Therapy management system, method and device
阅读说明：本技术 治疗管理系统、方法和设备 (Therapy management system, method and device ) 是由 J·斯霍伦德 A·斯瑞纳司 A·布坎寇 G·克罗塞尔 B·梅兹利什 S·马塔雷塞 L·马 于 2018-12-12 设计创作，主要内容包括：本公开的一个或多个实施方案整体涉及一种用于手动药物输送设备的可重复使用的附件。这种可重复使用的附件可包括无线通信接口、检测电路和推荐系统。在一个或多个实施方案中,适配器可被配置为将这种可重复使用的附件可逆地耦接到手动药物输送设备。可检测与手动药物输送设备处的给药相关联的给药事件。可响应于分析物测量值和/或给药事件而提供剂量推荐。(One or more embodiments of the present disclosure generally relate to a reusable accessory for a manual drug delivery device. Such reusable accessories may include a wireless communication interface, a detection circuit, and a recommendation system. In one or more embodiments, the adapter may be configured to reversibly couple such a reusable accessory to a manual drug delivery device. A drug administration event associated with a drug administration at a manual drug delivery device may be detected. The dose recommendation may be provided in response to an analyte measurement and/or a dosing event.)
1. A reusable accessory for a manual drug delivery device, comprising:
a wireless communication interface configured to receive analyte measurement data from an analyte sensor system;
a detection circuit configured to:
detecting a drug administration event associated with a drug administration action at the manual drug delivery device; and
storing a record for each of the one or more dosing events, wherein the record comprises a dosing time for the dosing event;
a recommendation system configured to provide one or more drug dose recommendations in response to one or more of the analyte measurement data and the dosing event; and
an adapter configured to reversibly couple to a predetermined portion of the manual drug delivery device.
2. The reusable accessory of claim 1, wherein the manual medication delivery device is a medication injection pen and the reusable accessory is a reusable cap of the medication injection pen, and wherein the medication administration event associated with the one or more medication administration actions is one or more of a capping event or a decapping event, and the detection circuit is configured to detect a capping event or a decapping event in response to a sensor signal.
3. The reusable accessory of claim 2, further comprising a timer configured to count a number of time units from a decapping event to a subsequent capping event, wherein the circuit is configured to record a time of administration in response to the determined count being greater than a threshold number of time units.
4. The reusable accessory of one of claims 1-3, wherein the wireless communication interface is configured to receive the analyte measurement data over a first wireless connection when the wireless communication interface is positioned proximate at least a portion of the analyte sensor system.
5. The reusable accessory of claim 4, wherein the wireless communication interface is configured to communicate medication administration events, treatment parameters, and analyte measurement data with a mobile computing device over a second wireless connection.
6. The reusable accessory of claim 5, wherein the wireless communication interface is configured to receive therapy parameters from the mobile computing device.
7. The reusable accessory of one of claims 5 and 6, wherein the first wireless connection has a first communication range and the second wireless connection has a second communication range, wherein the second communication range is greater than the first communication range.
8. The reusable accessory of one of claims 4-7, wherein the wireless communication interface comprises an NFC chip and the first wireless connection consists of NFC communication between the reusable accessory and the analyte sensor system.
9. The reusable accessory of one of claims 1-8, wherein the wireless communication interface comprises a radio adapted to enable bluetooth low energy communication between the reusable accessory and one or more mobile computing devices.
10. The reusable accessory of one of claims 1-9, wherein the analyte sensing system includes a blood glucose meter adapted to provide blood glucose data.
11. The reusable accessory of one of claims 1-9, wherein the analyte sensor system is a flash glucose monitor adapted to provide glucose data via near field communication.
12. The reusable accessory of one of claims 1-9, wherein the analyte sensor system is a continuous glucose monitor adapted to provide glucose data via wireless device communication (e.g., bluetooth low energy) and optionally Near Field Communication (NFC).
13. The reusable accessory of one of claims 1-12, further comprising at least one button for enabling and disabling an operational mode of the reusable accessory, including triggering receipt of analyte measurement data, changing a display, stopping or pausing an alarm, or a combination thereof.
14. A diabetes management system comprising:
a glucose sensor system adapted to wirelessly transmit glucose measurement data;
an insulin dose monitoring device adapted to be reversibly connectable to an insulin delivery device, the insulin dose monitoring device comprising a display, a memory storing insulin therapy dose parameters, and a processor adapted to detect delivery of insulin from the insulin delivery device, the insulin dose monitoring device adapted to wirelessly receive glucose measurement data from the glucose sensor system, the processor adapted to provide an insulin dose recommendation based on the stored insulin therapy dose parameters, the glucose measurement data, or a combination thereof; and
a mobile computing device comprising a processor, the mobile computing device configured to intermittently connect to the insulin monitoring device and receive the at least one characteristic related to the insulin monitoring device, the glucose measurement data, or a combination thereof from the insulin dose monitoring device via wireless communication.
15. The system of claim 14, wherein the insulin dose monitoring device comprises a pen cap and the insulin delivery device is an insulin injection pen, wherein the pen cap is adapted to detect delivery of insulin from the insulin injection pen by detecting a pen cap event that can be inferred as a drug administration event.
16. The system of claim 14, wherein the insulin dose monitoring device comprises a pen cap and the insulin delivery device is an insulin injection pen, wherein the pen cap is adapted to detect the amount of insulin remaining in the insulin injection pen to determine the time course and optionally the dose of each dose.
17. The system of claim 14, wherein the insulin dose monitoring device comprises an accessory that can detect movement of a plunger or associated mechanical element that moves during injection of insulin from the insulin injection pen.
18. The system of one of claims 14-17, wherein the mobile computing device is configured to receive data related to the at least one characteristic over a selected time period, the data including past data values substantially prior to a current time value.
19. A method of managing medication therapy with a manual medication delivery device, comprising:
receiving analyte measurement data from an analyte sensor system;
detecting a drug administration action event at an accessory configured to reversibly attach to a manual drug delivery device;
storing a record of each of the one or more drug administration action events, wherein the record comprises a time of drug administration for a drug administration action; and
providing one or more drug dose recommendations in response to the analyte measurement data.
20. The method of claim 19, further comprising receiving analyte measurement data over a first wireless connection in response to the wireless communication interface being positioned proximate to at least a portion of the analyte sensor system.
21. The method of claim 20, further comprising communicating the medication administration event, the therapy parameter, and the analyte measurement data with the mobile computing device over a second wireless connection.
22. The method of claim 21, further comprising receiving therapy parameters from the mobile computing device over the second wireless connection.
23. The method of claim 19, wherein the manual medication delivery device is a medication injection pen and the reusable accessory is a reusable cap of the medication injection pen, and wherein the medication administration action events associated with one or more medication administration actions are one or more of capping and uncapping events, and the detection circuitry is configured to detect capping and uncapping events in response to sensor signals.
24. An intelligent electronic module capable of being integrated with a manual medication delivery device, comprising:
a wireless communication interface configured to receive analyte measurement data from an analyte sensor system;
a detection circuit configured to:
detecting a drug administration event;
storing a record of each of the one or more dosing actions, wherein the record includes a dosing time for the dosing action; and
receiving analyte measurement data received from the analyte sensor system;
a recommendation system configured to provide one or more drug dose recommendations in response to the analyte measurement data; and
an adapter configured to reversibly couple to a predetermined portion of the manual drug delivery device.
25. The apparatus of claim 1, the system of claim 14, the method of claim 19, or the module of claim 24, wherein the glucose measurement data and/or glucose data is or is based on interstitial fluid glucose levels.
26. The apparatus of claim 1, the system of claim 14, the method of claim 19, or the module of claim 24, wherein the glucose measurement data and/or glucose data is a blood glucose level related to an interstitial fluid glucose level.
27. The apparatus of claim 1, the system of claim 14, the method of claim 19, or the module of claim 24, wherein the glucose measurement data and/or glucose data is a blood glucose level.
Technical Field
The present disclosure relates to therapy management systems, methods, and devices adapted to collect and/or transmit therapy-related data (e.g., time course of therapy) and/or other therapy-related data and provide therapy recommendations to a user. In particular embodiments, diabetes therapy management systems, devices, and methods are disclosed that may be used with insulin injection devices and include components adapted to provide insulin therapy recommendations to a user based on stored therapy parameters, blood glucose data, meal size estimates, and/or other parameters.
Background
Diabetes mellitus is a chronic metabolic disorder caused by the inability of the human pancreas to produce sufficient amounts of the hormone insulin, so that the human metabolism fails to properly absorb sugars and starches. This failure can cause hyperglycemia, i.e., the presence of excess glucose in the plasma. Persistent hyperglycemia is associated with a variety of severe symptoms and life threatening long term complications such as dehydration, ketoacidosis, diabetic lethargy, cardiovascular disease, chronic renal failure, retinal damage and nerve damage at risk of amputation. Since a cure is not yet possible, a permanent treatment is necessary, which provides constant glycemic control in order to keep blood analyte levels within normal limits at all times. This glycemic control is achieved by periodically providing an external drug to the patient's body, thereby causing elevated blood analyte levels to be reduced.
Biologically effective external drugs (e.g., insulin or analogs thereof) are typically administered by daily injection. In some cases, Multiple Daily Injections (MDI) of a mixture of fast-acting and long-acting insulin are made via a reusable transdermal liquid delivery device (commonly referred to as an "insulin pen") or hypodermic syringe. These injections are typically administered by People With Diabetes (PWD), and thus require self-monitoring of blood glucose and self-administration of insulin. PWDs that use MDIs to manage their care typically plan daily insulin injections in advance based on basal insulin needs as well as external factors such as meals, exercise, sleep, etc. A typical administration schedule will include the time of day of injection, the type of insulin (e.g., rapid acting, long acting, a mixture of rapid acting and long acting, etc.), and the amount of insulin per dose. In addition, the PWD will self-monitor its blood glucose and self-administer one or more "bolus" doses of fast-acting insulin in the event that its blood glucose is too high and consume carbohydrates (or sometimes glycogen) in the event that its blood glucose is too low.
The "correct" insulin dosage will vary with glucose levels in the blood, physiological factors such as the insulin sensitivity of a person, and lifestyle factors such as meals (e.g., recently consumed carbohydrates that have not been metabolized to glucose and absorbed into the blood). Furthermore, even with careful planning and self-monitoring, PWDs may miss doses, double doses, and administer incorrect amounts and/or types of insulin. Insulin deficiency can lead to hyperglycemia, while insulin excess can lead to hypoglycemia, which can result in clumsiness, difficulty speaking, confusion, loss of consciousness, epilepsy, or death. Therefore, PWDs face a considerable cognitive burden in determining the appropriate dose of insulin.
To assist in self-treatment, some diabetes treatment devices (e.g., glucose meters, insulin pumps, etc.) are equipped with an insulin bolus calculator that lets the user input an estimate (e.g., numerical estimate) of the amount of carbohydrates (or additionally or alternatively protein, fat, or other meal data) consumed or about to be consumed, and that outputs a recommended size of the insulin bolus amount. While the bolus calculator eliminates some of the mental effort required by the user in determining the appropriate bolus dose of insulin, the bolus calculator still subjects the user to the mental task of evaluating the composition of their meal, may require the use of auxiliary equipment, and typically requires manual input of data. Accordingly, there is a need for methods, systems, and devices that assist users in making appropriate treatment decisions while minimizing the burden on the user (e.g., data input, mental calculations, procedures, etc.).
Drawings
The disclosure may be more completely understood in consideration of the following detailed description of exemplary embodiments, which are illustrated in the accompanying drawings.
Fig. 1A illustrates a diabetes management system according to an embodiment of the present disclosure. FIG. 1B illustrates specific components of an exemplary diabetes management system. FIG. 1C illustrates a second exemplary diabetes management system.
FIG. 2 illustrates a user utilizing one or more portions of a diabetes management system according to an embodiment of the present disclosure.
Fig. 3-6 illustrate a display on a pen cap according to an embodiment of the present disclosure.
Fig. 7 illustrates an exemplary communication architecture of a system according to an embodiment of the present disclosure.
Fig. 8 illustrates a process for recommending insulin dosage according to one embodiment of the present disclosure.
Fig. 9 illustrates a process for injecting insulin according to one embodiment of the present disclosure.
Fig. 10 illustrates a process for recommending insulin dosage according to one embodiment of the present disclosure.
Fig. 11 shows a process for injecting insulin according to one embodiment of the present disclosure.
Fig. 12 shows a process for checking the status of a therapy system according to one embodiment of the present disclosure.
Fig. 13 illustrates a process for checking the status of a therapy system according to one embodiment of the present disclosure.
Fig. 14 illustrates a process for updating therapy information according to one embodiment of the present disclosure.
Fig. 15 shows a process for checking the status of a therapy system according to one embodiment of the present disclosure.
Fig. 16-25 illustrate an exemplary display and/or user interface of a portion of a system (e.g., of a mobile device) according to embodiments of the present disclosure.
Fig. 26 depicts an exemplary sliding scale chart of a diabetes management system according to an embodiment of the present disclosure.
Fig. 27-33 illustrate an exemplary display and/or user interface of a portion of a system (e.g., of a mobile device) according to embodiments of the present disclosure.
Fig. 34A-34D illustrate an exemplary communication architecture of a scalable system according to embodiments of the present disclosure.
Fig. 35A and 35B illustrate an exemplary display on a pen cap according to an embodiment of the present disclosure.
Detailed Description
Manual insulin delivery devices such as insulin pens, insulin inhalers, and the like (generally referred to herein as "manual insulin devices") provide a convenient, reusable insulin delivery device. However, improper administration of insulin due to human error, insulin pen malfunction, missed doses, double administration, and incorrect administration is always a problem. Although the methods, devices, and systems provided herein are described for delivering insulin, collecting blood glucose data, and/or treating diabetes, the methods, devices, and systems provided herein may be adapted for delivering other drugs, collecting other analyte data, and/or treating other diseases. Additionally, although the methods, devices, and systems provided herein are primarily described by describing features and functions included in a cap attachment for an insulin delivery pen or a method of using a cap attachment or a system including a cap attachment, the features discussed herein are also contemplated to be incorporated directly into a smart drug delivery pen or a smart drug delivery inhaler, other attachments adapted to be secured to or used with other manual drug delivery devices, or methods or systems including such smart drug delivery devices or smart attachments.
The systems, devices, and methods described herein may be operated or performed by a user, such as a PWD, a patient, a subject, a healthcare professional, a clinician, and a caregiver, respectively. Unless otherwise indicated, the terms healthcare professional, clinician, and caregiver are used interchangeably in this disclosure.
In general, embodiments of the therapy management systems (e.g., diabetes management systems such as insulin therapy management systems), methods, and devices described herein may include a user interface configured to receive user-specific dosage parameters from a user or healthcare professional and use these user-specific dosage parameters to provide recommendations and reports to the user. In some embodiments, the user interface for receiving user-specific dosage parameters may be incorporated into a mobile application or another computing device, and the user interface for displaying immediate drug delivery recommendations may be incorporated into an accessory to a manual drug delivery device or an intelligent manual drug delivery device. In some cases, the user interface for inputting user-specific dosage parameters may additionally be used to view reports, recommendations, alerts, warnings, notifications, recommended user dosage parameter changes.
Systems, devices, and methods provided herein may include a user interface adapted to simplify the input of treatment-related data to reduce the burden of self-treatment. In some embodiments, the systems, devices, and methods provided herein are adapted to assist a Person With Diabetes (PWD) or their caregiver in determining an appropriate dose of insulin. In some embodiments, the methods, apparatus, and systems provided herein can reduce or eliminate manual entry of numerical data after initial setup. In some embodiments, the methods, devices, and systems provided herein may be adapted to simplify monitoring of blood glucose levels. In some embodiments, the methods, devices, and systems provided herein can allow a user to carefully manage their treatment. In some embodiments, the methods, devices, and systems provided herein can reduce the cognitive burden associated with making daily treatment decisions.
Systems, devices, and methods provided herein may simplify the process for obtaining insulin therapy recommendations and/or simplify the collection of Estimated Glucose Values (EGVs) and/or insulin delivery data from one or more insulin delivery devices. The systems, devices, and methods provided herein may be designed to minimize changes that a diabetic Person (PWD) using injection to administer insulin therapy may need to make to their therapy/daily life in order to receive therapy recommendations and/or receive notifications, alerts, or alarms.
In some implementations, the systems, methods, and devices provided herein can give a user the option of when, where, and whether to receive notifications, alerts, or alarms, which can be based at least in part on the device of the system carried by the user. In some implementations, alerts and/or alarms can be customized over time based on feedback from the user (e.g., the user's likes and dislikes). In some embodiments, the systems, methods, and devices provided herein may include notifications, alerts, and/or alarms that use a combination of EGV data and insulin delivery data to determine whether to trigger the notification, alert, and/or alarm.
In some embodiments, the systems, devices, and methods provided herein may automatically capture insulin delivery data, which may be captured using a connected and/or intelligent insulin injection pen or a connected and/or intelligent insulin pen accessory (e.g., a connected pen cap accessory).
In some embodiments, the systems, devices, and methods provided herein may recommend insulin doses (e.g., doses of long-acting insulin and/or fast-acting insulin) using any suitable technique. In some embodiments, the recommended insulin dose may be based on blood glucose data (e.g., current EGV from CGM, flash glucose monitor, glucometer, or any other sensor, blood glucose trend data, etc.), insulin administration data (bolus dose of rapid acting insulin, dose of long acting insulin, time of administration, IOB and/or calculation of active insulin, etc.), meal data (meal time, user estimated carbohydrates, user estimated meal classification, user estimated meal boost, user meal history, user meal trend, etc.), and/or one or more insulin delivery parameters (e.g., total daily dose of basal or long acting insulin, carbohydrate to insulin ratio (CR), Insulin Sensitivity Factor (ISF), etc.). The methods, devices, and systems provided herein may, in some embodiments, adjust insulin delivery parameters over time based on glucose data and/or insulin administration data.
The systems, devices, and methods provided herein may include or use a mobile device (e.g., a mobile application running on a smartphone or tablet) to allow a user to set up the device or system, check the state of the device or system, adjust therapy settings, and/or learn how to improve their therapy options. In some embodiments, the mobile device may include information about maintenance tasks (e.g., reminders to perform certain maintenance tasks). In some embodiments, the methods, systems, and devices provided herein can detect patterns in treatment-related data and use that data to provide prompts, suggestions, alerts, and/or alarms to a user based on the patterns (which can be displayed on a mobile device). In some embodiments, the mobile device may provide a graphical display to the user of treatment-related data and/or treatment decisions (e.g., blood glucose data and/or insulin injection time) about the user. In some embodiments, the mobile device may provide an indication to the user that the user may wish to adjust their therapy (e.g., the amount of insulin needed for a meal, the amount of insulin needed to meet the user's basal needs, the time course of their insulin injections, etc.) and provide a mechanism (e.g., a link) for the user to adjust their therapy. In some embodiments, the mobile device may provide an indication to the user that the system has automatically adjusted its therapy (e.g., the amount of insulin needed for a meal, the amount of insulin needed to meet the user's basal needs, the time course of its insulin injection, etc.), and optionally provide a mechanism (e.g., a link) for the user to reject the automatic adjustment, confirm the automatic adjustment, or make a manual therapy adjustment.
In some embodiments, the diabetes management systems, devices, and methods provided herein may include a plurality of meal size categories (e.g., three meal sizes (small, medium, large), time-based meals (breakfast, lunch, dinner, snack)) that may be set by a user (e.g., on a mobile device). In some embodiments, the mobile device includes a setup user interface where the user is prompted to enter a user's typical insulin dosage required for different meal sizes (e.g., dosage required for a small meal, dosage required for a medium meal, dosage required for a large meal). In some embodiments, the settings user interface displays to the user exemplary pictures of meals that are to be considered within each meal category. In some embodiments, the device may analyze the meal size appropriate for the user (e.g., by analyzing input from the user, such as input related to the characteristics of the meal, pictures of the meal, etc.). In some embodiments, the settings user interface may be based on a user-entered amount of long-acting insulin (e.g.,
Systems, devices, and methods provided herein may include, use, or communicate with one or more accessories (e.g., a cap of an insulin pen) of a drug delivery device, such as an insulin pen, that are (a) adapted to be secured to an injection pen and detect when the cap is secured to and/or released from the injection pen, (b) adapted to receive blood glucose data from a glucose sensor, and/or (c) adapted to provide therapy-related information and/or recommendations to a user.
In some cases, the accessory may be a pen cap accessory adapted to detect pen capping information. Pen capping information (e.g., information about when a pen cap is secured to and/or released from an injection pen) may include information about a current capping time period (e.g., time since last capping), information about a duration of one or more decapping (which may also be referred to herein as "(one or more) decapping"), and a time course of each decapping and each capping (e.g., time of day or time elapsed thereafter). In some embodiments, pen capping information may be displayed to a user on the pen cap accessory. In some embodiments, pen capping information may be announced by a speaker in the pen cap. For example, in some embodiments, the cap may provide a timer clock timed from the last time the cap was secured to the injection pen. In some embodiments, the pen cap accessory may wirelessly transmit pen capping information to a remote computing device (e.g., a smartphone, a tablet, etc.). In some embodiments that do not include a pen cap accessory, the accessory or smart delivery device may detect other events associated with the drug delivery action and use this information in the manner described herein for pen capping information. For example, in some cases, an injection pen accessory may be secured to the injection pen such that it may detect mechanical movement of the drug delivery mechanism to determine when the drug is being administered.
Pen capping information may be used to modify a user experience (e.g., display content or information presented to a user). In some embodiments, the pen cap adjusts the presentation of therapy-related information and/or recommendations provided to the user based on the pen capping information. For example, in some embodiments, the pen cap may provide bolus recommendations based on data from a glucose sensor to correct elevated blood glucose levels, but presentation of such correction bolus recommendations may be limited to periods when the current pen capping duration is greater than a threshold period of time (e.g., at least 2 hours, at least 3 hours, at least 4 hours, or at least 5 hours). In some embodiments, the pen cap may provide a notification, alert, or alarm to the user based on the pen capping information. For example, if the cap is removed from the injection pen within a threshold period of time since the previous capping (e.g., within 30 minutes or 1 hour), the cap may provide a visual, audible, or vibratory notification to indicate that the user may have recently used the pen to administer insulin. In some embodiments, the pen cap may wirelessly communicate with a mobile computing device (e.g., smartphone, tablet), and may announce or display one or more notifications, alerts, or alarms based on pen capping information on the mobile computing device.
The pen capping information may be stored, displayed, and/or analyzed in conjunction with the glucose data to determine user behavior, such as whether the person properly administered the insulin required for a meal and/or corrected for elevated blood glucose levels. In some embodiments, pen capping information may be presented on a graphical representation of the user's blood glucose data and presented to the user and/or a healthcare professional. In some embodiments, blood glucose data from a period of time after each capping event may be evaluated to determine whether the user has properly administered insulin for the capping event, e.g., proper dosing, under dosing, or over dosing.
In some embodiments, a pen capping event may be ignored if other information indicates that no dose is being provided. For example, in the event that a change in the dosage selection (e.g., dial) of the insulin pen is not detected, the event can be ignored. In some embodiments, if the total decap time is less than a first threshold (e.g., 4-6 seconds), pen decap and recap events may be ignored. For example, the threshold may be determined by: the threshold is set to an amount of time that is too short to allow an injection to be made, but long enough to allow the user to check the end of the pen to see if there is insulin remaining or if there is a needle attached to the pen. In some cases, the total decap time for a decapping event (the time between a decapping event and subsequent recapping) may be analyzed in conjunction with blood glucose data to determine whether an injection is present during the decapping event. In some cases, if the total decap time exceeds a second threshold time period (e.g., at least 15 minutes, at least 30 minutes, etc.), the blood glucose data may be used to determine an approximate time of injection.
Accessories (e.g., caps) provided herein and associated methods and systems provided herein may be adapted to obtain blood glucose data for providing treatment-related information and/or treatment recommendations via the accessory (e.g., via the cap). In some embodiments, the treatment-related information displayed on the cap accessory may include a current Estimated Glucose Value (EGV) of the user. In some embodiments, the treatment-related information displayed on the cap may include a current blood glucose trend or rate of change indicator (e.g., a trend arrow). In some embodiments, the pen cap may include a recommended dose, which may be based on glucose data, or may be based on stored parameters without regard to the current EGV.
The accessories (e.g., pen caps) provided herein can be adapted to receive blood glucose data from any suitable glucose sensor. In some embodiments, the glucose sensor may be a Continuous Glucose Monitor (CGM), a flash glucose monitor, a Blood Glucose Meter (BGM), or any other suitable sensor. In the case of CGM and flash glucose monitors, they may be configured to provide glucose data based on the user's interstitial fluid glucose level (which may be related to blood glucose level). The BGM may be configured to provide blood glucose data, typically based on a blood sample. Thus, while the term "blood glucose" may sometimes be used as a generic term for convenience only, the present disclosure is not limited to using only blood glucose data, values, levels, etc., but may also use interstitial fluid glucose levels as well as any intermediate measurements.
In some embodiments, the pen cap can automatically receive glucose data from the CGM without user action as long as the pen cap is within range. In some embodiments, when the cap is positioned proximate to (e.g., swiped near) the flash glucose monitor, the cap may be adapted to wirelessly receive the current EGV (and optionally, the previous EGV) from the flash glucose monitor. In some embodiments, the EGV may be obtained via BGM, which may communicate wirelessly with the pen cap or a mobile computing device (which may then transfer the EGV to the pen cap), or may be input into a remote computing device by a user.
In some embodiments, accessories (e.g., caps) provided herein can be configured such that they retrieve glucose data only when a user interacts with the cap. For example, if the pen cap is adapted to obtain glucose data from a CGM or flash glucose monitor, the pen cap may be designed such that it needs to be swiped near the CGM or flash glucose monitor, or may be designed such that the glucose data may be retrieved only when the user makes a request (e.g., when a button is pressed). In some embodiments, the CGM may communicate wirelessly with a mobile computing device (e.g., smartphone, tablet) and transmit data from the CGM to the pen cap only when a button is pressed on the pen cap.
In some embodiments, an accessory (e.g., a pen cap) or mobile application provided herein can provide a reminder to a user to obtain glucose data. For example, with methods and systems that include a flash glucose monitor, a reminder may be sent to a user to obtain glucose data by swiping a pen cap near the flash glucose monitor. In some embodiments, the reminder to obtain glucose data may be timed based on pen capping information. For example, the reminder to obtain blood glucose data may be determined based on the time since the most recent capping (e.g., the current capping duration exceeding a threshold). In some embodiments, the threshold may be set to reduce the likelihood that a dose of insulin may cause a hypoglycemic event. In some embodiments, the pen cap may wirelessly receive blood glucose data and analyze patterns of the blood glucose data in comparison to pen capping information to determine a likelihood of a future hypoglycemic event or a predicted future blood glucose value. In some embodiments, the blood glucose data and pen capping information may be wirelessly transmitted to a remote computing device (e.g., a smartphone, tablet, etc.) and analyzed in the remote computing device or in a cloud or other network or device to determine the likelihood of a future hypoglycemic event or a predicted future blood glucose value, which may be used to issue a notification, alert or alarm and/or set a reminder to obtain the blood glucose data.
The pen caps provided herein may use any suitable technique to obtain pen capping information (e.g., information related to pen cap removal/application during insulin injection). In some embodiments, a pen cap provided herein may include a biasing element, such as a leaf spring inside the cap, that forms an electrical circuit when the pen cap is secured to the injection pen. In other embodiments, the cap may include a sensor (e.g., an optical sensor, a mechanical sensor, an electronic sensor, a magnetic sensor, etc.) that detects when the cap is applied to and/or removed from the pen.
The accessories (e.g., caps), methods, and systems provided herein can use any suitable method to make treatment recommendations. In some embodiments, the user or healthcare professional may set a recommended dose for starting the product, set one or more initial carbohydrate to insulin ratios, set one or more initial insulin sensitivity factors, create a corrected dose table for a particular glucose value range, and/or set one or more meal profile descriptions. For example, in some embodiments, a user or healthcare professional may set an initial recommended dose of long-acting insulin, a carbohydrate-to-insulin ratio, and an insulin sensitivity factor for determining a dose of fast-acting insulin. In some embodiments, a user or healthcare professional may set a typical meal size of carbohydrates for breakfast, lunch, and/or dinner. In some embodiments, the user or healthcare professional may set a rapid acting insulin dose based on a typical meal for the user for breakfast, lunch, and dinner. In some embodiments, the user or healthcare professional may set the characterization of different serving sizes of meals (small (S), medium (M), large (L)) for different times of the day (e.g., 10g carbohydrates for S, 25g for M, and 50g for L). In some embodiments, blood glucose data and/or pen capping information may be analyzed to make adjustments to user dosage parameters and/or meal-based dosage recommendations. In some embodiments, blood glucose data and/or pen capping information may be analyzed to make suggested changes to a user's dosage parameters and/or meal-based dosage recommendations given to a healthcare professional or user.
In some embodiments, accessories (e.g., pen caps) provided herein may provide meal-based bolus recommendations as a function of time of day and/or meal category. For example, in some embodiments, the pen cap may provide different meal-based bolus recommendations based on time for breakfast time (e.g., 8 am), lunch time (e.g., approximately noon), or dinner time (e.g., approximately 6 pm). In some embodiments, the pen cap may provide different meal-based bolus recommendations for different meal categories, meal preferences, or historical meal statistics, such as small (S), medium (M), and large (L), which may be based on the number of carbohydrates estimated or determined by the user or the glycemic effect of the meal. For example, for each treatment recommendation, the user may see a recommended meal-based bolus for the S meal, the M meal, and the L meal. In some embodiments, the user may press a button or user-selectable icon to request a recommendation for an S meal, an M meal, or an L meal. In some cases, the meal-based bolus recommendation for each meal category (S, M and L) may change depending on the time of day. In some embodiments, the meal-based bolus recommendation for each meal category (S, M and L) may vary depending on historical assessments and/or consistency of the user's meal size. In some embodiments, a single display may indicate different suggested insulin doses based on different meal characteristics, and/or display a range of doses based on a typical meal size of the user (e.g., customized per meal size of the user based on historical data), which may be based on time of day, day of week, day of year, location of the user, or any other collected data.
In some embodiments, the systems provided herein may include one, two, or more connected caps of an insulin pen or other accessories of an insulin pen (e.g., a connected dose capturing insulin cap), a continuous glucose monitoring system (CGM) (or flash glucose monitoring system), a mobile application, an alert accessory, and/or key Web services cloud software. In some embodiments, the connection to the cloud-based server may enable storing data for use by the system and transmitting information to other devices external to the system (e.g., optional secondary displays of data, reports) when needed. In some embodiments, components of the systems provided herein may be connected wirelessly, or may be connected wirelessly using Bluetooth Low Energy (BLE), 433MHZ Ultra High Frequency (UHF) radio, and/or Near Field Communication (NFC) protocols.
One or more embodiments of the present disclosure may include an insulin delivery system comprising an insulin delivery device; a user interface on or adapted to be (releasably or non-releasably) fixed to the insulin delivery device; a memory storing one or more user-specific dosage parameters; and one or more processors in communication with the memory and adapted to receive the blood glucose data, determine a recommended insulin dose, and/or determine an estimate of insulin to administer using the insulin delivery device. The user interface may display one or more recommended insulin doses using, at least in part, the blood glucose data and/or previous estimates of insulin administered, data regarding previous insulin doses (e.g., IOB characteristics associated with each of the user-selectable icons or buttons based on at least one of the user-specific dose parameters). The processor may be adapted to update the meal characteristics associated with each of the user-selectable icons or buttons based on the blood glucose data.
According to one or more devices, systems, or methods of the present disclosure, the systems or methods may include a glucose monitor that may provide blood glucose data via one or more communication (e.g., wireless communication) techniques. In some embodiments, the glucose monitor of the systems or methods provided herein can use a variety of wireless communication techniques to transmit blood glucose data. For example, the glucose monitor may include flash near field communication circuitry and a radio. In some embodiments, the systems and methods provided herein may cause one or more insulin pens or pen accessories to receive blood glucose data from a glucose monitor via a first communication technology (e.g., NFC) and cause another device (e.g., a mobile device) to receive data from the glucose monitor and/or insulin pen via a second communication technology (e.g., BLE or UHF). In some embodiments, the smart pen or pen accessory in the methods and systems provided herein may communicate with the continuous and/or glucose monitor of the methods and systems provided herein only within a first range, and the mobile device may be adapted to passively receive data whenever within a second range that is greater than the first range. In some embodiments, the smart pen or pen accessory provided herein may be configured such that the smart pen or pen accessory receives data only when the user chooses to take an action to receive the data (e.g., pressing a "wake" button and/or bringing the pen or pen accessory within close proximity of a glucose monitor), but another device (e.g., an associated mobile device) may be adapted to passively receive the data regardless of the user action if within a range determined by the communication method or link.
According to one or more devices, systems or methods of the present disclosure, the user interface on the smart insulin delivery device or an accessory thereof may include one or more user-selectable buttons or icons. In some embodiments, a user-selectable button or icon may be used to wake up a smart pen or pen accessory to receive blood glucose data from a blood glucose monitoring/sensor system (e.g., which includes a CGM, BGM, flash glucose monitor, etc.). In some embodiments, a user-selectable button or icon may be used to wake up a display on the smart pen or pen accessory to display a recommended insulin dose of insulin in the smart pen or an insulin pen secured to the pen accessory. In some embodiments, user-selectable buttons or icons may be used to cause the display to switch between different display contents. In some embodiments, a single user-selectable button or icon may be used to wake up the smart pen or pen accessory to receive blood glucose data, and may be used to wake up a display that may then display a recommended insulin dose when the blood glucose data is received by the smart pen or pen accessory. According to one or more devices, systems, or methods of the present disclosure, the processor may determine a dosage recommendation for fast acting insulin based on factors selected from the group consisting of: the amount of carbohydrates is divided by the carbohydrate to insulin ratio of the PWD, the difference between the current blood glucose level and the target blood glucose level is divided by the insulin sensitivity coefficient of the PWD, a reading 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 exercise, whether the PWD is ill, whether the PWD is pregnant, whether the PWD is undergoing menstruation, and whether the PWD has taken certain medications.
In some embodiments, a reusable smart pen may include a drug delivery detector, a reusable chamber, one or more types of insulin cartridges, and a manual delivery mechanism. The detector may be configured to detect a first insulin delivery event associated with the manual delivery mechanism.
System architecture for therapy management system
Fig. 1 shows an insulin therapy management system 10 (which may also be referred to as a diabetes management system) comprising an
While aspects of embodiments of the present disclosure are described in terms of accessories and caps, it will be understood by those of ordinary skill in the art that many of these features may be implemented in an electronics package (i.e., smart electronics) that can be integrated with, attachable to, insulin delivery devices, attachable to insulin containers, and the like, all of which are explicitly contemplated by the inventors of the present disclosure.
The first and
The
In general, embodiments of the present disclosure may use any suitable wireless communication protocol to communicate between an accessory, a manual delivery device, a glucose sensor, and a mobile device. Examples of suitable wireless communication protocols include near field communication (ISO/IEC 14443 and 18092 compliant technologies), wireless modems and routers (IEEE 802.11 compliant technologies), and
The
In some embodiments, the accessory may be associated with a particular type of insulin, for example, the
In some embodiments, the
In the polling (or interrogation) mode of operation,
In some embodiments, an application running at
In some embodiments,
Although system 10 is described as having two
In one embodiment, pairing may also involve sharing encryption keys that these devices may use to decrypt/authenticate messages from devices within system 10.
Each accessory paired with system 10 may have a profile created by
After creating the profile,
In one embodiment, each manual delivery device profile may comprise or be part of a user profile that includes a pre-configured correction dose for a particular blood glucose range. In one embodiment, a preconfigured dose may be entered at
As will be described in more detail below, in one embodiment, the user may select from available doses and the system will monitor the dosing action at the associated manual delivery device. As described more fully herein, the administration action may be explicitly detected (e.g., by detecting the drug exiting the needle of the delivery device) or inferred (e.g., using capping information). In some cases, a correction dose may not be available for a limited period of time after the insulin dose or the detected possible dose. For example, the methods, systems, and devices provided herein may be capable of detecting a dose or a possible dose, but not determining a dose size, and thus such systems, methods, and devices may not be capable of determining an amount of active insulin (e.g., IOB) remaining in a user, whereby such systems may prevent a correction dose from being calculated or suggested within a certain period of time (e.g., at least 2 hours, at least 3 hours, at least 4 hours, or at least 5 hours) after a previously detected dose or a detected possible dose of rapid acting insulin.
Since meal dosage recommendations may be calculated for a manual delivery device with fast acting insulin, the profile may also include or involve algorithms for calculating meal dosages in order to counteract the effect of small, medium or large meals on blood glucose levels. In one embodiment, the algorithm may initially personalize the user with physiological information about the user, and over time, may personalize with actual glucose sensor data and drug administration event information.
The system 10 is also configured such that the accessory can be removed. For example, at a setup screen of
The system 10 is also configured to add and remove the
Background activity and synchronization
When the necessary devices are available and online, the following activities may be performed in the background. These activities are described in the workflow below and may vary based on system state. For the following description, the
Program execution on a first accessory associated with long-acting insulin delivery
In one embodiment, the
When the updated therapy parameters are approved and available, the
Program execution on a second accessory associated with rapid-acting insulin delivery
In one embodiment, the
When the updated therapy parameters are approved and available,
Program execution on mobile applications
The
Updating treatment parameters
As shown in fig. 1A, the cloud service may execute algorithms to update and personalize user therapy parameters (ISF, CR, TDBD, glucose targets, correction charts, meal category doses) over time based on information provided from the local system (e.g., to the cloud). These values can be updated as data is pushed from
In some cases, the portal may alert the HCP that a new set of parameters is ready for review. The clinician may then review the values and approve or reject the values. If rejected, the cloud service is notified and no other action is taken.
If accepted,
In some cases, the algorithm may determine whether an update is suggested and send a notification to the user suggesting that the user update the user's treatment parameters (possibly after consultation with the user's physician).
Fig. 14 shows an exemplary process for updating therapy information according to one embodiment of the present disclosure. In operation 502, the user accesses therapy settings using
Pen cap and insulin pen system architecture
During use, the treatment management system 10 may assist the PWD (or its caregiver) in determining when to inject insulin and how much to inject insulin. The system 10 may be configured to provide recommendations based on current data from the glucose sensor, based on stored therapy parameters, and/or based on data regarding insulin injections to assist the PWD (or caregiver) in determining an appropriate insulin dose. In some embodiments,
In one embodiment, the
as an example, the
Insulin pens 110, 120 may include dials (not shown) that may be used to configure the pens to inject insulin doses corresponding to dial rotations. In some embodiments, each insulin injection pen may be a reusable insulin pen that includes a display or audio and/or input device, such as those disclosed with respect to the pen caps disclosed herein. One example of a reusable insulin pen is an insulin pen that includes a compartment for unloading spent insulin cartridges and loading new insulin cartridges.
Pen capping information (i.e., information about when a pen cap is secured to and/or released from an insulin pen (also referred to herein as "capping" and "uncapping", respectively)) may include information about the current capping period (e.g., the time since last capping), information about the duration of one or more uncappings, and the time course of each uncapping and each capping (e.g., the time of day or the time elapsed thereafter). In some embodiments, pen capping information may be displayed to a user at an interface of the pen cap. In some embodiments, pen capping information may be announced by a speaker in the pen cap. For example, in some embodiments, the cap may provide a timer clock (or countdown timer) that counts from the last time the cap was secured to the injection pen. In some embodiments, the pen cap may wirelessly transmit pen capping information to the mobile device 140 (e.g., a smartphone running a mobile application, a tablet, etc.).
Pen capping information may be used to adjust the user experience. In some embodiments, the pen cap adjusts the presentation of therapy-related information and/or recommendations provided to the user in response to the pen capping information. For example, in some embodiments, the pen cap may provide bolus recommendations based on data from the
The capping sensor for detecting possible capping, uncapping and recapping events may be an analog or digital electronic sensor integrated with the pen cap or more generally with the accessory, which is responsive to attachment or removal from the insulin pen. In one embodiment, it may incorporate a piezoelectric material that generates a small current when pressure is applied to the piezoelectric material (e.g., from a secure attachment to an insulin pen). In another embodiment, it may respond to relative motion between itself and a small magnetic element attached to the medical delivery device. In yet another embodiment, it may be responsive to opening and closing a circuit (e.g., open when the cap is removed, closed when the cap is closed). Any suitable sensor for detecting capping and uncapping may be used.
Capping/uncapping events and drug administration events
The pen capping information may be stored, displayed, and analyzed in conjunction with the glucose data to determine user behavior, such as whether the person properly administered the insulin required for a meal and/or corrected for elevated blood glucose levels. In some embodiments, pen capping information may be presented on a graphical representation of the user's blood glucose data and presented to the user and/or a healthcare professional. In some embodiments, blood glucose data from a period of time after each capping event may be evaluated to determine whether the user has properly administered insulin, an under-dose, or an over-dose for the capping event.
In some embodiments, a pen uncap event, pen cap event, or pen cap event may be ignored if the other information indicates that no dose is provided. For example, in the event that a change in the dosage selection (e.g., dial) of the insulin pen is not detected, the event can be ignored.
In one embodiment, the pen caps 112, 122 may be configured to track pen capping events, which may be used to infer a drug administration action. In various embodiments, system 11 and/or system 12 may be configured to infer that a capping event corresponds to a dosing action and record the capping event (e.g., as a dosing event), including one or more of time, insulin type, and amount of insulin delivered. In one embodiment, the amount of insulin delivered may be captured at
In some embodiments, the pen caps 112, 122 may include one or more of the following components: smart sensors that detect substances on the user's finger, sensors that determine whether insulin needs to be replaced or has deteriorated (e.g., along with blood glucose data), touch screens, and capacitive touch buttons. For example, the mobile application or one or more of the
In some embodiments, such a temperature sensor may be used in conjunction with a blood glucose sensor to indicate that insulin has no expected effect on the subject's blood glucose level if insulin has been exposed to a selected temperature level. For example, an alarm and/or alert may be provided where insulin has been exposed to an out-of-range temperature and where data from the blood glucose monitor indicates that insulin has no expected effect (e.g., less than or greater than an expected change) on the subject's blood glucose level. In some cases, the methods, systems, and devices provided herein may adjust notifications related to temperature exposure based on additional data that indicates that the effectiveness of insulin has been affected or may have been affected, in order to reduce user experience notification fatigue. In some embodiments, the mobile application or
In some embodiments, the mobile application or
Swipe/gather glucose information
FIG. 2 illustrates a PWD utilizing one or more portions of the diabetes management system 10 of FIG. 1. As shown in fig. 2, PWD20 may have
Fig. 3 shows a display on the cap of the pen. As shown in fig. 3, for example, the
Fig. 4 depicts the
For quick-acting delivery recommendations
In one embodiment, system 11 and/or system 12 may be configured to provide a correction dose recommendation and present the recommendation at a user interface. Turning to fig. 4, the display of the
The recommended correction dose may only be effective for a set period of time, for example, because blood glucose levels may change due to factors such as basal metabolism, diet, and exercise. In one embodiment, the
In one embodiment, in response to expiration of the timer, the
In one embodiment, the correction dose may only be displayed if the current blood glucose value is available (e.g., an effective blood glucose value from the previous 10 minutes, from the previous 15 minutes, or from the previous 30 minutes). If a valid blood glucose value is not available, a message may be displayed to the user that the current blood glucose value is desired.
Fig. 5 depicts a
In some embodiments, the
Alarm/alert thresholds for drug administration actions
In some embodiments, if the
Recommendations specific to long-acting insulin delivery
Fig. 6 depicts a
In some embodiments, if the user has recently removed the
In some embodiments, long-acting
In some embodiments, a time threshold parameter may be provided that defines a time period since the last inferred administration action. The time threshold parameter may be configurable so the user may set different time periods (e.g., a value may be entered by the user in a setup screen or selected from a list of recommended time periods). If the time since the last inferred administration action exceeds the time threshold parameter, a missing dose may be inferred and a missing dose alarm, alert, and/or notification may be generated and provided to the user.
In some embodiments, the
Treatment related information
In some embodiments, one or more of the
Exemplary System architecture
Fig. 7 depicts an exemplary communication architecture for a system (e.g., system 11 depicted in fig. 1B) illustrating possible communication links between components of the system. The various components may interface with each other via controlled wireless, NFC, or BLE protocols. Each of these components displays, transmits, and receives information based on an ongoing system workflow at a specified point in time. As shown, the glucose monitor 130 may communicate with the quick-acting
In some embodiments, the initial therapy parameters may be programmed into a mobile application on the
Delivering rapid acting insulin doses
When the user decides (e.g., before a meal) to deliver a rapid-acting insulin dose, the system may initiate the following workflow. Some actions are optional and may not be invoked if a particular device is not available or if the user chooses not to use the actions.
Collecting glucose readings
The user may initiate an NFC transmission from the sensor to a rapid acting insulin smart cap (RCap) by: the cap is woken up and swung over the sensor as shown in fig. 2 and 3.
After taking a glucose reading, the pen cap presents the user with their current glucose value and trend line along with a recommended correction dose or action. If no glucose value was available within the last 10 minutes, the pen cap displays a main screen with no value and the system proceeds to the next step in the workflow upon user initiation. In some embodiments, the suggested correction dose may depend on pen capping information, as discussed elsewhere. For example, in some embodiments, the recommended correction dose for an elevated glucose reading will only be displayed when the pen cap is on the pen for at least a threshold period of time (e.g., at least 2 hours, at least 3 hours, or at least 4 hours). The time of the last dose can be displayed, which will be based on the last capping of the pen cap.
Fig. 8 illustrates a corrective dose recommendation process according to one embodiment of the present disclosure. In operation 402, detected removal of the quick-acting cap 122 (e.g., by a user) enables a recommendation mode. In one embodiment, when the
User assessment of dietary glycaemic effect (optional)
If the user intends to administer a dose for a meal, they move to the next screen and will see three different dose recommendations for a meal for which the blood glucose will have a small, medium or large impact. These recommendations may change over time to adapt to the user's habits and physiology. The recommended dose includes a correction based on the user's glucose reading (if applicable).
Injecting a rapid acting insulin dose and capturing the insulin dose
The user removes the RCap from the insulin pen and installs the needle onto the insulin pen. The needle is pre-filled and then the user dials to his desired dose and injects insulin. The user removes the needle and replaces the cap on the rapid-acting insulin pen. The glucose values (if applicable) are transmitted via BLE to the mobile application where they are stored locally on the smartphone. When a connection to the cloud is available via cellular or WiFi, the data is then synchronized to the cloud. In some embodiments, a portion of the system (e.g., cap, mobile application) may monitor pen usage (e.g., based on data entered by a user relating to average usage of the device) to detect a priming action (e.g., clicks in the pen (such as two sets of clicks) and/or input from the user relating to priming or no priming) and/or selection of a dose. In some cases, the methods, systems, and devices provided herein can detect needle presence to infer priming behavior (i.e., priming is assumed if the needle is removed and replaced). In some cases, the methods, systems, and devices provided herein can assume priming based on dose volume and expected glucose effect.
Fig. 9 illustrates a rapid-acting dose injection process according to one embodiment of the present disclosure. In operation 422, the user activates the mobile application and enters meal information. In operation 424, the mobile application presents one or more correction dose recommendations to the user. In one embodiment, these recommendations are based on an aggressive (gliding) scale. In one embodiment, these recommendations may be based on low, medium, or high glycemic impact of the dietary information entered by the user. In another embodiment, the recommendations may be based on glucose readings, and the recommendations may be based on a confidence that the glucose readings are not too old. For example, if three recommendations are presented, the first recommendation may correspond to a high confidence that the last glucose reading was still valid. The second recommendation may correspond to a median confidence that the last glucose reading was still valid. The third recommendation may correspond to a low confidence that the last glucose reading was still valid. In operation 426, the user removes the
Delivering long-acting insulin doses
When the user decides to deliver a long acting insulin dose, the system initiates the following workflow. Some steps are optional and may not be invoked if a particular device is not available or if the user chooses not to use the steps.
Collecting glucose readings
The user may initiate an NFC transmission from a glucose sensor (typically CGM) to the extended
After taking a glucose reading, the pen cap presents the user with their current glucose value and trend line along with the recommended long-acting insulin dose. If no glucose value was available within the last 10 minutes, the pen cap only displays a long-acting insulin dose recommendation, which is customized according to the user's habits and physiology and may change over time with clinician supervision and approval.
Fig. 10 illustrates a corrective dose recommendation process according to one embodiment of the present disclosure. In operation 442, the user removes the
Insulin injection dose
The user removes the
Fig. 11 illustrates a rapid-acting insulin injection process according to one embodiment of the present disclosure. In operation 462, the user activates the mobile application and enters meal information. In operation 464, the mobile application presents one or more correction dose recommendations to the user. In one embodiment, these recommendations are based on an aggressive (gliding) scale. In one embodiment, these recommendations may be based on low, medium, or high glycemic impact of the dietary information entered by the user. In another embodiment, the recommendations may be based on glucose readings, and the recommendations may be based on a confidence that the glucose readings are not too old. For example, if three recommendations are presented, the first recommendation may correspond to a high confidence that the last glucose reading was still valid. The second recommendation may correspond to a median confidence that the last glucose reading was still valid. The third recommendation may correspond to a low confidence that the last glucose reading was still valid. In operation 466, the user removes the
Checking the status of quick-acting caps and long-acting caps
Fig. 12 illustrates a status check at the
Checking system status
The user may check the system state in the following locations:
FIG. 13 illustrates state checking at a mobile application according to one embodiment of the present disclosure. By way of example, the status information may include system maintenance information (remaining charge, remaining insulin, sensor status, etc.), date and time of last bolus or bolus dose, glucose trendlines, recent glucose readings and times, detailed predictions and trends, and recommended correction doses. In operation 492A, the user requests a status check from the mobile application. In operation 494A, the mobile application may display status information in response to the user's request.
FIG. 15 shows a process for checking the status of a system according to one embodiment of the present disclosure. In operation 522, the
Mobile application user interface
The methods and systems provided herein may additionally include a mobile application running on a mobile device (e.g., a smartphone or tablet) that is in wireless communication (e.g., via BLE) with one or more caps described herein. In some embodiments, blood glucose data may be transmitted from the glucose sensor system 101 (e.g., from the glucose monitor 130 and/or the glucose meter 150), via the pen cap and/or directly from the glucose sensor system. In some embodiments, the mobile application may have a user interface that displays a graphical representation of blood glucose data. In some embodiments, the graphical display of blood glucose data over time may include an indicator conveying pen capping information.
Fig. 16 illustrates an exemplary display of a system (e.g., a mobile device). For example, fig. 16 shows an exemplary user interface for a mobile application that includes a graphical representation of blood glucose data with markers (e.g., triangles, circles, wedges, or any other suitable dose icons or indications) along the x-axis that show the time course of certain actions, such as a recapping action (which may be considered the time course of an insulin dose) and/or other actions (such as the time course of a glucose reading). In some embodiments, if decapping is extended (e.g., if the pen remains uncapped for a longer period of time before the pen cap is applied), the triangle may be wider to indicate the time during which an insulin dose may have been administered. In some embodiments, these icons may be different (e.g., different colors or shapes) depending on the insulin type associated with the cap with the recapping action. In some embodiments, the graphical presentation of blood glucose levels may switch between a 3 hour and 12 hour time range. In some embodiments, the home screen may include a simplified presentation of the current EGV, a curve showing the EGV shown 30 minutes ago, and a curve showing the predicted EGV for the next 30 minutes.
A message may be displayed on the main screen to provide the user with reminders regarding recommended actions the user may take to improve their treatment. In some embodiments, the mobile application may provide guidance to the user based on a combination of glucose data and/or pen capping information. In some embodiments, the guidance via the application may be submitted to approval by a healthcare professional over a cloud connection before being provided to the user. For example, in some embodiments, blood glucose data after a capping action may indicate that insulin is typically under dosed or insulin is typically over dosed for a particular meal. In some embodiments, the methods and systems provided herein may then adjust the user-specific treatment parameters or recommended dosage of rapid-acting insulin based on the blood glucose data after each capping event. In some embodiments, glucose data after or around each capping event may be sent to the healthcare professional to cause the healthcare professional to update the user-specific dosage parameters or recommended dosages for the user (which may be based on the time of day). In some embodiments, the data surrounding each capping event may indicate that the user typically administers fast-acting insulin after a meal has begun, and may be adapted to guide the user to make a pre-bolus for the meal when the user intends to eat. In some embodiments, data surrounding each capping event along with blood glucose levels may be used to recommend an injection schedule relative to the time to start a meal after injection. In some embodiments, the data and/or blood glucose levels surrounding each capping event may be used to recommend an adjustment of the insulin dose received by the subject. Likewise, such guidance can be automated, approved by a healthcare professional, and/or formulated by a healthcare professional.
In some embodiments, the blood glucose level may further be used to track and/or make recommendations for the received insulin type. In some cases, blood glucose levels may be analyzed in conjunction with dose capture data to determine whether the wrong insulin was received. In some cases, the combination of blood glucose data and temperature sensor data from the pen cap may be analyzed to determine whether the insulin has deteriorated, whether the wrong insulin was received (e.g., as discussed above), whether there are other problems with the treatment or associated device.
The mobile application may be adapted to enable the user to provide additional information that may be used to determine the frequency with which the user follows the recommended dose. In some embodiments, the user may be provided with the possibility to enter the dose per capping event into the mobile application or directly into the pen cap and/or may enter multiple doses (e.g., the amount of insulin accepted throughout a selected time period, such as over a day) into the mobile application or directly into the pen cap. For example, the user may tap a marker along the graph to allow the user to enter the dose administered.
Fig. 17 illustrates another exemplary display 300 of a portion of a system (e.g., a mobile device, such as the
In embodiments where data is received from the blood glucose monitor only intermittently (e.g., data segments or blocks of data relating to BGVs are downloaded at discrete time periods on demand), data indicative of the most recent glucose reading ahead of the current data point circle 302 (e.g., the area between the current circle 302 and the immediately preceding circle 302) may be received from the glucose monitor and populated into trend line 304. In some embodiments, another marker (e.g., the nearest circle 306) may be positioned at the most recent reading (e.g., the nearest circle 302) and may be visually distinct from the previous circle 302. In some embodiments, the time of the last scan may be displayed on the display 300. In some embodiments, the horizontal position on the trend line 304 of the nearest circle or marker 306 may also be indicated on the display 300 using a marker (e.g., vertical line 308).
In some embodiments, the cap may query the blood glucose sensor when the user places the device near the sensor and/or when the user selects or presses (e.g., and holds) a button (e.g., virtual scan sensor button 310). In some embodiments, the display 300 may include an indicator (e.g., a gauge 312 extending around the user button 310) that displays measurements associated with the system. For example, the meter 312 may display the remaining life of the blood glucose sensor (e.g., the estimated time before the sensor needs to be replaced). As depicted, the meter 312 may increase (e.g., grow) or decrease (e.g., back) around the
As shown in fig. 18, in some embodiments, display 300 may enable a user to track previous values on trend line 304. For example, the user may drag the most recent circle or marker 306 (e.g., along with vertical line 308) back along the trend line to the previous time period. As depicted, the display 300 may track the location of the nearest circle 306 and display the time and blood glucose level for the selected time period.
In some implementations, the nearest circle 306 (e.g., along with vertical line 308) can be anchored to the nearest data location of trend line 304, and can jump back to the most current location after the user releases the nearest circle 306. For example, when the user releases, the vertical line 308 may deform into a "slingshot" and spring back the circle 306 to the most current reading position.
In some embodiments, the user may be asked from time to estimate the number of units of insulin remaining in the pen. In some embodiments, the user may be required to take a picture of an insulin pen, and the application may be adapted to analyze the image of the insulin pen to determine the approximate number of units remaining in the pen. For example, FIG. 19 shows an exemplary user interface where a user might take a picture of the pen using the camera of a smart phone. In some embodiments, the user interface may overlay a real-time view of the camera of the smartphone with a guide line corresponding to a feature on the pen in order to assist the user in aligning the pen with the camera of the smartphone. In some embodiments, the mobile application may be adapted to automatically take a picture of the pen when a feature within the field of view of the camera of the smartphone is aligned with the
In one embodiment, the device may automatically analyze the insulin vial and infer meal information based on changes in the insulin vial image. For example, based on several consecutive images, meal intake and meal time can be inferred from the change in the amount of insulin in the vial and the type of insulin (i.e., rapid acting).
In some embodiments, the pen may include a pointer (e.g., a scale mark) that enables a user to easily identify the position of a portion of the pen (e.g., a plunger) and enter an associated value into the application.
The pen cap may be configured to give insight into which recommended dose the user is likely to follow. For example, as described in U.S. patent application serial No. 15/717,805 entitled "medical Injection And Disease Management Systems, Devices And methods," filed on 27.9.2017, And the contents And disclosure of which are hereby incorporated by reference in their entirety, filed on 27.9.2017, the pen cap (whether or not there are any dose capturing features incorporated into the pen cap) may include a meal announcement classification (such as S, M, L) And the data from each announcement may indicate whether the user is likely to have been given the appropriate amount for S, M or L meal. In some embodiments, a button on the
System setup
Any suitable method may be used to set up the therapy management system provided herein. In some embodiments, the healthcare professional may enter initial treatment parameters from a Web portal or directly into the user's mobile device (e.g., during an appointment). In some embodiments, the user may enter initial treatment parameters based on comments given by the physician. The therapy management system provided herein provides a way for users to clearly understand their therapy settings to increase their trust in the system.
FIG. 20 illustrates an exemplary welcome screen in a mobile application of a
The mobile application may present a screen as shown in fig. 21, where the user is asked to enter his daily dosage of long acting insulin (e.g., in whole or half units or other resolutions based on the resolution of the user's long acting insulin pen 110). The user interface may use, for example, a wheel or a numeric keypad (as shown). In some embodiments, the user may be required to input the time (or times) of day at which the user approximately injected their long-acting insulin. In another screen (such as that shown in fig. 22), the user can enter their normal dosage required for different servings of meals. In some embodiments, each of these fields may be pre-filled with a recommended amount based on the user's long-acting daily insulin dose, which may be based on a population model. For example, the preset amount may be pre-populated based on the relationship as discussed in U.S. patent application serial number 15/717,805, but the user interface may allow the user to override these pre-populated numbers by: pressed in these fields to enter their own dose for each meal size. In some embodiments, the mobile application may show the user an example of the meals that fit into each category so that the user can compare their mental model of what constitutes a small meal, a medium meal, and a large meal to the assumptions of the system. Fig. 23 depicts an exemplary user interface for depicting an exemplary meal having serving sizes that conform to different categories. For example, for a "low carbohydrate" meal, each meal depicted will have a similar glycemic effect (e.g., similar carbohydrate amount). Likewise, the "medium carbohydrate" diet and the "large carbohydrate" diet will also have similar glycemic effects (e.g., the same amount of carbohydrates) for those diets depicted in each category. For example, the meals depicted for "low carbohydrate" may each include between about 15-20 grams of carbohydrate, the meals depicted for "medium carbohydrate" may each include between 35-45 grams of carbohydrate, and the meals depicted for "high carbohydrate" may each include between 60-80 grams of carbohydrate. After setting the meal dose, the user may then select a glucose target or a glucose target range.
FIG. 24 depicts an exemplary user interface in which a user may adjust a glucose target value up or down. In some embodiments, the glucose target value may default to a preset number (e.g., 100mg/dl, 80mg/dl, 120mg/dl, etc.).
In the screen shown in fig. 25, the user may review their settings (and optionally further adjust their settings).
In some embodiments, the diabetes management system provided herein can use data associated with a user to customize one or more correction doses.
In some embodiments, a user interface located on the
corrected dose ═ rounddown (current blood glucose-glucose target)/ISF.
In some embodiments, the glucose target set in fig. 24 may define a middle range of the glucose target range, and the formula may calculate the correction dose using the lower bound of the glucose target range. In some embodiments, the ISF may be inferred from a mathematical relationship between the daily doses of long-acting insulin of the user. Fig. 26 depicts how a sliding scale graph can be determined from ISF or space and glucose targets or targets. In some embodiments, a user interface on the mobile application or in the Web portal may generate a sliding scale chart for review by the PWD, caregiver, or healthcare professional before accepting the summary shown in fig. 24. In some embodiments, the sliding scale chart may be included in a treatment summary. Sliding scale charts may simplify the user's understanding of how the system adjusts its therapy based on real-time blood glucose readings from the glucose sensor. In some embodiments, the user interface may use sliders to enable a user to update the increments or starting points, or to dynamically update the generated sliding scale correction chart so as to enable a healthcare professional or PWD to have the generated chart match their desired treatment settings (e.g., as shown in fig. 33).
Fig. 27-30 depict different options that may be presented to a user via a user interface to enable a mobile application to create a sliding scale (e.g., as shown above in fig. 18). As shown in fig. 27, as a first option, the mobile application may prompt a user (e.g., a subject and/or caregiver) to enter a value related to an action taken by the subject while managing blood glucose levels (e.g., based on historical usage). For example, historical data relating to the amount (e.g., units) of insulin (e.g., fast acting insulin) received in response to a range of blood glucose levels. As shown in fig. 28, more than one range may be input to create a scale for the user input, which may be (e.g., generate) a non-linear scale.
As a second option, the mobile application may prompt the user to directly enter a value related to the subject's ISF, as shown in fig. 29. For example, the user may enter a mean drop in blood glucose level (measured in milligrams per deciliter (mg/dl)) for each unit of insulin received by the subject. In some implementations, the mobile application may enable the user to input a target blood glucose level.
In either option, the mobile application may display a confirmation of the scale (e.g., a non-linear scale) manually entered by the user at the first option, or a confirmation of the scale (e.g., a linear scale) generated using the ISF value entered by the user at the second option.
The methods, devices, and systems provided herein can detect patterns of blood glucose levels and/or patterns of injections, enabling these devices or systems to understand the effects of drug administration and determine recommended treatment setting changes to improve blood glucose results. In some embodiments, the mobile device can determine an appropriate treatment change. In some embodiments, the remote server may determine the appropriate treatment settings. In some embodiments, the methods, devices, and systems may automatically adjust the dosage incrementally for different meal servings, as described in U.S. patent application serial No. 15/717,805, which is hereby incorporated by reference. In some embodiments, the algorithm may update the ISF or the correction dose based on the detected pattern. In some embodiments, methods, devices, and systems may determine whether there is a recommended treatment-related change, and then use this information to inform the user of the pattern or inform the user of the pattern and triggers, prompts or suggestions to the user (e.g., messages in a mobile application); an example of which is depicted in fig. 31. For example, the message may be as shown in FIG. 31 and/or displayed on a mobile device as shown in FIG. 32. As shown in fig. 32, the message may include buttons to bring the user to a screen showing the user how to make the appropriate changes (e.g., in-application training) and/or to a screen where the user actually makes the changes. Pressing the button may take the user to a screen shown in fig. 33 that includes a plurality of sliders for each meal serving. In some embodiments, the user may choose to change the serving size of only one meal or may desire to change the value globally by changing the bottom slider. In some embodiments, changing the bottom slider may change the ISF value. In some embodiments, the settings may be based on the time of day (e.g., breakfast time, lunch time, dinner time), and the user may adjust the settings specifically for one or all of the meal times.
Warning and alarm
In some embodiments, the diabetes management systems, devices, and methods provided herein can provide notifications, alerts, and/or alerts. In some embodiments, notifications, alarms, and/or alerts may be automatically triggered on one or more portions of the system (such as the mobile device, the cap, and/or one or more separate alert accessories). In some embodiments, the therapy management systems, devices, and methods provided herein may include a smart pen or pen accessory (e.g., an accessory adapted to be secured to the pen, such as a pen cap and/or another accessory integral with or applicable and/or coupled to the pen) adapted to provide notifications, therapy recommendations, and/or alerts when a user takes action to retrieve blood glucose data. In some embodiments, the therapy management systems, devices, and methods provided herein may include one or more alert accessories and one or more smart pens or pen accessories that may each wirelessly receive blood glucose data (e.g., from a continuous glucose monitor). In some embodiments, the therapy management systems, devices, and methods provided herein may have one or more smart pens or pen accessories that communicate with a blood glucose monitoring system (e.g., a continuous glucose monitor) via a first communication technology (e.g., NFC) and have one or more alert accessories that communicate with the blood glucose monitoring system (e.g., the same continuous glucose monitor) via a second communication technology (e.g., UHF, BLE). In some embodiments, the communication technology used to communicate blood glucose data to the alert accessory has a greater range than the communication technology used to communicate blood glucose data to the smart pen or pen accessory. In some embodiments, the therapy management systems, devices, and methods provided herein can include one or more alert accessories that passively receive blood glucose data (e.g., via wireless communication) provided that the one or more alert accessories are within communication range; and one or more smart pens or pen attachments configured to wirelessly receive blood glucose data only when a user takes action to cause the smart pens or pen attachments to receive blood glucose data (e.g., presses a button, swipes the pen or pen attachment near a glucose sensor, etc.). In some embodiments, having a smart pen or pen accessory that receives blood glucose data only upon user action may reduce power consumption of the smart pen or pen accessory, thereby relieving the user of the burden of recharging or replacing a battery in the smart pen or pen accessory. In some embodiments, having a warning accessory as provided herein may enable a user to decide when and where to receive destructive alarms, warnings and notifications, and further allow the user to feel unnecessary to carry their insulin pen with them between doses.
The methods, systems, and apparatus provided herein may include one or more alert accessories, which may be in any suitable form. In some embodiments, the alert accessory can include one or more illuminable icons. In some embodiments, the alert accessory can include a digital display screen. In some embodiments, the alert accessory can include one or more speakers and/or vibrating motors. In some implementations, the alert accessory contemplated herein can be secured to a smartphone (e.g., as a phone case). In some embodiments, the alert accessory contemplated herein can be secured to a key fob. In some embodiments, the warning accessory contemplated herein may be adapted to function as a bedside alarm clock. In some embodiments, a warning accessory is contemplated herein.
In some embodiments, the methods, systems, and devices provided herein can provide guidance regarding the appropriate dosage of insulin. In some embodiments, a dose of insulin may be administered using an insulin delivery pen or syringe. In some embodiments, the insulin may be a long-acting insulin. In some embodiments, the insulin may be a rapid acting insulin. In some embodiments, the insulin delivery pen or its accessory (e.g., cap) can detect the amount of insulin delivered from the pen (or the amount of insulin set for delivery). In some embodiments, the insulin pen or its accessory can include a user interface that can display data or recommendations to the user and/or allow the user to enter data into the insulin pen or accessory.
The following exemplary therapy management system includes an insulin delivery pen having a dose capturing pen cap, but other embodiments are contemplated in which the functionality disclosed herein is incorporated into other accessories of the insulin delivery pen or the insulin delivery pen itself. Additionally, the following exemplary therapy management system includes a single alert accessory (e.g., CGM fob), but other embodiments are contemplated in which functionality including multiple alert accessories or alert accessories (e.g., using WiFi or cellular communications) is incorporated into a smartphone or other Web-connected mobile computing device.
In some embodiments, one or more portions of the system (e.g., the pen, the mobile application, the alert accessory) may be configured to present one or more of the following alerts or alerts:
glucose alert: low glucose, high probability of future low glucose, high probability of future high glucose, high degree of glucose variability
Time course alert: alerts to check for blood glucose (e.g., for a specific day time period), alerts for meal time periods, alerts for pen decapping for a certain duration, alerts for double dosing (e.g., pen decapping twice within a short time period)
Quick-acting insulin alerts: receiving correction dose, missing rapid-acting dose, dangerous rapid-acting dose, dose exceeding threshold
Long-acting insulin alerts: receiving a bolus, missing a bolus, a dangerous bolus, a dose exceeding a threshold
Switching insulin alerts: receiving dangerous dose-switching dose, and having error in cap
Temperature warning: detecting out of range insulin conditions, as discussed above
Maintenance alerts: insulin out, low battery, sensor failure, sensor expiration
Upgradeable system
The diabetes management system provided herein can be adapted to add or remove components from use and/or configured based on the needs of a Person With Diabetes (PWD). For example, fig. 34A-34D illustrate different systems and associated communication architectures that allow for PWDs with different types of diabetes (
Fig. 34A depicts a
Fig. 34B depicts a
Fig. 34C depicts a
Fig. 34C also indicates that the
Fig. 34D shows the continuous care and how components can be added to each system 3410-3440 to upgrade the system. Additionally, the
FIG. 35A illustrates exemplary displays 114A-114C of the
For the
Embodiments described herein may include the use of a special purpose or general-purpose computer including various computer hardware or software modules, as discussed in greater detail below.
Embodiments described herein may be implemented using a computer-readable medium for carrying or having computer-executable instructions or data structures stored thereon. Such computer-readable media can be any available media that can be accessed by a general purpose or special purpose computer. Special purpose computers are intended to be broadly construed and include embedded systems, microcontrollers, application specific integrated circuits, digital signal processors, and general purpose computers that are programmed for specific purposes. A segment (e.g., a code segment or a data segment) may refer to a portion (e.g., an address) of memory, virtual memory, or a target file.
By way of example, and not limitation, such computer-readable media can comprise non-transitory computer-readable storage media including Random Access Memory (RAM), Read Only Memory (ROM), Electrically Erasable Programmable Read Only Memory (EEPROM), compact disc read only memory (CD-ROM) or other optical disk storage, magnetic disk storage or other magnetic storage devices, flash memory devices (e.g., solid state memory 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 that can be accessed by a general purpose or special purpose computer. Combinations of the above should also be included within the scope of computer-readable media.
Computer-executable instructions comprise, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing device (e.g., one or more processors) to perform a certain function or group of functions. Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the above-described features and acts are disclosed as example forms of implementing the claims.
Any ranges expressed herein (including in the claims) are to be considered to give their broadest possible interpretation. For example, ranges are intended to include their endpoints (e.g., a range of "between X and Y" is intended to include X and Y) unless explicitly mentioned otherwise. In addition, ranges described using the terms "about" or "approximately" should be understood to be given the broadest meaning consistent with the understanding of those skilled in the art. Additionally, the terms "about" or "substantially" include any number that deviates within 10% or 5% or within manufacturing or typical tolerances.
The features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations are not expressly described herein, without departing from the scope of the disclosure. Indeed, variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the scope of the disclosure. Accordingly, the invention is not to be limited by the foregoing illustrative description, but is only limited by the following claims and their legal equivalents.
Additional non-limiting embodiments of the present disclosure relate generally to pen caps for insulin injection pens and associated methods and systems: