulin integrated management platform system may increase the amount of basal insulin administered by the insulin pump during a preset time interval (691) prior to the time interval (692) during which the administration of basal insulin by the insulin pump is stopped (e.g., set to twice the normal amount). This is intended to prevent the user's blood sugar from rising during the said interval (692) by administering more insulin in advance in preparation for a situation where the administration of basal insulin will be stopped in the future.

[0165]

[0166] [Example 2] When switching from an insulin pump to an insulin pump

[0167] In one embodiment, the infusion device used by the user may be switched from one insulin pump to another insulin pump. For example, this may occur when the user switches to another insulin pump due to an upgrade, breakdown, or loss of the insulin pump previously used, or when the user registers both insulin pumps in an integrated in vivo insulin management platform system and switches to the pump they use as needed.

[0168] In this case, first of all, regarding the management of meal bolus insulin, the above-mentioned intravenous insulin integrated management platform system (2) can determine the final amount of insulin to be administered through the switching insulin pump by considering the current time point IOB calculated through the amount of insulin administered through the previous insulin pump.

[0169] Next, regarding basal insulin management, since both the pre-switching and post-switching delivery methods are insulin pumps that continuously infuse small amounts of rapid-acting insulin, basal insulin can be injected through the new insulin pump immediately after discontinuing the use of the existing insulin pump, using the same target basal-acting insulin.

[0170]

[0171] [Example 3] When switching from an insulin pen to an insulin pump

[0172] Meanwhile, a transition may be made from MDI therapy (using an insulin pen), in which mealtime bolus insulin is injected with (ultra) rapid-acting insulin and basal insulin is injected with long-acting insulin, to CSII therapy (using an insulin pump), in which mealtime bolus insulin and basal insulin are injected using only (ultra) rapid-acting insulin. In this case, the in vivo insulin integrated management platform system may select the timing for the initiation of insulin injection by the second injection device, the insulin pump, based on the IOB calculated from the insulin already injected by the first injection device, the insulin pen. Figure 9 illustrates an example corresponding to this.

[0173] First, referring to FIG. 9, the management of meal bolus insulin is described. The bar (740) displayed on the UI screen indicates the timing and amount of rapid-acting insulin injected via the insulin pen in response to the user's meal time. After the switching point (700) of the injection device used by the user, the in vivo insulin integrated management platform system calculates the IOB based on the rapid-acting insulin injected via the insulin pen (indicated by a solid line following the bar (740)). When the time comes to inject the next rapid-acting insulin (e.g., meal time), the amount of rapid-acting insulin injected via the insulin pump can be determined by considering the IOB at the current time, which is indicated by the bar (760) in FIG. 9.

[0174] Next, regarding the management of basal insulin, the graph (730) displayed on the UI screen indicates the amount of action insulin that acts in the body from the long-acting basal insulin injected by the user through the insulin pen over the period during which the action effect of the insulin is maintained at a constant level. At this time, if the action period of the existing basal insulin has not ended even at the point (700) when the transition from the insulin pen to the insulin pump occurs, for example, the body insulin integrated management platform system can manage the body insulin in an integrated manner by delaying the injection of basal insulin by the insulin pump until the point in time when the action period of the basal insulin according to the existing insulin injection information ends.

[0175] In FIG. 9, the graph (750) represents the amount of basal insulin administered by the insulin pump, and there is a predetermined time interval (d1) between the time when the device switch occurs (700) and the time when basal insulin is administered by the insulin pump (780). This indicates that the in vivo insulin integrated management platform system has delayed the administration of basal insulin by the insulin pump until the time when the duration of action of the long-acting basal insulin previously administered by the insulin pen ends.

[0176] FIGS. 10a to 10d are conceptual diagrams for explaining the control of the timing of basal insulin administration by an in vivo insulin integrated management platform system according to one embodiment, FIG. 10a shows a case where the insulin pen is continuously used after switching from an insulin pump to an insulin pen in a state where there is no conventional in vivo insulin integrated management, and FIGS. 10b and 10c show cases where the timing and / or amount of insulin administration by the insulin pump is controlled by in vivo insulin integrated management according to the embodiments.

[0177] Meanwhile, the long-acting insulin used in this embodiment has a duration of action of about 3 days, has a normal distribution curve shape with a peak in the front, and decreases to a certain level at the beginning and end of the duration of action. It is described as a basal insulin known by the trade name Tresiba, such as insulin degludec, a long-acting basal insulin analog, administered once a day.

[0178] Referring to FIG. 10a, when the insulin pump is switched to an insulin pen at the point (800) indicated by the dotted line, graphs (801 to 805) represent the duration of action of the basal insulin (i.e., long-acting insulin) injected by the insulin pen. In this case, the action insulin stabilizes when the long-acting insulin is injected for consecutive days; in FIG. 10a, the action insulin is maintained at a stable value with a certain effect starting from the injection of the third long-acting insulin (803). That is, FIG. 10a shows that the action insulin stabilizes after about 3 to 4 days when the long-acting insulin with an action period of 3 days is injected daily.

[0179] In this case, the user can set the stable value of the action insulin as the target basal action insulin (806). In this embodiment, the target basal action insulin (806) is set as the stable value of the action insulin according to the injection of insulin, and this stable value may be a stable value in which basal insulin is injected and acts in the body according to the amount of sustained-release insulin determined by the prescription of a medical professional, or it may be an action insulin (U / day) corresponding to injecting an amount of insulin in a day that falls within the range of 40% to 60% of the patient's total daily insulin dose (Total Daily Insulin Dose, TDD), preferably 50%.

[0180] At this time, the stable value reached by the injection of basal insulin may refer to a value at which the sum of the action insulin corresponding to the basal insulin of each injection cycle converges when long-acting insulin is injected multiple times at intervals. In this specification, convergence is not limited to the sum of the action insulin necessarily becoming a specific value; rather, when the sum of the action insulin is maintained substantially constant within a pre-set error range, the constant value may be set by the body's insulin integrated management platform system to mean the stable value of the action insulin, i.e., the target basal action insulin (806). Alternatively, the target basal action insulin (806) may be calculated as the average amount of basal insulin per hour when rapid-acting insulin is injected via the insulin pump when using CSII therapy (insulin pump).

[0181] At this time, it is assumed that the patient wishes to switch from an insulin pen to an insulin pump at the point in time (810) indicated by the dotted line as in FIG. 10b. In FIG. 10b, the graph (820) represents the result of superimposing the action insulin graphs (801 to 805) shown in FIG. 10a into a single line. Conventionally, since there was no means to manage the patient's insulin in the body, switching to an insulin pump at a desired time was not recommended. Instead, the guideline was to wait until the point in time (811) when the action period of the previously injected basal insulin ended before wearing the insulin pump, as this method could minimize side effects such as preventing hypoglycemia. In other words, since one had to wait until the point in time (811) when all the IOB from the insulin injected with the insulin pen was depleted, there has been an inconvenient problem regarding the delay in switching to an insulin pump.

[0182] On the other hand, referring to FIG. 10b, when using the in vivo insulin integrated management platform system according to the embodiments, even if the insulin is switched to an insulin pump at a point in time (810) before the period of action of the basal insulin previously administered with an insulin pen ends, the administration of basal insulin by the insulin pump can be automatically delayed until the point in time (811) when the period of action of the previously administered basal insulin ends. That is, the in vivo insulin integrated management platform system calculates the user's IOB and automatically detects the point in time (811) when the IOB is completely depleted, and can provide information to the user or automatically set the injection device so that insulin administration is performed thereafter, as shown in the graph (840).

[0183] As another example, referring to FIG. 10c, the pump may be worn immediately from the point of transition (810), and the target basal action insulin (806) according to the user's basal insulin setting may be calculated and the amount and / or timing of the basal insulin administration by the insulin pump may be controlled based on this. For example, the target basal action insulin (806) may be set as a stable value of the body-acting insulin resulting from the injection of sustained-release insulin, as described above, but is not limited thereto.

[0184] The graph (860) of FIG. 10c represents basal insulin injection by an insulin pump through such control, and the hourly injection amount of basal insulin by the insulin pump can be determined by calculating the current in vivo action insulin resulting from the injection of sustained-release insulin from the target basal action insulin (806) and subtracting it.

[0185] The injection of basal insulin by an insulin pump is carried out by continuously injecting a small amount of rapid-acting insulin as basal insulin in very short cycles (e.g., 1 to 3 minutes). At this time, the amount of basal insulin injected by the insulin pump, taking into account the target basal-acting insulin (806), is the value obtained by subtracting the action insulin of the long-acting insulin injected with the insulin pen from the target basal-acting insulin (806) (unit (U / min)).

[0186] Alternatively, the basal insulin injection volume of the insulin pump may be calculated by multiplying the subtracted value by a predetermined parameter. In this case, the parameter may be a preset constant ratio, or may include a value obtained by multiplying a constant ratio by any one of the user's correction factor (CF), insulin-carbohydrate ratio (ICR), or the user's body weight, but is not limited thereto.

[0187] Furthermore, in another embodiment, if the in vivo insulin integrated management platform system can determine the target basal-acting insulin (806) but cannot determine the current in vivo-acting insulin value resulting from the injection of sustained-release insulin, the hourly basal insulin injection amount by the insulin pump may be determined such that the hourly basal insulin injection amount increases linearly during the period between the current time (i.e., the time when the injection means is switched from an insulin pen to an insulin pump) and the time when all previously injected basal insulin is depleted (811), as illustrated in FIG. 10d. In this case, the time when all basal insulin is depleted (811) can be determined as the period of action of the basal insulin.

[0188] In this case, the amount of basal insulin injected by the insulin pump can increase linearly, with the amount of basal insulin at which the value of the body-acting insulin corresponding to the basal insulin injected by the insulin pump reaches the target basal-acting insulin being the maximum value. However, when rapid-acting insulin, which acts and is depleted within a short time after injection, is used as basal insulin, the body-acting insulin corresponding to the basal insulin injected by the insulin pump may refer to the amount of basal insulin injected per hour itself.

[0189] In FIG. 10d, graph (860) represents the case where the insulin pump is switched at time point (810) shown by the dotted line, and graph (861) represents the case where the insulin pump is switched at another time point (812). As illustrated, the amount of basal insulin injected by the insulin pump can be set so that the amount of basal insulin injected increases linearly from each time point where the insulin pump is switched, reaching the target basal action insulin (806) at time point (811) when all previously injected basal insulin is depleted.

[0190] FIGS. 8 to 10 illustrate, by way of example, the integrated management of insulin in the body when switching from an insulin pump to an insulin pen or from an insulin pen to an insulin pump, but it will be readily understood by a person skilled in the art that the same principle can be applied when using other types of delivery means.

[0191] For example, the user may use an insulin pen for the administration of bolus insulin, as shown by bars (641 to 645, 660, 740, 760) in FIGS. 7 and 9, and an insulin pump for the administration of basal insulin, as shown by graphs (630, 650, 730, 750). Alternatively, the user, who is a diabetic patient, may use multiple insulin pens or multiple insulin pumps simultaneously to use two or more types of insulin with different properties (e.g., bolus insulin and basal insulin) at the same time. For example, the user may select the device to use through an app that communicates with an in vivo insulin integrated management platform system, or may automatically select the device to use through pairing the user device with the corresponding device.

[0192] In such cases, the in vivo insulin integrated management platform system according to the embodiments can calculate the user's insulin at the current time based on previous insulin injection information, regardless of the type of injection means used by the user, and adjust the amount of insulin to be injected next based on the calculated insulin (e.g., in the case of bolus insulin), or / or adjust the timing or amount of insulin to be injected next through target basal-acting insulin (e.g., in the case of basal insulin).

[0193]

[0194] [Example 4] When switching from an insulin pen to an insulin pen

[0195] In one embodiment, the injection device used by the user may be switched from one insulin pen to another insulin pen. For example, this may occur when the user switches to another insulin pen due to an upgrade, malfunction, or loss of the insulin pen previously used, or when the user registers both insulin pens in an integrated in vivo insulin management platform system and switches to the pen they use as needed.

[0196] In this case, first of all, regarding meal bolus insulin management, the in vivo insulin integrated management platform system can calculate the current insulin level in the body through the amount of insulin injected through the previous insulin pen, and if meal bolus insulin injection is required through the switched insulin pen, determine the final amount of insulin to be injected by subtracting the current insulin level in the body from the amount of insulin to be injected.

[0197] At this time, the type of insulin and target insulin amount to be injected by the user can be automatically set by the in vivo insulin integrated management platform system or entered directly by the user, and based on this, the insulin injection amount calculated by subtracting the current IOB can be determined as described above by referring to Table 1. The calculated injection amount can be provided to the user or set directly on the insulin pen. In addition, the in vivo insulin integrated management platform system can provide information regarding the timing of insulin injection to the user or set it on the insulin pen.

[0198] In one embodiment, the in vivo insulin integrated management platform system may provide the user with information regarding the insulin pen to be used based on the determined meal bolus insulin injection amount. For example, characteristic information regarding the type and injection amount of insulin injected by multiple types of insulin pens may be pre-registered in the in vivo insulin integrated management platform system, and the in vivo insulin integrated management platform system may determine which insulin pen to use, such as whether the currently linked insulin pen is sufficient or if the use of a different insulin pen is required, based on the insulin injection amount calculated by reflecting the current IOB.

[0199] Next, regarding basal insulin management, the in vivo insulin integrated management platform system considers the duration of action and the acting insulin of the long-acting insulin injected through the previous insulin pen. To achieve the same target basal acting insulin, the system informs the user of the same attributes, injection volume, and injection time as those used in the previous insulin pen, thereby enabling the injection of long-acting insulin through a new insulin pen. Management information, including the timing of injection by the new insulin pen, can be provided to the user or set directly on the insulin pen.

[0200]

[0201] [Example 5] When switching from a smart pen to a standard insulin injection pen

[0202] In one embodiment, there may be cases where the injection device is switched to a standard manual insulin pen due to participation in exercise such as swimming, while using a smart pen capable of communicating with a user device (1), such as a smartphone.

[0203] In this regard, regarding the management of mealtime bolus insulin, the in vivo insulin integrated management platform system calculates the current time point IOB based on the injection volume and timing of mealtime bolus insulin obtained through communication between the existing smart pen and the user device, and can determine the final injection volume by considering the current time point IOB when injecting mealtime bolus insulin via a manual insulin pen. Since this process may be identical to the calculation process described above with reference to Table 1, a detailed explanation is omitted. Next, regarding the management of basal insulin, the in vivo insulin integrated management platform system can determine the injection volume and timing of long-acting insulin by the new insulin pen by considering the duration of action of long-acting insulin injected via the existing smartphone. At this time, the injection volume and timing of basal insulin by the standard insulin pen can be determined to achieve the same target basal-acting insulin as when using the smart pen.

[0204] However, in the case of a standard insulin injection pen without wireless communication capabilities, since information cannot be obtained from the in vivo insulin integrated management platform system, the in vivo insulin integrated management platform system can transmit management information indicating the timing and amount of insulin injection to the user device. Additionally, the in vivo insulin integrated management platform system can transmit notification information to the user device urging the user to input the injection amount and timing of bolus insulin and basal insulin injections via the insulin pen into the user device.

[0205]

[0206] [Example 6] When switching from an insulin infusion device to a medication or vice versa

[0207] Meanwhile, the in vivo insulin integrated management platform system and method according to the embodiments are applicable even when the means used by the user for insulin administration is a drug. For example, even a patient who normally controls blood sugar with an insulin pen or insulin pump may use hypoglycemic agents such as biguanides, meglitinides, sulfonylureas, or SGLT-2 inhibitors when short-term blood sugar control with a drug is required without the use of an infusion device. In this case, oral hypoglycemic agents have a predetermined shelf life depending on the drug; for example, in the case of glimepiride among sulfonylurea agents, it is effective for 4 to 8.7 hours, which corresponds to its half-life.

[0208] Accordingly, the in vivo insulin integrated management platform system according to the embodiments may be applied in cases where a user switches from using oral medication to using an insulin infusion device, or where an oral medication is temporarily used while using an insulin infusion device such as a pump or pen. In this case, the in vivo insulin integrated management platform system may calculate the current insulin level in the user's body based on information regarding insulin administration previously administered by the user, and generate management information to administer insulin via an insulin pen, pump, or medication when the insulin level is depleted. In this case, if the user has previously administered insulin via medication, the timing of operation of the administration means to be used for future insulin administration may be delayed based on the known expiration date (e.g., half-life) of the said medication.

[0209] According to the in vivo insulin integrated management platform system and in vivo insulin integrated management method based on the embodiments described above, users can monitor their blood glucose levels in real time regardless of the type of administration method they use, identify their current status based on in vivo insulin, and take appropriate measures if necessary. In addition, by managing the user's insulin dosage and timing, the in vivo insulin integrated management platform system can automatically set the patient's insulin administration schedule and transmit management information in the form of notifications, thereby ensuring that the patient does not miss the administration schedule.

[0210] Since the above management is temporally continuous and allows for sustained care regardless of the user's insulin delivery method, continuous insulin management is possible even if the user temporarily switches to an insulin pen for exercise, such as swimming, while using an insulin pump; furthermore, continuity of blood glucose management can be realized through integration with each delivery device. As this continuous management can be performed regardless of the manufacturer of the delivery device used or the number of types or devices the user utilizes, it enables continuous blood glucose management in various environments that may arise in the daily lives of diabetic patients.

[0211] Furthermore, the in vivo insulin integrated management platform system according to the embodiments plays a role in helping medical professionals monitor a patient's condition in real time and provide appropriate advice or medical treatment as needed by linking insulin injection information of diabetic patients or management information based on integrated in vivo insulin to a health management server, such as a medical institution corresponding to the patient. In addition, the information linked between the in vivo insulin integrated management platform system and the medical institution can serve as educational material related to diabetes, helping patients understand and organize their situation.

[0212] The operation of the in vivo insulin integrated management method according to the embodiments described above may be implemented at least partially as a computer program and recorded on a computer-readable recording medium. A computer-readable recording medium on which a program for implementing the operation according to the methods of the embodiments is recorded includes all types of recording devices in which data readable by a computer is stored. Examples of computer-readable recording media include ROM, RAM, CD-ROM, magnetic tape, floppy disk, optical data storage device, etc. Additionally, the computer-readable recording medium may be distributed across networked computer systems, and computer-readable code may be stored and executed in a distributed manner. Furthermore, functional programs, codes, and code segments for implementing the present embodiment will be easily understood by a person skilled in the art to which the present embodiment belongs.

[0213] Additionally, each block or each step illustrated in the flowcharts of this specification may represent a module, segment, or part of code comprising one or more executable instructions for executing a specified logical function(s). Furthermore, in some alternative embodiments, the functions mentioned in the blocks or steps may occur out of order. For example, two blocks or steps illustrated in succession may actually be performed substantially simultaneously, or the blocks or steps may occasionally be performed in reverse order according to the corresponding function.

[0214] The present invention described above has been explained with reference to the embodiments illustrated in the drawings, but this is merely illustrative and those skilled in the art will understand that various modifications and variations of the embodiments are possible therefrom. However, such modifications should be considered to be within the technical scope of protection of the present invention. Accordingly, the true technical scope of protection of the present invention should be determined by the technical spirit of the appended claims.

[0215] The embodiments relate to an integrated intracellular insulin management platform system and method and a computer program for the same. More specifically, the embodiments relate to a technology that calculates and predicts intracellular insulin based on a user's insulin injection information, and provides an optimal insulin management method to a user by proposing a future insulin injection plan to the user or setting it in an infusion device based on the predicted intracellular insulin.

Claims

1. As an integrated in vivo insulin management platform system, A receiving module configured to receive insulin administration information including one or more of the user's past insulin administration amounts and administration times, and to receive administration means information to be used for the user's future insulin administration, through user input or a communication connection with one or more infusion devices used to administer insulin to the user; A management module configured to calculate the user's insulin in the body based on the insulin injection information, and to generate management information including one or more of an insulin injection amount and an injection timing for continuous management of the insulin in the body based on the insulin in the body and the injection means information; and An in vivo insulin integrated management platform system comprising an output module configured to provide the above-mentioned management information to the user.

2. In Paragraph 1, The receiving module is further configured to receive the insulin injection information from a first injection device that is communically connected to the in vivo insulin integrated management platform system. The above management module is further configured to set one or more of the insulin injection amount and injection timing of a second injection device that is communically connected to the above-mentioned in vivo insulin integrated management platform system based on the above-mentioned management information.

3. In Paragraph 2, The first injection device and the second injection device are devices with different insulin injection characteristics, The above insulin administration characteristics include one or more of the type of insulin administered, the amount of insulin administered, and the insulin administration cycle, and The above management module is, The insulin in the body is calculated based on the insulin injection information by the first injection device, and An in vivo insulin integrated management platform system further configured to determine one or more of the initial amount of insulin administered by the second injection device and the initial time of administration, based on the in vivo insulin and the insulin administration characteristics of the second injection device.

4. In Paragraph 1, The above-mentioned injection means information includes information defining the injection device or drug for the user to use for insulin administration, and The above management module is an in vivo insulin integrated management platform system further configured to calculate the in vivo insulin and the management information regarding the bolus insulin or basal insulin administered by the user.

5. In Paragraph 4, The above management module is an in vivo insulin integrated management platform system 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.

6. As a method for integrated management of insulin in the body, A system for an integrated in vivo insulin management platform receives insulin administration information including one or more of the user's past insulin administration amounts and administration times, through user input or a communication connection with one or more infusion devices used to administer insulin to the user; The above-described in-body insulin integrated management platform system calculates the user's in-body insulin based on the insulin injection information; The above-mentioned in vivo insulin integrated management platform system receives information on an injection means to be used for future insulin injection by the user; The above-described in vivo insulin integrated management platform system generates management information including one or more of an insulin dosage and a timing of administration for the continuous management of the in vivo insulin, based on the in vivo insulin and the information on the administration means; and A method for integrated intestinal insulin management comprising the step of the above-described integrated intestinal insulin management platform system providing the above-described management information to the above-described user.

7. In Paragraph 6, The step of receiving the insulin injection information includes the step of the in vivo insulin integrated management platform system receiving the insulin injection information from a first injection device that is communically connected to the in vivo insulin integrated management platform system. A method for managing insulin in the body, comprising the step of providing the above-mentioned management information, wherein the above-mentioned insulin integrated management platform system automatically sets one or more of the insulin injection amount and injection timing of a second injection device that is communicably connected to the above-mentioned insulin integrated management platform system based on the above-mentioned management information.

8. In Paragraph 7, The first injection device and the second injection device are devices with different insulin injection characteristics, The above insulin administration characteristics include one or more of the type of insulin administered, the amount of insulin administered, and the insulin administration cycle, and A method for integrated in vivo insulin management comprising the step of generating the above management information, wherein the integrated in vivo insulin management platform system determines one or more of the initial amount of insulin administered by the second injection device and the initial time of administration based on the insulin administered by the first injection device and the insulin administration characteristics of the second injection device.

9. In Paragraph 8, The first injection device is an insulin pump, and The second injection device mentioned above is an insulin pen, and The step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration is: The above-described in vivo insulin integrated management platform system calculates the current residual insulin in the body at the time of switching to the second injection device based on the insulin injection information by the first injection device; and A method for managing insulin in the body, comprising the step of determining the initial amount of insulin administered by the second injection device by reflecting the residual insulin in the body at the current time, using the above-mentioned in-body insulin integrated management platform system.

10. In Paragraph 8, The first injection device is an insulin pump, and The second injection device mentioned above is an insulin pen, and The step of generating the above management information is, The above-mentioned in vivo insulin integrated management platform system receives information regarding the time of switching from the first injection device to the second injection device; and A method for managing insulin in the body, comprising the step of generating management information such that the above-described in-body insulin integrated management platform system stops insulin administration by the first injection device during a preset time interval prior to the switching point.

11. In Paragraph 8, The first injection device is an insulin pen, and The above-mentioned second infusion device is an insulin pump, and The step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration is: The above-described in vivo insulin integrated management platform system calculates the remaining insulin in the body at the current time based on the insulin injection information by the first injection device; and A method for managing insulin in the body, comprising the step of delaying the timing of insulin administration by the second injection device by reflecting the residual insulin in the body at the current time, using the above-mentioned in-body insulin integrated management platform system.

12. In Paragraph 8, The first injection device is an insulin pen, and The above-mentioned second infusion device is an insulin pump, and The step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration is: The above-described in vivo insulin integrated management platform system calculates the in vivo acting insulin at the current time based on the insulin injection information by the first injection device; and A method for managing insulin in the body, comprising the step of determining the amount of insulin administered by the second injection device based on the amount obtained by subtracting the current in vivo-acting insulin from the preset target basal-acting insulin.

13. In Paragraph 12, The above target basal-acting insulin is a value at which the sum of the acting insulin corresponding to the sustained-release insulin injected multiple times at preset time intervals by the first injection device converges, in an integrated insulin management method within the body.

14. In Paragraph 13, A method for managing insulin in an integrated body, comprising the step of determining the amount of insulin administered by the second injection device, wherein the integrated body insulin management platform system linearly increases the amount of insulin administered by the second injection device until the insulin administered in the body based on the insulin administered by the second injection device reaches the target basal-acting insulin.

15. In Paragraph 8, The first injection device is an insulin pen, and The above-mentioned second infusion device is an insulin pump, and The insulin injection information by the first injection device includes the timing of the injection of sustained-release insulin by the first injection device, and A method for managing insulin in the body, comprising the step of determining one or more of the initial amount of insulin administered by the second injection device and the initial time of administration, wherein the in vivo insulin integrated management platform system determines the time of administration of insulin administered by the second injection device based on the duration of action of the sustained-release insulin.

16. In Paragraph 8, The above-mentioned injection means information includes information defining the injection device or drug for the user to use for insulin administration, and The above-mentioned intracellular insulin and the above-mentioned management information are an integrated intracellular insulin management method calculated for bolus insulin or basal insulin administered by the user.

17. In Paragraph 16, The step of receiving the insulin injection information includes the step of the in vivo insulin integrated management platform system receiving the insulin injection information from an injection device that is communically connected to the in vivo insulin integrated management platform system. The step of providing the above management information is, The above-described in vivo insulin integrated management platform system calculates the user's current remaining insulin in the body based on the insulin injection information; and A method for integrated in vivo insulin management comprising the step of the above-mentioned integrated in vivo insulin management platform determining one or more of the dosage and timing of administration of a drug administered by the user for blood glucose control based on the above-mentioned residual insulin in the body at the current time.

18. In Paragraph 16, The above-mentioned intracellular insulin and the above-mentioned management information are an integrated intracellular insulin management method calculated for each of the bolus insulin and basal insulin administered by the user.

19. A computer program stored on a computer-readable recording medium to be combined with hardware to execute an integrated in vivo insulin management method according to any one of claims 8 to 18.

20. A method for integrated intracellular insulin management that is performed by a computing device communicating with one or more infusion devices to provide continuous management functions even when the infusion device is switched, wherein A step of receiving first insulin injection information, including the type, amount, and timing of past insulin injections of the user, through user input or a communication connection with a first injection device used to inject insulin into the user; A step of calculating the user's residual insulin in the body if the past insulin is rapid-acting based on the first insulin administration information, and calculating the user's insulin acting in the body if the past insulin is sustained-acting; A step of receiving an insulin type corresponding to a second injection device to be used for future insulin administration by the user; and A method for integrated management of insulin in the body, comprising the step of automatically setting one or more of the insulin dosage and dosage timing by the second injection device to the second injection device based on the calculated residual insulin or insulin acting in the body of the user and the type of insulin corresponding to the second injection device.

21. In Paragraph 20, The first injection device and the second injection device are devices of different types of insulin, and A step of receiving second insulin injection information, including the type, amount, and timing of injection of insulin corresponding to the second injection device, via user input or a communication connection with the second injection device; A step of calculating the user's remaining insulin or body-acting insulin based on the above second insulin injection information; A step of receiving a type of insulin corresponding to a third injection device having a different type of insulin from the second injection device, for use in future insulin administration by the user; and A method for integrated management of insulin in the body, further comprising the step of automatically setting one or more of the insulin dosage and timing by the third injection device to the third injection device based on the user's residual insulin or body-acting insulin calculated based on the second insulin injection information and the type of insulin corresponding to the third injection device.

22. In Paragraph 21, The first injection device above is an insulin pump that uses rapid-acting insulin, and The above-mentioned second injection device is an insulin pen that uses sustained-release insulin, and The above-mentioned third infusion device is an insulin pump that uses rapid-acting insulin, and The step of automatically setting the second injection device is, The method includes the step of determining one or more of the insulin dosage and the timing of administration of the second injection device based on the residual insulin in the body based on the rapid-acting insulin injected into the body by the first injection device and the first insulin dosage information. The step of automatically setting the third injection device is, A method for integrated management of insulin in the body, comprising the step of determining one or more of the insulin dosage and the timing of administration of the third injection device based on the insulin acting in the body based on the sustained-release insulin injected into the body by the second injection device and the information on the second insulin injection.

23. In Paragraph 20, The first injection device above is an insulin pen that uses sustained-release insulin, and The above-mentioned second infusion device is an insulin pump that uses rapid-acting insulin, and The step of automatically setting the second injection device includes determining one or more of the insulin dosage and the timing of administration of the second injection device based on a preset target basal action insulin. The above target basal-acting insulin is a value at which the sum of the acting insulin corresponding to the sustained-release insulin injected multiple times at preset time intervals by the first injection device converges, in an integrated insulin management method within the body.

24. In Paragraph 23, The step of determining one or more of the insulin dosage and the timing of administration of the second injection device is: A method for integrated in vivo insulin management comprising the step of determining the insulin dosage of the second injection device based on the value obtained by subtracting the current in vivo-acting insulin based on the sustained-release insulin injected into the body by the first injection device from the above target basal-acting insulin.

25. In Paragraph 23, The step of determining one or more of the insulin dosage and the timing of administration of the second injection device is: A method for integrated in vivo insulin management comprising the step of linearly increasing the amount of insulin administered by the second injection device until the in vivo-acting insulin based on rapid-acting insulin administered into the body by the second injection device reaches the target basal-acting insulin.

Images