HK40057522B - Medicine injection and disease management systems, devices, and methods - Google Patents

Description

Drug injection and disease management systems, equipment and methods

This application is a divisional application of the application filed on September 27, 2017, with application number 201780059522.0 and entitled "Drug Injection and Disease Management System, Device and Method".

Cross-references to related applications

Pursuant to 35 U.S.C., 119(e), a claim is made for priority of U.S. Provisional Application No. 62/400,366 (’366 Provisional Application), entitled “Personalizing PresetMeal Sizes in Indian Delivery System,” filed September 27, 2016. The entire disclosure of Provisional Application ’366 is hereby incorporated by reference.

field

This disclosure relates to drug injection and disease management systems, devices, and methods, particularly those relating to the management of diabetes and/or insulin delivery. In some embodiments, the systems, methods, and devices provided herein can personalize user-selectable dietary amounts for the purpose of obtaining recommendations regarding the dosage of one or more drugs, allowing the user to input dietary data. In some cases, one or more buttons (e.g., user-selectable icons, physical buttons, etc.) can be personalized to describe the amount or range of amounts of insulin to be delivered and/or carbohydrates to be consumed.

background

Diabetes mellitus is a chronic metabolic disorder caused by the pancreas's inability to produce sufficient amounts of the hormone insulin, preventing the proper absorption of sugars and starches through metabolism. This failure leads to hyperglycemia, where there is an excess of analytes, such as glucose, in the blood plasma. Persistent hyperglycemia is associated with a variety of serious symptoms and life-threatening long-term complications, such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic kidney failure, retinal damage, and nerve damage with the risk of amputation. Self-monitoring of blood glucose and self-administration of insulin are typical methods used to manage diabetes. The "correct" insulin dose is a function of the level of glucose in the blood. Insufficient insulin doses can lead to hyperglycemia, while excessive insulin doses can lead to hypoglycemia, which can cause clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death. Therefore, people with diabetes mellitus (PWD) face a considerable cognitive burden in determining the appropriate insulin dose.

To aid in this self-management, many diabetes-related devices (such as blood glucose meters and insulin pumps) are equipped with insulin bolus calculators that allow users to input the amount of carbohydrates they have consumed (or will consume), and the calculators output a recommended insulin bolus dose. While bolus calculators eliminate some of the calculations that users need to perform to determine the appropriate insulin bolus dose, they still place a mental burden on users to determine the amount of carbohydrates in their diet and often require manual data entry. Therefore, there is a need for methods, systems, and devices that further reduce the cognitive burden on users while improving the accuracy of recommended insulin bolus doses.

Overview

The systems, apparatus, and methods provided herein can be configured to simplify the calculation of recommended insulin doses by streamlining the dietary notification process and/or simplifying the collection of estimated glucose values (EVG). The dietary notification process can be simplified by providing a user interface including one or more dietary notification buttons, which can be user-selectable icons on a touchscreen, physical buttons, push-to-talk dials, voice-activated commands, etc. In some cases, the dietary notification buttons can be located on a portion of the insulin delivery device or an accessory to the insulin delivery device. In some cases, the insulin delivery device can be an insulin pen, and the dose capture pen cap includes a dietary notification button. In some cases, the insulin delivery device or its accessory can communicate wirelessly with a remote user interface device (e.g., a mobile application on a smartphone), and the dietary notification buttons can be on the remote user interface device (as physical buttons or as user-selectable icons on a touchscreen). One or more dietary notification buttons can be personalized based on user use of the system. This personalization can be based on user interaction with various buttons or features (e.g., user selection of various dietary amounts for a bolus), by providing a bolus and measuring the effect of the bolus over time, or any other use of the apparatus or system according to this disclosure.

One or more embodiments of this disclosure may include an insulin delivery system comprising: an insulin delivery device; a user interface including a plurality of user-selectable icons or buttons, each user-selectable icon or button representing a different dietary feature; a memory storing one or more user-specific dose parameters; and a processor communicating with the memory and adapted to receive blood glucose data. The processor is also adapted to determine an initial dietary feature associated with each of the user-selectable icons or buttons based on at least one of the user-specific dose parameters. The processor is also adapted to update the dietary feature associated with each user-selectable icon or button based on blood glucose data.

According to one or more devices, systems, or methods disclosed herein, the device or system may include a blood glucose monitor or sensor.

According to one or more devices, systems, or methods of this disclosure, a system or device may include a flash glucose monitor and a system near-field communication circuit in communication with a processor, the flash glucose monitor including the flash near-field communication circuit. In these and other embodiments, the processor may be adapted to receive blood glucose data via NFC when the system near-field communication circuit and the flash near-field communication circuit are brought within near-field communication (NFC) communication range.

According to one or more devices, systems, or methods disclosed herein, a system or device may include a continuous glucose monitor, and a processor may be adapted to receive wireless communications from the continuous glucose monitor at predetermined time intervals.

According to one or more devices, systems or methods disclosed herein, a user may select an icon or button that may initially represent the amount of carbohydrates in increments of 5 grams or 10 grams.

According to one or more devices, systems, or methods of this disclosure, the amount of carbohydrate initially represented by each of a plurality of user-selectable icons or buttons can be determined based on the patient's (PWD) insulin sensitivity factor (ISF), carbohydrate ratio (CR), weight, age, total daily basal (TDB) rate, daily dose of long-acting insulin, weight-average total daily dose (TDD) of insulin, and/or combinations thereof.

According to one or more devices, systems, or methods disclosed herein, the processor may also be configured to determine the insulin delivery amount based on the amount of carbohydrates and/or blood glucose data associated with a selected user-selectable icon or button among user-selectable icons or buttons.

According to one or more devices, systems or methods disclosed herein, a user-selectable icon or button may each represent the number of units of insulin required to compensate for each meal, which is rounded to the nearest 0.5 units.

According to one or more devices, systems or methods of this disclosure, updates to dietary features associated with each of a plurality of user-selectable icons or buttons can be determined based on postprandial blood glucose data after the user selects a given user-selectable icon or button.

According to one or more devices, systems, or methods of this disclosure, a system or device may include a scanning glucose monitor that includes scanning near-field communication (NFC) circuitry, and the system or device may also include one or more system NFC circuits communicating with a processor. In these and other cases, the processor may be adapted to receive postprandial blood glucose data via NFC when one or more system NFC circuits and the scanning NFC circuitry are brought within NFC communication range. Additionally, the processor may be adapted to send a prompt to the user at a predetermined time after insulin delivery or after one of the user-selectable icons or buttons has been selected by the user, indicating that the user has retrieved postprandial blood glucose data by bringing one or more system NFC circuits close to the scanning glucose monitor.

According to one or more devices, systems, or methods disclosed herein, the user interface may be adapted to display a bolus recommendation based on blood glucose data and the selection of one of the user-selectable icons or buttons.

According to one or more devices, systems, or methods disclosed herein, the processor may determine a prescription recommendation based on factors selected from the following: the amount of carbohydrates divided by the carbohydrate-to-insulin ratio of the PWD, the difference between the current blood glucose level and the target blood glucose level divided by the PWD's insulin sensitivity factor, readings from a blood glucose meter (BGM), data from a continuous glucose monitor (CGM), blood glucose trend data, on-board insulin (IOB) data, on-board carbohydrate (COB) data, whether the PWD is exercising or planning to exercise, whether the PWD is ill, whether the PWD is pregnant, whether the PWD is menstruating, and whether the PWD has already consumed certain medications.

According to one or more devices, systems or methods of this disclosure, the processor may also be adapted to receive dose data from an insulin delivery device and update the dietary features associated with each of the user-selectable icons or buttons based on postprandial blood glucose data, dose data or a combination thereof after the user has selected the user-selectable icon or button.

According to one or more devices, systems, or methods of this disclosure, an insulin delivery device may include an insulin pen, and the user interface may be part of the insulin pen, part of a pen accessory adapted to reversibly connect to the insulin pen, or part of a mobile application of a smartphone that wirelessly communicates with the insulin pen or its accessory. In these and other embodiments, the device or system may be adapted to detect the amount of insulin remaining in one or more insulin pens or delivered by one or more insulin pens.

According to one or more devices, systems, or methods of this disclosure, a pen accessory may be adapted to be reversibly connected to an insulin pen, wherein the pen accessory may include a pen cap adapted to detect the amount of insulin remaining in the insulin pen during placement or removal from the insulin pen or when attached to the insulin pen.

According to one or more devices, systems, or methods disclosed herein, the user interface may be located on a mobile application of a smartphone, wherein the smartphone also includes a processor, and the insulin pen or its accessory is adapted to detect insulin volume or delivery data and wirelessly transmit insulin volume or delivery data to the processor.

One or more embodiments of this disclosure may include a cap for an insulin pen, the cap including: one or more sensors adapted to detect the position of a plunger within the insulin pen; and a user interface including one or more user-selectable icons or buttons adapted to signal a meal or meal intention.

According to one or more devices, systems, or methods of this disclosure, the cap may include a processor and a memory, wherein the processor may be adapted to determine the timing and dose of insulin delivery based on data from one or more sensors and store that information in the memory.

According to one or more devices, systems or methods disclosed herein, the user interface may include at least two and no more than six user-selectable icons or buttons suitable for announcing a diet or meal intention, each user-selectable icon or button representing a different dietary feature stored in memory for each user-selectable icon or button.

According to one or more devices, systems, or methods disclosed herein, the user interface may include a display section adapted to display a recommended dose based at least in part on the selection of one or more user-selectable icons or buttons.

According to one or more devices, systems, or methods disclosed herein, the cap may include a wireless communication device adapted to communicate with a blood glucose monitor or sensor, wherein the display may be adapted to display the current blood glucose level, an indication of the current rate of change, a recommended corrected bolus dose based on glucose data, or a combination thereof.

According to one or more devices, systems, or methods disclosed herein, the wireless communication device of the cap may include NFC circuitry.

According to one or more devices, systems, or methods disclosed herein, the device or system may include a signaler adapted to prompt a user to obtain blood glucose data from a blood glucose monitor or sensor at a predetermined time following the selection of one or more user-selectable icons or buttons.

According to one or more devices, systems, or methods disclosed herein, a device or system may include a signaler adapted to provide an alarm when data from a blood glucose monitor or sensor indicates a need for treatment.

According to one or more devices, systems, or methods of this disclosure, a system or device may include a processor and a memory that stores dietary characteristics of each of one or more user-selectable icons or buttons, and the processor is adapted to receive blood glucose data and update the dietary characteristics of each of one or more user-selectable icons or buttons based on the blood glucose data.

According to one or more devices, systems, or methods disclosed herein, the system or device may include a memory that can store multiple dietary features of a single user-selectable icon or button based on the time of day.

According to one or more devices, systems, or methods disclosed herein, a system or device may include a cap that further includes a sensor adapted to detect characteristics of an insulin pen or the type of insulin in the insulin pen, a memory storing information about different types of insulin pens or different types of insulin, and a processor for determining the type of insulin pen or the type of insulin.

According to one or more devices, systems, or methods disclosed herein, a system or device may include a processor adapted to change the user interface according to the type of insulin pen or the type of insulin, some of which result in a user interface that does not include any user-selectable icons or buttons suitable for announcing dietary or meal intentions.

Brief description of the attached diagram

Figure 1A illustrates a hypothetical insulin delivery system, which includes an insulin pen, a glucose monitor or sensor, and a remote user interface device with a remote user interface.

Figure 1B shows an exemplary meal notification screen of a remote user interface device, which can be displayed by the remote user interface device of Figure 1A.

Figures 2A and 2B depict an insulin pen with a first exemplary insulin pen cap, which has some of the features disclosed herein.

Figures 3A and 3B depict an insulin pen with a second exemplary insulin pen cap, which has some of the features disclosed herein.

Figure 4 shows a schematic diagram of the internal components that can be included in the insulin pen cap of Figures 2A-3B.

Figures 5A and 5B depict an exemplary dose capture technology that can be incorporated into the pen cap of Figures 2A-3B.

Figure 6A is a flowchart showing how a user can interact with the insulin pen cap provided in this article.

Figure 6B illustrates an exemplary user interface that a user can see on the pen cap (or insulin delivery pen) during the use of some of the methods, systems, and devices provided herein.

Figure 7 shows an exemplary user interface that a user can see on a pen cap (or insulin delivery pen) when some of the methods, systems and devices provided herein are ready for use.

Figures 8A and 8B depict notifications that may appear on remote user interface devices in some embodiments of the methods, systems, and devices provided herein.

Figures 9A and 9B are diagrams illustrating how dietary characteristics and user-specific dosage parameters can be initiated or updated.

Figures 10A and 10B depict how a user can transfer data between a scanning glucose monitor and an insulin pen or cap before administering insulin.

Detailed description

Insulin delivery systems and devices, and methods for delivering insulin, can be designed to minimize the cognitive and activity burden on patients with diabetes (PWD) or their caregivers when deciding to administer insulin. In some embodiments, the methods, systems, and devices provided herein can passively capture diabetes-related data (e.g., insulin delivery data, blood glucose data, etc.) with or without providing recommendations to the PWD (or caregiver). In some embodiments, the methods, systems, and devices provided herein can provide guidance on the appropriate dosage of insulin. In some embodiments, the dose of insulin can be administered using an insulin delivery pen or syringe. In some cases, the insulin can be long-acting insulin. In some cases, the insulin can be rapid-acting insulin. In some embodiments, the insulin delivery pen or its accessory (e.g., a cap) can detect the amount of insulin delivered from the pen (or be set to the amount of insulin to be delivered). In some cases, the insulin pen or its accessory may include a user interface that can display data or recommendations to the user and/or allow the user to input data into the insulin pen or accessory. The exemplary systems described below include an insulin delivery pen with a dose-capping pen cap, but alternative embodiments are also contemplated where the functionality disclosed herein is incorporated into other accessories of the insulin delivery pen or the insulin delivery pen itself.

Exemplary insulin delivery system

Figure 1A illustrates a hypothetical insulin delivery system 100, comprising a rapid-acting insulin (QAI) pen 160 (e.g., Humalog™, Novolog™, Apira™), a long-acting insulin (LAI) pen 170 (e.g., Lantus™, Levemir™, Toujeo™, Tresiba™), a glucose monitor or sensor 150, and a remote user interface device 110. As shown, each insulin pen 160 and 170 includes dose-capture caps 182 and 184, respectively, that wirelessly communicate with other components of system 100. As shown, the pens may include dials 161 and 171 for allowing the user to set the dose to be delivered, and dose indicator windows 162 and 172. In optional systems, insulin pens 160 and/or 170 may themselves include dose-capture technology and/or wireless communication with other components of system 100. Additional details regarding possible insulin pens and/or insulin caps will be disclosed below in more detail.

The glucose monitor or sensor 150 can be any suitable sensor device and/or monitoring system capable of providing data that can be used to estimate one or more blood glucose values. As shown, the glucose monitor or sensor 150 can be a sensor configured to wirelessly transmit blood glucose data. For example, the glucose monitor or sensor 150 may include optical communication devices, infrared communication devices, wireless communication devices (such as antennas) and/or chipsets (such as Bluetooth devices (e.g., Bluetooth Low Energy, Bluetooth Classic, etc.), Near Field Communication (NFC) devices, 802.6 devices (e.g., Metropolitan Area Network (MAN), Zigbee devices, etc.), WiFi devices, WiMax devices, cellular communication facilities, etc.) and/or the like. The glucose monitor or sensor 150 can exchange data with a network and/or any other device or system described in this disclosure. In some cases, the glucose monitor or sensor 150 is queried using an NFC device by a user moving one or more components of the system near the glucose monitor or sensor 150 to power the glucose monitor or sensor 150 or to transmit blood glucose data from the glucose monitor or sensor 150 to other components of the system 100.

As shown, the remote user interface device 110 is a smartphone, but any suitable remote user interface device can be used, such as a computer tablet, smartphone, wearable computing device, smartwatch, fitness tracker, laptop computer, desktop computer, smart insulin pen (e.g., dose capture caps 182 and/or 184) and/or other suitable computing device. As shown in the exemplary user interface of an exemplary mobile application running on the depicted smartphone, the user interface may include a push calculator button 114 and optionally other buttons for allowing the user to enter data or request recommendations. The exemplary user interface may also include a display of past, current, or predicted blood glucose data. As shown, the user interface includes a curve 123 from historical data of the previous 30 minutes, a continuation 124 of the curve with projected data, a dot indicator 122 showing the current (or most recent) estimated blood glucose value, and a display 121 showing the current (or most recent) estimated blood glucose value. The user interface may also include text 131 interpreting the glucose data, text 132 and 133 providing suggested actions, such as text 132 providing insulin, carbohydrate, or other treatment recommendations, and/or text 133 suggesting the user obtain blood glucose data. In some cases, the user interface may allow users to tap on glucose data or otherwise navigate within the mobile application to obtain more detailed or complete blood glucose data.

The user interface can also depict insulin data. In some cases, the user interface can indicate the amount of on-board insulin (IOB) 135, which may be used only for rapid-acting insulin. In some cases, IOB calculations can be used for both rapid-acting and long-acting insulin. In some cases, the user interface can display the time and/or amount of the most recent dose of rapid-acting and/or long-acting insulin 134. In some cases, the user interface can allow users to tap on insulin data, or otherwise navigate to more detailed or complete insulin delivery data within the mobile application. In some cases, the user interface can overlay blood glucose data and insulin delivery data in any suitable format, such as a graphical display of blood glucose data timing relative to insulin delivery data timing.

In use, users (e.g., PWD and/or caregivers) can use system 100 to obtain recommendations regarding the appropriate insulin dose. In cases where a long-acting insulin delivery is imminent, the message 132 may change to provide a recommended long-acting insulin dose. In some cases, the recommended dose may appear on the pen cap 184. If a user wishes to administer a bolus of rapid-acting insulin, the user can press the bolus calculator button 114 to access the bolus calculator. While any suitable bolus calculator can be used in the systems, methods, and devices provided herein, Figure 1B depicts a possible user interface for the user to input a meal notification as corrected only 141, small meal 142, normal-sized meal 143, or large meal 144. When selecting a meal size, the user interface may provide a recommended bolus dose based on the amount of carbohydrates associated with the corresponding button and optionally based on blood glucose data.

Alternatively or additionally, the dose-capture pen cap for the rapid-acting insulin pen 160 may include a user interface that allows the user to announce a small, medium, or large meal. Figures 2A-3B depict possible embodiments of dose-capture pen caps 200 and 300 with buttons 221-223 and 321-323, which allow the user to announce a small (S), medium (M), or large (L) meal. In use, the user can announce whether the meal they have just eaten or will eat is their normal dietary size (M) or larger (L) or smaller (S), and the methods, devices, and systems provided herein can determine the appropriate bolus dose of insulin based on this announcement and optionally on blood glucose data (if available). Optionally, the insulin pen may include dose-capture technology and include the user interface provided herein, which is described as being on the dose-capture pen cap. In some cases, a smart pen with dose-capture capability may wirelessly communicate with a remote user interface (e.g., a smartphone).

Personalized meal notification button

As discussed above, the methods, devices, and systems provided herein can provide users with a meal notification button that offers them a reduced amount of food intake options based on their normal dietary intake. This can reduce the cognitive burden on users seeking to administer insulin for meals, while improving the accuracy of insulin bolus recommendations. This section describes how the methods, systems, and devices provided herein can determine the amount of insulin and/or carbohydrates in a manner associated with each of the meal selection buttons (e.g., 141-144, 221-223, 321-323). Optionally, additional buttons may be present, such as buttons indicating small or extra-large meals to the user, such that any number of buttons are within the scope of this disclosure. Additionally or optionally, the system may include a single button, icon, or pattern for notifying the user of a meal from the system or device of this disclosure.

In some cases, each of the meal notification buttons 142-144, 221-223, and 321-323 can be associated with a number of carbohydrates, which are personalized for the user based on other user-specific dose parameters entered by the user for the insulin delivery system (e.g., total daily long-acting insulin dose (e.g., U/day), total daily insulin dose (e.g., total of long-acting and rapid-acting), carbohydrate-to-insulin ratio, insulin sensitivity factor, glucose set point, or a combination thereof). In some cases, when an icon or button is selected based on glucose response after each meal, the amount of carbohydrates assigned to each preset icon or button can be personalized over time based on an estimate of the size of each meal consumed. In some cases, the amount of carbohydrates assigned to each preset icon or button can be rounded to the nearest 5 grams and displayed. In some cases, the amount of carbohydrates for each button is not displayed. In some cases, the user can manually enter personalized meal amounts for multiple user-selectable icons or buttons. In some cases, the amount of carbohydrates assigned to each user's selectable icon or button can be initially set at a predetermined starting point, or it can be determined based on the user information entered, and then iteratively adjusted up or down over time based on the blood glucose response to that selected meal amount and the bolus.

The initial settings of one or more dietary notification buttons 142-144, 221-223, 321-323 included in the device or system provided herein may be preset with predetermined values or ranges (e.g., small = 20g or 15-25g, medium = 30g or 30-45g, and large = 50g or 50-75g). Alternatively or additionally, the initial settings may be set based on input user data or based on one or more user-specific dose parameters input into the device or system provided herein. In some cases, the initial settings of one or more user-selectable icons or buttons may be based on the initially input or determined and programmed total daily long-acting insulin (TDLAI) dose (e.g., U/day). For example, the relationship between LAI dose [U/day] and geometric mean dietary intake [g], characterized by a line corresponding to the major axis of a hyperelliptic, is: μ*MS = 12.1*BR0.387. The relationship between the geometric mean dietary intake [g] and the geometric standard deviation dietary intake is: σ*MS = 1.92 - μ*MS/186, where MS represents dietary intake and BR represents the basal rate of insulin. Therefore, by combining the above equation (optionally rounding the dietary intake set to the nearest 1, 5, or 10 grams), the initial dietary intake set can correspond to a predetermined percentile of the dietary intake distribution. In some cases, the relationship between typical dietary intake and other user-specific dosing parameters can be determined based on demographic data. In some cases, the amount of carbohydrates associated with each user-selectable icon or button can be displayed on and/or near the user-selectable icon or button, which can help users understand how to use the insulin delivery device or system and avoid user unfamiliarity. For example, seeing the assumed amount of carbohydrates for each dietary intake helps users who consider their diet from a carbohydrate perspective adjust to using the button to indicate the amount of food consumed. Additionally, by starting with a display number rounded to the nearest 5 grams, users are aware that precision is unnecessary, thus reducing the cognitive burden on the user. Additionally, as the system repeatedly personalizes the amount of carbohydrates for each specific user-selectable icon or button, the system can adjust these numbers in smaller units (e.g., 1 gram) to show the user that the system is adjusting the amount of carbohydrates associated with the user-selectable icon or button.

In some cases, the user interface can be configured to allow the PWD to interact with the interface to input more detailed information about the feed size beyond the default options. For example, the PWD can present a series of preset sizes that can be easily adjusted in 5g increments by selecting a size and scrolling up or down. By further interacting with the user's device (e.g., pressing and holding the feed amount), the user can have the option to manually input the feed size or adjust the size in 1g increments.

The methods, systems, and devices provided herein can use any suitable method to update the amount of carbohydrates associated with each user-selectable icon or button. In some cases, the methods, systems, and devices can use postprandial blood glucose data (e.g., between 1 and 3 hours after the advised meal) to assess whether PWD is likely to consume significantly more or significantly less carbohydrates than programmed for the user-selectable icon or button. In some cases, one or more postprandial blood glucose thresholds can be used to assess the match between the amount of carbohydrates consumed and the amount of carbohydrates associated with the selected user-selectable meal icon or button. For example, the methods, devices, and systems provided herein can query the user for postprandial blood glucose readings from a glucose sensor, glucose monitor, or blood glucose meter. In some cases, the glucose sensor can be a scanning glucose monitor, and the methods, systems, and devices provided herein can prompt the user to query the scanning glucose monitor at a predetermined postprandial time period. As used herein, the term "flash glucose monitor" can refer to a device configured to provide blood glucose readings in response to manual invocation (typically via physical signals such as buttons, taps, etc.) or wireless signals such as near field communication (NFC), Bluetooth communication, etc.). These blood glucose readings can be performed periodically and reported when the device is invoked, or can be taken upon invocation. In some cases, the methods, devices, and systems provided herein can receive postprandial blood glucose data from a continuous glucose monitor. In some cases, the methods, systems, and devices provided herein can use a single postprandial blood glucose data point and compare that data point to one or more upper thresholds and one or more lower thresholds during that time period to determine whether the amount of carbohydrates associated with that user-selectable meal icon or button should be adjusted upwards or downwards. For example, if a user selects a general meal icon indicating a 30-gram carbohydrate meal, but their 2-hour postprandial blood glucose reading is above 200 mg/dL, the grams associated with that icon or button might be adjusted upwards by 2 grams; if it's above 170 mg/dL, it might be adjusted upwards by 1 gram; if it's below 130 mg/dL, it might be reduced by 1 gram; and if it's below 100 mg/dL, it might be reduced by 2 grams. Therefore, over time, the meal icon will be adjusted to more closely resemble the user's typical consumption pattern in a way that matches their mental model of the meals they eat. Specific thresholds can be determined based on postprandial time, the grams associated with the meal icon or button, daily doses of CR, ISF, and LAI, and the PWD setpoint, among others.

In some cases, the meal notification button can be personalized based on the time of day. For example, in some situations, a user might have a larger average dinner and a smaller average breakfast, and the methods, devices, and systems provided herein can estimate the user's carbohydrate intake based on the time of day. In some cases, the amount of carbohydrates and meal quantity (S, M, L) can be displayed together to help the user understand that the personalization is specific to their daily pattern. In some cases, the button can be personalized based on the day of the week (e.g., a user's weekend meal pattern may differ significantly from their weekday pattern).

Because diabetes is a highly personalized disease that places a significant cognitive burden on PWD or their caregivers (multiple caregivers) regarding determining the appropriate insulin dose, some PWDs or caregivers have developed their own techniques (or mental models) for estimating the appropriate insulin dose. While the methods, systems, and devices presented herein can be adapted to provide recommendations to users, users are free to allocate insulin doses based on their preferences and specific knowledge of what the PWD will eat and/or is experiencing (e.g., exercise, disease, etc.). In some cases, meal notification buttons can be altered based on a repetitive pattern of insulin doses administered by the user at doses higher or lower than the recommended dose, causing the meal notification buttons to begin matching the user's mental model of typical meal amounts. However, adjustments to the amount of carbohydrates represented by each meal notification button can be determined based on the PWD's postprandial blood glucose readings, using the actual dose as a guide. For example, if a postprandial blood glucose reading indicates an appropriate dose, it can indicate that the user's mental model is suited to that meal, and the system can therefore adjust the meal notification button to match the user's mental model (e.g., reducing the amount of food in the (S) meal hypothesis based on a repetition pattern of the user administering less insulin than recommended for the (S) meal choice if postprandial blood glucose readings are generally within a predetermined range). However, in some cases, the methods, devices, and systems provided herein can use postprandial blood glucose readings to determine whether the user's mental model has failed to determine an appropriate dose. In some cases, high or low postprandial blood glucose readings can prevent the methods, systems, and devices provided herein from adjusting the meal notification button based on the meal (in cases where the meal notification button is adjusted based on the meal, one or more postprandial blood glucose readings indicate a mismatch between the dose and the meal). For example, if the user administers less insulin than recommended for a selected small meal and has one or more high postprandial blood glucose readings, the methods, systems, and devices provided herein can ignore that administration for the personalization of the meal notification button. In some cases, the methods, systems, and devices provided herein can provide notifications to users where a mismatch exists between the user's mental model and the physiological and food consumption patterns of PWD, and where the user consistently ignores the recommended dosage, which in some way causes PWD to be higher or lower after meals. For example, if a user consistently administers less insulin than recommended and consistently has high blood glucose readings after meals, the notification can instruct the user to consider administering the recommended dose at mealtimes for better glycemic control. Therefore, in some cases, the methods, systems, and devices provided herein can be designed to improve the match between the user's mental model and the physiological and food consumption patterns of PWD.

In some cases, the remote user interface device 110 may allow a user to manually enter a specific amount of carbohydrates into the recommendation calculator for a specific diet. In other cases, methods, systems, and devices may use a recurring pattern of user requests for the same dietary quantity recommendation to update the size of the diet notification button or add another diet notification button.

Dose capture pen cap

Figure 1A depicts a system that may include dose-capture pen caps 182 and 184, which can transmit data to and/or from a glucose monitor or sensor 150 and/or to/from a remote user interface device 110. The pen caps in Figure 1A may or may not include a user interface. Pen caps 182 and 184 may use any suitable technology to determine the amount of insulin that has been administered from insulin pens 160 and 170. In some cases not shown, insulin pens 160 and 170 may include dose-capture technology and may communicate wirelessly with the remote user interface device 110 and/or the glucose monitor or sensor 150.

Figures 2A-3B depict alternative embodiments of pen caps 200 and 300, which can be used with an insulin pen to help PWD or caregivers (users) make dosing decisions.

Figures 2A and 2B depict an embodiment of a pen cap 200 including a display screen 210, which may display the estimated glucose value (EVG) 212, the unit of EVG 211, and an EVG trend indicator 213. The display may also provide a recommended dose 214 and an identifier 215 for the type of insulin. The pen cap 200 may also include meal notification buttons 221-223. Additionally, the display may indicate the time and amount of previous doses and/or IOB values to remind the user of their recent dose. Although three meal notification buttons are shown, in some cases, the pen cap may not include meal notification buttons, and meals may be notified on a remote user interface device (e.g., device 110 shown in Figure 1A). In some cases, the pen cap 200 may include a single meal notification button. In some cases, the pen cap 200 may include between two and six different meal notification buttons. In some cases, the pen cap 200 may include a correction-only button. The pen cap 200 may also include one or more indicator lights (such as indicator light 218) that can be lit to indicate that it is transmitting data, to indicate that the user’s attention is required, and/or to indicate whether the dose capture function is working.

Figures 3A and 3B depict another embodiment of the pen cap 300 including a touchscreen user interface 310, which may include buttons 321-323 and display the estimated glucose value (EVG) 312, EVG units 311, an EVG trend indicator 313, a recommended dose 314, and an identifier 315 for the insulin type. Additionally, the display may indicate the time and amount of previous doses and/or IOB values to remind the user of their recent dose. Although three meal notification buttons are shown, the touchscreen user interface 310 of the pen cap 300 can be customized based on user preferences and/or insulin type to display different numbers of meal notification buttons 321-323 and/or exclude meal notification buttons altogether. For example, if the pen cap 300 is placed on a long-acting insulin pen, it may be able to detect the insulin type and automatically update the display at 315 to correctly identify the insulin type, but also remove the meal notification buttons 321-323 and replace them with other content.

Although pen caps 182, 184, 200 and 300 can be used with any suitable technique to estimate insulin dose, Figures 4, 5A and 5B depict exemplary embodiments of pen cap components that can be used to detect insulin dose.

Figure 4 illustrates a representation of the internal components of an exemplary pen cap 400. As shown, the pen cap may include one or more displays 410, one or more buttons 420, and one or more transducers 416, each controlled by a processing system 432. The processing system 432 includes a processor 434, a data storage device (or memory) 436, and a communication subsystem 440. The communication subsystem 440 enables wireless communication between the pen cap and a remote user interface device (e.g., 110 in Figure 1A) or a glucose sensor or monitor (e.g., 150 in Figure 1A). In some cases, the communication subsystem 440 may include a near-field communication (NFC) chip. In some cases, the communication subsystem 440 may include a Bluetooth Low Energy (BLE) chip. In some cases, the communication subsystem 440 may include optical communication devices, infrared communication devices, wireless communication devices (such as antennas) and/or chipsets (such as Bluetooth devices (e.g., Bluetooth Low Energy, Bluetooth Classic, etc.), Near Field Communication (NFC) devices, 802.6 devices (e.g., Metropolitan Area Network (MAN), Zigbee devices, etc.), WiFi devices, WiMax devices, cellular communication facilities, etc.) and/or the like. In these and other cases, the communication subsystem 440 may exchange data with a network and/or any other device or system described in this disclosure. The pen cap 400 includes a power supply 450, which may be a rechargeable or non-rechargeable battery. The processing system may determine the pen type from data from the pen type detector 490. The processing system may also use one or more optical or position sensors and/or microswitches (such as microswitch 480), optical sensors (multiple optical sensors) 470, and position sensors (multiple position sensors) 460 to determine the position of the plunger within the insulin delivery pen. Figures 5A and 5B illustrate the arrangement of a position sensor 460, a microswitch 480, and an optical sensor 470 within the pen cap 400. The optical sensor 470 may include a lamp 471 and a photoreceptor 472 located on opposite sides of the insulin delivery pen, such that light passes through the insulin vial 163 and is received by the photoreceptor 472 until the plunger 164 of the insulin pen 160 passes the optical sensor 470. The tip of the insulin pen 160 is received by a slider 462, which slides within the pen to trigger a microswitch 480 with a trigger 482, instructing the pen cap to use the optical sensor 470 to identify when the plunger 164 passes the optical sensor 470. Data from the position sensor 460 (which includes a spring 464, a slider 462, and a proximity sensor 466) determines the distance the insulin pen has inserted into the pen cap when the plunger passes the optical sensor 470, and thus determines the amount of insulin remaining in the insulin vial 163. Data from previous use of the pen cap 400 can then be used to estimate the amount of insulin delivered to the patient. Further details on how this dose capture technology can be used are disclosed in PCT Publication WO 2017/009724 A1, which is hereby incorporated in its entirety by reference.

Exemplary use of dose capture devices/systems

Figure 6A is a flowchart illustrating how a user can determine the insulin dosage while eating, using the methods, systems, and devices provided herein. As shown, process 600 begins in step 610 with the user deciding to eat something (or deciding to inject a bolus of food already eaten), followed by the user retrieving the pen syringe in step 620. After retrieving the pen syringe, the user can decide to announce the meal in step 640 and/or retrieve glucose data in step 630, which can occur in either order. After announcing the meal and/or retrieving glucose data, the user can view a dosage recommendation, which may appear on the pen cap or on a remote user interface device, in step 650. After viewing this recommendation, the user can then decide how much insulin to administer and administer the insulin in step 660.

Figure 6B depicts an exemplary user interface display of the user's pen cap as the user follows process 600. As shown, the user screen 611 may indicate that the system is active and display data 612 (such as type, amount, and time of day) and/or IOB value 613 regarding the most recent dose. If the user obtains a blood glucose value indicating a hypoglycemic condition in step 630, the user screen 631 may instruct the user to consume carbohydrates and may continue to display information about the most recent dose and/or the estimated IOB. If the user obtains a blood glucose value indicating a hyperglycemic condition in step 630, the user screen 636 may instruct the user to administer a dose of insulin and provide the recommended dose, and may continue to display information about the most recent dose and/or the estimated IOB. In some cases, the recommended dose may indicate the amount the user should add to the dose they are otherwise taking for their diet. If the user subsequently enters a dietary notification in step 640, the user screen 641 may appear and indicate the recommended insulin dose, citing the diet and current EGV. However, the user screen 671 can appear at any time when the pen cap detects that something is wrong or otherwise requires the user's attention. In some cases, pressing a button on the pen cap can cause the user screen on the pen cap to display more information and/or the user screen 671 can guide the user to troubleshoot system problems on a remote user interface device (such as device 110 in Figure 1A).

When a user administers insulin in step 660, the amount of insulin administered may differ from the recommended dose, and/or the recommendation may simply be an adjustment to the user's mental model of how much insulin to administer for a meal, for example, in the case where the user has not made a meal notification and the insulin dose is dispensed based on user screen 636. As shown in user screen 636, the dose recommendation may be indicated in parentheses to indicate the amount of insulin that should be used to correct elevated blood glucose levels, and thus the user can add this amount to the amount of insulin the user normally administers for a meal. Therefore, the methods, systems, and devices provided herein can infer the amount of carbohydrates consumed for a meal in the user's mental model based on the amount of insulin delivered by the user. For example, if the user retrieves EGV from a glucose sensor or monitor in step 630 and sees a recommendation to take 3 units of Humarlog in addition to their usual medication and then doses 10 units of Humarlog, then the methods, systems, and devices provided herein can infer that the user ate a meal and estimate the amount of the meal based on the bolus size. The system can then use the estimated meal intake to further personalize the meal notification buttons (e.g., buttons 142-144, 221-223, and 321-323) and user-specific dosage parameters. Additionally, in some cases, the user will notify of a meal but administer an insulin dose different from the recommended amount. In such cases, the methods, systems, and devices provided herein can either ignore postprandial data from that administration for the personalized meal notification buttons (e.g., buttons 142-144, 221-223, and 321-323) or use postprandial data to update the user-specific dosage parameters. For example, if a user is about to eat a meal that falls between their mental model of a medium meal and their mental model of a large meal, the user can retrieve the EGV (e.g., in step 630) and view a screen similar to user screen 636 to determine the amount of corrected dose, and then be notified of a meal as a medium meal (e.g., in step 640) to view a screen similar to user screen 641, and then be notified again of a meal as a large meal (e.g., repeat step 640) to view different recommendations, and then the user can deliver a certain amount of insulin between these two recommendations. The methods, systems, and devices provided herein can use data from dose capture technology to estimate the amount of insulin actually delivered and use that insulin delivery data to determine the estimated amount per meal, regardless of whether the user is notified of a meal or follows a recommendation. Additionally, deviations from recommendations and changes in postprandial glucose data can be used to determine adjustments to the amount of carbohydrates represented by each meal notification button (e.g., buttons 142-144, 221-223, and 321-323) such that they match the user's mental model, as discussed above.

In many cases, users will use their own mental model for administering insulin to their diet and will only use the system to determine the corrective dose after obtaining EGV (e.g., in step 630) and viewing a screen similar to user screen 631 or 636. In some cases, this screen may only indicate the corrective dose or may display two recommendations: (a) if the user is only trying to correct a hyperglycemic or hypoglycemic condition, the recommendation is the amount to be quantified or a suggestion to eat; and (b) if the user is eating, the recommendation is a change in how much the user would normally quantify. In some cases, different equations may be used for calculations based on reducing the risk of hypoglycemic conditions. In some cases, if the user is eating, the calculation of the amount used to change the user's normal insulin dose may be combined with adjustments based on detected patterns of over- or under-quantified insulin doses for the user's diet, in order to adjust for detected mismatches between the user's mental model and the physiological and food consumption patterns of PWD.

Figures 10A and 10B depict an exemplary system for how a user can retrieve blood glucose values from a glucose sensor that communicates via near-field communication by waving a pen cap 1005 (optionally using a waving motion 1005) near the glucose sensor 50. The cap may include a near-field communication chip 1182. After the waving, a display 1010 may appear on the pen cap 1005.

Wireless communication and pairing process

Referring again to Figure 1A, the system provided herein may include one, two, or more pen caps 182 and 184 (or alternatively, pen caps 200 and 300 in Figures 2A-3B) that can all wirelessly communicate with each other, a remote user interface device 110 (e.g., a smartphone), and a glucose sensor or monitor 150 (e.g., a scanning glucose monitor, a continuous glucose monitor, a blood glucose meter). In some cases, the glucose sensor or monitor 150 may be a scanning glucose monitor adapted to communicate with pen caps 182 or 184 via near-field communication. In some cases, the glucose sensor or monitor 150 may be a continuous glucose monitor adapted to communicate with pen caps 182 or 184 via radio signals (such as radio signals using the Bluetooth Low Energy protocol). Alternatively or optionally, such communication may occur via NFC, WiFi, Zigbee, Bluetooth Classic, or any other communication protocol, device, or technology. In some cases, a scanning glucose monitor or continuous glucose monitor may require a pairing process to communicate with other devices, and/or may require a warm-up period before it is ready to be used. For example, a broadcasting device (which may be (1) a scanning glucose monitor/continuous glucose monitor, a glucose sensor or monitor 150 or (2) a pen cap 182 or 184 or other processing device according to this disclosure) may broadcast a pairing signal received by another device, after which a series of data exchanges or handshakes may occur to establish a secure communication session between the two devices. In some cases, this pairing process can be facilitated by invoking one or more buttons on the pen cap 182 or 184. Alternatively or optionally, the pairing process may be invoked using a user interface device paired or otherwise coupled to one or both of the glucose sensor or monitor 150 or the pen cap 182 or 184.

Figure 7 illustrates an exemplary process 700 for starting to use a system (such as the system depicted in Figure 1A). In the user screen 711, the pen cap may include a welcome screen, which includes a connection indicator 712 indicating that the pen cap has not yet been paired. The connection indicator 712 may include segments indicating steps that must be completed before the system can be used. In some cases, the screen may be on a remote user interface device (e.g., device 110 in Figure 1A), instructing the user how to pair the pen cap with the remote user interface device. In step 720, the user receives instructions to pair the remote user interface device (e.g., a smartphone) with the pen cap or pen cap on the remote user interface device. After successful pairing of the remote user interface device with the pen cap, screen 721 may appear to indicate successful pairing with the remote user interface device. Subsequently, in step 730, instructions for connecting the pen cap and/or the remote user interface to the glucose sensor or monitor 150 may appear on the pen cap or the remote user interface. In some cases, the glucose sensor or monitor 150 may be a scanning glucose monitor using near-field communication, and the methods, devices, and systems provided herein may instruct the user to establish a near-field communication link between the glucose sensor or monitor 150 and a remote user interface device and/or with pen caps 182 or 184 to establish a communication link. In screen 731, the pen cap user screen may indicate that the sensor or monitor is warming up, possibly with a decrementing count clock. In screen 736, the pen cap user screen may indicate that the glucose sensor or monitor 150 is ready for use (after the warm-up period has been completed). Screen 741 may also appear at any time during system use or during the pairing process to indicate a pairing failure, and then return the user to step 720 or 730 to resolve the pairing problem. For example, glucose sensors and monitors may have a service life (e.g., 3 days, 7 days, 10 days, 14 days) and need to be replaced after their service life. Therefore, screen 741 may appear after the glucose sensor or monitor has expired, and the user can view instructions in step 730 for replacing the sensor or monitor and connecting the system to the new glucose sensor or monitor. Furthermore, if there is a problem communicating with the remote user interface device, screen 741 may appear, allowing the user to return to step 720 to connect a new remote user interface device or reconnect the remote user interface device.

Passive and active information gathering

The methods, devices, and systems provided herein are suitable for passively collecting information about insulin use and a user's dietary patterns without requiring additional steps from the user, but can be used to assist the user in determining appropriate action upon request. Therefore, the methods, systems, and devices provided herein can use dose capture technology in or attached to an insulin pen to estimate the amount of insulin delivered to a patient with diabetes (PWD). Additionally, the estimated glucose value (EGV) can be pushed or pulled to the pen cap and/or a remote user interface device via wireless communication as discussed above, and can be used by the user to assist in making insulin delivery decisions. In some cases, the glucose sensor or monitor 150 may be a scanning glucose monitor that requires user interaction to retrieve the EGV. In some cases, a system including a scanning glucose monitor can receive the current and past EGV from interrogations by the scanning glucose monitor, which can be used by the methods, devices, and systems provided herein to make treatment recommendations and update user-specific dosage parameters.

In some cases, methods, devices, and systems may include user prompts to request information or request EGV from the user based on the risk to the user, and/or to obtain data. For example, as discussed above, postprandial data can be used to update the meal notification button. Furthermore, postprandial data can be used to update other user-specific dosage parameters. Additionally, after a meal, the user faces an elevated risk of hyperglycemia or hypoglycemia. Therefore, in some cases, the methods, systems, and devices provided herein may request EGV from the user. For example, in Figure 8A, the remote user interface device 110 may include a notification 810 displayed 90 minutes after administration of a bolus dose of insulin to encourage the user to scan a glucose monitor. Optionally, notification 810 may request blood glucose data from any other suitable glucose monitor or sensor (e.g., from a blood glucose meter that requires finger pricking). Optionally, notification 810 may appear on a pen cap or smart insulin pen. By obtaining postprandial blood glucose data, the methods, systems, and devices provided herein can (a) determine whether a dose correction might be prudent and/or (b) determine how to personalize the meal notification button.

The methods, devices, and systems provided herein can also seek feedback from the user regarding the user's mental model, particularly when the user fails to report meal amounts. For example, in some cases, a user determines that the rapid-acting insulin dosage can follow the steps shown in Figure 6B, but abruptly stops reporting meals after seeing the suggested corrected dose on the user's screen 636, instead only administering a bolus of the meal. As discussed above, the methods, systems, and devices provided herein can estimate the amount of carbohydrates in the meal based on the difference between the recommended corrected dose and the actual dose. In some cases, when the user accesses a remote user interface, the methods, devices, and systems provided herein can seek confirmation from the user regarding the estimated amount of carbohydrates. For example, Figure 8B depicts a message 820 that may appear on the remote user interface device 110, requesting the user to confirm that the PWD ate a particularly large meal by selecting YES 821, or to deny that the PWD ate a particularly large meal by selecting NO 822. In some cases, message 820 may appear after blood glucose data has been retrieved. In some cases, message 820 may use multiple blood glucose values to determine the possible timing and size of a meal, which may differ from the amount of carbohydrates inferred based on insulin levels. Alternatively or additionally, the methods, systems, and devices of this disclosure may continue analysis and/or data collection using estimated meal amounts from the PWD, even without input from the PWD regarding meal amounts, or even without information on whether the PWD consumed the meal. In some cases, the difference between estimated meal amounts based on postprandial blood glucose and insulin delivery data and estimated meal amounts based solely on insulin delivery data may indicate a mismatch between the user's mental model and the PWD's physiological and food consumption. In some cases, message 820 may be passive (i.e., without audible alarms), but available to the user to respond when the user looks at a remote user interface device or opens a mobile application for the system on a remote user interface device. In some cases, message 820 may provide insights to the user showing the methods, systems, and devices their understanding of the user's usage patterns in order to build user trust in the devices and systems. In some cases, the user may select button 823 to provide additional details about the push. The data received from the user after the meal can then be used to generate updates for meal notification buttons 142-144, 221-223, and 321-323.

Calculate and update recommendations, user-specific dosage parameters, and active insulin.

The methods, apparatus, and systems provided herein can be used with any suitable technique for making recommendations, updating user-specific dose parameters (e.g., a person's ISF, CR, total daily LAI dose, etc.), and estimating the amount of ineffective insulin (e.g., for calculating IOB). In some cases, user-specific dose parameters may vary depending on the time of day. In some cases, user-specific dose parameters can be determined using fixed relationships between them. For example, in some cases (such as users with type 1 diabetes), fixed relationships between the carbohydrate-to-insulin ratio of total daily LAI and PWD, and the insulin sensitivity factor of PWD, can be based on fixed mathematical relationships. In some cases, relationships can be determined by one of the drawn lines 915, 925, 935, 945, 955, 965, 975, or 985 shown in Figures 9A and 9B, or by any drawn line between lines 915 and 945 and between lines 955 and 985. By establishing a fixed mathematical relationship between total daily LAI, ISF, and CR, the methods, systems, and devices presented in this paper can update CR and ISF to PWD in response to past changes in insulin over time.

In some cases, methods, systems, and devices can make recommendations to users to adjust the dose of LAI based on fasting blood glucose readings (e.g., blood glucose readings obtained in the morning before a PWD meal). In some cases, the methods, devices, and systems provided herein can increase the recommended dose of LAI by a predetermined number of units (e.g., 0.5 units) based on a fasting blood glucose reading above a threshold, and reduce the recommended dose of LAI based on a fasting blood glucose reading below different lower thresholds. In some cases, if the user fails to deliver LAI at the appropriate time, methods, devices, and systems can provide recommendations regarding the dose of LAI and rapid-acting insulin (QAI).

The methods, devices, and systems provided herein can calculate the recommended corrected dose by subtracting the target blood glucose value from the EGV, dividing that number by the insulin sensitivity factor (ISF), and then subtracting the IOB. The methods, devices, and systems provided herein can also calculate the recommended bolus for food consumption by dividing the amount of carbohydrates associated with the food alert button by the ratio of carbohydrates to insulin (CR) stored in the PWD. Conversely, if the PWD delivers a bolus of insulin after calculating the corrected bolus without entering a meal and that bolus differs from the recommended corrected bolus, the methods, systems, and devices provided herein can calculate the amount of carbohydrates inferred for the meal by subtracting the recommended corrected bolus from the amount of insulin delivered and multiplying that number by the CR stored in the user's database. In other words, inferred carbohydrates = (delivered insulin bolus - recommended corrected bolus) * CR. The methods, systems, and devices provided herein can then use the calculated inferred carbohydrates when calculating the predicted blood glucose level, which can be used to issue an alert or warning to the PWD (e.g., a predicted hypoglycemia or predicted hyperglycemia alert or warning). In some cases, the recommended corrected bolus may be negative. In some cases, when the user does not input or retrieve the EGV and/or does not cause the system to calculate the recommended corrected dose, the devices, systems, and methods provided herein can calculate the inferred amount of carbohydrates by multiplying the dose by the CR. By enabling the methods, systems, and devices to infer the amount of carbohydrates, the methods, devices, and devices provided herein can match the user's mental model without requiring user input data.

Systems for the treatment of type 2 diabetes

In some cases, the methods, systems, and devices described herein can be used to treat people with type 2 diabetes (PWT2D) and to personalize insulin therapy for the treatment of type 2 diabetes (T2D). For example, the system shown in Figure 1A can be used to treat PWT2D.

Type 2 diabetes is often treated by slowly adding treatments. Initially, PWT2Ds may be advised to control their diet and exercise to prevent high blood sugar levels, which can be monitored by recording blood glucose readings obtained with BGM. If diet and exercise are insufficient to achieve blood glucose control—defined by an HBA1C value of less than 7% and fasting/pre-meal blood glucose readings of less than 110 mg/dL (but can be individualized based on several factors)—then PWT2Ds may begin treatment with a variety of medications designed to lower blood glucose levels, such as GLP-1RAs, SGLT-2i, or DPP-4i. If these medications do not achieve adequate blood glucose control, then PWT2Ds may begin insulin therapy with one or two injections of LAI, with or without other medications. The systems, devices, and methods described in this article can be used to help PWT2Ds create a data log of blood glucose readings, document meals, and remind them when to obtain post-meal blood glucose readings (even when the PWT2D is not on insulin therapy).

If PWT2D is taking LAI instead of QAI based on diet, the methods and systems described herein can be used to adjust LAI injections, in addition to logging BGM data and diet and issuing reminders. When the systems and methods described herein are started, the user and/or provider of the healthcare service can set the initial LAI dose based on PWT2D's previous LAI treatments. If PWT2D is starting LAI treatment for the first time, the total daily LAI dose can be set to approximately 0.2 U/kg or any amount between 0.1 and 0.3 U/kg when PWT2D starts the system. For example, if PWT2D has an A1C of less than 8%, the healthcare provider can typically set the total LAI treatment between 0.1 and 0.2 U/kg. If PWT2D has an A1C of greater than 8%, the healthcare provider can typically set the total LAI treatment between 0.2 and 0.3 U/kg. For example, a PWT2D weighing 100 kg with 8% A1C could allow a healthcare provider to set a total daily dose of LAI at 20 units (e.g., 10 units at 8 AM and 10 units at 8 PM). In some cases, the mobile application may include an interface for enabling the PWT2D or its healthcare provider to initiate LAI treatment, which may be updated or adjusted later (both via algorithms provided below or manually). In some cases, LAI treatment may initially be set and/or updated by the healthcare provider in a remote web interface connected to the mobile application via the cloud. In some cases, the methods and systems described herein may require a qualified healthcare professional to input or confirm the initial LAI treatment.

The methods, devices, and systems described herein allow for the use and adjustment of LAI treatment by tracking blood glucose data and LAI injections. In some cases, LAI can be adjusted upwards if the mean fasting blood glucose reading over a period of time (e.g., 1 day, 2 days, 3 days, 5 days, 7 days, or longer). In some cases, the amount of adjustment may depend on how much the mean fasting blood glucose value exceeds the threshold. For example, in some cases, a 3-day mean fasting blood glucose value between 110 and 140 mg/dL will result in an increase of 1 unit of LAI per day, a 3-day mean fasting blood glucose value between 140 and 180 mg/dL will result in a 10% increase in LAI, and a 3-day mean fasting blood glucose value of at least 180 mg/dL will result in a 20% increase in LAI. In some cases, the percentage increase in LAI may be linearly proportional to a 2- or 3-day mean exceeding 110 mg/dL.

In some cases, if any blood glucose reading is below a threshold (which could be hypoglycemia or indicate a risk of hypoglycemia), the LAI can be adjusted downwards. This reduction can be proportional to the hypoglycemic reading. In some cases, if the blood glucose reading is between 40 and 70 mg/dL, the LAI will be reduced by 10-20%, and blood glucose readings below 40 mg/dL will result in a reduction of 20-40%. In some cases, the methods and systems described herein reduce the LAI by 10% for readings of approximately 70 mg/dL, by 20% for readings of approximately 40 mg/dL, and by 40% for readings of approximately 30 mg/dL or less.

Typically, if LAI treatment is achieving glycemic control, the system should not generate contradictory upward and downward adjustments. Furthermore, glycemic control should result in the absence of hypoglycemia, preventing fasting and pre-meal blood glucose readings greater than 110 mg/dL and A1C less than 7%. If the method and system fail to achieve glycemic control after a sufficiently long period (e.g., 1 month, 2 months, etc.) preset or set by the healthcare provider, the system can send a message to the healthcare provider indicating that additional treatment can be considered. Additional treatment includes medications (such as GLP-1RAs, SGLT-2i, or DPP-4i) or treatment with LAI and QAI. If other medications besides QAI are added to the treatment, the system can continue to adjust the LAI as described above and determine whether glycemic control is achieved after a sufficiently long period (e.g., 1 month, 2 months, etc.).

If PWT2D switches from LAI-only treatment to a combination of LAI and QAI, healthcare providers may switch to QAI for some meals or all meals. For example, in some cases, a healthcare provider might reduce the LAI by 10% or 5 units and set the dietary QAI bolus for the largest meal at that 10% or 5-unit value, potentially increasing the dietary QAI bolus for additional meals (if that fails to achieve glycemic control). In some cases, a healthcare provider might decide to reduce the LAI by 50% and set the dietary QAI dose at the same value as the reduction in LAI, possibly estimating different amounts for different meals. Regardless of the dosage of LAI and dietary QAI boluses or the timing set by the healthcare provider, the methods and systems described herein can be adjusted for both LAI and QAI injections based on blood glucose readings. For any fasting blood glucose reading, the same guidelines discussed above can be used to reduce or increase the total daily LAI units. Each dietary QAI bolus can be adjusted by increasing the bolus when the average postprandial blood glucose reading is above a high threshold and decreasing it when the reading is below a low threshold. For example, if the postprandial blood glucose reading 2 hours after a meal is between 70 and 40 mg/dL, the QAI bolus for that meal will be reduced by 10% to 20%, and if the reading is below 40 mg/dL, the bolus will be reduced by 20% to 40%. A postprandial blood glucose reading above 140 mg/dL may, for example, cause the system to increase the QAI bolus for that meal by 10% or by 1-2 units. Therefore, the system and method presented herein can personalize the size of the dietary QAI bolus, which may be due to typical dietary intake during PWT2D or variations in insulin sensitivity and the carbohydrate-to-insulin ratio throughout the day. If the dietary QAI bolus produces highly variable postprandial blood glucose readings, the system described in this article can also notify the user to instruct PWT2D that the amount of food consumed should remain roughly constant.

The systems, devices, and methods described herein can also flag unusual situations for users or healthcare providers and suggest additional tasks. For example, in some cases, a user may have a postprandial blood glucose reading of 130 mg/dL but wake up with a fasting blood glucose reading greater than 160 mg/dL. This may indicate that PWT2D may be experiencing nocturnal hypoglycemia, followed by a rebound in blood glucose levels due to biological responses (e.g., the release of glucagon from the liver), and the system may therefore suggest occasional additional blood glucose readings at night. Nocturnal hypoglycemia may indicate a need to adjust the units of dinner QAI bolus or LAI. In some cases, the methods and systems described herein may have data about the next appointment with a healthcare provider and request additional blood glucose measurements from PWT2D in the days leading up to the appointment.

Based on system inference

In some cases, the methods, apparatus, or systems of this disclosure can infer certain information by observing and/or analyzing data collected based on this disclosure. For example, inferences can be made about whether a meal was consumed, the amount of meal consumed, whether an insulin bolus was received, and/or the size of the insulin bolus received.

In some cases, the methods, devices, or systems of this disclosure can analyze historical blood glucose readings and record the moments when blood glucose levels rise, particularly around mealtimes. By observing the elevated blood glucose levels, inferences about dietary consumption can be made. Alternatively or additionally, using user-specific parameters (e.g., carbohydrate-to-insulin ratio (CR), insulin sensitivity factor (ISF), on-plate insulin (IOB), etc.) and/or historical data, the amount of food consumed can be inferred based on the amount of change in blood glucose levels and data collected regarding the amount of food consumed during a meal plan (PWD). For example, if a known amount of insulin is repeatedly administered to the PWD as a bolus for a meal and a known response is expected for a desired amount of food consumed, then a change in that response can convey a change in the amount of food consumed.

In some cases, the methods, devices, or systems of this disclosure can analyze historical blood glucose readings and record the time when blood glucose levels decrease. For example, an inference can be made as to whether a user has received an insulin bolus based on a decrease in blood glucose levels (a decrease in blood glucose levels based on an expected bolus associated with a meal). For example, an initial increase in blood glucose levels around mealtime following a decrease in blood glucose levels can indicate that the user has indeed received a bolus for a meal. Alternatively or additionally, the size of the bolus can be estimated using user-specific parameters and/or historical data. For example, if the meal amount is known (or estimated) and the typical response for PWD is known (or expected), a decrease in blood glucose levels can allow the methods, devices, or systems of this disclosure to infer the bolus size. In some cases, the methods, devices, or systems of this disclosure can use inference to act as a safety check to verify that PWD has received a bolus associated with a meal. For example, PWD can use a bolus insulin pen that does not communicate with other components of the systems or devices of this disclosure, and this method can verify that a bolus for a meal has been given.

In some cases, the expected change in blood glucose levels can be combined with the overlap of expected blood glucose levels due to LAI, QAI, and consumed carbohydrates. This data can be inferred, read from one or more sensors or devices, or input by the user or PWD.

The embodiments described herein may include the use of dedicated or general-purpose computers that include various computer hardware or software modules, as discussed in more detail below.

The various embodiments described herein can be implemented using a computer-readable medium for carrying or having computer-executable instructions or data structures stored thereon. Such a computer-readable medium can be any available medium accessible by a general-purpose or special-purpose computer. By way of example and not limitation, such a computer-readable medium can include non-transitory computer-readable storage media, including random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), optical disc read-only memory (CD-ROM) or other optical disc storage devices, magnetic disk storage devices or other magnetic storage devices, flash memory devices (e.g., solid-state storage devices), or any other storage medium that can be used to carry or store desired program code in the form of computer-executable instructions or data structures and is accessible by a general-purpose or special-purpose computer. Combinations of the foregoing items can also be included within the scope of computer-readable media.

Computer-executable instructions include, for example, instructions and data that cause a general-purpose computer, a special-purpose computer, or a special-purpose processing device (e.g., one or more processors) to perform a function or group of functions. Although the subject matter has been described in language specific to structural features and/or methodological actions, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the features and actions described above are disclosed as exemplary forms for implementing the claims.

Any ranges indicated herein (including in the claims) are considered to give their broadest possible interpretation. For example, unless otherwise expressly stated, ranges will include their endpoints (e.g., the range "between X and Y" will include both X and Y). Additionally, ranges described using the terms "approximately" or "about" should be understood to give the broadest meaning consistent with the understanding of one skilled in the art. Furthermore, the term "approximately" includes any number within 10% (or 5%) or within manufacturing tolerances or typical tolerances.

All examples and conditional language listed herein are intended for pedagogical purposes to aid the reader's understanding of this disclosure and the concepts contributed by the inventors to advance the art, and should be construed as not being limited to such specifically listed examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims (19)

1. An apparatus comprising: A user interface configured to display data and one or more dose recommendations to a user; A memory for storing information, wherein the information includes user-specific dose parameters, including one or more of the following: total daily long-acting insulin dose, total daily insulin dose, weight, age, average daily total insulin dose per body weight, carbohydrate to insulin ratio, insulin sensitivity factor, or glucose set point; and A processor for receiving blood glucose data, the processor communicating with the memory to determine the amount of correction dose based on the blood glucose data and the amount of carbohydrates determined based on the user-specific dose parameters. 2. The apparatus of claim 1, wherein one of the dose recommendations is an indication of the amount of the corrected dose. 3. The apparatus of claim 1, wherein the information stored in the memory includes the amount of insulin to be administered for a diet. 4. The device of claim 3, wherein one of the dosage recommendations is an indication of the amount of insulin to be administered for the diet. 5. The apparatus of claim 1, wherein the information stored in the memory includes the corresponding amount of insulin to be administered for multiple meals. 6. The device of claim 5, wherein the dosage recommendation is an indication of the corresponding amount of insulin to be administered for multiple meals. 7. The apparatus of claim 1, wherein the information stored in the memory includes the amount of insulin to be administered for the diet; and wherein one of the dosage recommendations is an indication of the number of insulin units, the number of insulin units representing the amount of insulin to be administered for the diet and the amount of insulin to be added to correct elevated blood glucose levels. 8. The apparatus of claim 1, wherein the information stored in the memory includes the amount of insulin to be administered for the meal; and wherein the dosage recommendation is a plurality of indications of a plurality of units of insulin, the plurality of units of insulin representing the amount of insulin to be administered for the meal and an additional amount of insulin for correcting elevated blood glucose levels. 9. The apparatus of claim 1, wherein the blood glucose data comprises one or more readings from a blood glucose meter or data from a continuous glucose monitor. 10. A system comprising: Insulin delivery equipment; A glucose monitor or sensor, said glucose monitor or sensor for providing blood glucose data; and The accessories of the insulin delivery device include: A user interface configured to display data and one or more dose recommendations to a user; A memory for storing information, wherein the information includes user-specific dose parameters, including one or more of the following: total daily long-acting insulin dose, total daily insulin dose, weight, age, average daily total insulin dose per body weight, carbohydrate to insulin ratio, insulin sensitivity factor, or glucose set point; and A processor is configured to receive the blood glucose data and communicate with the memory to determine the amount of correction dose based on the blood glucose data and the amount of carbohydrates determined based on the user-specific dose parameters. 11. The system of claim 10, wherein one of the dose recommendations is an indication of the amount of the corrected dose. 12. The system of claim 10, wherein the information stored in the memory includes the amount of insulin to be administered for a diet. 13. The system of claim 12, wherein one of the dosage recommendations is an indication of the amount of insulin to be administered for the diet. 14. The system of claim 10, wherein the information stored in the memory includes the corresponding amount of insulin to be administered for multiple meals. 15. The system of claim 14, wherein the dosage recommendation is an indication of the corresponding amount of insulin to be administered for multiple meals. 16. The system of claim 10, wherein the information stored in the memory includes the amount of insulin to be administered for the diet; and wherein one of the dosage recommendations is an indication of the number of insulin units, the number of insulin units representing the amount of insulin to be administered for the diet and the amount of insulin to be added to correct elevated blood glucose levels. 17. The system of claim 10, wherein the information stored in the memory includes the amount of insulin to be administered for the meal; and wherein the dosage recommendation is a plurality of indications of a plurality of units of insulin, the plurality of units of insulin representing the amount of insulin to be administered for the meal and an additional amount of insulin for correcting elevated blood glucose levels. 18. The system of claim 10, wherein the blood glucose data includes one or more readings from a blood glucose meter or data from a continuous glucose monitor. 19. The system of claim 10, wherein the accessory of the insulin delivery device is wirelessly connected to the glucose monitor or sensor.