System and method for remote prescription of drug administration regimens

Abstract

This invention provides a system and method for remote prescription of drug administration regimens. [Solution] The healthcare professional (HCP) portal user interface of the HCP system In a manner that includes presenting multiple drug administration regimens relevant to the patient. Each of the presented drug administration regimens is based on a different drug administration algorithm. It is associated with the following. The method is also via the HCP portal user interface. Receiving at least one HCP option from the presented drug administration regimen, and the patient In the mobile medical application (MMA) on the mobile device associated with the person, Send HCP selection regimen data showing at least one HCP selection drug administration regimen. This includes the act of doing something.

Description

[Technical Field]

[0001] This disclosure relates to medical devices and medical information systems, specifically the remote administration of drug regimens. This relates to systems and methods for prescription. [Background technology]

[0002] There are countless illnesses and other medical conditions for which patients seek treatment. In many cases, this treatment is , including one or more administration regimens of one or more drugs.

[0003] overview Disclosed herein are systems and methods for remote prescription of drug administration regimens. This system and method are for a wide variety of diseases and other medical conditions. Applicable to the following medications. Patients are referred to in this disclosure as healthcare professionals (HCPs). These conditions are treated. When used herein, HCP means to the patient Persons and / or entities that directly provide medical care (e.g., physicians, nurses, senior nurses) Nurses, medical assistants (PAs), and others who do not directly provide medical care to patients but provide support to patients. Persons and / or entities that indirectly support the provision of Ruscare (e.g., administrative staff) Staff, database administrators, other information technology personnel, and those involved in insurance and / or other payments. This includes both personnel and other relevant personnel. Prescription drug administration regimens and / or In the circumstances described herein, if an HCP prescribes other treatments, the HCP will issue such prescriptions. The HCP that will need to have the appropriate education, training, certifications, and licenses It is anticipated. Examples of drugs managed by the drug administration regimen in question are not limited to those mentioned above. However, insulin, insulin lispro, or insulin glargine, and other insulin-like substances. Body, insulin derivatives, glucagon, glucagon analogs, glucagon derivatives, and any One or more therapeutic agents, including therapies for which delivery by drug delivery devices is used. Is it possible, or without the assistance of a drug delivery device (e.g., orally or on the patient's skin)? It may be ingested by the patient (through application to the skin). The drug is formulated with one or more excipients. obtain.

[0004] One area of ​​application for this system and method is diabetes mellitus (sometimes also called diabetes mellitus). This is because high levels of glucose (e.g., blood glucose) persist in the human body for extended periods. This is a general term for a group of metabolic disorders generally characterized by (blood glucose, or blood glucose levels). As is known in the technical and medical fields, another term for high glucose levels is high This is a blood glucose disorder, typically characterized by a threshold of 180 milligrams (m³) per deciliter (dL). Defined as a glucose level greater than 10 g (mg / dL), per liter (L) It can also be expressed as a millimoles (mmol / L). The reverse state ( In other words, insufficient levels of glucose are known as hypoglycemia, and typically It is defined as a glucose level of 70 mg / dL (3.9 mmol / L) or less.

[0005] There are two main types of diabetes, known as type 1 diabetes and type 2 diabetes. Each of these is related to insulin in a different way, and insulin is used immediately. The glucose is either converted into energy or stored for later use. It is a hormone that is central to the body's processing of metabolic enzymes. Type 1 diabetes generally affects the patient's immune system. It is considered an autoimmune disease in which the system mistakenly attacks the insulin-producing "beta cells" of the pancreas. Type 2 diabetes is generally a condition in which the pancreas is unable to produce enough insulin for the body to meet its needs. It is characterized by either being unable to respond to insulin, or the patient's body losing its ability to respond to insulin.

[0006] One treatment for type 1 and / or type 2 diabetes is subcutaneous injection of synthetic insulin. In general, synthetic insulin has an initiation time (i.e., the speed at which they typically exert their effects). (a), peak (i.e., the typical elapsed time until maximum effect is achieved), duration ( In other words, according to many dimensions, including the amount of time the effect typically lasts, and concentration. It is classified. The typical way to express concentration is in units of milliliters (mL), For example, a concentration of 100 units per 1 mL would typically be represented as U100. cormorant.

[0007] For type 1 and / or type 2 diabetes, typically for subcutaneous injection, typically HCP Therefore, the synthetic insulin prescribed consists of two types: basal insulin and bolus insulin. There are several main categories. Basal insulin is also background insulin and It is known by many other terms, such as long-acting insulin, and is taken when fasting, sleeping, or between meals. The purpose is to maintain a specific baseline level of insulin in the patient for a given period of time. Therefore, it is administered at regular intervals and in a consistent dose, once or twice a day, generally by diabetic patients. It is ingested. Bolus insulin is also known to have many names, and is taken in food. Examples include prandial insulin, mealtime insulin, and rapid-acting insulin, and are typically taken at mealtime, although they may also be taken at other times, to control glucose spikes that are typical at mealtime but can occur at other times as well, and are most typically taken at mealtime, and even more as needed, by patients with diabetes. Although the methods and systems are surely applicable to many types of drugs for many types of diseases, conditions, etc., they are intended to at least partially assist with the management (sometimes intensive) of basal insulin and / or bolus insulin regimens by HCPs and patients with type 1 or type 2 diabetes. Indeed, some of the examples of the present disclosure generally relate to the prescription and implementation of bolus insulin administration regimens in the case of diabetes, which is an example and not a limitation and in no way excludes the present systems and methods related to other types of insulin (e.g., basal insulin) and / or administration regimens for other types of diseases. Generally, and as noted above, it should be understood that the present systems and methods are applicable to a wide variety of administration regimens for a wide variety of diseases, conditions, etc. The inventors of the present systems and methods recognize that managing the complexity of insulin therapy can be difficult not only for patients but also for HCPs. The present systems and methods differ from the implementation of conventional medical devices and medical technologies in that HCPs generally select at least one drug administration regimen (e.g., a bolus-insulin administration regimen) from a plurality of pre-determined and pre-programmed administration regimens for a particular patient.

[0008]

[0009] ​​​​​​​​​​​​​​​​ It is customized and then runs on the mobile device associated with the patient. By using a remote communication tool, we can communicate with the patient through the data network. This provides a mechanism that allows for the prescription of at least one of those regimens. This system addresses many technical issues related to conventional technology, including the technical problem of not being able to do so. According to some embodiments of the system and method, a plurality of predetermined and pre-programmed The logic of the administered regimen operates on the patient's mobile device, but the patient does not have access to It can be locked from the start to prevent this, provided using an application. It is possible. Furthermore, according to some embodiments, HCP is for its patient At least one specific HCP selection from multiple pre-programmed dosing regimens The regime can be remotely unlocked on the mobile device, and then the device The chair instructs the patient to implement at least one regimen, and in some cases This includes one or more additional medical devices (as is, or also medical devices associated with the patient). Perform at least one HCP selective dosing regimen, or part or all of it, on the device. This can be instructed. This system and method address at least its technical problems. This corresponds to a technical solution to other technical problems. Please note that this does not mean that the decision is not subject to this disclosure.

[0010] One embodiment involves an HCP portal application running on the HCP system. This method takes the form of presenting multiple drug administration regimens relevant to the patient. Each of the drug administration regimens presented is associated with a different drug administration algorithm. The method is also presented via the HCP portal user application. The method involves receiving at least one HCP selection from a drug administration regimen. Furthermore, a medical mobile application (MMA) on a mobile device associated with the patient. ) HCP selection regimen data showing at least one HCP selection drug administration regimen Including sending.

[0011] Another embodiment includes one or more communication interfaces, one or more processors, and A connected care server system including one or more servers, each containing data storage. It takes the form of. In at least some embodiments, the connected care server system is This is a Connected Care Cloud (C3) server system, where each of one or more servers is: It is a cloud server. The data storage of one or more servers is the same as the devices listed in the previous paragraph. To have a set of server system functions, including Noh, run on the Connected Care Server System This collectively includes instructions that can be executed by one or more processors on one or more servers. Yet another embodiment, when executed by one or more processors, is as listed in the previous paragraph. A set of functions, including the function, is a set of operable instructions that cause one or more processors to perform the same function. It is contained in one or more non-temporary computer-readable media (CRM). In relation to the embodiment, the CRM is any non-temporary data storage as referred to herein. The medium, and / or any other non-temporary medium that is deemed suitable for a given implementation by those skilled in the art. It may take the form of a data storage medium. For example, any suitable form of memory ( This includes both volatile and non-volatile memory, disk storage, optical storage, etc. It can be listed.

[0012] Another embodiment is an MMA that runs on a mobile device associated with the patient, Multiple drug administration regimens, each associated with a different drug administration algorithm. From among these, HCP selection regimen data that indicates HCP selection for HCP-selective drug administration regimens. It takes the form of a method that includes receiving. HCP selection is performed by HCP on an HCP system. This has been done by HCP for patients via the P portal application. Method In addition, in response to receiving the HCP selection regimen data, it was shown This includes unlocking the selected HCP drug administration regimen on the MMA.

[0013] Another embodiment takes the form of a mobile device associated with the patient. The ISS includes a mobile device communication interface, a mobile device processor, and Includes mobile device data storage. Mobile device data storage is the preceding To perform a set of MMA functions, including the functions listed below, an MM is installed on a mobile device. Includes instructions that can be executed by the mobile device processor to perform A. Another embodiment, when executed by one or more processors, is the same as the machines listed in the previous paragraph. It stores instructions that can be manipulated to cause one or more processors to perform a set of functions, including a function. It takes the form of one or more non-temporary CRMs.

[0014] Another embodiment includes the above-mentioned connected care server system and the above-mentioned mobile device It takes the form of a system including a . At least one embodiment is the above HCP system It also includes.

[0015] Another embodiment involves a processor on a mobile device associated with the patient, This involves simultaneously presenting multiple panels on the visual display of a mobile device, Multiple panels include a first panel that displays the number of units of insulin administered to the patient, and Carbohydrates expected to be supplemented by the number of insulin units displayed on the first panel The presentation includes a second panel that displays the amount of the monster, and the first panel that displays User input on a mobile device represents the required adjustments to the number of insulin units administered. To receive and request for the number of insulin units displayed on the first panel This involves updating each panel of multiple panels by the processor according to the adjustments, Updating means displaying the adjusted number of insulin units on the first panel. and adjusted carbohydrates expected to be supplemented by adjusted insulin units A method that includes updating the amount, including displaying it using a second panel. Take it.

[0016] In some embodiments, multiple panels display carbohydrates shown by a second panel. It may further include and update a panel that displays an indicator of meal size corresponding to the amount of food. This includes displaying an indicator of adjusted meal size corresponding to a controlled amount of carbohydrates. In addition, multiple panels are available between small and large meal sizes. A panel that displays an area showing the range of meal sizes, and a second panel that displays It may further include an indicator showing where the amount of carbohydrates falls within this region. In addition, multiple panels show the amount of carbohydrates shown by the second panel. Indicates whether it corresponds to a small, medium, or large meal size. It may further include panels. Or, in addition, multiple panels may be related to the first panel. The expected glucose level of the patient resulting from the administration of the number of insulin units displayed. It may further include a panel that displays a decrease in insulin, and update the adjusted insulin single Display the adjusted decrease in the patient's glucose level that is expected to result from the administration of the number of doses. This includes doing so.

[0017] In some embodiments, the method involves determining the maximum carbohydrate threshold for a moderate meal size, and the medium This may further include receiving a minimum carbohydrate threshold for a given meal size on a mobile device. The carbohydrate value displayed by the second panel is the received maximum carbohydrate threshold and Based on the minimum carbohydrate threshold, small meal size, medium meal size, or large meal size One of several panels indicates whether it corresponds to the size of the event. The method also relates to the patient. Further receiving the insulin-to-carbohydrate ratio (ICR) on a mobile device May contain, and the amount of carbohydrates shown on the second panel may be, as shown on the first panel. The processor calculates the amount based on the number of units received and the ICR received. Furthermore, patient-associated insulin effectiveness (ISF) values ​​can be received on a mobile device. This may further include the patient's glucose level as displayed by one of several panels. The decrease in insulin units and received ISF displayed by the first panel is due to the decrease in the number of insulin units and received ISF. It is calculated based on [the following].

[0018] Many variations and substitutions of the embodiments listed above are described herein. Furthermore, any modifications or substitutions described herein may be applied to any type of embodiment. Please note in particular that it can be implemented in relation to the embodiments of the method. The modifications or substitutions described primarily are those of the system and / or CRM. Such embodiments can be implemented in exactly the same way. Furthermore, such embodiments Any slight difference in wording used to describe and / or characterize (e.g., P Regardless of the process, method, steps, function, set of functions, etc., this flexibility of the embodiment Interoperability exists. [Brief explanation of the drawing]

[0019] A more detailed understanding can be gained from the following explanation, which is presented as an example along with the following drawings. Throughout the drawings, similar reference numbers in the drawings are used in relation to similar elements. . [Figure 1] The illustration shows an exemplary communication context, including an exemplary HCP system, an exemplary health information technology (IT) system, an exemplary mobile device associated with and communicating with a plurality of exemplary personal medical devices, an exemplary server system including one or more exemplary servers (e.g., connected care cloud servers) interconnected to communicate with each other via an exemplary network, and an exemplary administrator portal system, according to at least one embodiment. [Figure 2] Figure 1 illustrates an exemplary physical architecture of the exemplary HCP system according to at least one embodiment. [Figure 3]Figure 1 illustrates an exemplary physical architecture of the exemplary mobile device according to at least one embodiment. [Figure 4A] Figure 1 illustrates one exemplary physical architecture of a server in the exemplary server system according to at least one embodiment. [Figure 4B] Figure 1 illustrates an exemplary physical architecture of the exemplary administrator portal system according to at least one embodiment. [Figure 5] An exemplary functional architecture of the exemplary server system shown in Figure 1 is illustrated according to at least one embodiment. [Figure 6] The diagram illustrates various entities in an exemplary communications and processing ecosystem, according to at least one embodiment. [Figure 7] A first exemplary method, which can be performed by the server system shown in Figure 1, is illustrated according to at least one embodiment. [Figure 8] A second exemplary method is illustrated, which may be performed by the mobile device shown in Figure 1, performing an exemplary MMA according to at least one embodiment. [Figure 9] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 10] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 11] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 12] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 13]Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 14] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 15A] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 15B] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 16] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 17] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 18] Various exemplary screenshots for display via the exemplary HCP system shown in Figure 1, according to at least one embodiment, are illustrated. [Figure 19] A flowchart illustrating an exemplary process for calculating, presenting, and compiling recommended insulin doses implemented by MMA, according to at least one embodiment, is shown. [Figure 20] An exemplary screenshot from the MMA is shown, illustrating the MMA automatically synchronizing with the patient's glucose sensor, according to at least one embodiment. [Figure 21A] An exemplary screenshot from the MMA, showing the MMA receiving the patient's glucose levels, is illustrated in at least one embodiment. [Figure 21B] An exemplary screenshot from the MMA, showing the MMA receiving the patient's glucose levels, is illustrated in at least one embodiment. [Figure 21C] An exemplary screenshot from the MMA, showing the MMA receiving the patient's glucose levels, is illustrated in at least one embodiment. [Figure 22A] An exemplary screenshot from MMA, used by MMA for a daily titration dosing regimen according to at least one embodiment, is illustrated. [Figure 22B] An exemplary screenshot from MMA, used by MMA for a daily titration dosing regimen according to at least one embodiment, is illustrated. [Figure 22C] An exemplary screenshot from MMA, used by MMA for a daily titration dosing regimen according to at least one embodiment, is illustrated. [Figure 22D] An exemplary screenshot from MMA, used by MMA for a daily titration dosing regimen according to at least one embodiment, is illustrated. [Figure 23A] An exemplary screenshot from MMA, used by MMA for a fixed-dose regimen according to at least one embodiment, is illustrated. [Figure 23B] An exemplary screenshot from MMA, used by MMA for a fixed-dose regimen according to at least one embodiment, is illustrated. [Figure 23C] An exemplary screenshot from MMA, used by MMA for a fixed-dose regimen according to at least one embodiment, is illustrated. [Figure 23D] An exemplary screenshot from MMA, used by MMA for a fixed-dose regimen according to at least one embodiment, is illustrated. [Figure 24A] An exemplary screenshot from MMA is shown, used by MMA to receive carbohydrate values ​​for a carbohydrate bolus dosing regimen, according to at least one embodiment. [Figure 24B] An exemplary screenshot from MMA is shown, used by MMA to receive carbohydrate values ​​for a carbohydrate bolus dosing regimen, according to at least one embodiment. [Figure 24C] An exemplary screenshot from MMA is shown, used by MMA to receive carbohydrate values ​​for a carbohydrate bolus dosing regimen, according to at least one embodiment. [Figure 24D] An exemplary screenshot from MMA is shown, used by MMA to receive carbohydrate values ​​for a carbohydrate bolus dosing regimen, according to at least one embodiment. [Figure 25A] An exemplary screenshot from MMA is shown, used by MMA to receive the number of units of mealtime insulin for a carbohydrate bolus administration regimen, according to at least one embodiment. [Figure 25B] An exemplary screenshot from MMA is shown, used by MMA to receive the number of units of mealtime insulin for a carbohydrate bolus administration regimen, according to at least one embodiment. [Figure 25C] An exemplary screenshot from MMA is shown, used by MMA to receive the number of units of mealtime insulin for a carbohydrate bolus administration regimen, according to at least one embodiment. [Figure 25D] An exemplary screenshot from MMA is shown, used by MMA to receive the number of units of mealtime insulin for a carbohydrate bolus administration regimen, according to at least one embodiment. [Figure 26A] An exemplary screenshot from MMA is shown, used by MMA for a carbohydrate meal size-based computer dosing regimen according to at least one embodiment. [Figure 26B]An exemplary screenshot from MMA is shown, used by MMA for a carbohydrate meal size-based computer dosing regimen according to at least one embodiment. [Figure 26C] An exemplary screenshot from MMA is shown, used by MMA for a carbohydrate meal size-based computer dosing regimen according to at least one embodiment. [Figure 26D] An exemplary screenshot from MMA is shown, used by MMA for a carbohydrate meal size-based computer dosing regimen according to at least one embodiment. [Figure 27A] An exemplary screenshot from the MMA, used by the MMA to present and / or edit recommended insulin doses, is illustrated in at least one embodiment. [Figure 27B] An exemplary screenshot from the MMA, used by the MMA to present and / or edit recommended insulin doses, is illustrated in at least one embodiment. [Figure 27C] An exemplary screenshot from the MMA, used by the MMA to present and / or edit recommended insulin doses, is illustrated in at least one embodiment. [Figure 28] An exemplary user interface display having four information panels related to a presented insulin dose is illustrated, according to at least one embodiment. [Figure 29] An exemplary set of user interface displays is illustrated, showing how four information panels are updated when the presented insulin dose is adjusted, according to at least one embodiment. [Figure 30] The following illustrates an exemplary embodiment in which the user interfaces of Figures 28 and 29 are displayed on a connected drug delivery device, according to at least one embodiment. [Figure 31]A flowchart illustrating an exemplary process performed by a mobile device to display and update the user interfaces of Figures 28, 29, and 30, according to at least one embodiment, is shown.

[0020] For the purpose of facilitating understanding of the principles of this disclosure, the embodiments shown in the drawings described below are The embodiments are referred to below. The embodiments disclosed herein are not exhaustive, or this disclosure is not exhaustive. It is not intended to be limited to the exact form disclosed in the following detailed description. Rather, The embodiments are such that other persons skilled in the art can utilize the teachings. Selected and described. Therefore, they do not limit the scope of this disclosure. Unintentional.

[0021] Throughout this disclosure and the claims, the first, second, third, and other relevant provisions may apply as applicable. Numerical modifiers such as "and 4th" refer to data such as various components and various identifiers. It is used to refer to, and / or other elements. Such use refers to a specific order of elements. It is not intended to indicate or point to any specific order. Rather, this number is not intended to indicate or point to any particular order. The terminology used is intended to identify the referenced element and distinguish it from other elements for the reader. Used to support and should be interpreted narrowly as asserting any particular order. It's not.

[0022] Furthermore, before proceeding to this detailed explanation, various diagrams are illustrated and explained in relation to them. Please note that the entities and arrangements shown are presented as examples, not as limitations. I want to be able to draw a specific drawing that "illustrates" a specific element or element within that drawing. Anything that Ntiti "is" or "has," as well as any and all similar descriptions Any and all descriptions or other representations relating to (these are standalone and out of context) (which can be understood as absolute and therefore limited) means "at least one implementation form Only when phrases such as "in the manner" are interpreted as preceding it (unless that this is actually the case), It can be properly understood. Also, this is because the preceding phrase is repeated multiple times in this detailed explanation. This means that it will not be repeated, for reasons similar to the brevity and clarity of the presentation. . [Modes for carrying out the invention]

[0023] I. Exemplary Architecture A. Exemplary communication context Figure 1 shows an exemplary HCP system 102 according to at least one embodiment. Health IT system 118, associated with exemplary patient 124, and also exemplary patient 124 Multiple exemplary personal medical devices associated with this (in this figure, exemplary glucons) An exemplary motor that communicates with the meter 126 and an exemplary connected injection device 134. Mobile devices 104 can communicate with each other via an exemplary private network 138. An exemplary server system including one or more exemplary servers 140-146 that are capable of interconnecting Exemplary communication contexts, including Mu 106 and exemplary administrator portal system 148 The diagram shows the Stor 100. Also, the diagram in Figure 1 shows the data network 10. 8. Communication links 110, 112, 114, 116, 128, 136, 150, 152, and 154, the display 120 of the HCP system 102, and mobile device 1 This is display 122 of 04. Also displayed is association arrow 125, general These are the conceptual information flow arrow 130 and the conceptual information flow arrow 132, and these are both Both are explained below. The entities and arrangements illustrated in Figure 1, as well as their These interconnections are provided for illustrative purposes only, not as an extension, and may involve other entities, arrangements, etc. And the interconnections are not only considered suitable for a given context by those skilled in the art, It should be understood that this can be implemented.

[0024] The HCP system 102 (including the display 120) is, from a physical architecture perspective... As will be explained more fully below in relation to Figure 2, generally, the HCPs described herein are Any computer equipped, configured, and programmed to perform total functions It may take the form of a ping device. Some options for the HCP system 102 include Desktop computers, laptop computers, tablet computers, Mobile devices such as smartphones, or voice, augmented reality (AR) or virtual reality ( Examples include devices that interact with HCP using VR. In some embodiments, H CP system 102 is an internet browser (that is, to give just a few examples) As a standalone application, it will probably function as a separate application. Any electronic device capable of supporting and operating any web browser. As shown in Figure 1, the HCP system 102 communicates via the communication link 116 to the health The IT system 118 and the data network 108 via the communication link 110 are connected to the IT system 118 and to the data network 108 via the communication link 110. Reliably connected. Communication link 116 is separated from data network 108 and shown in the diagram. However, in some cases, all or part of Link 116 may be used in the data network. It should be understood that it may pass through at least a portion of Ku 108. The HCP system 102, instead of going directly through link 116 as shown in Figure 1, It is possible to communicate indirectly with the HIT system 118 via the data network 108. Among the typical users of the HCP system 102 are HCPs who have a prescribing role (for example) For example, physicians, medical assistants (PAs), senior nurses, etc., as well as in other cases, integrated delivery Regarding the Network (Integrated Delivery Network, IDN) This includes non-prescription HCPs who are part of the linked care team, as well as the users.

[0025] In various different embodiments, among other examples that may be enumerated herein, the HCP system 102 refers to drug administration regimens (e.g., basal insulin administration regimens, bolus insulin). Prescription of insulin administration regimens (such as insulin administration regimens), changes to existing administration regimen prescriptions. Furthermore, setting and / or changing administration regimen parameters, as well as reviewing individual patient data. Provides and supports functions such as viewing. HCP via HCP system 102 Prescription and parameter setting for the administration regimen helps patients determine their drug dosage. Among other functions, the HCP system 102 communicates with the health IT system via the communication link 116. Download patient EHR data from Stem 118 and access the EHR data in the HCP portal. Browse, view the available drug administration regimens, and select the administration regimen to prescribe to the patient. Select and choose the parameters required for the selected administration regimen (example for an insulin administration regimen). Therefore, we provide HCP with a function to assign values ​​to (starting dose, insulin-to-carbohydrate ratio, etc.). The HCP system 102 allows HCP users to view patient history data again. Further data visualization capabilities are provided to enable this. In various embodiments, this patient's historical data The data can be in chart format, graph format, tabular format, and / or implemented by a person skilled in the art. It is available for viewing in one or more other formats deemed preferable.

[0026] The mobile device 104 (including the display 122) is from the perspective of physical architecture. As will be explained more fully below in relation to Figure 3, generally speaking, the mobile devices described herein Any computer equipped, configured, and programmed to perform the functions of a device It may take the form of a mobile device. Several options for mobile device 104 and For example, mobile phones, smartphones, personal digital assistants (PDAs), and tablet computers. via laptop computers, wearable devices, voice or virtual reality Examples include mobile devices that interact with the device. As illustrated in Figure 1, mobile devices Vice 104 is connected to glucose meter 126 via communication link 128, and communication link 13 The injection device 134 is connected via 6, and the data network is connected via the communication link 112. Connected to network 108 for communication. Correspondence arrow 125 with dotted lines at both ends. As illustrated, the mobile device 104 is, for example, a subscription By counting, ownership, possession, and / or one or more other means, Patient 124 is related They can be linked together.

[0027] Regarding the C3 server system 106, this is one example from among the C3 servers 140-146. This will be explained more fully in relation to Figure 4A, from the perspective of the following physical architecture. In addition, the C3 server system 106 as a whole has a functional architecture (for example, software From the perspective of the underlying architecture, this will be explained more fully below in relation to Figure 5. However, However, generally speaking, the C3 server system 106 is a C3 server system machine as described herein. One or more systems are collectively equipped, configured, and programmed to collectively perform a function. The server may take any configuration. As shown in Figure 1, the C3 server system 1 06 is connected to the data network 108 via the communication link 114 in a communicative manner.

[0028] As shown in Figure 1, each C3 server 140 in the C3 server system 106 Each of the ~146 has its own respective communication link 11 with the data network 108. It may have 4, or, instead, a single communication link 114 may be C3 server systems are accessed via firewalls, network access servers (NAS), etc. Please note that Tem 106 may be connected to the data network 108 in a way that allows communication. To clarify the presentation, one or more communication links 114 are described in the remainder of this disclosure as " It is called "communication link 114". Furthermore, as shown in Figure 1, each C3 The members 140-146 can communicate with each other via the private network 138. Connected, private networks are local area networks (LANs), virtual Suitable for a given implementation by a private network (VPN) and / or by a person skilled in the art. It may take the form of one or more other options that are considered to be, or may include these. In one embodiment, the illustrated network 138 is as shown in the illustration. They do not exist as separate networks, and in such embodiments, each C3 server 1 Units 40-146 communicate with each other via their links to data network 108. Regarding the communication connection between the C3 server system 106 and the administrator portal system 148. This will be discussed below.

[0029] In general, the C3 server system 106 is the HCP system 102, the Health IT System Entities such as TEM 118 and mobile device 104 (and specifically Mo One or more applications, such as MMA, run on the mobile device 104 Regarding (i), it functions as "cloud" as a term used in the relevant technical field. In some embodiments, a subset of C3 servers 140-146 are HCP system 10 2 (For example, providing the HCP portal application 572 which is described in detail below) (for this purpose), at least of the health IT system 118 and mobile device 104 It may be dedicated to providing one. However, in some embodiments, C3 Each of servers 140-146 will play the role of one of these three entities. It may be possible to achieve this. Regardless of the specific architecture implementation, C3 server system Tem106 has at least one cloud with a specific purpose for those entities and Therefore, in at least one embodiment, the C3 server system 106 and All communication with any one or more other entities is secure communication, for example, Such communications can be encrypted and / or signed as is known in the art. Such communications may be considered suitable for various contexts by those skilled in the art. Among other communication security and data security options that can be implemented, This can occur inside tunnels such as VPNs.

[0030] In various different embodiments, and as will be further described below, the C3 server system M106 operates on the HCP system 102 and on a mobile device associated with the patient. Information and data between MMA (e.g., related to prescriptions), data storage, Managing the relationship between patients and HCPs, ensuring safe and reliable transfers such as IDNs, etc. Provides and supports the functionality of the affected entity and possibly other entities. In some embodiments, instead or in addition, which are considered suitable for a given implementation by those skilled in the art It provides and supports one or more other functions that are performed. Furthermore, in some embodiments The C3 server system 106 handles data sharing involving payers (e.g., insurance companies). To facilitate, in some such embodiments, such data with the payer entity Data sharing is contingent on the associated patient choosing to allow such communication. Other examples of the features provided and supported are similarly listed herein. It is possible.

[0031] The administrator portal system 148, from a physical architecture perspective, is related to Figure 4B. The administrator portal system functions described herein are generally as follows, although they will be explained in more detail below. Any computing device equipped, configured, and programmed to perform It may take the form of a s. Several options for the administrator portal system 148 For example, desktop computers, laptop computers, and tablet computers. Examples include workstations, etc. As shown in Figure 1, at least one actual In this configuration, the administrator portal system 148 is accessed via the communication link 150 (specifically In the illustrated example, the C3 server system is accessed via private network 138. It can be operated to communicate with M106. In other embodiments, as also illustrated in Figure 1 The administrator portal system 148 then connects to the HCP system via the data network 108. M102 communicates with mobile device 104 and / or C3 server system 106. It is operable in such a way. Also, in some embodiments, the administrator portal system 14 8 can be operated to do both.

[0032] In general, in various different embodiments, the administrator portal system 148 is HC P portal 102, MMA running on mobile device 104, and / or C3 We provide various services related to server system 106. One example of such services is... The categories relate to user management, login, access levels, etc. In at least one embodiment, a user with sufficient permission accesses the administrator portal system 14 Using 8, the MMA is run on the HCP portal 102 and the mobile device 104. and / or change and / or manage various settings of the C3 server system 106. This is possible. In some cases, changes made via the administrator portal system 148 are, It only affects a single MMA, a single user, a single HCP, etc., and in other cases, Such changes can affect multiple MMAs, multiple user accounts, multiple HCPs, etc. For example, an Integrated Delivery Network (IDN) (for example, a healthcare organization's network). ) provides an administrator portal system 148 for managing patient accounts registered with the IDN. It may be provided. In some embodiments, the administrator portal system 148 updates, It is possible to operate it to deploy upgrades, etc. In some embodiments, administrator Portal system 148 manages individual HCP accounts, individual patient accounts, etc. It is possible to operate it in this way. Additionally, the administrator portal system 148 can be used. Indeed, numerous other exemplary management functions can be listed herein.

[0033] In the illustrative scenario shown in Figure 1, the data network 108 is a communication link 110 The HCP system 102 is connected via the communication link 112, and the mobile device 104 is connected via the communication link 112. via communication link 114 to the C3 server system 106, and via communication link 152 It is then connected to the administrator portal system 148 in a communicative manner. In this scenario, the data network 108 is typically the internet and widespread A global network of networks, one or more public IP networks A network, one or more private (e.g., corporate) IP networks, and / or the same business One or more other types of IP networks that are deemed suitable for a given implementation by the person concerned. One or more Internet Protocol (IP) networks, such as a work network, are listed. Entities that communicate via data network 108 have an IP address ( For example, it can be identified by an address such as an IPv4 address or an IPv6 address. However, this is just an example, so data network 108 is an IP network It does not need to be a work environment or involve an IP network.

[0034] As used herein, “communication link” means one or more wired communications (for example, Ethernet, Universal Serial Bus (USB), and / or other links, and / or 1 Examples include more than one wireless communication method (e.g., cellular, Wi-Fi, Bluetooth, etc.). It also includes any suitable relay devices such as routers, switches, and bridges. Specifically, communication link 112 enables bidirectional data communication with mobile device 104. To facilitate this, it may include at least one wireless communication link. Furthermore, communication link 1 Either or both of 28 and 136 are Near Field Communication (NFC) links, Blue Tooth link, Radio Frequency Identification (RFID) link, Direct Radio Frequency (RF) link , and / or at least one form of one or more other types of wireless communication links It may take or at least include these. Furthermore, communication links 128 and 136 (i) mobile device 104 and (ii) glucose meter 126 and connection It may be a point-to-point link between the injected device 134 and the other device, but the need In some embodiments, one or both of the communication links 128 and 136 are used. For example, if you have a Wi-Fi or ZigBee router, or a cellular network... This is an indirect link via a tower (not shown). Similarly, other implementation examples are also indeed These may be listed herein.

[0035] In the illustrative scenario shown in Figure 1, the health IT system 118 is connected to communication link 11 It is connected to the HCP system 102 via 6 in a communicative manner, and generally takes the form of one or more servers. It is acceptable to take this stance. The health IT system 118 has its own monitor display, keyboard The code, mouse, touchscreen, or other user interface itself It may or may not have a local user interface. In various different embodiments The health IT system 118 is optional, presumably by those skilled in the art. Among other functions considered suitable for the system, there is the patient's electronic health record (EHR - electronic in the industry). Secure maintenance, secure storage, and secure access to medical records (also known as EMRs). It provides and supports the following. Furthermore, the health IT system 118 communicates via the communication link 154. The data network 108 is then connected to it for communication. The health IT system 118 also It can communicate with the C3 server system 106 via the data network 108. In some embodiments, the health IT system 118 is, for example, Fast Heal Healthcare Interoperability Resources (FHIR) Rotcor, or Substitutable Medical Application ns and Reusable Technologies (SMART) protocol C3 server systems 106 and / or HC, via standardized protocols such as these. Connect to the P system 102 via an interface.

[0036] In the exemplary scenario described herein, patient 124 is associated with HCP system 102. Diabetes has been diagnosed and is being treated based on the assigned HCP, but this is purely an example. This is and is not limited to the embodiments described. In the embodiments described, the mobile device 104 (and mobile A device with at least one MMA operating on it, a glucose meter 126, and a connection Both of the injected injection devices 134 are connected to each other in at least that manner to each patient 124. The above association arrow 125 indicates the relationship between patient 124 and mobile device 104. It is intended to represent general associations and user interface-level interactions.

[0037] Figure 1 shows the mobile device 104 connected to the glucose meter 126 and the injection device. Although shown connected to both sides of the vice 134, in some cases the glucose meter 12 Only one of the 6 and the connected injection device 134 exists in various different scenarios. It should be noted that both are possible and not necessarily required. In fact, patients can be separately manually Systems that need to measure glucose levels and / or record dosage information In the case of mu, or when the drug is taken orally, one or more levels, conditions, or This is for situations where a device is not needed to monitor or test other parameters. In one scenario, additional medical devices connected to the mobile device 104 are also connected. It does not contain. In some cases, the patient may have two or more glucose meters and / or two The above connected injection devices may be connected to the MMA, for example, a patient may have one at home A glucose meter and / or injection device, as well as one glucose meter in the workplace It may have a faucet and / or injection device. Each MMA supports multiple connections. It can be configured to do so. Furthermore, in some cases, a glucose meter and / Alternatively, there may be one or more connected medical devices other than the connected injection device. Some examples include blood pressure monitors and pulse / oxygen monitors. Also, there are certainly many Other examples can be listed herein.

[0038] The glucose meter 126 is associated with patient 124 for medical, diabetes treatment purposes, and The mobile device 104 is connected to the communication link 128 described above. As for glucose meters 126, blood glucose meters (BGM), continuous glucose meters ( (Continuous glucose monitoring (CGM), flash glucose meter (FGM), or patient blood glucose meter (FGM) or other devices that measure glucose levels from other sources (e.g., contact lens debits) Examples include a vice or a device that measures glucose levels using near-IR radiation. This can be done. The background music is (for example, when pricking the patient's finger and examining the patient's capillaries and whole blood glucose levels). By performing Bell's spot measurement, individual spot measurements of the patient's blood glucose level are taken. Measurement is performed. Both CGM and FGM use sensors to measure glucose in the interstitial fluid. The CGM system may include sensors, transmitters, and receivers / apps. This involves more frequent (i.e., more continuous) measurements of the patient's interstitial fluid glucose levels. It is possible, and optionally, for a relatively long period of time (e.g., several hours or several days at a time), the patient It can be continuously attached by the user. One example of such a CGM is Dexcom, Inc. This is a G6 sensor manufactured by [company name]. The FGM system is attached to a part of the patient's body. The inserted sensor, and when activated, or when placed near the sensor, the sensor A reader that receives glucose level readings from (for example, a handheld reader) ) may include. One example of such FGM is Abbott Diabetes Care This is a FreeStyle Libre device manufactured by Inc. In that embodiment, the FGM does not require a finger-prick test. Also, certainly 1 Other types of glucose meters may also be included.

[0039] CGM and FGM systems can measure interstitial fluid glucose levels, The GM system can measure blood glucose levels. It is concise and easy to read. For the purposes of this disclosure, the remainder of this disclosure refers simply to “glucose” levels, or “GL” Such references may be used to measure blood glucose or interstitial fluid glucose as needed. It is understood that it could refer to any of the following.

[0040] The connected injection device 134 is also associated with the patient 124 for medical and diabetes treatment purposes. The device is then connected to the mobile device 104 via the above communication link 136, enabling communication between the two devices. The device 134 may further contain a drug or pharmaceutical. In some embodiments, The stem may include one or more devices, including device 134, and a drug or medication. The terms “drug” or “medicine” are not limited to, but include insulin, insulin risprud. Insulin analogs such as insulin glargine, insulin derivatives, and glucagon , glucagon analogs, glucagon derivatives, and other substances that can be delivered by the above device Refers to one or more therapeutic drugs, including the therapeutic drug of choice. Drugs used in device 134 Alternatively, the drug may be formulated with one or more excipients. The device is generally described herein. As described above, the drug is administered to a person in a manner that is controlled by the patient, caregiver, or healthcare worker. To be created.

[0041] In at least one embodiment, the connected injection device 134 is connected to the injection device Phosphate delivery devices and what are sometimes referred to in the art (e.g., injected insulin) Integrated and / or mounted for automatically detecting the amount and reporting it to another electronic device It is an insulin pen (such as a pen with an electronic device that can be used) or has a small This includes, however. In various different embodiments, the connected injection device 134 is, each Any of the following patent applications, each incorporated herein in its entirety by reference It takes one or more forms of the insulin delivery devices described above, or includes them. . • Application filed on December 8, 2017, for Medication Delivery Devi PCT application No. PCT / US1 titled "ce with Sensing System" Case No. 7 / 65251 (Attorney Reference Number X21353), • Application filed on February 22, 2018, for Dose Detection and Drug Identification for a Medication Delivery PCT application No. PCT / US18 / 19156, titled Device (Attorney's Office) (No. X21457), and • Application filed on August 31, 2017, for Dose Detection with Piez oelectric Sensing for a Medication Deliv U.S. Provisional Patent Application No. 62 / 552,659, titled "ery Device" (arranged by attorneys) (Number P21462).

[0042] Furthermore, in some cases, one of the functions of these two devices of this disclosure One or more of those two devices, and / or one or more additional devices It is either a single device or is supplemented by them instead. For example, a single device is a group Monitoring (and reporting) insulin levels, and injecting (and injecting) insulin. It can also report the amount used. It can be listed in writing.

[0043] Furthermore, as will be described below, in some embodiments, the mobile device 1 MMA executed on 04 is for various reasons (e.g., sending administration commands, dose confirmation reports). Receiving notifications, requests for readings (e.g., glucose), receiving one or more measurements, etc. For example, a glucose meter 126 and a connected injection device 134 It communicates with one or more connected medical devices. Such communication is with a given device. It can be directional or bidirectional. Transmission from a connected medical device to the MMA. Examples of additional information that can be added include error codes, device metrics, dosage records, and This could include and / or administration confirmation. And certainly other examples could be listed herein. It is possible. Furthermore, in some cases, the glucose meter 126 and the connected injection device 1 Direct communication links exist between various connected medical devices, such as between device 34 and other devices.

[0044] The conceptual information flow arrow 130 is explained more fully below, among other pieces of information. Therefore, the HCP system 102 directly connects to the C3 server via the data network 108. via system 106, or some other intermediate component or network via any of the following methods, HCP selective drug administration regimens (e.g., bolus administration regimens) ) Sending the prescription to the MMA running on the mobile device 104, as shown in the diagram. This means to illustrate conceptually. Similarly, the conceptual information flow arrow 132 is other Among the information, as will be explained more fully below, it runs on mobile device 104 The MMA is administered either directly or via the C3 server system 106 to the patient's glucose Regarding urinary tract diseases and / or one or more other health-related conditions, topics, etc., according to the patient. The concept of transmitting health data that is tracked and shared by patients is conceptually illustrated in the diagram. It means to illustrate.

[0045] In general, in at least one embodiment, the HCP system 102, the health IT system The system 118, mobile device 104 (including MMA running on the mobile device) ), including C3 server system 106 and administrator portal system 148, but these Any of the entities described herein, without limitation, may be one or more other entities Without needing to route that communication through Titi, those entities It should be understood that it is possible to communicate with any other of the others. For example. In at least one embodiment, the HCP system 102 and the mobile device 104 This allows for the exchange of information without requiring the information to pass through the C3 server system 106. It is possible. However, in some embodiments, one or more entities are less They communicate with each other through at least one additional entity, for example, at least one In this embodiment, the data (e.g., HCP selection regimen data) is sent to the HCP system 10 From 2, MM is executed on the mobile device 104 via the C3 server system 106. The message is sent to A.

[0046] B. Exemplary HCP System (Exemplary Physical Architecture) Figure 2 shows an exemplary physical arc of the HCP system 102 according to at least one embodiment. The architecture is illustrated. Other architectures deemed preferable by those skilled in the art are also implemented. Therefore, this architecture is provided as an example, not an exhaustive one. Figure 2 As shown in the figure, the HCP system 102 has a communication interface 202, a processor User interface including the 204, data storage 206, and the aforementioned display 120 Includes Turface 208.

[0047] The communication interface 202 is a combination of one or more devices, such as an Ethernet card for wired communication. Component, and / or one or more components such as a Wi-Fi chip for wireless communication It may include a NENT. Processor 204 is a general-purpose microphone such as a central processing unit (CPU). It could be a processor. Data storage 206 is memory (for example, read-only memory). ROM (Random Access Memory), RAM (Random Access Memory), Flash Memory, Solid State Memory Any suitable non-temporary computer-readable medium (C) such as a tether drive, optical memory, etc. RM) may be, or may include, at least the HCP porters described herein. This may include instructions that can be executed by the processor 204 to perform system functions. The user interface 208 includes a speaker, indicator, and display 120. It may include one or more output devices such as LEDs, and as known in the art, key Add one or more input devices such as a board, mouse, trackpad, and microphone. This may include various components of the HCP system 102 via the system bus 210. It is illustrated as being interconnected in a way that enables communication.

[0048] Furthermore, in at least one embodiment of the system and method, the HCP system 10 2 is (illustrated in Figure 5, and also referred to herein as "HCP Portal Application 572") It should be understood that the HCP Portal 572 (also known as) is operational or implemented. The HCP Portal 572 is software that runs on the hardware of the HCP System 102. This could be a wearable or firmware application. For example, HCP Portal 57 2 takes the form of a widget that runs within the HCP's electronic health record (EHR) system. It is acceptable to do so. Such widgets are FHIR (Fast Healthcare). SMART(Substance) on Interoperability Resources Itutable Medical Apps, Reusable Technolog It can be integrated with HCP's EHR system using protocols such as y). In some embodiments, the HCP portal 572 is a web browser that operates within a web browser. It may take the form of an application. In an exemplary example, HCP is HCP System 10 2. By pointing your web browser to the hyperlink, you can access the HCP Portal 57. Log in to 2, and then the HCP portal 572 will open in your browser. In an embodiment like this, the HCP portal content within the HCP portal 572 is C3 It is hosted by the HCP system 106. Therefore, in some examples, the HCP system Tem102 handles patient data (e.g., patient medical records, administration regimen data, etc.) And or not store at all, instead, the HCP user and C3 server system 106 It serves merely as a means of transmitting such patient data between them. Some such implementations In terms of form, the web browser itself (for example, Microsoft Edge, Google Code for Chrome, Apple Safari, etc., and similarly probably web apps Data stored locally in the form of application code (e.g., Java) add-ons. There is also operable code and which can be considered suitable for a given implementation by those skilled in the art. / Other variations relating to the centralized and / or distributed nature of other substantial data The following can certainly be listed herein.

[0049] C. Exemplary mobile device (exemplary physical architecture) Figure 3 shows an exemplary physical representation of the mobile device 104 according to at least one embodiment. —The architecture is illustrated. As can be understood by examining it, Figure 3 is many The method is the same as in Figure 2, and therefore is not described in detail in this specification. However, However, since mobile device 104 is a mobile device, a person skilled in the art can distinguish between the corresponding differences. However, wireless wide-area network (WWAN) communication (e.g., via LTE) and wireless Local Area Network (WLAN) communication (e.g., via Wi-Fi), and N Both have additional wireless communication capabilities such as FC, Bluetooth, RFID, and RF. A communication interface 302 is likely equipped, programmed, and configured for use by the user. You will understand that it can be present in each of the components. Furthermore, Processor 3 In at least one embodiment, 04 is selected to be suitable for implementation in a mobile device. Selected, data storage 306 performs the MMA described herein, but not limited to. A processor 3 that performs at least the mobile device functions described herein, including the above. Includes instructions that can be executed by 04. Finally, in addition to display 122, user input Surface 308 is suitable for the installation of mobile devices and has one or more user inputs and / or user output components (e.g., touchscreen, stylus, pointy) Clicking and clicking devices, soft keys, keyboards, microphones, speakers, cameras, etc. This includes various components of the mobile device (such as a data port). They are shown interconnected and able to communicate via bus 310.

[0050] D. Exemplary C3 server (exemplary physical architecture) Figure 4A shows the C3 server of the C3 server system 106 according to at least one embodiment. An example of C3 server 140, selected as one of the examples from 140 to 146. The architecture is illustrated. As shown above, the C3 server system 106 is one It may take the form of any number of servers, including and including two or more. In Figure 1, the The four C3 servers 140-146, which have an ellipsis between 3 and 4, have this numerical flexibility. It is intended to show gender. Also, so that it can be understood, Figure 4A is similar in many ways to Figure 2. Both are similar to Figure 3 and are therefore not described in detail herein.

[0051] In most scenarios, the architecture of the C3 server 140 is such that various There is no reason other than the performance level and data processing capabilities that the architecture allows. In this case, typically, the architecture of the mobile device 104 is superior to that of the HCP system 10 It would be similar to architecture 2. However, compared to HCP system 102 Even when comparing, in at least one embodiment there is a difference in the architecture of the C3 server 140. Yes. For data security reasons, communication interface 402 is wired communication hardware. It may include only hardware (e.g., an Ethernet card) and compared to the HCP system 102. This may include more data communication interfaces.

[0052] Similarly, the processor 404 and data storage 406 are typically HCP systems. It has more communication, storage, and data processing capabilities than would typically be required for the TEM102. Which will be selected to process? Data storage 406 will at least this item Instructions executable by processor 404 for performing the C3 server functions described in the document. This includes. Finally, the user interface 408 is present in all embodiments. It is illustrated with a dashed line to show that this is not the case. For example, in some cases, C3 The 140 can access users via data connections such as remote desktop connections and shell connections. Accessible only in the form of The Interface. Various C3 Server 140 The components are shown as interconnected and able to communicate via the system bus 410. It is shown.

[0053] As described herein, in at least one embodiment, the C3 server system 1 06 is the C3 server system, and the C3 server system functions described herein. To run various combinations, one or more C3 servers 140-146 It collectively includes instructions that can be executed by one or more processors. See Figure 7 below for details. Method 700 is one such exemplary combination. In fact, at least 1 In one embodiment, the logic for implementing the C3 server system 106 is a plurality of physical servers It is distributed throughout the entire network. In at least one embodiment, it contains specific access requests, etc. Hardware used to simplify (e.g., data storage, processor functions, Web servers, switches, routers, communication links, etc., can handle different access requests through hardware. It is dynamically provisioned so that different sets of ware can be easily configured. The hardware is designed to handle the geographical location of the requests, load balancing, required quality of service (QoS), and service Based on various factors such as the agreement parameters, dynamic processing is performed for specific access requests. It can be redefined. Then, the C3 server system can be defined as the term in the relevant technical field. It can be thought of as the "cloud" used in [the context of the internet], and this cloud brings together virtual services. Includes a distributed network of servers that operate collectively and dynamically. At least one embodiment Therefore, each such virtual service is a self-contained software process of its own. Furthermore, a specific hardware server that actually executes a given case of a given virtual service. (or multiple servers) may be turned on depending on one or more factors, such as those mentioned in this paragraph. It is dynamically allocated by TheFly.

[0054] E. Exemplary Administrator Portal System (Exemplary Physical Architecture) Figure 4B shows an exemplary administrator portal system 148 according to at least one embodiment. The physical architecture is illustrated in Figure 4, which can be understood by verification. B is similar in many ways to each of Figures 2, 3, and 4A, and therefore this specification The document does not explain in detail. As mentioned above, for the administrator portal system 148 Some of the options include desktop computers, laptop computers, and tablets. Examples include red-light computers and workstations. Administrator portal system 1 48 is suitable for performing at least the administrator portal system functions described herein. The form of any one or more computing devices equipped, programmed, and configured It is acceptable to take this stance. As shown in Figure 4B, the administrator portal system 148 communicates Interface 452, processor 454, administrator porter as specified herein Data containing instructions executable by processor 454 for performing system functions This includes storage 456 and user interface 458, all of which are, They are connected to each other via Stembus 460, enabling communication between them.

[0055] Furthermore, in at least some embodiments, the administrator is also present in the HCP system 102. The portal system 148 operates an administrator portal application (not shown) or It should be understood that implementation is necessary. The administrator portal application is for administrators. Software or firmware that runs on the hardware of the Tal system 148 may be an application. For example, the administrator portal application may be in the form of a web application that operates within a web browser. An administrator or user can log in to the administrator portal application by pointing a web browser on the administrator portal system to a hyperlink, and then the administrator portal a pplication will open in the browser. In such an embodiment, the content within the administrator portal application may be hosted by the C3 server system 106, and patient data (e.g., patient medical records, dosing regimen data, etc.) may be stored locally on the administrator portal system 14 8 little or not at all. Instead, the administrator portal system 14 8 functions as merely a means of transmitting patient data between that administrator / user and the C3 server system 106. (For example, patient medical records, dosing regimen data, etc.) Instead, the administrator portal system 14 8 functions as merely a means of transmitting patient data between that administrator / user and the C3 server system 106. Instead, the administrator portal system 148 functions as merely a means of transmitting patient data between that administrator / user and the C3 server system 106.

[0056] <了 F. Exemplary C3 Server System (Exemplary Functional Architecture) Figure 5 illustrates an exemplary functional architecture of the C3 server system 106 according to at least one embodiment. This functional architecture is provided by way of example and not limitation, and it should be understood that other functional architectures may be implemented as deemed suitable by those skilled in the art in various different contexts. The functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are Figure 5 illustrates an exemplary functional architecture of the C3 server system 106 according to at least one embodiment. This functional architecture is provided by way of example and not limitation, and it should be understood that other functional architectures may be implemented as deemed suitable by those skilled in the art in various different contexts. The functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are illustrated as being suitable by those skilled in the art for various different contexts. It should be understood that the functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are illustrated as being suitable by those skilled in the art for various different contexts. It should be understood that the functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are illustrated as being suitable by those skilled in the art for various different contexts. It should be understood that the functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are illustrated as being suitable by those skilled in the art for various different contexts. It should be understood that the functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are<了 illustrated as being suitable by those skilled in the art for various different contexts. It should be understood that the functional architecture of the C3 server system 106, including each of various data stores, services, gateways, links, and interfaces, may be implemented in hardware, firmware, and / or software (the firmware and / or software are It can be implemented using any combination of (operating on hardware). Also note that in addition to the C3 server system 106, an entity is also associated with the architecture shown in FIG. 5. This is made clear by the left curly brace labeled " 106" of the C3 server system 106, and components outside the left curly brace are associated with the entity in addition to the C3 server system 106.

[0057] As can be understood from FIG. 5, the architecture 500 includes four of what are known in computing and programming technologies as "layers" separated by an "interface", which, among other advantages, are logical structures that facilitate the encapsulation and manageability of complex systems. The architecture 500 includes a data layer 50 2, an internal web service (IWS) layer 504, an external-facing service (EFS) layer 506, and an application layer 508. The data layer 502 is separated from the IWS layer 504 by a data IWS interface 503, the IWS layer is separated from the EFS layer 506 by an IWS-EFS interface 505, and the EFS layer is separated from the application layer 508 by an EFS application interface 507. Further, interface 509 represents the logical part of the architecture 500 through which a user will interact with the entire system, specifically with the application layer 508 directly. In other words, note that interface 509 is often what is referred to in the art as a "man-machine interface".

[0058] In the illustrated embodiment, the data layer 502 has multiple data stores 510a to e Includes. Each data store 510a-e includes the microservices 514, 51 as described herein. Corresponds to one of 6, 518, 520, and / or 522. Datastore 51 0a-e are personal identification information such as name, address, telephone number, email address, and social security number. Includes patient and / or medical data, including PII information. Datastore 5 10a-e also cover PII, including treatment, definition, and administration regimens (i.e., templates). Other information may be aggregated. In at least one embodiment, the data layer 502 is A subsidiary of Amazon.com, Inc. (Seattle, Washington) On-Demand, operated and provided by Amazon Web Services It will be implemented using cloud computing platforms and services. In at least one other embodiment, the data layer 502 is Heroku (San Fra PostgreSQL products developed by Cisco (California) It is implemented using this method. And indeed, other options can also be enumerated herein. In at least one embodiment, the data layer 502 is Health Level S even International(HL7)(Ann Arbor,Michig) It is organized according to the FHIR standards presented by an).

[0059] IWS layer 504 contains multiple microservices 514, 516, 518, 520, and Includes 522. The abbreviation between service 520 and service 522 is known to those skilled in the art. Any number of services that are considered suitable for the given implementation may exist in IWS layer 504. This means that each microservice handles a specific type of data or It is a data gateway implemented as a software service responsible for processing functions. An example of a microservice is a PII related to registered or future patients. A "personal" microservice for processing data related to prescription orders. A "order" microservice, entered by HCP or mobile device To process data related to patient observations observed by MMA performed above The "Observation" microservice processes data related to user access rights and permissions. For "user access" microservices, users' mobile devices can access the C3 system. "Client compatibility" to ensure compatibility with the features provided by 106. "Sexual" microservices, as well as the types of drugs processed by / or administered to patients. Examples include "material" microservices for processing data related to each micro Services 514-522 connect to one data station via the corresponding communication links 511a-e. You can access A510a~e.

[0060] Each internal service 514-522 is, in at least one embodiment, a data store 51 Access to data stored in 0a~e, including read and write access. Seth, in the manner defined and permitted by each internal service 514-522, It is only available for various gateways 524-530 of the EFS layer 506. Designed. In at least one embodiment, the IWS layer 504 is Amazon Web It is implemented using Services. In another embodiment, the IWS layer 504 may also be implemented using the Heroku Platform developed by Heroku . Also, surely other options can be similarly enumerated herein.

[0061] The "link" described in relation to FIG. 5 represents a logical access link and need not be a physical communication link. It should be further noted that in at least the described embodiments, appropriate configurations, authorizations, authentications, permissions, etc. are arranged to facilitate communication between corresponding entities. The logical access links present in FIG. 5 are, in at least the described embodiments, such that appropriate configurations, authorizations, authentications, permissions, etc. are arranged to facilitate communication between corresponding entities. It should be further noted that in at least the described embodiments, appropriate configurations, authorizations, authentications, permissions, etc. are arranged to facilitate communication between corresponding entities.

[0062] The EFS layer 506 includes the HCP portal gateway 524, MMA gateway 526, MMA gateway 528, and management gateway 530. Further, the ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one The ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one The ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one The ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one The ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one The ellipsis between MMA gateways 526 and 528 indicates that any suitable number of MMA gateways can be implemented. The ellipsis between mobile devices 104 and 532 within the application layer 508 means the same. Each MMA gateway corresponds to a specific type or version of MMA. Implementing a dedicated MMA gateway instance for each type or version of MMA is a design choice and others are possible. In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one In this illustrated embodiment, it can be understood that any of the gateways in the EFS layer 506 can call any of the internal services 514 - 522 as needed, as shown by the illustration of the system bus of the IWS - EFS interface 505 as a whole. At least one In this embodiment, access to the internal services 514-522 of the IWS layer 502 is provided for each In the manner defined and permitted by gateways 524-530, the application Each gate in EFS layer 506 is available only to entities in layer 508. Ways 524-530 are designed. For example, in one embodiment, on the HCP system 102 The HCP portal 572 being executed is accessed through the HCP portal gateway 524, which provides internal access. Services 514-522 can be accessed, and similarly on mobile devices 104. The MMA568 that is executed will access internal services 514-5 through the MMA gateway 526. Access to 22 is possible. In at least one embodiment, the EFS layer 506 is It will be implemented using Amazon Web Services. In this embodiment, the EFS layer is implemented using the Heroku Platform. Indeed, other options can also be similarly listed herein.

[0063] Application layer 508 is Health Information Techno HCP system running logy User Interface (HIT UI) 574 This includes Tem 102, which in turn runs HCP Portal 572. The 508 layer is the above mobile device (which runs MMA568 in accordance with this disclosure). 104, (Another type or version illustrated as MMA570 in accordance with this disclosure) A second mobile device 532 (which performs MMA), a management portal 534, and management It further includes portal 536. Similar to the ellipse mentioned above, it includes mobile device 104 and mobile The ellipsis between device 532 and any suitable number of mobile devices is used for the application. This means that it can exist in layer 508. Furthermore, a single MMA gate Each way (for example, MMA Gateway 526) is of the same type or version as the MM It can be connected to multiple mobile devices running A (e.g., MMA568). The ellipsis between management portal 534 and management portal 536 is any preferred number of systems A system administrator-level portal is considered suitable for a given context by those skilled in the art. This means that it can be implemented in such a way. In one embodiment, the management portal 53 4 is configured for the management of the C3 server system 106 in relation to clinical aspects. 3. Management Server. In one embodiment, the management portal 536 is located on the manufacturing-support side. In connection with the management of the C3 server system 106, the manufacturing-support C3 management system is configured for this purpose. It is a ba. And certainly other examples can be listed herein. At least one In this embodiment, either or both of the management portals 534 and 536 are managed This is a process that runs on the Administrator Portal System 148. Furthermore, it is also available on the HCP Portal. Related abbreviations or additional HCP portals are not shown in Figure 5, but may be used at any time. It is also true that an appropriate number of HCP portals can be implemented within a given context.

[0064] HCP System 102 is a Health Information Tech system for HCP. The Nology User Interface (HIT UI) 574 is provided. Yes, it is possible. In some embodiments, HIT UI574 stores HCP in HIT118. To view, edit, create, or interact with patient or non-patient data and records. Enables web applications, shells, or other suitable user interfaces. It is possible. In fact, HIT UI574 is an HCP command, HIT UI574 The HCP Portal 572 can be launched as a separate user interface within the system. Exemplary screenshots of the HCP Portal 572 are provided as part of Figures 9-18. As previously stated herein, the HCP portal 572 is where HCP is a C3 server. This enables access to or provision of patient data to and from system 106. It may take the form of a web application that runs within a web browser. In some embodiments, the HCP portal 572 also interacts with the HIT118. - Face-to-face interaction and access to or provision of patient data with HIT118. This allows the HCP to view the records of a specific patient within the HIT UI574. Launch HCP Portal 572 by clicking a button or key while doing so. Prescribe drug administration regimens, review the patient's observed or recorded administration history, and use this specification. You can access other features of the HCP portal described.

[0065] In some embodiments, the HIT UI 574 and the HCP portal 572 are both This may also be provided by the same vendor. In other embodiments, HIT UI574 is the first The HCP Portal 572 may be provided by a second vendor. It is possible. HCP Portal 572 uses industry standards such as SMART on FHIR as mentioned above. This method allows integration with HIT UI574. By integrating, HCP will no longer need to manually enter data through Portal 572. This allows access to patient data from HIT118 and returns to HIT UI574. Without needing to do so, the HCP will select an appropriate administration regimen based on medications, medical history, test results, and past blood tests. This makes it possible to re-view important patient data such as blood glucose records and insulin dosage information. In some cases, the HCP Portal 572 also provides demographic data relevant to specific patients. A minimum set of data (e.g., patient name, date of birth, patient-specific identifier, or patient's EHR) Extract a unique identifier from HIT118 and use this demographic data for banners or other purposes. It can also be configured to display in the area where it is shown to stand upright. This is because HCP is positive This can be helpful in ensuring you are working with accurate patient records.

[0066] The HCP portal 572 is encapsulated and illustrated within HITUI 574. HCP Portal 572 is also a standalone app outside of any health IT system. It may be implemented as a communication. In such a case, the HCP system 102 will HIT HCP-Portal 572 would run or be implemented without UI574. In this implementation, the HCP portal 572 can optionally still be accessed from the health IT system. Patient data can be retrieved, but within the user interface of the health IT system. It can be launched as a separate window or graphical user interface. No. Naturally, HCP Portal 572 also does not communicate with the health IT system at all. It can also be configured in such an embodiment, in which patient medical and personal data is manually entered. It may need to be stored in HCP Portal 572.

[0067] Throughout the EFS application interface 507, only the HCP system 102 You can access the HCP portal gateway 524 via link 558. Only MMA568 (on mobile device 104 or multiple mobile devices) You can access the MMA gateway 526 via link 560 and MMA570 (On mobile device 532, or on multiple mobile devices) only, link 562 You can access the MMA gateway 528 via the C3 management gateway 5 30 is C3 Management Portal 534 (via link 564) and C3 Management Portal 53 Accessible by both of 6 (via link 566). Such restricted In the illustrated embodiment, access is bidirectional, in which case the C3 server system M106 connects to the HCP system via HCP portal gateway 524 and link 558. Only Tem 102 can access it, and the C3 server system 106 is the MMA gate. Access to MMA568 is only possible via Way 526 and Link 560. Similarly, to the MMA 570 via the MMA gateway 528 and link 562, and via the C3 management gateway 530 and links 564 and 566 to each C3 You can access management portals 534 and 536.

[0068] G. Exemplary Ecosystem Figure 6 shows an exemplary communication and processing ecosystem 60 according to at least one embodiment. This illustrates various entities in 0. Naturally, the term ecosystem is used here. The specification does not refer to the biological meaning of the term, but rather to the computing of communications and processing. Used in context. If necessary, the elements discussed above in relation to Figures 1-5 are also included. Furthermore, by placing such elements within the context of Ecosystem 600, the reader To aid in understanding, the ecosystem is labeled in Figure 6, and the HCP-involved area Area 602, patient involvement area 604, group management area 606, and care management area 608 These include, and all of them communicate with each other via the C3 server system 106. They are correlated, and in Figure 6, the C3 server system 106 includes a data analysis engine. This is shown in the figure. As described above, in some embodiments, the C3 server system M106 connects to payer entities such as insurance companies and Medicare in a way that enables communication (e.g.) For example, data is shared (presumably only under conditions the patient opted in to), and data is also shared from the payer. (Receives).

[0069] The data analysis engine uses data collected by patients' mobile devices or from them. By analyzing data accessible through and / or health record data, we can identify diseases or conditions. It may be configured to promote insights into patient behavior or symptoms related to the analysis. The data is unique to a single patient and is used to extract insights specific to that patient. It is possible. For example, the data analysis engine can analyze the glucose readings of diabetic patients. Through the analysis of the g, it was found that patients under certain conditions, for example, at a certain time, at a certain type After eating a certain type of food, on a certain day of the week, entering and leaving a certain geographical location, a certain species Pre-, during-, or after certain types of physical activity, and in other conditions, tend to exhibit hyperglycemia or hypoglycemia. It is possible to determine that there is a direction. Based on these insights, the data analysis engine Notify the patient's HCP and provide education related to observed hyperglycemia or hypoglycemia episodes. Recommend relevant content to patients, or to patients at a specific time or place where it is most likely to be effective. Encourage the patient to change their behavior (for example, immediately before going to bed, immediately after exercise, or in a specific geographical location). Various actions such as encouraging patients to take medication when entering or leaving a designated area. It can be taken.

[0070] Ecosystem 600's HCP involvement area 602 is HCP system 102 and Health I The T system 118 is included, as described in Figure 6, and the HCP is the C3 server system Order products from companies or other organizations that operate 106 and access insights into such products. This enables the integration of current systems and methods into existing clinical workflows. .

[0071] The patient engagement area 604 of Ecosystem 600 is a mobile device running MMA568. Chair 104, patient 124, glucose meter 126, connected injection device 134, This includes many other patient-related medical devices such as blood pressure or other measurement devices. In the patient involvement area 604 of Stem 600, the objectives of this system and method are as described in Figure 6. As described above, relevant and high-value approaches to reduce patient burden and improve outcomes. This includes providing support for decision-making.

[0072] Ecosystem 600's collective management area 606 is (presumably HCP system 102) Computing devices (similar in physical architecture to things), as well as multiple patients EMR / HIE (Electronic Medical Records / High-Intensity Exchange) for the proper storage and maintenance of individuals' personal medical information. This includes the system. In the collective management area 606 of ecosystem 600, this system and method The objective of the law, as described in Figure 6, is to benefit clinical and financial stakeholders (payers, health care providers). Healthcare systems, etc., evaluate populations and provide better services to high-risk patients. This includes making it possible.

[0073] Ecosystem 600's care management area 608 is also the same as that of HCP system 102. Computing devices such as, and their own EMR / HIE systems, generally This often includes remote monitoring and clinical decision-making, including those referred to as the patient's "care team." This is dedicated to Decision Support (CDS). This care team is fully committed to the patient's health and well-being. Multiple different HCPs (different types of doctors, different types of physicians) with various different roles involved. This may include nurses, therapists, caregivers, etc. (Ecosystem 600 care management area) In 608, the objective of this system and method is to provide care to the care team, as described in Figure 6. However, this makes it possible to identify and prioritize patients who need support, and also to connect patients and care teams. This includes enabling direct dialogue between them.

[0074] In at least one embodiment, a caregiver, relative, etc., can communicate with patient 1 via MMA568. Access to some or all of the data received, recorded, tracked, or entered by 24 A companion MMA will be provided to enable this. In terms of administration methods, those using Companion MMA should keep a patient logbook (e.g., glucose). This includes measurement data, dosage information, diet-related information, etc., as well as prescribed administration regimens. Men(s), and / or other types deemed suitable for a given mounting by those skilled in the art. It is possible to view the data. Data viewable via Companion MMA The quantity and / or type can be set to the default value, and also HCP, patient 124 , and / or by one or more other individuals, according to the design parameters of a given implementation. It may be possible to adjust it.

[0075] According to this system and method, the C3 server system 106 is connected to the ecosystem 600. It provides and supports many features that facilitate the above-mentioned objectives and other objectives. One such feature is data storage, and in at least one embodiment, C 3. Server system 106 securely stores data, thereby enabling HCP system 102 And it enables MMA568 to communicate securely with each other. (For example, MMA app) 568 is a mobile device 104, as well as a smartphone, which is very common. Patient 124 may have both a MacBook and a tablet, possibly another mobile device associated with the patient. In embodiments instantiated on a device, and / or, patient 124, As is commonly implemented in the field, for example, via a web portal In an embodiment where functions and information can be accessed, the C3 server system 106 is Furthermore, MMA users can securely back up their medical data and store it on multiple devices. This enables the achievement of data consistency across different data sets.

[0076] In various embodiments, as described herein, the HCP is the HCP system 102 and set the administration regimen via the C3 server system 106, and the C3 server system 1 The administration regimen is sent to the MMA568 via the secure data transfer function of 06. Furthermore, In various embodiments, the C3 server receives patient history data, administration regimen status, etc., from HC. To make available via P system 102 and / or MMA568. Furthermore, less In one embodiment, HCP is provided via the HCP system 102, and MMA568 and A C3 server system 106 communicates with patient 124 via mobile device 104. This facilitates secure communication (i.e., message sending / receiving or inbox functionality). Furthermore, In various different embodiments, the C3 server system 106 performs software updates and recalls. Notice and / or deemed suitable for a given implementation or a given context by those skilled in the art To facilitate other functions.

[0077] I. Exemplary Operations A. HCP Portal Figure 7 shows the operation performed by the C3 server system 106 according to at least one embodiment. An exemplary method 700 is illustrated. A C3 server system that performs method 700. The description in this specification of 106 is provided for illustrative purposes only, not as an limitation, and Method 70 0 is preferably equipped, programmed, and configured to perform any device or method. It should be understood that this can be accomplished by the combination of devices that are assembled.

[0078] In step 702, the C3 server system 106, via the HCP portal 572, Using the user interface 208 of the HCP system 102, related to patient 124 Multiple drug administration regimens are presented. In at least one embodiment, the presented drugs Each administration regimen is associated with a different drug administration algorithm. Exemplary drug administration regimens and algorithms are discussed in more detail below.

[0079] One or more of the proposed drug administration regimens are open-loop regimens. Or it may be a closed-loop regimen that is known in the art. Generally speaking As shown, closed-loop regimens are taken with respect to the patient (e.g., glucos). Automation based at least partially on automatic sensing feedback such as (level) measurements. In this format, the dosage (e.g., amount, timing, etc.) of one or more drugs is repeatedly adjusted. On the other hand, open-loop regimens repeatedly prepare drug doses in an automated manner. No. However, in many cases, open-loop drug administration regimens are used when the patient feeds It consists of similar historical data in a more manual format, where back parameters are entered manually. Open-loop drug administration regimens also require the patient to manually control drug distribution. It is possible. More generally, this system and method can be used with any particular type of dosing regimen, A specific drug or type of drug, or a specific method of drug delivery to the patient (for example, note It is not limited to injections, intravenous administration, or oral administration.

[0080] In step 704, the C3 server system 106, via the HCP portal 572, Using the user interface 208 of the HCP system 102, the presented drug administration Receive at least one HCP selection from the regimen (for patient 124). In the terminology of the indication, at least one selected regimen is "at least one HCP This is referred to as a "selective drug administration regimen" or "at least one HCP selective regimen."

[0081] In at least one embodiment, the drug administration regimen presented in step 702 is 1 A regimen comprising one or more insulin administration regimens and at least one HCP-selective drug administration regimen This includes at least one HCP-selective insulin administration regimen. Any number of presented The regimen may be a basal insulin administration regimen, and any number may be bolus insulin administration. This may be a regimen. In some cases, a basal insulin administration regimen or bolus insulin may be used. One of the lancel administration regimens will be selected by the HCP for patient 124. Depending on the case, HCP may involve one or more basal insulin administration regimens and one or more basal insulin regimens. Both of the last insulin administration regimens will be prescribed to patient 124 simultaneously.

[0082] In at least one embodiment, at least one HCP-selective bolus insulin administration The regimen is of the type referred to herein as a daily titration bolus insulin administration algorithm. The administration regimen associated with the daily titration bolus insulin administration regimen described herein This includes the type known as Dimen. Other types of HCP selective bolus insulin administration regimens Therefore, the administration algorithm referred to herein as the fixed-dose bolus insulin administration algorithm Associated with the type of rhythm, fixed-dose bolus insulin administration regimens as defined herein Types referred to as; Carbohydrate bolus calculator bolus insulin administration algorithm Carbohydrate bolus calculations associated with the type of dosing algorithm referred to herein. Types referred to as bolus insulin administration regimens; and carbohydrate dietary regimens as used herein. A type of administration algorithm called a computer-based bolus insulin administration algorithm. This specification includes a calculator for bolus insulin based on carbohydrate meal size, associated with the term "m". These are examples of what are called administration regimens. These are the four types of open-loop bowels mentioned above. Examples of each insulin administration regimen / algorithm can be found under the corresponding title below. It is explained in section B.

[0083] In step 706, the C3 server system 106 is associated with patient 124. On the device 104, at least one HCP selection in step 704 is performed on the MMA568. Send HCP selected regimen data indicating the regimen.

[0084] An exemplary method 700 is described above as being implemented by the C3 server system 106. However, method 700 can also be directly implemented by the HCP system 102. In such embodiments, the HCP portal 572 connects to the C3 server via a network connection. It doesn't have to be a web application hosted by Stem106; instead, The HCP portal 572 is locally hosted and run by the HCP system 102. It may include a user interface. In these cases, the C3 server system 106 Without any support from or communication with the C3 server system 106, the HCP system 1 Step 02 presents HCP with multiple drug administration regimens (Step 702), and the presented drugs Receive HCP selection from the administration regimen (Step 704), HCP selection regimen day The data is sent to the MMA568. In such an embodiment, the HCP system 102 sends the data The data passes through or is processed by the C3 server system 106. Without needing to do so, the mobile device 104 and the data network 108 can be directly connected. It can communicate with each other.

[0085] Method 700 is implemented by the C3 server system or the HCP portal 102. Regardless, in at least some embodiments, the MMA568 is a user interface Through Phase 308, we provide dosing recommendations based on at least one HCP-selective regimen. It is configured to be such that, in some embodiments, the MMA568 is a user interface Prompt via S308 to recommend (i.e., prescribed) dosage regimen Provide patient 124 with the option to accept or reject the treatment. In one embodiment, the C3 server system 106, via the user interface 308 Therefore, MMA568 indicates a patient refusal indication associated with at least one HCP-selected regimen. In response to receiving a regimen rejection message indicating that it has been received, disable MMA568. It is configured in such a way. Disabling MMA568 allows the user to use one of MMA568's functions. Preventing access to part or all of it, or preventing users from accessing MMA568 This may include preventing access to some or all of the submitted data. For example, disabling MMA568 is a dosage regimen prescribed or recommended by HCP. This may include preventing users from accessing or using the data. In other cases, the C3 server system 106 instead uses the user interface 308. Through this, the patient acceptance indication associated with at least one HCP selection regimen is M MA568 receives a regimen acceptance indicator, which indicates that it has received the regimen.

[0086] In at least one embodiment, at least one HCP selection regimen is MMA568 Unlock above, by MMA568 of the HCP selection regimen data in step 706 This is a reception. In some cases, this unlock occurs after receiving the HCP selection regimen data. Only, of the possibility of being part of at least one HCP selection regimen (as part of MMA568) The MMA568 accesses the implementation data already stored in a mobile device 104. This includes enabling the setting. In other implementations, this unlocking is done by HCP selection. Only after receiving the regimen data, download the implementation data for at least one HCP selected regimen. Downloading includes transitioning the MMA568 from inoperable to operable. Hmm. In these implementations, the implementation data for at least one HCP selection regimen is C3 server It can be downloaded from system 106 and / or HCP system 102. ru.

[0087] In some cases, this unlocking applies to at least one HCP selection regimen. The MMA568 receives patient acceptance indications via the user interface 308. This is done only in response to and. MMA568 is only after receiving HCP selection regimen data. This will allow you to unlock or download specific HCP selection regimens. This helps ensure compliance with regulations enforced by the U.S. Food and Drug Administration (FDA). Obtain. Such FDA regulations require that patients have a prescription from a qualified and licensed physician. It may be necessary to have access to a particular dosing regimen only through this. In these embodiments, MMA568 is administered until HCP selection regimen data is received. By restricting access to Dimen, patients can receive their treatment regimens without the necessary prescription. I cannot reliably access [the site].

[0088] Step 70 on mobile device 104 (for example, as part of MMA568) In 2 and 704, the actual regimens presented to HCP and available for selection by HCP The data is stored, and after receiving the HCP selection regime data transmitted in step 706, An embodiment of unlocking one or more regimens on a mobile device is described in this system. It provides several technical advantages that improve the efficiency and / or functionality of the method. For example, By storing all regime implementation data on the mobile device 104, Download additional potentially large implementation data for the regimen prescribed for device 104. Without requiring a download, the HCP can prescribe specific prescriptions on the patient's mobile device 104. This makes it possible to activate the regimen. This allows the patient's mobile device 1 04 has only an intermittent or low-bandwidth communication link 112 with the data network 108. In cases such as (for example, a network failure event, or if the mobile device is in airplane mode) (In some cases) to allow patients to easily access and implement the prescribed regimen. .

[0089] This includes bundling implementation data for all regimes as part of MMA568. The implementation format is also available on certain popular online repositories for mobile applications. To facilitate patient access, it is possible to write the MMA568. Such an online mobile application repository is the HCP system. 102, Administrator Portal 148, or Patient 124 own, maintain, and / or are affiliated with Management by a third-party entity other than the entity (or multiple entities) that is managing We can list the repositories that are managed, and such online mobile applications As a repository, there is the App Store maintained by Apple, Inc. e. Or, Google Play, which is maintained by Google LLC. Such online repositories are typically used by written apps. The application must include all implementation logic when written. In other words, mobile To ensure the safety and stability of applications running on the device, Administrators of such online repositories often have third-party enterprises that maintain the online repositories. Each update is sent by the company (e.g., Apple or Google), and viewed again. and / or unless authorized, the application developer writes the application It is possible to prohibit updating or changing the code of the administration. Each time a regimen or algorithm is prescribed, the implemented data is stored on the mobile device 104. Embodiments that involve downloading may result in timely submissions by third-party entities. Further review and / or approval process may be required. This is in accordance with FDA regulations. Access to dosing regimens should be accessible only to patients with prescriptions. This is specific to the field of medical mobile applications that enable this, and occurs particularly in that field. This is a problem. When writing, all regime implementation data is written as part of the MMA568. Only when you receive HCP selection regimen data will the prescribed regimen be selected. By unlocking it, MMA568 allows patients to be prescribed a new dosing regimen. The need for such a time-consuming submission, review, and / or approval process each time Avoid this. Additionally, this bundle increases the safety and stability of MMA.

[0090] As described above, in at least one embodiment, the MMA568 is its host mobile Through device 104, one or more insulin delivery associated with patient 124 and / or connects to communicate with an insulin monitoring device. The glucose meter 126 is This is an example of such an insulin monitoring device. MMA568 is associated with patient 124. In at least some embodiments, a connected insulin delivery device is communicatively connected to the insulin delivery device. The MMA568 communicates with its insulin delivery device to at least one HCP The selected regimen is executed. The connected injection device 134 is used for insulin delivery. This is an example of a device. In some embodiments, the C3 server system 106 and / or Alternatively, the HCP system 102 is relayed by the MMA568, for example, as described herein. Insulin injection record data and glucose measurement data, etc., are recorded in the patient data. Received from delivery and / or monitoring devices.

[0091] B. MMA on mobile devices Figure 8 shows a mobile device running the MMA568 according to at least one embodiment. An exemplary method that can be performed by 104 is illustrated. Mobile device 10 The description herein of method 800 performed by MMA568 performed on 4 is Provided for illustrative purposes only, not as an limitation, Method 800 can be used with any device, A set of devices that are preferably equipped, programmed, and configured to perform the method. It should be understood that this can be done by [the specified method].

[0092] In step 802, MMA568 is involved in each of the different drug administration algorithms. From among multiple linked drug administration regimens, at least one drug administration regimen Receive HCP selection regimen data indicating the HCP selection of at least one embodiment. So, the HCP selection is done via the HCP system 102 (for example, the C3 server system 10 Provided by 6 and accessed by HCP via HCP system 102 The procedure was performed for patient 124 via the interface (HCP portal 572). As shown above, MMA568 is obtained directly from the HCP system 102, or as described in this example. Therefore, HCP selection regimen data can be received from the C3 server system 106. It is possible. At least one HCP-selective drug administration regimen is one of the possible regimens described herein. It may include any combination of n or regimen.

[0093] In step 804, MMA568 uses the HCP selection regimen data from step 802. In response to what was received, at least partially, the indicated HCP-selective drug administration regimen is M Unlock on MA568. As mentioned above, in at least one embodiment, step P804 is a previously stored HCP selection regimen in the mobile device 104. This includes accessing implementation data that was previously inaccessible. These embodiments include accessing implementation data that was previously inaccessible. It may be desirable for at least the technical reasons discussed above. So, step 804 is the implementation of the HCP selection regimen that was previously inaccessible. This includes downloading data.

[0094] In at least one embodiment, step 804 is performed after step 802. Before doing so, the MMA568 provides the user interface 308 of the mobile device 104. Through this, patient acceptance or rejection of at least one HCP-selective drug administration regimen A user interface 3 presents a prompt and then responds to the presented prompt. User input is received via 08, and in at least one such embodiment, step The MMA568, which performs 804, will check if the received user input is at least one HCP selected It is required that the patient acceptance indication be for the selected drug administration regimen. Furthermore, at least In one embodiment, the MMA568 receives user input from the C3 server system 1. Send to 06 and / or HCP system 102.

[0095] Is the prescribed regimen a bolus insulin regimen or does it include a small amount? In at least one embodiment, patient acceptance indicates that the user has accepted the prescribed administration regimen. Upon receiving the input notification, the MMA568 selects the option to enter the recommended bolus dose workflow. The limb is presented to the user, and during this time, in at least one embodiment, the MMA568 is used by the user The system prompts the user to select a mealtime and asks them to enter and / or confirm their glucose measurement. The system encourages users to do so and, accordingly, presents them with a recommended bolus dose. It can be shown to MMA568 that a certain amount has been ingested, and in that case, MMA568 will respond accordingly. The recommended dose will be stored in memory. Alternatively, the user may take an insulin dose different from the recommended dose. It can be shown that the dose of MMA568 was taken, and MMA568 was actually taken. The amount of insulin taken will be recorded. The record may include the time the dose was taken. It is automatically set to the time when user confirmation is received or the time indicated by the user. It is possible.

[0096] In at least one embodiment, the MMA568 via the mobile device 104 is patient Can communicate with the insulin delivery (and / or glucose monitoring) device associated with the user. Connected to the function, in at least one such embodiment, MMA568 delivers insulin. It communicates with the device to execute an HCP selection regimen or an insulin delivery device Use the system to receive information about the dose manually delivered by the patient. In one embodiment, the MMA568 receives patient data from the insulin delivery device. The received patient data is sent to the C3 server system 106 and / or the HCP system 102. It relays. Patient data is among many other examples that can be listed herein, Phosphate injection record data (e.g., including the time and amount of insulin delivered in previous doses) ) and / or glucose measurement data may be included. In at least one embodiment, M MA568, via the user interface 308 of the mobile device 104, We provide administration recommendations based on P-selection regimens.

[0097] In at least one embodiment, the MMA568 is used by a patient who is using an unsafe or incorrect device. It may include safety features that prompt the patient if it detects that they may have ingested a large amount. For example, MMA568 is the expected "baseline" for the expected drug for each dose. The amount can be calculated. This "baseline" dose can be determined using multiple methods. This is possible. For example, the "baseline" dose can be determined by HCP and / or patient. This could be a pre-set amount of medication measured in grams, or it could be the patient's medical or personal information. (For example, gender, age, weight, type and severity of disease, etc.) are used algorithmically and automatically It can be derived dynamically. The "baseline" dose is also (for example, the past 3, 5, A certain number of previous doses (10 or more doses) or a shift window of previous time. Moving average of doses taken over the past 3, 5, 10, or more days, and most frequent doses. It can be derived from the value or the median mean. In some embodiments, the base The "line" dose is determined based on the time of day or the upward or downward trend detected in previous doses. It may vary. Before recommending a dose based on the HCP selection regimen, MMA568 recommends The dose can be compared to this "baseline" dose. MMA568 is compared to this base If it is detected that a dose significantly different from the prescribed dosage is being recommended, then there is a recommended dosage. MMA5 68 can warn the patient and encourage them to confirm the dosage. For example, recommended The amount may be due to an incorrectly entered insulin onboard parameter, meal size value, or current This may be based on incorrectly entered patient information, such as glucose levels. In addition, if the user plans to take a different amount of medication than the recommended amount. When MMA is shown, MMA568 is similarly the baseline dose indicated by the user. It is possible to determine if the quantity differs significantly from the amount indicated by the user. If the quantity indicated by the user differs significantly, M MA568 indicates that the indicated dose is significantly higher or lower than the baseline dose. This can alert the patient. These additional prompts and warnings ensure the user is safe. Warning the user that they may be missing or attempting to take the wrong amount of medication. This can be helpful. If necessary, the user can override the warning.

[0098] In at least one embodiment, the MMA568 performs at least two levels of action Seth: Public access available for anyone to download, self-register, and use, and Prescription access provides additional features unlocked through electronic dosing regimen prescriptions. , provides. In one embodiment, general access is, for example, glucose level (G L), basal insulin, bolus insulin, carbohydrate input, and exercise / stress / illness (ii) recording of diabetes-related data, which may include factors related to the body, and (ii) user data It provides functionality including access to visualizations (e.g., graphs), but in one embodiment, Remedy access unlocks the recommended bolus insulin dose through the implementation of administration regimens. To remove. In some embodiments, the appearance of the user interface of the MMA568 is M MA568 is in general access mode or prescription access mode (and / or It probably changes depending on whether it is in another mode. Such changes are not limited to However, additional and / or fewer menu items, color scheme changes, icon changes, etc. Changes in the IOUT system can be cited as examples.

[0099] In at least some embodiments, the general access (non-prescription) mode of the MMA568 It provides one or more of the following features: Data entry • Users enter data related to diabetes and HCP tracks and reviews that data. This makes viewing easier. • The user can specify the bolus insulin dose, basal insulin dose, and glucose readings. Enter your carbohydrate intake (either manually or via a wireless connection to a glucose meter). It is possible. • Users may also identify the following factors that may be affecting them: activity, stress, illness, steroids, etc. It can also record menstruation, as well as yes / no data points. • The patient's glucose level (either automatically or manually from the sensor), and current activity level. MM You can input into A. • Digital logbook • Users can track data related to diabetes, so all of the user's data can be tracked. Data is easily accessible and can be viewed in one place. • Users can view any of the entered data in digital logbook format. It is possible. • Pairing of glucose meters • I want to store all of the user's data in one place, or use glucose data. This simplifies the glucose input process for users who want to receive recommended dosages. • Users can use blood glucose meters, continuous glucose meters, and flash glucose meters. Select the option to pair with a device such as Nita or another glucose monitoring device. It is possible. When a glucose monitoring device is paired, the user can receive a recommended bolus. Dosage workflow (available only in prescription mode) or data entry workflow (general When you go to (available in access mode), MMA will display the latest glucose readings. It is likely. • Users are Personal Connected Health Alliance Issued by e(PCHAlliance)(Arlington, Virginia) The Continua standard (also known as the Continua Design Guideline) It can be paired with a connected glucose meter that requires compliance with ES. In some embodiments, the user performs an activity and measures its effect on glucose levels. This allows you to conduct experiments. Users can view the experiments they have performed again. Yes, it is possible. Such experiments can be based on activity, food, and / or other factors. In some embodiments, third-party data sources (e.g., HealthKit, Fit) are used. Bits (and so on) create experiments for the user. In fact, in some embodiments, MM A connects and communicates with wearables such as Fitbit and Apple Watch. This facilitates monitoring and / or integrating insights into one or more physiological parameters. It is possible. • Data visualization • Users can view the collected data for a certain period of time to make it easier to understand. It is possible. • Users can navigate to the MMA section that hosts the data visualizations. Next, you can select the type and time period of data you wish to view. • MMA also shows a pie chart of recorded glucose values, indicating whether they are outside the range or within the range. This will show values ​​below the range, and values ​​that fall into the hypoglycemic level (≤70 mg / dL). cormorant. • Reminder • When your schedule is busy, glucose testing or recommended bolus dose workflow - Useful for reminding the user to enter something. • Users can choose to have glucose level testing and / or insulin administration at their preferred times. You can set reminders. • Users will receive reminder messages on their mobile devices. • Onboarding Users can register for MMA and learn about its useful features. • Users create login credentials, enter basic information about themselves, and agree to the terms of service. By agreeing, you can register to use MMA. • MMA includes features such as pairing a glucose meter or setting personal reminders. To help users learn about useful features, we offer choice-based activities (for example) They will provide a tutorial. Education on diabetes • Help users learn about diabetes from reliable sources. • Users can access links to diabetes education from within MMA. UnaLink can be launched within MMA or through a browser application, among other possibilities. You can start the program.

[0100] C. Exemplary HCP portal screenshot As described below, Figures 9-21 show various different implementations of the HCP system 102. Various screenshots of the state are illustrated.

[0101] Figure 9 shows the HCP user operating on the "[Dosage] Method Selection" tab, and the HCP has made a selection. The script lists four bolus insulin administration regimens as options for doing so. The bolus insulin regimen is 900mg, and these four bolus insulin administration regimens are as follows: Further details will be provided. In one embodiment, one of the presented regimens is used Clicking it will bring up a pop-up window that provides further details. In another embodiment, when HCP selects one of these four dosing regimens The HCP system 102 then transmits the HCP selection regimen data to the mobile device 104. This allows patients to access their selected dosing regimen on their mobile device. This becomes possible.

[0102] Figure 10 shows a screenshot of electronic health record (EHR) data related to one exemplary patient. This is a screenshot of the 1000-shot program, illustrating various patient data in graph format. In the case of LeanShot 1000, the exemplary patient has not yet been prescribed a treatment regimen.

[0103] Figure 11 shows pending changes to administration recommendations or prescriptions that are still awaiting patient acceptance. Screenshot 1100 shows a warning message 1102 indicating that it is present. This screenshot 1100 shows that the patient has the prescribed effective method of administration. Furthermore, the patient does not have historically recorded data regarding glucose levels or dosage information. Although prescribed a fixed-diet bolus administration method, the patient has not yet received the prescribed administration method. I haven't included it.

[0104] Figure 12 shows that warning message 1202 is displayed regarding pending changes to the administration recommendation. Or, the prescription is still waiting for the patient to be admitted, as shown in screenshot 1200. Yes. In this screenshot 1200, the patient previously used a carbohydrate bolus calculator. I was previously prescribed a bolus insulin regimen, but now I am using a fixed-dose bolus insulin. The patient has been prescribed a treatment regimen. The patient has not yet accepted the newly prescribed treatment method. do not have.

[0105] Figure 13 shows that the selected dosing regimen is also called a "daily titration" regimen, Screen showing the "Configuration Settings" tab for the daily titration bolus insulin administration regimen. The number of shots is 1300. As shown in Figure 13, the daily titration regimen setting tab is: The option of prescribing bolus doses for breakfast, lunch, and dinner to HCP. Give. HCP should choose one of the following for each meal: "titrate", "stable", or "none". This can be done. The titration options are determined according to the algorithm described below herein, for that meal. This results in titration using the recommended dose. The "stable" option allows HCP to fix its mealtime. It will be possible to specify a fixed bolus dose. The "None" option will not specify a bolus dose for that time. This means that no quantity has been prescribed.

[0106] Figure 14 shows that the selected dosing regimen is again "daily titration," and "re-view and Screenshot 1400 illustrates the "Confirmation" tab. Here, the HCP administers the treatment to the patient. Before proceeding, you may review and confirm the future daily titration regimen.

[0107] Figures 15A and 15B show that the selected dosing regimen is simply a “fixed diet” regimen. The "Configuration Settings" tab, also known as a fixed-dose bolus insulin administration regimen, is illustrated in the diagram. This is screenshot 1500. HCP users can use the relevant patient regimen. You will be presented with an opportunity to review the customizable details of the system. For example, HCP users can ( i) morning, (ii) afternoon, and (iii) evening and nighttime. The LASS dosage settings can be customized. The start time of each time block is HCP This can be adjusted by the HCP user. In each time block, the target glucose level Bell, insulin response value (explained in more detail below), bolus dose, various health Factors (explained in more detail below, e.g., activity, illness, stress, steroids, etc.) (and menstruation, etc.), setting permission (if enabled, patients can change their prescription settings) The option to enable (becoming active) and effective insulin (explained in more detail below). You can select an option.

[0108] Figure 16 shows that the selected administration regimen is again a fixed diet administration regimen. Screenshot 1600 illustrates the "and confirmation" tab. Here, HCP is patient Before prescribing to a patient, they may review and confirm future fixed dietary regimens. .

[0109] Figure 17 shows that the selected dosing regimen is also simply called the "carbohydrate meal size" regimen. This is a bolus insulin administration regimen calculated based on carbohydrate meal size, and is called "composition This is screenshot 1700 illustrating the "Settings" tab. As shown in Figure 17, The carbohydrate meal size regimen settings tab allows you to set (i) breakfast, (ii) afternoon, and (iii) Options for prescribing bolus doses in three time blocks: evening and nighttime. The start time of each time block can be adjusted by HCP. For each time block, the user sets the target glucose level, insulin effect value (and further details below). (explained in detail below), and the insulin-to-carbohydrate ratio (explained in more detail below) They can choose between "small" and "medium". Regardless of the duration, HCP users can also choose "small" or "medium". Select the expected number of grams of carbohydrates from each of the following meals: This is possible. Finally, HCP users can choose the duration of insulin administration.

[0110] Figure 18 shows that the selected dosing regimen is also simply called the "carbohydrate counting" regimen. This is a carbohydrate bolus calculator and bolus insulin administration algorithm, called "Configuration Settings". This is a screenshot 1800 illustrating the tabs. As shown in Figure 18, carbohydrates The Count Regimen Settings tab allows HCP users to choose from "Small," "Medium," and "Large" settings. Except for not giving the option to choose the expected number of grams of carbohydrates in the meal, This is similar to the hydrate meal size regimen settings tab.

[0111] II. Exemplary Open-Loop Bolus Insulin Administration Algorithms and Related Regulatory Systems Men Exemplary open-loop bolus insulin administration algorithms described herein and Some or all of the relevant regimens are listed on Insulin Onboard (IOB). Based on this, the recommended bolus can be calculated. IOB is the previously injected bolus. This explains the amount of insulin that is still expected to be effective in the patient's body based on the insulin dose. This is a calculated value. This value represents the amount of insulin the algorithm recommends the patient inject. This may reduce the IOB. IOB is calculated using at least two different approaches. It is possible.

[0112] The first approach is necessary to correct glucose readings that are higher than desired. IOB can be calculated by considering only a portion of the previous dose. The single dose of insulin taken at individual time points should (i) be higher than the desired glucose level. (ii) the amount of insulin needed to correct the reading, (ii) immediately after, immediately before, or after administration. Additional amounts necessary to "supplement" or constitute the amount of carbohydrates the patient consumes through diet during treatment. (iii) Lifestyles that may affect the amount of insulin required or health factors (e.g., whether the patient is ill, whether the patient exercises or not) Is movement expected? Is the patient menstruating? Is the patient taking steroids? Any adjustments necessary to consider whether the patient is experiencing stress or / or Based on several parameters, including either positive or negative values, or all of them. This allows us to determine the parameter (i), i.e., desired Only consider the amount of insulin needed to correct glucose readings that are higher than the actual reading. By doing so, the IOB can be calculated. The first approach is to calculate the IOB. When doing so, either parameter (ii) or (iii) can be excluded.

[0113] The second approach is to take into account all insulin taken as part of the previous dose. In some cases, the IOB is calculated by doing this. In other words, in the second approach, Not only parameter (i), but also parameter (ii) (i.e., the amount of carbohydrates in the diet) The amount of insulin needed to "compensate" for it, and parameter (iii) (taking health factors into consideration). The IOB is calculated by also considering any adjustments made. This second approach is Generally, a negative adjustment from parameter (iii) results in a positive contribution from parameter (ii). Unless the offset exceeds the calculated IOB, it will result in a higher IOB than anticipated.

[0114] Other approaches to calculating IOB are also certainly possible. For example, other apps Roach considers parameters (i) and (iii), but does not consider parameter (ii). IOB can be calculated without using insulin onboard or I It is understood that references to OB can be calculated using one of the approaches mentioned above. In some embodiments, the HCP, the patient, or both calculate the IOB. To instruct the insulin dosing algorithm to use a specific approach. This is possible. For example, screenshot 1500 in Figure 15B shows that HCP is enabled. For example, when calculating IOB, you have either a "conservative" option or a "standard" option. This indicates that one of the following can be chosen. The "standard" option is the first one discussed above. In response to the first approach, the "conservative" option corresponds to the second approach. MMA is, It includes logic that allows the IOB to be calculated using both the first and second approaches. When calculating the recommended bolus, the patient, the HCP, and / or both are two approaches. You may be given a choice to select from among the options.

[0115] A. Daily titration An exemplary daily titration algorithm and associated dosing regimen are described below.

[0116] The recommended dose starts from the initial value set by HCP when the administration regimen is prescribed. The starting dose of Fault is 10% of the total daily basal insulin in breakfast or lunch titrations, and evening titrations. The titration is 5% for food. The recommended dose for each day is the glucose reading recorded the previous day. It is calculated based on the glucose readings on day 1. In other words, the recommended dose for day 2 is calculated based on the glucose readings on day 1. The recommended dose for day 3 is calculated based on the glucose readings on day 2. The calculation is performed, and the same applies thereafter. Here are some exemplary rules for calculating each recommended dose for the following day. The following table will be provided. [Table 1]

[0117] An example of a daily titration regimen is for patients aged 18-85 years who meet the following criteria: T2DM (Type 2) Suitable for users of diabetes mellitus. • Blood glucose targets were not achieved regardless of metformin administration or basal insulin optimization. Unable to do • Treatment intensification with mealtime insulin is necessary. • Individuals for whom a set glucose target of 85-114 mg / dL is appropriate.

[0118] To enable exemplary daily titration dosing regimens, HCP sets the following parameters: To determine. • Daily total basal insulin (TBI) measured in insulin units • Initial starting dose and meal for insulin titration

[0119] In addition, HCP allows you to set the following parameters: • Stable dose(s) per meal(s) in insulin units (multiple doses possible)

[0120] MMA will calculate the recommended dose using the following additional inputs: • Current GL in mg / dL: The current GL is when the patient has hypoglycemia (glucose ≤ 70 mg / dL). To prevent recommending insulin doses when ( / dL) is present, MMA Used • Pre-meal GL (GL) in mg / dL: Pre-meal GL was collected following the titration dose from the previous day. GL

[0121] In at least one embodiment, an exemplary daily titration regimen calculates the recommended dose. The input values ​​for this purpose include corrected dose, IOB (Insulin Onboard), or adjustment factors. This is not taken into consideration.

[0122] In at least one embodiment, MMA568 receives glucose input by the patient. We provide recommendations for initiating and titrating basal insulin administered with a single meal using the values. Provided, and under the instructions from HCP to enter glucose levels and receive dosing recommendations, 1 This format is intended to be used multiple times a day.

[0123] B. Fixed dose An exemplary fixed-dose algorithm and associated regimen are described below. The dosage algorithm indicates that HCP is detecting when the patient's glucose levels are outside the desired range. The "fixed" bowl per meal can be modified by any adjustments needed to compensate for this. It may become possible to set the amount of [something].

[0124] Meal options include no meal (e.g., corrected dose only), breakfast, lunch, or dinner. It can be listed as follows: HCP is a fixed dose value for a single mealtime, and the same fixed dose value for multiple mealtimes. A fixed dose value, or different fixed dose values ​​can be assigned to multiple meal times. Dimen is used for dose adjustments on insulin onboard (IOB), above or below the GL target. Correction of glucose levels (GL), and lifestyle or health factors (e.g., exercise) This may include stress, illness, steroids, or menstruation.

[0125] The exemplary fixed-dose regimen is either unfamiliar with bolus therapy or bolus dose Individuals with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) requiring optimization. This may be suitable for users who use rapid-acting insulin analogs. In some cases, users may use rapid-acting insulin analogs. This may require multiple daily injections of insulin during meals.

[0126] To enable exemplary fixed-dose regimens, HCP sets the following parameters. It is possible. • Fixed dose (FD) of insulin per type of meal selected by the patient. • Target GL (GL) in mg / dL T ) • Insulin effect (ISF) in mg / dL / insulin units • Insulin duration (ID) per hour

[0127] In some embodiments, HCP allows users to change regimen-specific settings. Whether or not such changes are possible can be controlled. For example, HCP can enable such changes. Unless otherwise specified, users may not be able to change the insulin-to-carbohydrate ratio. Yes, there are. And indeed, other examples can also be listed herein. In addition, several In that embodiment, HCP is any or all of the following lifestyle change factors: Alternatively, you can enable "None" and set the corresponding adjustment amount. When enabled, LifeS Due to tile-changing factors, MMA patient users, for example, on mobile devices, can interact with the user interface. Through the face, one can experience certain conditions that can affect the amount of insulin the body needs. It becomes possible to show whether or not a patient is exercising, and such a state would be, for example, if the patient is exercising. Whether the patient is present or engaging in physical activity, whether the patient is experiencing stress, or whether the patient is Whether the patient is ill, taking steroids, or menstruating, For each of these lifestyle change factors, HCP adjusts the amount per Set in cents. Percentage values ​​are converted to decimal values ​​for use in equations. HC If P does not enable the modification factor, the dosing regimen will use a value of 0. • Percentage of activity factors (AF) • Stressors in Percentage (SF) • Percentage of disease factors (IF) • Steroid Factor (StF) in Percentage • Percentage of menstrual factors (MF)

[0128] MMA will calculate the recommended dose using the following additional inputs: • Meal selection to determine FD values ​​in insulin units (no meal, breakfast, lunch, dinner) ) • Current GL (GL) in mg / dL • Current time in hours (t) Note: The current time may include hours, minutes, and seconds, but fractions of a time are used in calculations. It is possible.

[0129] Insulin onboard (IOB), that is, all insulin that is still effective during the current period. The insulin dose will be incorporated into the calculation. The previous dose was ID (insulin duration). If taken less than ) hours prior, it is considered "effective". In some embodiments, previously The dosage can be calculated using the following parameters: • Insulin delivery bolus (DB) in units • Bolus delivery time in units of time (t DB ) ·Magnification (X) • When individual delivery boluses are administered within 0.5 hours, X=0 • When individual delivery boluses are administered more than 0.5 hours but less than ID time before, X=1

[0130] As mentioned above, the DB parameter in the IOB calculation for a specific insulin dose previously administered. A meter can be defined in one of two ways. According to this, the DB parameter is (i) only the glucose-corrected portion of the previous dose, or (ii) The total amount of insulin injected at a previous dose, or can be set as either of the following: Yes. Option (i) corresponds to the first approach discussed above, and is shown in Figure 15B of this specification. This is also referred to as the "standard" option. Under this option, the glucose-corrected portion of the previous dose The formula is as follows:

number

[0131] According to an exemplary fixed-dose regimen, the recommended bolus insulin dose (RD) is given by the following formula: It can be calculated using

number

[0132] The term FD refers to the fixed-dose portion of an equation.

number

number

[0133] The following considerations apply to the formula. • If the patient chooses to go without food, the fixed dose value is 0, however, in the applicable case In total, the patient will still receive the corrective dose. ·Correction dose

number

number

[0134] If the calculated recommended dose returns a negative value, MMA recommends 0 units of insulin. It is possible. Alternatively, MMA may detect that the patient is or is likely to be in a hypoglycemic state. If administered, and / or if MMA is too high in the patient, IOB (onboard insulin, In other words, if it is determined that the patient has the amount of insulin in their body, MMA is determined by diet or Patients may be advised to consume a specific amount of carbohydrates. In some embodiments, If the MMA determines that the patient is or will be in a state of hypoglycemia, the MMA will The patient is injected with glucagon or several other drugs that increase the patient's glucose levels. It can be recommended that this be done.

[0135] This exemplary immobilization regimen is based on an immobilization regimen constructed by HCP. By enabling users to receive the recommended dose, bolus insulin administration This can reduce the complexity. If the user accepts the dosing regimen prescription, The user can choose to enter the app and proceed to the recommended bolus dose workflow. The user selects a meal, enters and / or confirms glucose measurements, and engages in activity or Select any additional modifying factors, such as changes in stress levels, and receive the recommended bolus dose. The regular administration regimen includes the amount of insulin allocated by the HCP to supplement meals, and the current blood glucose level. and corrected dose based on target blood glucose levels, as well as internal insulin PKPD data. Consider the onboard setup.

[0136] C. Carbohydrate Bolus Calculator An exemplary carbohydrate bolus calculator algorithm and related regimen are described below. ru.

[0137] An exemplary carbohydrate bolus calculator regimen is for "supplementing" the carbohydrate content of a diet. This method is based on rules and is an individualized approach to matching pre-meal insulin to meal intake. It is recommended in clinical guidelines as such. Therefore, it can be used at any time of day. It is possible, and there is no need to be fixed to a specific diet. This regimen is insulin-sensitive, carbohydrate Based on food intake, GL target, and current GL, calculate the recommended bolus insulin dose. They will also consider adjustment factors for corrected dose, IOB, and choice.

[0138] Bolus is due to two factors: (i) insulin needed to supplement food or carbohydrates. (ii) the insulin needed to correct hyperglycemia can be calculated based on (ii) the insulin required. ru.

[0139] The bolus dose for supplementing food or carbohydrates is calculated based on the insulin-to-carbohydrate ratio (ICR). It is prescribed based on the following. The insulin-to-carbohydrate ratio is supplemented with 1 unit of insulin. This represents the number of grams of carbohydrates processed. Generally, 1 unit of rapid-acting insulin is equivalent to 1 It processes 2-15 grams of carbohydrates, however, this parameter is insulin Depending on individual sensitivity, the amount of carbohydrates can vary from 4 to 30 grams or more. Sensitivity can vary depending on the time of day, the individual, and is influenced by physical activity and stress. ru.

[0140] An exemplary carbohydrate bolus calculator regimen is one that accurately counts carbohydrates or HC T1DM can learn to accurately count carbohydrates in the P judgment. Alternatively, it is suitable for T2DM users. In some cases, users may require rapid-acting insulin. This may require multiple daily injections of insulin with a similar substance during meals.

[0141] To enable exemplary carbohydrate bolus calculator regimens, HCP uses the following parameters You can set the data type. • Target GL (GL) in mg / dL T ) • Insulin effect (ISF) in mg / dL / insulin units • Insulin-to-carbohydrate ratio (ICR), carbohydrates / insulin units in grams • Insulin duration (ID) in hourly units,

[0142] In addition, HCP is determined by any, all, or none of the following lifestyle change factors. It can be enabled and the corresponding adjustment amount can be set. HCP provides appropriate percentages to the patient. Use the percentage to set adjustments for lifestyle factors. Percentage values ​​are used in the equation. It is converted to a decimal value for use. If HCP does not enable the modifying factor, it is administered. The regimen will use a value of 0. • Percentage of activity factors (AF) • Stressors in Percentage (SF) • Percentage of disease factors (IF) • Steroid Factor (StF) in Percentage • Percentage of menstrual factors (MF)

[0143] MMA will calculate the recommended dose using the following additional inputs: • Current GL (GL) in mg / dL • Current time in hours (t) • Carbohydrate intake (CHO), carbohydrates in grams, or dietary intake in insulin units Nsling (MI)

[0144] Insulin onboard (IOB), that is, all insulin that is still effective during the current period. The insulin dose will be incorporated into the calculation. The previous dose was ID (insulin duration). If taken less than ) hours prior, it is considered "effective". In some embodiments, previously The dosage can be calculated using the following parameters: • Insulin delivery bolus (DB) in units • Bolus delivery time in units of time (t DB ) ·Magnification (X) oWhen individual delivery boluses are administered within 0.5 hours, X=0 oWhen individual delivery boluses are administered more than 0.5 hours but less than ID time before, X=1

[0145] As mentioned above, DB parameters in IOB calculations can be defined in multiple ways. For example, the DB parameter is (i) the total amount of insulin from the previous dose, or ( ii) It can be set to either the glucose-corrected portion of the previous dose or only.

[0146] MMA users can track their carbohydrate intake (CHO) (for example, the estimated amount of carbohydrates in their meals). Either mealtime insulin (MI) (for example, expressed in units of insulin) You can choose to input it. MMA users can choose to input mealtime insulin. In that case, MMA users will need to take the insulin they expect to supplement with a particular diet. You can enter the number of digits. For example, an MMA user can enter the number of digits for carbohydrates in a particular meal. I don't know the exact number in grams, but to supplement that type of meal, you need a certain number of units of insulin. If you know from experience that it should be sufficient, MMA users can expect the carbohydrate You can choose to enter the number of insulin units taken with a meal instead of the amount of food consumed. Depending on whether the MMA user enters carbohydrate intake or dietary insulin, The recommended dose will then be calculated using the following appropriate formula.

[0147] When the user enters a value for carbohydrate intake, the recommended bolus insulin dose (RD) is calculated as follows: It is calculated using the following formula:

number

number

[0148] When the user enters their mealtime insulin level, the recommended bolus insulin dose is calculated using the following formula: It is calculated using,

number

[0149] The following considerations apply to the formula. ·Correction dose

number

number

[0150] If the calculated recommended dose returns a negative value, MMA recommends 0 units of insulin. It is possible. Alternatively, MMA may detect that the patient is or is likely to be in a hypoglycemic state. If administered, and / or if MMA is too high in the patient, IOB (onboard insulin, In other words, if it is determined that the patient has the amount of insulin in their body, MMA is determined by diet or Patients may be advised to consume a specific amount of carbohydrates. In some embodiments, If the MMA determines that the patient is or will be in a state of hypoglycemia, the MMA will The patient is injected with glucagon or several other drugs that increase the patient's glucose levels. It can be recommended that this be done.

[0151] An exemplary carbohydrate bolus calculator regimen is a bolus calculator configured by HCP. By enabling users to receive recommended doses based on their regimen, It helps reduce the complexity of insulin administration. Users receive a prescription for their administration regimen. If enabled, the user will enter the app and choose to enter the recommended bolus dosage workflow. The user can select and / or confirm the glucose level measurement. Enter the amount of carbohydrates you plan to consume, and any additional information such as changes in activity or stress. The user will select a change factor and receive the recommended bolus dose. Alternatively, you can choose to enter the number of insulin units needed to supplement your diet. This helps with dose correction using the regimen and consider insulin onboard. Hydrate bolus dosing regimens are insulin-based regimens used to supplement planned carbohydrate intake. The amount of insulin, the corrected dose based on current blood glucose levels and target blood glucose levels, and internal insulin PK Consider insulin onboarding based on PD data.

[0152] D. Carbohydrate meal size calculator A computational algorithm and associated regimen based on exemplary carbohydrate meal sizes This will be explained below. The calculator regimen based on exemplary carbohydrate meal sizes is the exemplary regimen described above. Using the carbohydrate bolus calculator regimen function, we can determine the low and moderate dietary carbohydrate content. Additional settings are made by HCP for qualitative assessment of the degree and magnitude of meals. For example For example, the expected amount of carbohydrates in a meal for an MMA user, or the amount of insulin used during a meal. Instead of typing, MMA users can choose to be "small," "medium," or "large." You can simply indicate your meal plans. Next, the MMA user's choice is, "small," Pre-set values ​​for "moderate" or "large" meals (for HCP and / or MMA users) Therefore, it is converted to an estimated value of carbohydrates based on (the constructible).

[0153] The exemplary carbohydrate meal size-based calculator regimen calculates meal size, specifically meal size. A user with T1DM and T2DM that can estimate the size of the carbohydrate content inside It is suitable for the patient. In some cases, the user may use a rapid-acting insulin analog during meals. Multiple daily insulin injections may be required.

[0154] To enable a calculator regimen based on exemplary carbohydrate meal sizes, HCP, The following parameters can be set. • Target GL (GL) in mg / dL T ) • Insulin effect (ISF) in mg / dL / insulin units • Insulin-to-carbohydrate ratio (ICR), carbohydrates / insulin units in grams • Insulin duration (ID) in hourly units, • Estimated carbohydrate content in grams for a "small" meal size • Estimates of carbohydrates in grams for a "moderate" meal size • Estimated amount of carbohydrates in grams for a "large" meal size

[0155] In addition, HCP is determined by any, all, or none of the following lifestyle change factors. It can be enabled and the corresponding adjustment amount can be set. HCP provides appropriate percentages to the patient. Use the percentage to set the adjustment of lifestyle factors. The percentage value is converted to a decimal value for use in the equation. If the HCP has not enabled the change factor, the dosing regimen will use a value of 0. · Activity Factor (AF) in percentage · Stress Factor (SF) in percentage · Illness Factor (IF) in percentage · Steroid Factor (StF) in percentage · Menstrual Factor (MF) in percentage

[0156] MMA will calculate the recommended dose using the following additional inputs. · Current GL (GL) in mg / dL · Current time (t) in time units · Carbohydrate intake meal size (MS ) as a choice of small, medium, large, or none · MMA will replace the meal size with the corresponding gram number of carbohydrates based on the HCP's preset for the selected meal. · If the patient selects the option of no meal, MMA will replace the meal size with a value of 0.

[0157] Insulin on board (IOB), i.e., all insulin doses still effective during the current period, will be incorporated into the calculation. Previous doses are considered "effective" if taken less than ID (insulin duration ) hours ago. In some embodiments, previous doses can be calculated using the following parameters. · Delivery bolus (DB) in insulin units · Bolus delivery time (t DB ) in time units · Multiplier (X) · When individual delivery boluses are administered within 0.5 hours, X = 0 • When individual delivery boluses are administered more than 0.5 hours but less than ID time before, X=1

[0158] As mentioned above, DB parameters in IOB calculations can be defined in multiple ways. For example, the DB parameter is (i) the total amount of insulin from the previous dose, or ( ii) It can be set to either the glucose-corrected portion of the previous dose or only.

[0159] The recommended bolus insulin dose (RD) is calculated using the following formula:

number

number

[0160] The following considerations apply to the formula. ·Correction dose

number

number

[0161] If the calculated recommended dose returns a negative value, MMA recommends 0 units of insulin. It is possible. Alternatively, MMA may detect that the patient is or is likely to be in a hypoglycemic state. If administered, and / or if MMA is too high in the patient, IOB (onboard insulin, In other words, if it is determined that the patient has the amount of insulin in their body, MMA is determined by diet or Patients may be advised to consume a specific amount of carbohydrates. In some embodiments, If the MMA determines that the patient is or will be in a state of hypoglycemia, the MMA will The patient is injected with glucagon or several other drugs that increase the patient's glucose levels. It can be recommended that this be done.

[0162] The calculator regimen based on exemplary carbohydrate meal sizes is a meal composed by HCP. This allows users to receive recommended doses based on a calculated regimen derived from the size of the event. This may help reduce the complexity of bolus insulin administration. If the user accepts the prescription for the administration regimen, they will enter the app and check the recommended bolus dose. You can choose to enter the workflow. The user enters a glucose measurement. Call / confirm, select meal size, and any additional information such as changes in activity or stress. You will select the modification factor and receive the recommended bolus dose based on carbohydrate meal size. The calculated dosage regimen is the amount of insulin needed to supplement the planned carbohydrate intake, currently Corrected dose based on blood glucose levels and target blood glucose levels, as well as internal insulin PKPD data. Consider the onboard insulin regimen.

[0163] Figure 19 shows MMA running on a mobile device (for example, mobile device 104 MMA568 running on the above, or MMA57 running on mobile device 532. A flowchart illustrating an exemplary process 1900 implemented by MMA. Process 1900 is used to collect information about the patient's condition and to prescribe effective medications. The recommended insulin dose on the MMA is determined according to the insulin administration regimen.

[0164] In step 1902, the MMA receives glucose readings from the patient. This can be done in various ways. For example, Figure 20 shows MMA as a continuous glucose meter. Automatically synchronizes with the patient's connected glucose sensor, such as a CGM, from the MMA. An illustrative screenshot is shown. As shown in Figure 20, the MMA connects The time when the glucose meter reading was taken from the glucose meter (in this example, At 9:31 AM, the blood glucose level (in this case, 355 mg / dL) can be illustrated. Additionally, by touching the button labeled "or edit blood glucose level," the patient can edit their blood glucose level. Allows editing of readings received by the patient from a connected glucose meter. If you agree to the glucose level, or if the patient stops editing the glucose level If so, the patient can touch the button labeled "Check Blood Glucose Level," and at that point... The MMA will record the presented glucose levels in the patient's log.

[0165] Alternatively, MMA allows patients to manually enter their glucose levels, or It is possible to prompt the MMA to synchronize with the connected glucose meter. These methods for receiving the patient's glucose level are shown in Figures 21A, 21B, and 21C. As shown in Figure 21A, the MMA asks the patient to input their glucose level. It prompts the patient to do so. If the patient touches the button labeled "Enter blood glucose level," the MMA will... The patient then moves to the screen shown in Figure 21B, where they monitor their glucose levels. It can be entered manually. Once the patient enters the glucose level, the patient will say "Next". Touch the button to have the MMA record the entered glucose level in the patient's log. Instructions can be given. The patient touched the button labeled "or synchronize with meter". In this case, the MMA transitions to the screen shown in Figure 21C, where the MMA connects to the patient. It synchronizes with the glucose meter (e.g., BGM, CGM, or FGM). In addition, as shown in Figure 21C, the MMA is connected to the patient's glucose meter and measures 35 The patient receives a glucose level of 5 mg / dL. Alternatively, the patient may receive the "or May" shown in Figure 21B. If you touch the "Sync with" button, MMA will also move to the screen shown in Figure 21C. The MMA will then receive glucose levels from the connected meter, and the patient will say, "Next." By touching the "To" button, MMA will start recording glucose levels in the patient's log. You can give instructions to them.

[0166] Returning to Figure 19, when the MMA receives the glucose reading, the MMA steps Move to 1904. At this point, MMA will determine which dosing regimen has been prescribed and on MMA Determine if it is effective. If a daily titration regimen is prescribed / effective, the process Step 1900 branches to Step 1906. A fixed-dose regimen is prescribed / effective. If so, process 1900 branches to step 1908. Carbohydrate bolus calculation If a medical regimen has been prescribed / is in effect, process 1900 proceeds to step 1910. It branches off. A calculator regimen based on carbohydrate meal size is prescribed / effective. In this case, process 1900 branches to step 1912.

[0167] Step 1906 (used in daily titration regimens) uses MMA based on the type of meal. Alternatively, the time selection is received from the patient. For example, an exemplary screen shown in Figures 22A-22C Lean Shot is administered to patients at breakfast (Figure 22A), lunch (Figure 22B), and dinner (Figure 22B). C) Allows you to indicate whether you plan to take a certain dose at bedtime (Figure 22D). MMA uses this information to provide the above example for the “daily titration” dosing regimen. The recommended insulin dose is calculated according to an exemplary algorithm.

[0168] Step 1908 (used in fixed-dose regimens) involves selecting the type of meal. Select and receive any applicable health factors from the patient. For example, Figures 23A-23D The illustrative screenshot shown is of a patient eating any meal (Figure 23A), at breakfast ( Figure 23B), a certain dose unrelated to lunchtime (Figure 23C) or dinnertime (Figure 23D) It will be possible to indicate whether or not the patient plans to consume it. Regardless of the dietary choices the patient makes, The patient may also be experiencing stress, activity, illness, steroids, and / or menstruation. You can select any health factors you are experiencing. MMA will use this information to For "fixed-dose" dosing regimens, follow the example algorithm described above to recommend the following Calculate the phosphorus dose.

[0169] In Step 1910 (used in the carbohydrate bolus calculator regimen), MMA is, The expected number of grams of carbohydrates the patient is expected to consume, and / or the expected amount the patient is expected to consume. The expected amount of insulin needed during a meal, which the patient predicts will be sufficient to supplement a certain amount of carbohydrates. The number of units is received. MMA also receives any applicable health factors from the patient. For example, Figure 24A shows the patient being prompted to enter the expected number of grams of carbohydrates to be consumed. The patient can enter estimated carbohydrate values ​​using the numeric keypad. Figure 2 As illustrated in 4B, the patient plans to consume 96 grams of carbohydrates. This was shown. When the patient pressed the "Next" button, the MMA displayed the screen shown in Figure 24C. The patient then transitions to a stage where stress, activity, illness, steroids, and / or menstruation may be contributing factors. Patients can select any health factors they are currently experiencing. Once finished, the patient will see a "Next" button that appears when at least one health factor has been selected. It is possible to touch (not shown). Alternatively, the patient may have any of these health factors If neither of these has been experienced, the patient can press the "skip" button. If one health factor is selected, or if the patient presses the "skip" button, MMA The screen then transitions to the one shown in Figure 24D. Figure 24D shows the screen for the patient's confirmation. MMA displays the selected number of grams of carbohydrates, as well as any selected health factors. The patient can confirm by touching the "Next" button.

[0170] Alternatively, (for example, based on experience) it would supplement the meals you plan to eat. The patient can determine the number of insulin units they expect to take with meals. The user selects the "Meal Insulin" radio button in Figure 24A to indicate that they are eating a meal. MMA can indicate when insulin will be entered. "Dietary insulin" If a radio button is selected, the MMA will display a series of screens as shown in Figures 25A-D. Transition. In Figure 25A, MMA uses the numeric keypad to measure dietary insulin. The patient is prompted to enter the number of units. For example, as shown in Figure 25B, the patient, 12 units of mealtime insulin were entered. When the patient pressed the "Next" button, the MMA displayed the following diagram. The patient then moves to the screen shown at 25C, where the patient is assessed for stress, activity, illness, and steroids. You can select any health factor you are currently experiencing, such as drowsiness and / or menstruation. Alternatively, if the patient has not experienced any of these health factors, the patient will be told The "Skip" button can be pressed. In Figure 25D, for patient confirmation, MMA This displays the number of units of insulin administered during meals, as well as any selected health factors. The patient can confirm by pressing the "Next" button.

[0171] Returning to Figure 19, step 1912 (used for calculating regimens based on carbohydrate meal size) In use, MMA is used to select meal sizes and to address any applicable health factors. Received from the person. For example, the exemplary screenshots shown in Figures 26A-D are from the patient. However, any meal (Figure 26A), a "small" meal (Figure 26B), a "medium" sized meal ( Taking a certain dose, not associated with a “large” size meal (Figure 26C) or a “large” size meal (Figure 26D) This allows you to indicate whether you plan to do so. These meal size options are based on the aforementioned pre-set The expected carbohydrate values ​​are converted according to the defined meal size. Regardless of the meal size choice, patients may also be affected by stress, activity, illness, steroids, etc. You can choose any health factor that the patient is currently experiencing, such as menstruation or / or menstruation. MMA uses this information to create a "Carbohydrate Meal Size Calculator" regimen. The recommended insulin dose is then calculated according to the exemplary algorithm described above.

[0172] Returning to Figure 19, in step 1906, 1908, 1910, or 1912, the patient After gathering information, the MMA branches off to step 1914, where the recommended insulin dose is determined. Calculate and present. What algorithms are currently used to calculate the recommended insulin dose? This varies depending on whether the prescribed administration regimen is effective, as mentioned above. Next, M MA administers this dose to the user as shown in the illustrative screenshot in Figure 27A. Present (in this example, a dose of 10 units of mealtime insulin is recommended). The patient also, For example, by touching the "Edit Dosage" button in Figure 27A, you can edit the recommended dosage. They will be given a meeting.

[0173] In step 1916, MMA determines whether the user has edited the recommended dosage. If this occurs, MMA branches to step 1918 and updates the dosage presented therein. The process is shown in Figure 27B, where the patient has a "+" to the right of the presented dose. You can increase the recommended dose by pressing the button, or to the left of the displayed dose... The recommended dose can be reduced by pressing the "-" button. Once editing is complete, the patient can touch the "Save" button, which allows the patient to view the diagram. Return to the screen shown in 27A. A daily titration regimen is prescribed / effective. In some cases, the MMA may optionally display an additional message as shown in Figure 27C. This allows the titration regimen to adjust the insulin dose for the following day, It is important to remind patients that it is crucial to check their blood sugar levels before their next meal. To make someone do it.

[0174] If the patient has not edited the suggested dosage, the MMA branches to step 1920. Here, it is determined whether the user has confirmed the dosage intake. If not edited, MMA will Return to step 1916. If edited, proceed to step 1922 and use here Record the amount. This process is shown in Figures 27A and 27C, and the patient says, "This By touching the button labeled "Dose Taken," it is confirmed that the patient has taken the dose. You can check this. By touching this button, you can send the suggested dosage to MMA. Have the patient record the information in their logbook.

[0175] Figure 28 shows the drugs administered to patients, currently administered to patients, and / or recently administered to patients. An alternative user interface display that shows the administered insulin dose. Figure 2800. The insulin dose is one of the insulin administration regimens mentioned above. One may be recommended, or manually entered or adjusted by the patient. It may also be shown in Figures 27A to 27C. The user interface display 2800 is shown in Figures 27A to 27C. Instead of, or in addition to, the screenshot shown, is displayed on MMA To obtain. Alternatively, or in addition, the user interface display 2800 is in This can be displayed on a drug delivery device, such as on a visual screen attached to a slimpen. ru.

[0176] The user interface display 2800 includes multiple panels. The panels are visually A portion of the sensory display screen contains data displayed by the processor. Obtain. Panel 1 2802 is administered to the patient, currently administered to the patient, or The number of units of insulin recently administered to the patient is shown, and in the illustrated example, the first panel Lu2802 indicates 3.5 units of insulin.

[0177] The second panel 2804 is based on the number of insulin units displayed by the first panel. The amount of carbohydrates expected to be supplemented is indicated. As used in the context of "supplementation," a certain number of units Y of insulin is "expected to be supplemented." The amount of carbohydrates X, when consumed by a patient with diabetes, is equivalent to the carbohydrate content of that amount X. After ingesting the substance, the patient's glucose level returns to the same level as before ingesting the amount X of carbohydrates. To maintain the glucose level, the patient will need to be given Y units of insulin. This must correspond to the estimated amount of carbohydrates. In the illustrated example, Panel 2 804 is expected to be supplemented by 3.5 units of insulin, provided that 28g of carbohydrates are consumed. This indicates that the carbohydrate values ​​shown by the second panel 2804 are The number of insulin units shown by the first panel 2802 is shown as insulin versus carbohydrates. It can be calculated by dividing by the ratio (ICR). User interface design The Display 2800 is for all patients, or by patients, caregivers, or HCPs. You can use the default ICR value that applies to the patient-specific ICR provided. In some embodiments, the ICR of a particular patient follows a predictable pattern over time. If it is known to fluctuate, ICR can be specific to both the patient and the time. In this example, it is used by the user interface display 2800. If the ICR is 0.125, the carbohydrates shown by the second panel 2804 The number of Rams (28g) is the number of insulin units (3) displayed by the first panel 2802. It can be derived by dividing 0.5 units by ICR's 0.125.

[0178] The third panel 2806 shows that the carbohydrate values ​​displayed by the second panel are small. This indicates whether it corresponds to a regular meal size or a larger meal size. In the example illustrated in Figure 28, This third panel 2806 includes "small" meal sizes, "medium" meal sizes, and It takes the form of an area that displays the range of meal sizes between "large" meal sizes, and also the second Panel 2804 shows where the carbohydrate values ​​fall within this range. Includes indicator 2810. In other embodiments (not shown), a third panel 2806 is You may simply display letters, words, or symbols indicating the classification of meal sizes. In the simplest case... So, meals can be easily divided into one of two categories: "small" or "large" They can be similar. In some embodiments, meals are “small,” “medium,” or “large.” It can be classified into one of the three categories of "i". In yet another embodiment, the meal is It can be classified into four or more meal size categories.

[0179] The third panel, 2806, is based on adjustable parameters that define different meal size classifications. It can be calculated based on the following. For example, meals can be categorized into three categories (e.g., "small", "medium"). In embodiments that classify as "large" or "large", such adjustable parameters are: The minimum carbohydrate threshold for a "moderate" sized meal (e.g., 30g), and the minimum carbohydrate threshold for a "moderate" sized meal. This may include the maximum carbohydrate threshold (e.g., 60g) of a meal. Any carbohydrate level that falls between the major carbohydrate threshold and the "moderate" size meal is classified as such. It is possible. Any carbohydrate value that falls below the minimum carbohydrate threshold is a "small" size meal. It can be classified as such, and any carbohydrate value that falls above the maximum carbohydrate threshold is "large It can be classified as a meal of the size shown in Figure 28. The panel containing the area to be displayed also includes, for example, a section along the area, depending on the definition of the meal size. By measuring the position of the indicator, the indicator can be determined based on the definition of these meal sizes. The location of the food can be determined. As mentioned above, these meal size definitions This may be customizable by the patient, caregiver, or HCP.

[0180] The fourth panel 2808 shows the units of insulin displayed by the first panel 2802. The expected decrease in the patient's glucose level resulting from the number of doses is shown. In one example, panel 2808 showed a decrease in blood glucose of 75 mg / dL, compared to the first panel. This is what is expected to result from the administration of 3.5 units of insulin, as shown on panel 2802. This indicates that the glucose decrease shown by the fourth panel 2808 is compared to the first panel Multiply the number of insulin units displayed by Nell 2802 by the insulin effect value (ISF). It can be calculated by performing calculations. User interface display 280 0 is for all patients, or patient-specific information provided by the patient, caregiver, or HCP. You can use the default ISF that applies to the existing ISF. Several implementations In this state, it has been found that the ISF of a particular patient fluctuates according to a predictable pattern over time. If present, ISF can be specific to both the patient and the time. In this example, I If SF is 21.4, the expected BG decrease (75m) is shown by the fourth panel 2808. g / dL) is the number of units (3.5 units) displayed by the first panel 2802 to ISF This can be derived by multiplying by 21.4.

[0181] Figure 28 includes all four panels 2802, 2804, 2806, and 2808. The user interface display 2800 is shown, but some embodiments You may choose to display only a subset of these four panels, or display additional panels. They may be shown. For example, some embodiments show a first panel 2802, a second panel 2 It may include only panel 804 and the third panel 2806, and may not display the fourth panel 2808. This may also be the case. In other embodiments, the user interface display 2800 is the first It may include only panel 2802 and the fourth panel 2808, and not the second panel 2804 or The third panel 2806 does not need to be displayed. In yet another embodiment, the user interface The face display 2800 consists of a first panel 2802 and a second panel 2804. This may include the following. The panels may be in the order, configuration, or relative size shown in Figure 28. It does not need to be placed.

[0182] Regardless of which specific panel is displayed, the administration, currently being administered, and When the user adjusts the number of units of insulin recently administered, all the displayed units Nell may be updated. Figure 29 shows the number of insulin units, display 2900a 3. From 5 units to 4.0 units for display 2900b, and 4 units for display 2900c. This shows a series of user interface displays when adjusted to 5 units. As shown, the number of units displayed on the first panel is 3.5 or It then changes to 4.0 for panel 2902b, and then to 4.5 for 2902c. Similarly, the second panel The carbohydrate values ​​shown on the label (Panels 2904a, 2904b, and 2904) See c), the third panel's meal size indicator (Panels 2906a, 2906b, See also 2906c), and the expected glucose decrease in the fourth panel (Panel 2 (See 908a, 2908b, and 2908c) When the number of insulin units changes It will be updated automatically.

[0183] The example shown in Figure 29 illustrates a case where the insulin dosage is adjusted in increments of 0.5 units. However, they do not need to be the same. Generally, the number of units on the disclosure user interface. The level of fine-tuning that can be adjusted is related to the delivery data associated with the user interface. This may depend on the dose analysis capability of the Vice. For example, if the delivery device (such as an insulin pen) is 1. If it is possible to deliver different doses in increments of 0 units, the user interface will be Furthermore, it may be configured to allow dose adjustment in 1.0 unit increments. The delivery device is 2. If it is possible to deliver different doses in increments of 0 units, the user interface will be Furthermore, it can be configured to allow adjustment in increments of 2.0 units, 0.1 units, and 5.0 units. The same applies to the dose analysis capabilities of other delivery devices, such as any other dose analysis capabilities. The dose analysis capabilities of the user interface are matched to those of the patient's delivery device. This allows patients to easily determine how to set the dosage on their delivery device. This becomes possible. In some cases, the user interface may have different dose analysis capabilities. It can be designed to work with multiple types of delivery devices. In such embodiments, The dose analysis capability on the user interface corresponds to the dose analysis capability on the delivery device for a specific patient. To ensure consistency, it may be composed of the patient, caregiver, or HCP.

[0184] The number of units of insulin to be administered / currently administered / recently administered, along with the number of units to be supplemented. The carbohydrate content, meal size, and / or expected glucose level are indicated. By demonstrating this, several benefits are offered to the patient. Patients often use a certain type of charcoal. To supplement hydrate levels, to supplement a specific meal size, or glucose levels Insulin is administered to achieve a specific reduction in the blood sugar level. Some or all of this information By displaying this to the patient, it becomes easier for the patient to determine if the displayed dosage will meet their goals. This allows for a determination, and the displayed dosage can be adjusted accordingly.

[0185] Furthermore, by displaying this information simultaneously, it becomes possible to determine whether over-dosing or under-dosing is caused by rounding errors. By reducing the user interface of conventional known delivery devices, Technical problems are solved. For example, a patient tries to calculate the dosage to supplement a specific diet. Often, patients begin by estimating the carbohydrate content of the meal they are about to eat. When the patient reaches the estimated carbohydrate level, the patient then uses the estimated carbohydrate level as a basis. Calculate the dose size. However, when calculating the dose size, the use of the drug delivery device Depending on the ability to analyze the dosage, patients are often asked to round up the insulin dose to the nearest unit or half unit. Rounding up five times. In this process, the patient rounds up two times to reach the insulin dose. Or estimation step: The first step is for the patient to estimate the amount of carbohydrates in their diet, and The patient must go through a second step in which they convert the estimated amount of carbohydrates into units of insulin. There is a reason for this. This two-step process overestimates the dosage needed to supplement a particular diet. This increases the risk of underestimation.

[0186] This is best explained using an illustrative scenario: A patient consumes 75g of carbohydrates. Consider the case where it is presumed that the patient is about to consume a meal containing the following: the appearance of the meal and This estimate is reached based solely on one's previous experience. Then, the user installs The dosage is calculated based on a carbohydrate-to-nutrient ratio of 8, resulting in 75g / 8 = 9.375 units. A quantity can be obtained. However, due to the dose analysis capability of the user's drug delivery device, Since only one unit of insulin can be administered at a time, it is rounded down to 9 units. Administer. In this case, the patient underestimates the amount of carbohydrates in their diet (for example, the patient's eye If the previous meal actually contained 80g of carbohydrates, then discarding it, the patient A person may underestimate twice the amount needed to supplement their diet. If not supplemented, this Underdosing with lancel may make it more difficult for patients to achieve their blood glucose targets.

[0187] By displaying the amount of carbohydrates supplemented and the number of insulin units, the user The interface display reduces errors caused by rounding. By dialing 9 to 10 units on the interface, the patient can receive 9 units. It supplements 72 grams of carbohydrates, and 10 units would supplement 80 grams of carbohydrates. A decision can be made quickly. Next, the user determines that the meal in front of them contains 72 grams of charcoal. It is possible to estimate whether it is closer to a hydrate or closer to 80 grams of carbohydrates. In contrast to the aforementioned scenarios which require a calculation or estimation step, this calculation is performed by the patient This involves only a single, simple estimation step by which the patient supplements the meal in front of them. This increases the chances of reaching the correct dosage. For example, 72 grams to 80 grams When faced with this choice, the patient decides that their previous meal was actually close to 80 grams. The probability may increase, and you may choose to administer 10 units of insulin. .

[0188] The user interface of the disclosure also similarly allows patients to see meal size rather than carbohydrates. Other situations in which a dosing decision is made based on a reduction in the target glucose level and / or Rounding errors in the scenario can be reduced. Along with the presented insulin dose, By displaying the estimated decrease in event size and / or glucose levels, disclosure The user interface also includes the estimation / rounding steps required by the patient. This reduces the frequency of certain dietary changes, and therefore, patients can supplement certain diets or specific glucose levels. This increases the chances of reaching the correct dosage to achieve the bell.

[0189] As previously mentioned, the disclosed user interface 2800 is shown in Figures 27A-27C. Instead of, or in addition to, screenshots of the disclosure, run on a mobile device. It can be displayed on the MMA. In addition, however, the disclosure of the user interface The Face 2800 also connects to mobile drug delivery devices such as insulin pens. It can be displayed in Figure 30, and This is connected to a screen 3000 that displays the aforementioned user interface. This shows an insulin pen 3002. Such a connected insulin pen 3002 is via Bluetooth, WiFi, NFC, or other wireless links, mobile devices It can communicate wirelessly with mobile devices such as the Vice 104. The connected insulin pen 3002 measures the insulin-to-carbohydrate ratio (ICR), and insulin Phosphorus Efficacy Value (ISF), and / or minimum and maximum carbohydrate content of a “moderate” sized meal. User interface panels such as the definition of meal size, including the object threshold (as mentioned above) It can detect various parameters for calculating the information displayed by the system. .

[0190] Figure 31 shows how mobile devices (such as smartphones or drug delivery devices) can be used. A flowchart illustrating an exemplary process to be performed is shown. In step 3102 Mobile devices allow multiple people to interact through the visual display on the mobile device. The Nell panel is presented simultaneously. These panels include the number of units of insulin administered to the patient. The first panel displays the number of insulin units displayed by the first panel. A second panel displays the amount of carbohydrates that are expected to be supplemented. The carbohydrate values ​​shown are for small, medium, or large meal sizes. A third panel indicating the size compatibility, and / or the first panel. This displays the expected decrease in the patient's glucose level resulting from the administration of a given number of insulin units. A fourth panel can be cited. As mentioned above, some embodiments are four You may choose to display only a subset of these panels, rather than all of them. The embodiment may also display additional panels.

[0191] In step 3104, the mobile device is administered to the patient, currently administered to the patient User input to adjust the number of insulin units currently and / or recently administered to the patient. It receives the following: For example, this user input is similar to the MMA discussed above in Figure 27B. You can do this via the "plus" or "minus" buttons on the screen, or via the numeric keypad. It can be received using a connected insulin pen or similar device. The device receives user input by the user dialing the knob on the delivery device. It is possible.

[0192] In step 3106, the mobile device will administer the adjusted number of insulin units according to the instructions. , update the first panel, the second panel, the third panel, and / or the fourth panel. As mentioned above, this adjustment converts the number of insulin units into the amount of carbohydrates that can be supplemented. Parameters (insulin-to-carbohydrate ratio, i.e., ICR), and the number of insulin units are predetermined. A parameter that translates to a decrease in the expected glucose level (insulin effect value, i.e., I Use parameters such as SF (Small Food Quantity) or parameters that convert the amount of supplemented carbohydrates into meal size. It can be done by doing so.

[0193] Although the present invention has been described as having exemplary designs, embodiments of the present disclosure are as follows: The concepts and scope of this disclosure may be further modified. Therefore, this application is not intended to be used in general terms. The use of the rules does not mean to include any variation, use, or adaptation of any embodiment of the present disclosure. It is illustrated. It should be noted that the present invention includes the following embodiments. [Aspect 1] It is a method, Multiple medications related to a patient can be accessed through the Healthcare Professional (HCP) portal application. The purpose is to present the administration regimens, and each presented drug administration regimen is different. The presentation of the drug administration algorithm is related to the following: The presented drug administration regimen via the HCP portal application To receive at least one HCP selection, Medical mobile application (MM) on the mobile device associated with the aforementioned patient A) The HCP selective regimen that shows the at least one HCP selective drug administration regimen. A method that includes sending data. [Aspect 2] The aforementioned drug administration regimen includes one or more insulin administration regimens. The aforementioned at least one HCP-selective drug administration regimen is at least one HCP-selective The method according to embodiment 1, comprising a lancel administration regimen. [Aspect 3] The one or more presented insulin administration regimens include at least one basal insulin Embodiment 2 includes a insulin administration regimen and one or more bolus insulin administration regimens. Methods used. [Aspect 4] The aforementioned at least one HCP-selective insulin administration regimen is at least one HCP Selective basal insulin administration regimen and at least one HCP selective bolus insulin The method according to embodiment 3, including an administration regimen. [Aspect 5] From the Health Information Technology (HIT) system, the electronic health record (EHR) related to the patient is obtained. Accessing the data and The EHR data is presented via the aforementioned HCP portal application, The method according to embodiment 1, further comprising: [Aspect 6] The aforementioned at least one HCP-selective insulin administration regimen involves daily titration bolus in Daily titration bolus insulin administration regimens associated with insulin administration algorithms The method according to embodiment 2. [Aspect 7] The aforementioned at least one HCP-selective insulin administration regimen is a fixed-dose bolus insulin Includes a fixed-dose bolus insulin administration regimen associated with a phosphorus administration algorithm. The method according to embodiment 2. [Aspect 8] The aforementioned at least one HCP-selective insulin administration regimen is a carbohydrate bolus calculator Carbohydrate bolus calculator associated with bolus insulin administration algorithms The method according to embodiment 2, including an insulin administration regimen. [Aspect 9] The aforementioned at least one HCP-selective insulin administration regimen is based on carbohydrate meal size. The carbohydrate meal size associated with the bolus insulin administration algorithm of the calculator The method according to embodiment 2, comprising a computer-based bolus insulin administration regimen. [Aspect 10] Through the mobile device user interface of the aforementioned mobile device, the MM A patient acceptance table associated with the at least one HCP-selective drug administration regimen. Further receiving a regimen acceptance indication from the MMA that the indication has been received The method according to embodiment 1, including [Aspect 11] Through the mobile device user interface of the mobile device, the few The MMA indicates that the patient refusal indication is associated with at least one HCP-selective drug administration regimen. Receiving a regimen rejection indication from the MMA, and the patient rejection In response to the display, disable the MMA on the mobile device associated with the patient. The method according to embodiment 1, further comprising doing the following: [Aspect 12] The HCP selection regimen data is the at least one HCP selection drug administration regimen. The method according to embodiment 1, wherein the MMA is operable to unlock it. [Aspect 13] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the above means the MMA is pre-stored on the mobile device. Access the implementation data of the at least one HCP-selective drug administration regimen that has been implemented. The method according to embodiment 12, which is operable in such a way. [Aspect 14] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the MMA, the at least one HCP selector The implementation data for the drug administration regimen can be downloaded to the mobile device. The method according to embodiment 12, which is capable of performing. [Aspect 15] The patient acceptance indication for the aforementioned at least one HCP-selective drug administration regimen is the M Conditional on receiving by MA, the HCP selection regimen data is at least It is also possible to operate on the MMA to unlock another HCP-selective drug administration regimen. A method according to one aspect 12. [Aspect 16] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. The method described in embodiment 1. [Aspect 17] The MMA communicates via the mobile device user interface of the mobile device. And, it provides administration recommendations based on the aforementioned at least one HCP-selective drug administration regimen. The method according to embodiment 1, configured as follows. [Aspect 18] A connected care server system, One or more servers, each server having one or more communication interfaces, one or more Includes one or more servers, including a processor and data storage, When executed by one or more of the processors of the one or more servers, the connector The TedCare server system can be operated to perform a set of server system functions. The instructions are collectively included in the data storage of one or more servers, and the server system A set of system functions, Communicating with at least one of the communication interfaces of the one or more servers Through the Health Care Professional (HCP) portal application, multiple medications related to the patient The purpose is to present the administration regimens, and each presented drug administration regimen is different. The presentation of the drug administration algorithm is related to the following: The presented drug administration regimen is accessed via the HCP portal application. To receive at least one of our HCP selections, via at least one of the communication interfaces of the one or more servers , a medical mobile application (MM) on the mobile device associated with the patient A) The HCP selective regimen that shows the at least one HCP selective drug administration regimen. A connected care server system that includes sending data. [Aspect 19] The aforementioned drug administration regimen includes one or more insulin administration regimens. The aforementioned at least one HCP-selective drug administration regimen is at least one HCP-selective The system according to embodiment 18, comprising a lancel administration regimen. [Aspect 20] The one or more presented insulin administration regimens include at least one basal insulin Embodiment 1, comprising a insulin administration regimen and one or more bolus insulin administration regimens. The system described in section 9. [Aspect 21] The aforementioned at least one HCP-selective insulin administration regimen is at least one HCP Selective basal insulin administration regimen and at least one HCP selective bolus insulin The system according to embodiment 20, including an administration regimen. [Aspect 22] The aforementioned set of server system functions, From the Health Information Technology (HIT) system, electronic health record data (EH) related to the patient Accessing R) and The EHR data is presented via the aforementioned HCP portal application, The system according to embodiment 18, including the system described in embodiment 18. [Aspect 23] The aforementioned at least one HCP-selective insulin administration regimen involves daily titration bolus in Daily titration bolus insulin administration regimens associated with insulin administration algorithms The system described in embodiment 19. [Aspect 24] The aforementioned at least one HCP-selective insulin administration regimen is a fixed-dose bolus insulin Includes a fixed-dose bolus insulin administration regimen associated with a phosphorus administration algorithm. The system described in aspect 19. [Pattern 25] The aforementioned at least one HCP-selective insulin administration regimen is a carbohydrate bolus calculator Carbohydrate bolus calculator associated with bolus insulin administration algorithms The system according to embodiment 19, comprising an insulin administration regimen. [Aspect 26] The aforementioned at least one HCP-selective insulin administration regimen is based on carbohydrate meal size. The carbohydrate meal size associated with the bolus insulin administration algorithm of the calculator The system according to embodiment 19, comprising a computer-based bolus insulin administration regimen. [Aspect 27] Through the mobile device user interface of the mobile device, the few The patient acceptance indication associated with at least one HCP-selective drug administration regimen is the MM. A regimen acceptance indication that A has received the regimen is displayed by the set of server system functions M The system according to embodiment 18, further comprising receiving from MA. [Aspect 28] Through the mobile device user interface of the mobile device, the few The MMA indicates that the patient refusal indication is associated with at least one HCP-selective drug administration regimen. The set of server system functions receives a regime rejection message from the MMA indicating that it has been received. To receive and in response to the regimen refusal indication, the mobile associated with the patient The method according to embodiment 18 further includes disabling the MMA on the device. Stem. [Aspect 29] The HCP selection regimen data is the at least one HCP selection drug administration regimen. The system according to embodiment 18, wherein it is operable on the MMA to unlock it. [Aspect 30] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the above means the MMA is pre-stored on the mobile device. Access the implementation data of the at least one HCP-selective drug administration regimen that has been implemented. The system according to embodiment 29, which is operable in such a manner. [Aspect 31] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the MMA, the at least one HCP selector The implementation data for the drug administration regimen can be downloaded to the mobile device. The system described in embodiment 29 is capable of performing the function. [Aspect 32] The patient acceptance indication for the aforementioned at least one HCP-selective drug administration regimen is the M Conditional on receiving by MA, the HCP selection regimen data is at least It is also possible to operate on the MMA to unlock another HCP-selective drug administration regimen. A system as described in one aspect 29. [Aspect 33] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. The system described in embodiment 18. [Aspect 34] The MMA communicates via the mobile device user interface of the mobile device. And, it provides administration recommendations based on the aforementioned at least one HCP-selective drug administration regimen. The system according to embodiment 18, which is configured as follows. [Aspect 35] When executed by one or more processors, the set of functions is assigned to the one or more processors. One or more non-temporary computer-readable files that store instructions that can be manipulated to be executed. A medium (CRM) in which the set of functions is Multiple drug administration regimens related to a patient can be accessed via the HCP portal application. The purpose is to present each drug administration regimen, and each presented drug administration regimen is different in its own way. The act of presenting, which is associated with gorism, The presented drug administration regimen via the HCP portal application To receive at least one HCP selection, Medical mobile application (MM) on the mobile device associated with the aforementioned patient A) The HCP selective regimen that shows the at least one HCP selective drug administration regimen. A non-temporary computer-readable medium that includes the transmission of data. [Aspect 36] The aforementioned drug administration regimen includes one or more insulin administration regimens. The aforementioned at least one HCP-selective drug administration regimen is at least one HCP-selective The CRM according to embodiment 35, comprising a lancel administration regimen. [Aspect 37] The one or more presented insulin administration regimens include at least one basal insulin Embodiment 3, comprising a insulin administration regimen and one or more bolus insulin administration regimens. CRM as described in 6. [Aspect 38] The aforementioned at least one HCP-selective insulin administration regimen is at least one HCP Selective basal insulin administration regimen and at least one HCP selective bolus insulin A CRM according to embodiment 37, including an administration regimen. [Aspect 39] The aforementioned set of functions, From the Health Information Technology (HIT) system, the electronic health record (EHR) related to the patient is obtained. Accessing the data and The EHR data is presented via the aforementioned HCP portal application, The CRM according to embodiment 35, further comprising: [Aspect 40] The aforementioned at least one HCP-selective insulin administration regimen involves daily titration bolus in Daily titration bolus insulin administration regimens associated with insulin administration algorithms Including the CRM described in embodiment 36. [Aspect 41] The aforementioned at least one HCP-selective insulin administration regimen is a fixed-dose bolus insulin Includes a fixed-dose bolus insulin administration regimen associated with a phosphorus administration algorithm. , the CRM described in embodiment 36. [Aspect 42] The aforementioned at least one HCP-selective insulin administration regimen is a carbohydrate bolus calculator Carbohydrate bolus calculator associated with bolus insulin administration algorithms The CRM according to embodiment 36, comprising an insulin administration regimen. [Aspect 43] The aforementioned at least one HCP-selective insulin administration regimen is based on carbohydrate meal size. The carbohydrate meal size associated with the bolus insulin administration algorithm of the calculator A CRM according to embodiment 36, comprising a computer-based bolus insulin administration regimen. [Aspect 44] Through the mobile device user interface of the mobile device, the few The patient acceptance indication associated with at least one HCP-selective drug administration regimen is the MM. The set of functions receives a regimen acceptance indication from the MMA that A has received it. The CRM according to embodiment 35, further comprising the following: [Aspect 45] Through the mobile device user interface of the mobile device, the few The MMA indicates that the patient refusal indication is associated with at least one HCP-selective drug administration regimen. The set of functions receives a regimen rejection indication from the MMA that it has been received. In response to the patient refusal indication, on the mobile device associated with the patient, The CRM according to embodiment 35, further comprising disabling the MMA. [Aspect 46] The HCP selection regimen data is the at least one HCP selection drug administration regimen. The CRM according to embodiment 35, which is operable on the MMA to unlock it. [Aspect 47] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the above means the MMA is pre-stored on the mobile device. Access the implementation data of the at least one HCP-selective drug administration regimen that has been implemented. A CRM according to embodiment 46, which is operable in such a manner. [Aspect 48] The aforementioned at least one HCP-selective drug administration regimen is the HCP-selective regimen data Only after being unlocked by the MMA, the at least one HCP selector The implementation data for the drug administration regimen can be downloaded to the mobile device. The CRM described in embodiment 46. [Aspect 49] The patient acceptance indication for the aforementioned at least one HCP-selective drug administration regimen is the M Conditional on receiving by MA, the HCP selection regimen data is at least It is also possible to operate on the MMA to unlock another HCP-selective drug administration regimen. A CRM as described in one aspect 46. [Aspect 50] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. The CRM described in embodiment 35. [Aspect 51] The MMA communicates via the mobile device user interface of the mobile device. And, it provides administration recommendations based on the aforementioned at least one HCP-selective drug administration regimen. A CRM according to embodiment 35, configured as follows. [Aspect 52] It is a method, Multiple drug administration regimens, each associated with a different drug administration algorithm. Healthcare professionals (HCs) who indicate an HCP selection of at least one drug administration regimen from among the available options. P) Selected regimen data is executed on the patient's associated mobile device. Receiving via a mobile application (MMA), wherein the HCP selection is HC The following was done for the patient via the P portal application: In response to receiving the aforementioned HCP selection regimen data, at least partially, the indicated Unlock at least one HCP-selective drug administration regimen on the MMA. A method that includes "toto". [Aspect 53] Receiving the aforementioned HCP selection regimen data is the HCP portal application The method according to embodiment 52, comprising receiving the HCP selection regimen data from N. [Aspect 54] Receiving the aforementioned HCP selection regimen data is the HCP portal application The connected care server system that is communicating with both the HC and the MMA will receive the HC. The method according to embodiment 52, which includes receiving P-selection regimen data. [Aspect 55] After the receiving step and before the unlocking step, the mobile device The at least one HCP-selective agent via the Vile device user interface To present a prompt for the patient to accept or refuse the administration regimen, via the mobile device user interface to the presented prompt This further includes receiving corresponding user input, Performing the unlock step means that the received user input is less Both are subject to the condition that the patient acceptance indication pertains to one HCP-selective drug administration regimen. The method described in embodiment 52. [Aspect 56] The received user input is used by the HCP portal application and the HCP portal Connected care servers communicating with both the application and the MMA The method according to embodiment 55, further comprising transmitting to one or both of the stems. [Aspect 57] The unlocking step involves previously accessed data that was pre-stored on the mobile device. It was not possible to implement the data for the aforementioned at least one HCP-selective drug administration regimen. The method according to embodiment 52, including accessing. [Aspect 58] The unlocking step involves accessing the at least one HC that was previously inaccessible. The implementation data for the P-selective drug administration regimen is downloaded to the mobile device. The method according to embodiment 52, including the following. [Aspect 59] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. The method described in embodiment 52. [Aspect 60] Through the mobile device user interface of the mobile device, the few This further includes providing dosing recommendations based on at least one HCP-selective drug administration regimen. The method according to embodiment 52. [Aspect 61] A mobile device associated with a patient, wherein the mobile device is Mobile device communication interface, Mobile device processor and A medical mobile application (MMA) for performing a set of MMA functions To be executed by the mobile device, the execution of the mobile device processor The set of MMA functions includes, mobile device data storage, including instructions, Multiple drug administration registers, each associated with a different drug administration algorithm. Healthcare professionals should indicate the selection of at least one drug administration regimen from among the available options. The HCP selection regimen data is received by the MMA, and the HCP selection is , received for the patient via the HCP portal application , In response to receiving the HCP selection regimen data, at least partially, Unlock at least one of the indicated HCP-selective drug administration regimens on the MMA. Mobile devices, including the term "things." [Aspect 62] Receiving the aforementioned HCP selection regimen data is the HCP portal application The mobile device according to embodiment 61, which includes receiving the HCP selection regimen data from the device. A device. [Aspect 63] Receiving the aforementioned HCP selection regimen data is the HCP portal application The connected care server system that is communicating with both the HC and the MMA will receive the HC. A mobile device according to embodiment 61, which includes receiving P-selection regimen data. [Aspect 64] The set of MMA functions further includes a mobile device user interface, After the receiving step and before the unlocking step, the mobile device user Through the interface, patients of the at least one HCP-selective drug administration regimen To present a prompt for acceptance or refusal of the patient, via the mobile device user interface to the presented prompt This further includes receiving corresponding user input, Performing the unlock step means that the received user input is less Both are subject to the condition that the patient acceptance indication pertains to one HCP-selective drug administration regimen. The mobile device described in embodiment 61. [Aspect 65] The aforementioned MMA function set processes the received user input into the HCP portal application. The system that communicates with both the HCP portal application and the MMA A manner that further includes transmitting to one or both the next care server system and the next care server system. Mobile devices as described in section 64. [Aspect 66] The unlocking step involves previously accessed data that was pre-stored on the mobile device. It was not possible to implement the data for the aforementioned at least one HCP-selective drug administration regimen. A mobile device according to embodiment 61, including accessing. [Aspect 67] The unlocking step involves accessing the at least one HC that was previously inaccessible. The implementation data for the P-selective drug administration regimen is downloaded to the mobile device. A mobile device according to embodiment 61, including the following. [Pattern 68] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. A mobile device as described in embodiment 61. [Aspect 69] The mobile device user interface further includes the set of MMA functions, The at least one HCP selector via the mobile device user interface The mobile device according to embodiment 61 further includes providing administration recommendations based on drug administration regimens. Ill device. [Aspect 70] When executed by one or more processors, the set of functions is assigned to the one or more processors. One or more non-temporary computer-readable files that store instructions that can be manipulated to be executed. A medium (CRM) in which the set of functions is Multiple drug administration regimens, each associated with a different drug administration algorithm. Healthcare professionals (HCs) who indicate an HCP selection of at least one drug administration regimen from among the available options. P) Selected regimen data is executed on the mobile device associated with the patient. Receiving via Medical Application (MMA), where the HCP selection is HC The following was done for the patient via the P portal application: In response to receiving the aforementioned HCP selection regimen data, at least partially, the indicated Unlock at least one HCP-selective drug administration regimen on the MMA. A non-temporary computer-readable medium that includes "toto". [Aspect 71] Receiving the aforementioned HCP selection regimen data is the HCP portal application The CRM according to embodiment 70, which includes receiving the HCP selection regimen data from N. . [Aspect 72] Receiving the aforementioned HCP selection regimen data is the HCP portal application The connected care server system that is communicating with both the HC and the MMA will receive the HC. A CRM according to embodiment 70, which includes receiving P-selection regimen data. [Aspect 73] The aforementioned set of functions, After the receiving step and before the unlocking step, the mobile device The at least one HCP-selective agent via the Vile device user interface To present a prompt for the patient to accept or refuse the administration regimen, via the mobile device user interface to the presented prompt This further includes receiving corresponding user input, Performing the unlock step means that the received user input is less Both are subject to the condition that the patient acceptance indication pertains to one HCP-selective drug administration regimen. The CRM described in embodiment 70. [Aspect 74] The aforementioned set of functions processes the received user input with the HCP portal application. Connect associated with both the HCP portal application and the MMA Embodiment 73 further includes transmitting to one or both the TedCare server system and / or the TedCare server system. The CRM described above. [Aspect 75] The unlocking step involves previously accessed data that was pre-stored on the mobile device. It was not possible to implement the data for the aforementioned at least one HCP-selective drug administration regimen. A CRM according to embodiment 70, including accessing. [Aspect 76] The unlocking step involves accessing the at least one HC that was previously inaccessible. The implementation data for the P-selective drug administration regimen is downloaded to the mobile device. A CRM according to embodiment 70, including the following. [Aspect 77] The MMA is connected in a way that allows it to communicate with the insulin delivery device associated with the patient. The CRM described in embodiment 70. [Aspect 78] The function via the mobile device user interface of the mobile device The set provides administration recommendations based on the aforementioned at least one HCP-selective drug administration regimen. The CRM according to embodiment 70, further including the following. [Aspect 79] It is a method, The processor on the mobile device associated with the patient determines the mobile device The presenting of multiple panels simultaneously on a visual display of the computer, wherein the multiple panels Nell, A first panel displaying the number of units of insulin to be administered to the patient, and This is supplemented by the number of insulin units displayed on the first panel. To present, including a second panel that displays the estimated amount of carbohydrates, The required adjustment for the number of insulin units displayed by the first panel. The mobile device receives user input representing the above, The number of units of insulin displayed by the first panel is the requested In accordance with the adjustment, each panel of the plurality of panels is updated by the processor. Therefore, updating the above means adjusting the number of insulin units by the first panel To display, and to be supplemented by the adjusted number of insulin units as expected. Updates include displaying the adjusted carbohydrate amount in the second panel mentioned above, Includes, method. [Aspect 80] The plurality of panels correspond to the amount of carbohydrates displayed by the second panel. It further includes a third panel that displays an indicator of meal size, and the update of the adjustment This includes displaying an adjusted meal size indicator corresponding to a balanced amount of carbohydrates. The method described in item 79. [Aspect 81] The third panel above shows the range of meal sizes between small and large meal sizes. The area that displays the amount of carbohydrates displayed by the second panel The method according to embodiment 80, including an indicator that shows where in the region the region is located. [Aspect 82] The amount of carbohydrates displayed by the second panel is for small meal size, medium size. The third panel indicates whether it corresponds to a meal size or a larger meal size, The method described in 80. [Aspect 83] Maximum carbohydrate threshold for a moderate meal size, and minimum carbohydrate threshold for a moderate meal size. The value is further received by the mobile device and displayed by the second panel. The carbohydrate values ​​obtained are compared with the received maximum carbohydrate threshold and minimum carbohydrate threshold. Based on this, it corresponds to small, medium, or large meal sizes. The method according to embodiment 82 as shown in the third panel. [Aspect 84] The insulin-to-carbohydrate ratio (ICR) associated with the patient is transmitted to the mobile device The amount of carbohydrates displayed by the second panel is further included in receiving the amount of carbohydrates displayed by the second panel. Based on the number of units displayed by the first panel and the received ICR The method according to embodiment 79, calculated by the processor. [Aspect 85] The plurality of panels the number of units of insulin displayed by the first panel A third panel displays the expected decrease in the patient's glucose level resulting from the administration. This includes, and the update is expected to result from the administration of the adjusted number of insulin units. A possible embodiment includes displaying a controlled decrease in the patient's glucose level. Method 79. [Aspect 86] The plurality of panels the number of units of insulin displayed by the first panel A fourth panel displaying the expected decrease in the patient's glucose level resulting from the administration. This includes, and the update is expected to result from the administration of the adjusted number of insulin units. A possible embodiment includes displaying a controlled decrease in the patient's glucose level. The method described in 80. [Aspect 87] The mobile device receives the insulin effect value (ISF) associated with the patient. The further includes the patient's glucose level as displayed by the third panel. The aforementioned decrease in the amount of insulin is due to the number of units of insulin and the amount of insulin displayed by the first panel. The method according to aspect 85, calculated based on the received ISF. [Pattern 88] The mobile device receives the insulin effect value (ISF) associated with the patient. This further includes the patient's glucose level as displayed by the fourth panel. The aforementioned decrease in the amount of insulin is due to the number of units of insulin and the amount of insulin displayed by the first panel. The method according to aspect 86, calculated based on the received ISF. [Aspect 89] The method according to embodiment 79, wherein the mobile device is a mobile smartphone. [Aspect 90] The method according to embodiment 79, wherein the mobile device is a drug delivery device. [Aspect 91] The drug delivery device communicates wirelessly with a mobile smartphone, and the drug delivery device However, insulin-to-carbohydrate ratio (ICR), insulin effectiveness (ISF), and moderate meals are all important indicators. The smaller of the maximum carbohydrate threshold for a given size and the minimum carbohydrate threshold for a medium-sized meal. The method according to embodiment 90, wherein at least one is received from the mobile smartphone. [Aspect 92] Executed by one or more processors on a mobile device associated with the patient. and, By simultaneously presenting multiple panels on the visual display of the aforementioned mobile device There are, and the aforementioned multiple panels, A first panel displaying the number of units of insulin to be administered to the patient, and This is supplemented by the number of insulin units displayed on the first panel. To present, including a second panel that displays the estimated amount of carbohydrates, The required adjustment for the number of insulin units displayed by the first panel. The mobile device receives user input representing the above, The requested adjustment to the number of insulin units displayed by the first panel. In accordance with this, updating each panel of the plurality of panels, the updating is To display the adjusted number of insulin units shown by the first panel, and the adjusted carbohydrates expected to be supplemented by the adjusted number of insulin units Updating, including displaying the quantity of the item on the second panel, and the one or more of the A non-temporary computer that stores instructions that can be manipulated to be performed by the processor. Reader-facing media (CRM). [Aspect 93] The plurality of panels correspond to the amount of carbohydrates displayed by the second panel. It further includes a third panel that displays an indicator of meal size, and the update of the adjustment Includes displaying meal size indicators adjusted according to the amount of carbohydrates, The CRM described in item 92. [Aspect 94] The third panel above shows the range of meal sizes between small and large meal sizes. The area that displays the amount of carbohydrates displayed by the second panel A CRM according to embodiment 93, including an indicator that shows where in the region the location is. [Aspect 95] The amount of carbohydrates displayed by the second panel is for small meal size, medium size. The third panel indicates whether it corresponds to a meal size or a larger meal size, CRM as described in 93. [Aspect 96] When the instruction is executed by one or more processors, Maximum carbohydrate threshold for a moderate meal size, and minimum carbohydrate threshold for a moderate meal size. The mobile device further manipulates the value to cause one or more processors to receive it. It is possible to make the carbohydrate value displayed by the second panel, and the received Based on the maximum and minimum carbohydrate thresholds, small meal size, moderate meal size The third panel indicates whether it corresponds to a small meal size or a large meal size, in embodiment 9. CRM as described in 5. [Aspect 97] When the instruction is executed by one or more processors, The insulin-to-carbohydrate ratio (ICR) associated with the patient is determined by one or more of the following procedures. The mobile device can be further operated to allow the sesser to receive the data, and the second The amount of carbohydrates displayed by the panel is before the amount displayed by the first panel. The CRM according to embodiment 92, calculated based on the number of units and the received ICR. [Aspect 98] The plurality of panels the number of units of insulin displayed by the first panel A third panel displays the expected decrease in the patient's glucose level resulting from the administration. This includes, and the update is expected to result from the administration of the adjusted number of insulin units. A possible embodiment includes displaying a controlled decrease in the patient's glucose level. CRM as described in 92. [Aspect 99] The plurality of panels the number of units of insulin displayed by the first panel A fourth panel displaying the expected decrease in the patient's glucose level resulting from the administration. This includes, and the update is expected to result from the administration of the adjusted number of insulin units. A possible embodiment includes displaying a controlled decrease in the patient's glucose level. CRM as described in 93. [Aspect 100] When the instruction is executed by one or more processors, The insulin effect value (ISF) associated with the patient is sent to one or more processors. The mobile device can be further operated to receive the data, and the third panel Therefore, the decrease in the patient's glucose level displayed by the first panel The calculation is based on the displayed number of insulin units and the received ISF. The CRM described in item 98. [Aspect 101] When the instruction is executed by one or more processors, The insulin effect value (ISF) associated with the patient is sent to one or more processors. The mobile device can be further operated to receive the data, and the fourth panel Therefore, the decrease in the patient's glucose level displayed by the first panel The calculation is based on the displayed number of insulin units and the received ISF. The CRM described in item 99. [Aspect 102] The CRM according to embodiment 92, wherein the mobile device is a mobile smartphone. . [Aspect 103] The CRM according to embodiment 92, wherein the mobile device is a drug delivery device. [Aspect 104] The drug delivery device communicates wirelessly with a mobile smartphone, and the drug delivery device However, insulin-to-carbohydrate ratio (ICR), insulin effectiveness (ISF), and moderate meals are all important indicators. The smaller of the maximum carbohydrate threshold for a given size and the minimum carbohydrate threshold for a medium-sized meal. The CRM according to embodiment 103, wherein at least one is received from the mobile smartphone.

Claims

1. The insulin effect value (ISF) associated with the patient is received by a processor on a mobile device associated with the patient, The processor on the mobile device simultaneously presents a plurality of panels on the visual display of the mobile device, wherein the plurality of panels are: A first panel displaying the number of units of insulin to be administered to the patient, and The system includes a fourth panel displaying the expected decrease in the patient's glucose level resulting from the administration of the number of insulin units displayed by the first panel, wherein the decrease in the patient's glucose level displayed by the fourth panel is calculated based on the number of insulin units displayed by the first panel and the received ISF, and the system is presented as follows: The mobile device receives user input representing the required adjustment to the number of insulin units displayed on the first panel, Updating each of the plurality of panels by the processor in accordance with the requested adjustment to the number of insulin units displayed by the first panel, wherein the updating includes displaying the adjusted number of insulin units by the first panel and displaying the adjusted decrease in the patient's glucose level expected to result from the administration of the adjusted number of insulin units by the fourth panel. Includes, The plurality of panels further include a second panel that displays the amount of carbohydrates expected to be supplemented by the number of insulin units displayed by the first panel, and the update includes displaying the adjusted amount of carbohydrates expected to be supplemented by the adjusted number of insulin units. A method wherein the plurality of panels further include a third panel that displays an index of meal size corresponding to the amount of carbohydrates displayed by the second panel, and the updating includes displaying an index of adjusted meal size corresponding to the adjusted amount of carbohydrates.

2. The method according to claim 1, wherein the third panel includes a region for displaying a range of meal sizes between small and large meal sizes, and an indicator for showing where in the region the amount of carbohydrates displayed by the second panel falls.

3. The method according to claim 1, wherein the third panel indicates whether the amount of carbohydrates displayed by the second panel corresponds to a small meal size, a medium meal size, or a large meal size.

4. The method according to claim 3, further comprising receiving a maximum carbohydrate threshold for a medium-sized meal and a minimum carbohydrate threshold for a medium-sized meal on the mobile device, wherein the third panel indicates whether the carbohydrate value displayed by the second panel corresponds to a small, medium, or large meal size based on the received maximum and minimum carbohydrate thresholds.

5. The method according to claim 1, further comprising receiving an insulin-to-carbohydrate ratio (ICR) associated with the patient on the mobile device, wherein the amount of carbohydrates displayed by the second panel is calculated based on the number of insulin units displayed by the first panel and the received ICR.

6. The method according to claim 1, wherein the mobile device is a mobile smartphone.

7. The method according to claim 1, wherein the mobile device is a drug delivery device.

8. The method according to claim 7, wherein the drug delivery device communicates wirelessly with a mobile smartphone, and the drug delivery device receives from the mobile smartphone at least one of the following: insulin-to-carbohydrate ratio (ICR), insulin effect value (ISF), maximum carbohydrate threshold for a moderate meal size, and minimum carbohydrate threshold for a moderate meal size.

9. When executed by one or more processors on a mobile device associated with the patient, To receive the insulin effectiveness value (ISF) associated with the aforementioned patient, The presenting of multiple panels simultaneously on the visual display of the mobile device, wherein the multiple panels are A first panel displaying the number of units of insulin to be administered to the patient, and The system includes a fourth panel displaying the expected decrease in the patient's glucose level resulting from the administration of the number of insulin units displayed by the first panel, wherein the decrease in the patient's glucose level displayed by the fourth panel is calculated based on the number of insulin units displayed by the first panel and the received ISF, and the system is presented as follows: The mobile device receives user input representing the required adjustment to the number of insulin units displayed on the first panel, Updating each panel of the plurality of panels in accordance with the requested adjustment to the number of insulin units displayed by the first panel, wherein the updating includes displaying the adjusted number of insulin units displayed by the first panel and displaying in the fourth panel the adjusted decrease in the patient's glucose level that is expected to result from the administration of the adjusted number of insulin units. A non-temporary computer-readable medium (CRM) storing instructions that can be operated to cause one or more processors to perform the following, The plurality of panels further include a second panel that displays the amount of carbohydrates expected to be supplemented by the number of insulin units displayed by the first panel, and the update includes displaying the adjusted amount of carbohydrates expected to be supplemented by the adjusted number of insulin units. A CRM comprising the plurality of panels further including a third panel that displays an index of meal size corresponding to the amount of carbohydrates displayed by the second panel, wherein updating includes displaying an index of adjusted meal size corresponding to the adjusted amount of carbohydrates.

10. The CRM according to claim 9, wherein the third panel includes a region for displaying a range of meal sizes between small and large meal sizes, and an indicator for showing where in the region the amount of carbohydrates displayed by the second panel falls.

11. The CRM according to claim 9, wherein the third panel indicates whether the amount of carbohydrates displayed by the second panel corresponds to a small meal size, a medium meal size, or a large meal size.

12. When the above instruction is executed by one or more processors, The CRM according to claim 11, wherein the mobile device is further operable to cause one or more processors to receive a maximum carbohydrate threshold for a medium meal size and a minimum carbohydrate threshold for a medium meal size, and the third panel indicates whether the carbohydrate value displayed by the second panel corresponds to a small meal size, a medium meal size, or a large meal size based on the received maximum and minimum carbohydrate thresholds.

13. When the instruction is executed by one or more processors, The CRM according to claim 9, wherein the mobile device is further operable to cause one or more processors to receive an insulin-to-carbohydrate ratio (ICR) associated with the patient, and the amount of carbohydrates displayed by the second panel is calculated based on the number of insulin units displayed by the first panel and the received ICR.

14. The CRM according to claim 9, wherein the mobile device is a mobile smartphone.

15. The CRM according to claim 9, wherein the mobile device is a drug delivery device.

16. The CRM according to claim 15, wherein the drug delivery device communicates wirelessly with a mobile smartphone, and the drug delivery device receives at least one of the following from the mobile smartphone: insulin-to-carbohydrate ratio (ICR), insulin effect value (ISF), maximum carbohydrate threshold for a moderate meal size, and minimum carbohydrate threshold for a moderate meal size.

17. The insulin effect value (ISF) associated with the patient is received by a processor on a mobile device associated with the patient, The process involves the processor on the mobile device simultaneously presenting a plurality of panels on the visual display of the mobile device, wherein the plurality of panels include a first panel that displays the number of units of insulin administered to the patient. The mobile device receives user input representing the required adjustment to the number of insulin units displayed on the first panel, Updating each of the plurality of panels by the processor in accordance with the requested adjustment to the number of insulin units displayed by the first panel, wherein the updating includes displaying the adjusted number of insulin units by the first panel. Includes, The method further comprises a third panel which displays a meal size index corresponding to the amount of carbohydrates expected to be supplemented by the number of units of insulin calculated by the processor, wherein the update includes displaying an adjusted meal size index corresponding to the adjusted amount of carbohydrates.

18. The method according to claim 17, wherein the plurality of panels further include a second panel displaying the amount of carbohydrates expected to be supplemented by the number of insulin units displayed by the first panel, and the update includes displaying the adjusted amount of carbohydrates expected to be supplemented by the adjusted number of insulin units.

19. When executed by one or more processors on a mobile device associated with the patient, To receive the insulin effectiveness value (ISF) associated with the aforementioned patient, The presenting of multiple panels simultaneously on the visual display of the mobile device, wherein the multiple panels include a first panel that displays the number of units of insulin administered to the patient, The mobile device receives user input representing the required adjustment to the number of insulin units displayed on the first panel, Updating each of the plurality of panels in accordance with the requested adjustment to the number of insulin units displayed by the first panel, wherein the updating includes displaying the adjusted number of insulin units displayed by the first panel. A non-temporary computer-readable medium (CRM) storing instructions that can be operated to cause one or more processors to perform the following, The CRM further includes a third panel which displays a meal size index corresponding to the amount of carbohydrates expected to be supplemented by the number of units of insulin, calculated by one or more processors, and the updating includes displaying an adjusted meal size index corresponding to the adjusted amount of carbohydrates.

20. The CRM according to claim 19, wherein the plurality of panels further include a second panel displaying the amount of carbohydrates expected to be supplemented by the number of insulin units displayed by the first panel, and the update includes displaying the adjusted amount of carbohydrates expected to be supplemented by the adjusted number of insulin units.

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