Treatment support information and / or tracking devices and related methods and systems

Abstract

To provide methods, systems, and devices that support users in making appropriate treatment decisions while minimizing the burden on the user. [Solution] A monitoring mechanism for an insulin delivery device, such as a pen cap, may include at least one circuit adapted to detect at least one of the cap being attached to an insulin pen or the cap being removed from an insulin pen, and a processor for using information regarding at least one of the cap being attached to or removed from the pen cap. The monitoring mechanism for an insulin delivery device includes at least one circuit adapted to detect the use of the insulin delivery device.

Description

Technical Field

[0001] Claim of Priority This application claims the benefit of the filing dates of U.S. Provisional Patent Application No. 62 / 597,868, filed on Dec. 12, 2017, entitled “Therapy Assist Information and / or Tracking Device and Related Methods and Systems”; U.S. Provisional Patent Application No. 62 / 597,809, filed on Dec. 12, 2017, entitled “Medicine Injection and Disease Management Systems, Devices, and Methods”; U.S. Provisional Patent Application No. 62 / 628,808, filed on Feb. 9, 2018, entitled “Diabetes Therapy Management Systems, Methods and Devices”; and U.S. Provisional Patent Application No. 62 / 682,872, filed on Jun. 9, 2018, entitled “Diabetes Therapy Management Systems, Methods, and Devices”, the disclosures of each of which are hereby incorporated by reference in their entireties.

[0002] The present disclosure relates to therapy management systems, methods, and devices adapted to collect and / or transmit data related to therapy (e.g., timing of therapy) and / or other therapy-related data and to provide therapy recommendations to a user. In certain embodiments, diabetes therapy management systems, devices, and methods are disclosed, which may be used with an insulin infusion device and include components adapted to provide insulin therapy recommendations to a user based on stored therapy parameters, blood glucose data, estimated meal sizes, and / or other parameters.

Background Art

[0003] Diabetes mellitus is a chronic metabolic disorder that occurs when a person's pancreas is unable to produce enough insulin, resulting in an inability to properly absorb sugars and starches. This deficiency leads to hyperglycemia, i.e., an excess of glucose in the plasma. Persistent hyperglycemia is associated with a variety of serious symptoms, as well as life-threatening long-term complications such as dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage with a risk of limb amputation. Since there is currently no cure, permanent treatment is necessary to maintain blood analyte concentrations within the normal range, requiring regular blood glucose control. Such blood glucose control is achieved by regularly administering topical agents to the patient's body to lower the elevated blood analyte concentrations.

[0004] Bioeffective topical agents (e.g., insulin or its analogues) are typically administered by daily injections. In some cases, frequent injections (MDIs) of a mixture of rapid-acting and long-acting insulin are administered via a reusable transdermal liquid infusion device (commonly referred to as an "insulin pen") or subcutaneous syringe. Infusions are typically administered by persons with diabetes mellitus (PWDs) and therefore require self-monitoring of blood glucose and self-administration of insulin. PWDs who manage their own care using MDIs often plan each day's insulin infusion in advance based on their basal insulin requirements as well as external factors such as diet, exercise, and sleep. A typical dosing plan would include the time of infusion, the type of insulin (e.g., rapid-acting, long-acting, or a mixture of rapid-acting and long-acting insulin), and the amount of insulin in each dose. In addition, PWDs self-monitor their blood glucose and self-administer a "bolus" dose of rapid-acting insulin if their blood glucose is too high, or consume carbohydrates (or possibly glycogen) if their blood glucose is too low.

[0005] The "correct" insulin dosage depends on physiological factors such as blood glucose concentration and a person's insulin sensitivity, as well as lifestyle factors such as diet (e.g., recently consumed carbohydrates that have not yet been metabolized into glucose and absorbed into the bloodstream). Furthermore, even with careful planning and self-monitoring, PWDs may forget to administer insulin, administer duplicate doses, or administer the wrong amount and / or type of insulin. Insufficient insulin can lead to hyperglycemia, and excessive insulin can lead to hypoglycemia, which can result in clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death. Therefore, PWDs face a considerable cognitive burden in determining the appropriate insulin dosage. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] To support self-management, some diabetes treatment devices (e.g., blood glucose meters, insulin pumps) are equipped with an insulin bolus calculator that allows users to input predictions (e.g., numerical predictions) of the amount of carbohydrates consumed or planned to be consumed (or, in addition, protein, fat, or other dietary data), and the bolus calculator outputs a recommended size for the insulin bonus dose. While the bolus calculator eliminates some mental calculations that users would otherwise have to perform to determine the appropriate insulin bolus dose, it still burdens users with the intellectual task of evaluating the components of their own diet and may require the use of secondary devices, often necessitating manual data entry. Therefore, there is a need for methods, systems, and devices that help users make appropriate therapeutic decisions while minimizing the burden on the user (e.g., data entry, mental calculation, procedures, etc.).

[0007] This disclosure can be better understood by referring to the following detailed description of exemplary embodiments shown in the accompanying drawings. [Brief explanation of the drawing]

[0008] [Figure 1A] This disclosure describes a diabetes management system according to an embodiment of this disclosure. [Figure 1B] This illustrates specific components of an exemplary diabetes management system. [Figure 1C] A second exemplary diabetes management system is shown. [Figure 2] This disclosure describes a user who uses one or more parts of a diabetes management system according to an embodiment of this disclosure. [Figure 3] An embodiment of the present disclosure shows a display on a pen cap. [Figure 4] This shows a display on a pen cap according to an embodiment of the present disclosure. [Figure 5] This shows a display on a pen cap according to an embodiment of the present disclosure. [Figure 6] This shows a display on a pen cap according to an embodiment of the present disclosure. [Figure 7] An exemplary communication architecture of a system according to an embodiment of this disclosure is shown. [Figure 8] This disclosure illustrates a process for recommending an insulin dosage according to an embodiment of this disclosure. [Figure 9] This invention illustrates a process for injecting insulin according to an embodiment of this disclosure. [Figure 10] This disclosure illustrates a process for recommending insulin dosage according to embodiments of this disclosure. [Figure 11] This invention illustrates a process for injecting insulin according to an embodiment of this disclosure. [Figure 12] This disclosure describes a process for checking the status of a treatment system according to embodiments of this disclosure. [Figure 13] This disclosure describes a process for checking the status of a treatment system according to embodiments of this disclosure. [Figure 14] This disclosure describes a process for updating treatment information according to an embodiment of this disclosure. [Figure 15]Shows a process for checking the status of a treatment system according to an embodiment of the present disclosure. [Figure 16] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 17] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 18] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 19] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 20] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 21] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 22] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 23] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 24] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 25] Shows an exemplary display and / or user interface of a part of the system (e.g., of a mobile device) according to an embodiment of the present disclosure. [Figure 26] Shows an exemplary sliding scale chart of a diabetes management system according to an embodiment of the present disclosure. [Figure 27] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 28] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 29] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 30] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 31] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 32] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 33] Shows an exemplary display and / or user interface of a part of a system (e.g., a mobile device) according to an embodiment of the present disclosure. [Figure 34A] Shows an exemplary communication architecture of an upgradable system according to an embodiment of the present disclosure. [Figure 34B] Shows an exemplary communication architecture of an upgradable system according to an embodiment of the present disclosure. [Figure 34C] Shows an exemplary communication architecture of an upgradable system according to an embodiment of the present disclosure. [Figure 34D] Shows an exemplary communication architecture of an upgradable system according to an embodiment of the present disclosure. [Figure 35A] Shows an exemplary display on a pen cap according to an embodiment of the present disclosure. [Figure 35B] Shows an exemplary display on a pen cap according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0009] Manual insulin delivery devices, such as insulin pens and insulin inhalers (collectively referred to herein as “manual insulin devices”), provide a convenient and reusable means of delivering insulin. However, improper insulin administration due to human error, insulin pen malfunction, missed doses, duplicate doses, and inaccurate administration is always a concern. While the methods, devices, and systems provided herein describe insulin delivery, blood glucose data collection, and / or treatment of diabetes, the therapeutic applications of the methods, devices, and systems provided herein may be adapted for the delivery of other drugs, the collection of other analyte data, and / or treatment of other diseases. In addition, while the methods, devices, and systems provided herein are primarily described by describing the features and functionality contained in a pen cap accessory for an insulin delivery pen, or a method of using a pen cap accessory, or a system including a pen cap accessory, the features discussed herein are also intended to be smart drug delivery pens or smart drug delivery inhalers, other manual drug delivery devices, or directly incorporated into other accessories adapted for use with such devices, or methods or systems including such smart drug delivery devices or smart accessories.

[0010] The systems, apparatus, and methods described herein may be operated or performed by users, such as PWDs, patients, subjects, healthcare professionals, clinicians, and caregivers. Unless otherwise specified, the terms healthcare professionals, clinicians, and caregivers are used interchangeably in this disclosure.

[0011] In general, the treatment management systems (e.g., diabetes management systems such as insulin treatment management systems), methods, and apparatus described herein may include a user interface configured to receive user-specific dosage parameters from a user or healthcare professional and to 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 integrated into a mobile application or another computing device, and the user interface for displaying immediate drug delivery recommendations may be integrated into an accessory for a manual drug delivery device or a smart manual drug delivery device. In some cases, the user interface for entering user-specific dosage parameters may be additionally used to display reports, recommendations, warnings, alerts, notifications, and recommended changes to user dosage parameters.

[0012] The systems, devices, and methods provided herein may include user interfaces adapted to simplify the input of treatment-related data and 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 insulin dosage. In some embodiments, the methods, devices, and systems provided herein may reduce or eliminate manual input of numerical data after initial setup. In some embodiments, the methods, devices, and systems provided herein may be adapted to simplify blood glucose monitoring. In some embodiments, the methods, devices, and systems provided herein may enable a user to carefully manage their own treatment. In some embodiments, the methods, devices, and systems provided herein may reduce the cognitive burden associated with making daily treatment decisions.

[0013] The systems, devices, and methods provided herein can simplify the process of obtaining insulin therapy recommendations and / or collecting estimated glucose values ​​(EGV) and / or insulin delivery data from one or more insulin delivery devices. The systems, devices, and methods provided herein may be designed to minimize any changes to the treatment / routine that may be required for a person with diabetes (PWD) who administers insulin therapy using injections to receive treatment recommendations and / or notifications, alerts, or warnings.

[0014] In some embodiments, the systems, methods, and apparatus provided herein can give the user choices about when, where, and whether to receive notifications, alerts, or warnings, which may be at least partially based on the apparatus of the system being run by the user. In some embodiments, warnings and / or alerts may be customized over time based on user feedback (e.g., user likes and dislikes). In some embodiments, the systems, methods, and apparatus provided herein may include notifications, alerts, and / or warnings using a combination of EGV data and insulin delivery data to determine whether to trigger alerts and / or warnings.

[0015] In some embodiments, the systems, apparatus, and methods provided herein can automatically capture insulin delivery data, which may be captured using a connected and / or smart insulin injection pen, or using a connected and / or smart insulin pen accessory (e.g., a connected pen cap accessory).

[0016] In some embodiments, the systems, apparatus, and methods provided herein can recommend insulin dosages (e.g., dosages of long-acting and / or rapid-acting insulin) using any preferred technique. In some embodiments, the recommended insulin dosage can be obtained based on blood glucose data (e.g., CGM, flash glucose monitor, blood glucose meter, or any other sensor, current EGV from blood glucose trend data, etc.), insulin administration data (e.g., bolus dose of rapid-acting insulin, dose of long-acting insulin, number of administrations, IOB and / or active insulin calculations, etc.), meal data (e.g., meal times, user-estimated carbohydrates, user-estimated meal categories, user-estimated effect of meals on blood glucose, user's dietary history, user's dietary trends, etc.), and / or one or more insulin delivery parameters (e.g., basal insulin, i.e., total daily dose of long-acting insulin, carbohydrate-to-insulin ratio (CR), insulin sensitivity factor (ISF), etc.). In some embodiments, the methods, apparatus, and systems provided herein can adjust insulin delivery parameters over time based on glucose data and / or insulin administration data.

[0017] 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 enable a user to configure the device or system, check the status of the device or system, adjust treatment settings, and / or learn how to improve treatment options. In some embodiments, the mobile device may include information about maintenance tasks (e.g., reminders to take specific maintenance tasks). In some embodiments, the methods, systems, and devices provided herein may detect patterns in treatment-related data and use such data to provide the user with hints, suggestions, alerts, and / or warnings based on these patterns, which may be displayed on the mobile device. In some embodiments, the mobile device may provide the user with a graphical representation of the user's treatment-related data and / or treatment decisions (e.g., blood glucose data and / or number of insulin infusions). In some embodiments, the mobile device may provide the user with a display encouraging them to adjust their treatment (e.g., the amount of insulin per meal, the amount of insulin relative to the user's basal requirements, the timing of insulin infusions, etc.) and provide the user with a method (e.g., a link) to adjust their treatment. In some embodiments, the mobile device may provide the user with a display indicating that the system has automatically adjusted the user's treatment (e.g., the amount of insulin in relation to meals, the amount of insulin relative to the user's basal needs, the timing of insulin infusions, etc.), and may optionally provide a way (e.g., a link) to reject the automatic adjustment, confirm the automatic adjustment, or manually adjust the treatment.

[0018] In some embodiments, the diabetes management systems, devices, and methods provided herein may include multiple meal size categories (e.g., three meal sizes (large, medium, small), time-based meals (breakfast, lunch, dinner, snack)) that can be set by the user (e.g., on a mobile device). In some embodiments, the mobile device includes a setup user interface that prompts the user to input typical insulin dosages for different meal sizes (e.g., dosage for small meals, dosage for medium meals, dosage for large meals). In some embodiments, the setup user interface displays exemplary photographs of meals that are likely to be included in each meal category. In some embodiments, the device can analyze the approximate size of the user's meals (e.g., by analyzing user input, such as input about meal characteristics, photographs of meals, etc.). In some embodiments, the setup user interface may provide estimates of what the user is expected to input for each meal size, based on the amount of long-acting insulin (e.g., Lantus® dosage) entered by the user.

[0019] The systems, apparatus, and methods provided herein may include, be used with, or communicate with one or more accessories for drug delivery devices such as insulin pens (e.g., pen caps for insulin pens), which are (a) attached to the injection pen and adapted to detect when the pen cap is attached to the injection pen and / or when the pen cap is released from the injection pen, (b) adapted to receive blood glucose data from a glucose sensor, and / or (c) adapted to provide the user with treatment-related information and / or recommendations.

[0020] In some cases, the accessory may be a pen cap accessory adapted to detect pen cap attachment information. Pen cap attachment information (e.g., information about when the pen cap is attached to and / or released from the injection pen) may include information about the current cap attachment period (e.g., time since the last cap attachment), information about one or more cap removal times (sometimes referred to herein as “cap removal”), and the timing of each cap removal and each cap attachment (e.g., time or elapsed time). In some embodiments, the pen cap attachment information may be displayed to the user on the pen cap accessory. In some embodiments, the pen cap attachment information may be announced by a speaker inside the pen cap. For example, in some embodiments, the pen cap may provide a timer that counts up from when the pen cap was last attached to the injection pen. In some embodiments, the pen cap accessory can wirelessly transmit the pen cap attachment information to a remote computing device (e.g., a smartphone, tablet, etc.). In some embodiments that do not include a pen cap accessory, the accessory or smart delivery device may detect other events related to drug delivery operations and use such information in the manner described herein with respect to pen cap attachment information. For example, in some cases, an attachment for the injection pen may be fixed to the injection pen, and as a result, the mechanical movement of the administration mechanism can be detected to determine the time of drug administration.

[0021] The pen cap wearing information may be used to modify the user experience (e.g., the display or information presented to the user). In some embodiments, the pen cap adjusts the presentation of treatment-related information and / or recommendations provided to the user based on the pen cap wearing information. For example, in some embodiments, the pen cap may provide a bolus recommendation to correct elevated blood glucose levels based on data from a glucose sensor, but the presentation of such a corrective bolus recommendation may be limited to a period longer than the current pen cap wearing period (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 the user with notifications, alerts, or warnings based on the pen cap wearing information. For example, if the pen cap is removed from the injection pen within the threshold period (e.g., within 30 minutes or 1 hour) since the last cap wearing, the pen cap may provide a visual, audible, or vibratory notification indicating that the user may have recently used the pen to administer insulin. In some embodiments, the pen cap may communicate wirelessly with a mobile computing device (e.g., a smartphone or tablet), and one or more notifications, alerts, or warnings based on the pen cap attachment information may be announced or displayed on the mobile computing device.

[0022] Pen cap attachment information can be stored, displayed, and / or analyzed in conjunction with glucose data to determine user behavior, such as whether a person is appropriately administering insulin in response to a meal, and / or to correct elevated blood glucose levels. In some embodiments, pen cap attachment information may be presented to the user and / or a healthcare professional on a graphical display of the user's blood glucose data. In some embodiments, blood glucose data from the period following each cap attachment event may be evaluated to determine whether the user appropriately administered insulin in response to that cap attachment event, for example, whether it was an appropriate, under-administered, or over-administered dose.

[0023] In some embodiments, the pen cap attachment event may be ignored if other information indicates that no administration occurred. For example, the event may be ignored if no change is detected in the insulin pen's dosage selection (e.g., dial). In some embodiments, the pen cap removal and cap reattachment events may be ignored if the total cap removal time is less than a first threshold (e.g., 4–6 seconds). For example, the threshold may be determined by setting a time that is too short to inject but long enough for the user to check the end of the pen to see if any insulin remains or if the needle attached to the pen is still present. In some cases, the total cap removal time of a cap removal event (the time between the cap removal event and the subsequent cap reattachment event) may be analyzed in combination with blood glucose data to determine whether an injection occurred during the cap removal event. In some cases, if the total cap removal time exceeds a second threshold period (e.g., at least 15 minutes, at least 30 minutes, etc.), blood glucose data may be used to determine the approximate time of injection.

[0024] Accessories provided herein (e.g., pen caps), and related methods and systems provided herein, may be adapted to acquire blood glucose data for use in providing treatment-related information and / or treatment recommendations via the accessories (e.g., via the pen caps). In some embodiments, the treatment-related information displayed on the pen cap accessory may include the user's current estimated glucose value (EGV). In some embodiments, the treatment-related information displayed on the pen 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 dosage that can be obtained based on glucose data or, without considering the current EGV, based on stored parameters.

[0025] Accessories provided herein (e.g., pen caps) may 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 background glucose meter (BGM), or any other suitable sensor. In the case of CGMs and flash glucose monitors, they may be configured to provide glucose data based on the user's interstitial fluid glucose concentration which can correlate with blood glucose levels. BGMs may typically be configured to provide blood glucose data based on a blood sample. Thus, although the term “blood glucose” may sometimes be used simply as a general term for convenience, this disclosure is not limited to using only blood glucose data, values, concentrations, etc., but also to using interstitial fluid glucose concentration and any intermediate measurements.

[0026] In some embodiments, the pen cap may automatically receive glucose data from the CGM without user intervention, as long as the pen cap is within range. In some embodiments, the pen cap may be adapted to wirelessly receive the current EGV (and optionally, previous EGV) from the flash glucose monitor when the pen cap is positioned close to the flash glucose monitor (e.g., swiped adjacent to it). In some embodiments, the EGV may be acquired via a BGM that can wirelessly communicate with the pen cap or a mobile computing device (the EGV can then be transmitted to the pen cap), or it may be input by the user to a remote computing device.

[0027] In some embodiments, the accessories provided herein (e.g., pen caps) may be configured to retrieve only glucose data relating to a user interacting with the pen cap. For example, if the pen cap is adapted to acquire glucose data from a CGM or flash glucose monitor, it may be designed to require swiping near the CGM or flash glucose monitor, or to retrieve only glucose data at the user's request (e.g., when a button is pressed). In some embodiments, the CGM may communicate wirelessly with a mobile computing device (e.g., a smartphone or tablet), and when a button is pressed on the pen cap, only data from the CGM is transferred to the pen cap.

[0028] Accessories (e.g., pen caps) or mobile applications provided herein may, in some embodiments, provide a reminder to the user to take glucose data. For example, in a method and system including a flash glucose monitor, a reminder may be sent to the user to take glucose data by swiping the pen cap near the flash glucose monitor. In some embodiments, the reminder to take glucose data may be time-set based on pen cap wearing information. For example, the reminder to take blood glucose data may be identified based on the time since the most recent cap wearing (e.g., the current cap wearing period exceeding a threshold). In some embodiments, the threshold may be set to reduce the likelihood that an insulin dose could cause a hypoglycemic event. In some embodiments, the pen cap may wirelessly receive blood glucose data and analyze the pattern of the blood glucose data in comparison with pen cap wearing information to identify the likelihood of a future hypoglycemic event or predicted future blood glucose levels. In some embodiments, blood glucose data and pen cap attachment information may be wirelessly transmitted to a remote computing device (e.g., a smartphone or tablet) and analyzed on the remote computing device, or in the cloud or other network or device, to identify potential future hypoglycemic events or predicted future blood glucose levels, and to be used to issue notifications, alerts, or warnings, and / or to set reminders to take blood glucose data.

[0029] The pen caps provided herein may utilize any preferred technology to obtain pen cap attachment information (e.g., information regarding the removal / application of the pen cap during insulin injection). In some embodiments, the pen caps provided herein may include a biasing element, such as an internal leaf spring, that completes the 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 the pen and / or removed from the pen.

[0030] The accessories (e.g., pen caps), methods, and systems provided herein may be used in any preferred manner to make therapeutic recommendations. In some embodiments, a user or healthcare professional may set a recommended dose to start the product, set one or more initial carbohydrate-to-insulin ratios, set one or more initial insulin sensitivity factors, create a table of corrected doses to be used for a specific range of glucose values, and / or set one or more meal characteristics. For example, in some embodiments, a user or healthcare professional may set a carbohydrate-to-insulin ratio and insulin sensitivity factors used in determining the initial recommended dose of long-acting insulin, as well as the dose of rapid-acting insulin. In some embodiments, a user or healthcare professional may set typical meal sizes in terms of carbohydrates for breakfast, lunch, and / or dinner. In some embodiments, a user or healthcare professional may set a typical meal-based rapid-acting insulin dose for the user for breakfast, lunch, and dinner. In some embodiments, a user or healthcare professional may set different meal size characteristics (e.g., 10g of carbohydrates for S, 25g for M, and 50g for L) for different times of day. In some embodiments, blood glucose data and / or pen cap attachment information may be analyzed to adjust recommendations regarding the user's dosage parameters and / or meal-based dosage. In some embodiments, blood glucose data and / or pen cap attachment information may be analyzed to suggest changes to the user's dosage parameters and / or meal-based dosage recommendations to the healthcare professional or user.

[0031] In some embodiments, the accessories provided herein (e.g., a pen cap) may provide meal-based bolus recommendations based on time and / or meal category. For example, in some embodiments, the pen cap may provide different meal-based bolus recommendations based on breakfast time (e.g., around 8 a.m.), lunch time (e.g., around noon), or dinner time (e.g., around 6 p.m.). In some embodiments, the pen cap may provide different meal-based bolus recommendations based on the number of carbohydrates in a meal or its impact on blood glucose estimated or identified by the user for different meal categories, dietary preferences, or past dietary statistics, e.g., large (L), medium (M), small (S), etc. For example, for each treatment recommendation, the user may receive recommended meal-based bolus recommendations for S meals, M meals, and L meals. In some embodiments, the user may press a button or user-selectable icon to request recommendations for S meals, M meals, and L meals. In some cases, meal-based bolus recommendations for each meal category (S, M, and L) may vary based on time. In some embodiments, meal-based bolus recommendations for each meal category (S, M, and L) may vary based on the user's past evaluation and / or consistency of meal sizes. In some embodiments, a single display may show different recommended insulin doses based on different meal characteristics and / or display a range of doses based on the user's typical meal size (e.g., the user's meal size is customized based on past data), which may be obtained based on time, day of the week, date, user's location, or any other collected data.

[0032] In some embodiments, the systems provided herein may include one, two, or more connected pen caps or other accessories for insulin pens (e.g., connected dose-capture insulin pen caps), a continuous glucose monitoring system (CGM) (or flash glucose monitoring system), a mobile application, an alert accessory, and / or critical web service cloud software. In some embodiments, connectivity to a cloud-based server may enable the storage of data for use by the system when needed, and the transfer of information to other devices outside the system (e.g., optional data, secondary display of reports). In some embodiments, the components of the systems provided herein may be wirelessly connected, or can be wirelessly connected using any of the following protocols: Bluetooth Low Energy (BLE), 433 MHz ultra-high frequency (UHF), and / or near-field communication (NFC).

[0033] One or more embodiments of the present disclosure may include an insulin delivery system comprising: an insulin delivery device; a user interface adapted to be fixed (releasable or inreleasable) on or to the insulin delivery device; a memory for storing one or more user-specific dosage parameters; and one or more processors adapted to communicate with the memory, receive blood glucose data, identify recommended insulin doses, and / or identify estimates of insulin administered using the insulin delivery device. The user interface may display one or more recommended insulin doses, at least partially using blood glucose data and / or previous estimates of administered insulin, and data on 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 dosage parameters). The processors may be adapted to update dietary characteristics associated with each of the user-selectable icons or buttons based on blood glucose data.

[0034] In accordance with one or more devices, systems, or methods of this disclosure, a system or method may include a glucose monitor capable of providing blood glucose data via one or more communication (e.g., wireless communication) technologies. In some embodiments, the glucose monitor of the system or method provided herein may use multiple wireless communication technologies to transmit blood glucose data. For example, the glucose monitor may include a flash near-field communication circuit and a wireless communication device. 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 the glucose monitor via a first communication technology (e.g., NFC), and another device (e.g., a mobile device) to receive data from the glucose monitor and / or insulin pens 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 only within a first range of the continuous and / or glucose monitor of the methods and systems provided herein, and the mobile device may be adapted to passively receive data whenever it is within a second range greater than the first range. In some embodiments, the smart pen or pen accessory provided herein may be configured to receive data only when the user chooses to perform an action to receive data (e.g., pressing a “activate” button and / or bringing the pen or pen accessory very close to a glucose monitor), while another device (e.g., an associated mobile device) may be adapted to passively receive data regardless of user action, within the range specified by the communication method or link.

[0035] In accordance with one or more devices, systems, or methods of this disclosure, the user interface on a smart insulin delivery device or accessory may therefore include one or more user-selectable buttons or icons. In some embodiments, a user-selectable button or icon may be used to activate a smart pen or smart pen accessory to receive blood glucose data from a blood glucose monitoring / sensing system (including, for example, a CGM, BGM, or flash glucose monitor). In some embodiments, a user-selectable button or icon may be used to activate a display on the smart pen or pen accessory to display a recommended insulin dose in an insulin pen fixed to the smart pen or pen accessory. In some embodiments, a user-selectable button or icon may be used to switch between different displays. In some embodiments, a single user-selectable button or icon may be used to activate the smart pen or pen accessory to receive blood glucose data and also to activate a display, which then displays a recommended insulin dose on the smart pen or pen accessory that receives the blood glucose data. In accordance with one or more devices, systems, or methods of this disclosure, a processor may identify a rapid-acting insulin dosage recommendation based on factors selected from the following: the number of carbohydrates divided by the PWD's carbohydrate-to-insulin ratio; the difference between the current blood glucose level and the target blood glucose level divided by the PWD's insulin sensitivity factor; readings from a blood glucose meter (BGM); data from a continuous glucose monitor (CGM); blood glucose trend data; residual insulin (IOB) data; residual carbohydrates (COB); whether the PWD is exercising or plans to exercise; whether the PWD is ill; whether the PWD is pregnant; whether the PWD is menstruating; and whether the PWD has consumed a particular medication.

[0036] In some embodiments, a reusable smart pen may include a dose detector, a reusable chamber, one or more insulin cartridges, and a manual delivery mechanism. The detector may be configured to detect a first insulin delivery event related to the manual delivery mechanism.

[0037] System architecture of treatment management systems Figure 1 shows an insulin treatment management system 10 (sometimes referred to as a diabetes management system) including an analyte sensor system 101, a first accessory 102, a second accessory 103, and a mobile application 104. The treatment management system 10 may include one or more web services 105 that communicate with the mobile application 104 via a network 108. The first accessory 102 and the second accessory 103 are two of many accessories that may be added to and removed from the insulin treatment management system 10 to help assist the user with manual insulin delivery.

[0038] While embodiments of the present disclosure are described in relation to accessories and caps, those skilled in the art will understand that many of these features can be implemented in electronic packages (i.e., smart electronics) specifically envisioned by the inventors of the present disclosure, such as being able to integrate with an insulin delivery device, be attachable to an insulin delivery device, and be attachable to an insulin container.

[0039] The first accessory 102 and the second accessory 103 may be configured to capture information regarding insulin delivery by the manual delivery device 106 and the manual delivery device 107, and in various embodiments may include an internal sensor for dose capture, a user interface for displaying information and receiving user input, and other interfaces for wireless or wired communication with one or more of the manual delivery device 106, the manual delivery device 107, the mobile application 104, the analyte sensor system 101, and the mobile application 104.

[0040] The mobile application 104 may run on any suitable mobile computing device that can store and run a mobile application adapted to display and input treatment-related information received wirelessly from other components of the system, as well as from a graphical user interface that allows the user to interact with the application. In one embodiment, the mobile device may also store and run a trusted mobile application within a trusted execution environment (hardware and / or software) that is generally inaccessible to users or devices communicating with the mobile device 140, but accessible to other applications running on the mobile device 140. Various functions and calculations relating to the treatment management system, including alerts and recommendations presented to the user, may be performed in part or in whole by the trusted mobile application. Furthermore, some or all of the communication with the insulin pen, pen cap, glucose sensor, and other accessories may be limited to the trusted mobile application.

[0041] In general, embodiments of the present disclosure may use any wireless communication protocol suitable for communication between accessories, manual delivery devices, glucose sensors, and mobile devices. Examples of suitable wireless communication protocols include short-range wireless communication (ISO / IEC 14443 and 18092 compliant technologies), wireless modems and routers (IEEE 802.11 compliant technologies), and Bluetooth® / Bluetooth Low Energy (BLE) (IEEE 802.15 compliant technologies).

[0042] The glucose sensor system 101 may be any suitable glucose sensor system 101, such as a blood glucose meter (BGM) and flash glucose monitor or a continuous glucose monitor (CGM) adapted to identify blood glucose levels using blood glucose test strips. In some cases, the glucose sensor system 101 can function as both a flash glucose monitor and a continuous glucose monitor by enabling both intermittent and on-demand transmission of blood glucose data. In some embodiments, the glucose sensor system 101 can wirelessly transmit data when queried from a reader device (e.g., using NFC communication). In some embodiments, the glucose sensor can wirelessly transmit data at predetermined intervals (e.g., using radio frequencies) using any suitable communication standard (e.g., Bluetooth Low Energy (BLE)). In some cases, the systems and methods provided herein may include a plurality of glucose sensor systems (e.g., continuous or flash glucose monitors and blood glucose meters).

[0043] In some embodiments, the accessories may relate to a specific type of insulin; for example, the first accessory 102 may relate to long-acting insulin delivery, and the second accessory 103 may relate to rapid-acting insulin delivery.

[0044] In some embodiments, the glucose sensor system 101 can transmit glucose data using multiple communication technologies. In some embodiments, one or more of the mobile application 104 and / or manual delivery devices 106, 107 or accessories 102, 103 may include an NFC reader adapted to acquire blood glucose data from the glucose sensor system 101 when brought within query distance of the glucose sensor system 101. In some embodiments, one or more of the mobile application 104 and / or manual delivery devices 106, 107 or accessories 102, 103 may wirelessly receive blood glucose data from the glucose sensor system 101 that is broadcast at predetermined intervals (e.g., every 30 seconds, every minute, every 2 minutes, every 3 minutes, every 5 minutes, every 10 minutes, every 15 minutes, etc.).

[0045] In polling (or query) mode operation, the glucose sensor system 101 can wirelessly transmit blood glucose data corresponding to past periods to one or more of the accessories 102, 103, and the mobile application 104. For example, when the first accessory 102 queries the sensor system 101, it may receive stored glucose data from 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, etc. In some cases, the broadcast blood glucose data may include only the current or more recent blood glucose values. For example, in some cases, the blood glucose data received by the mobile application 104, received directly from the glucose sensor system 101, may include only the most recent reading (e.g., from the last 10 minutes), which may be used by the mobile application 104 to issue warnings or alerts based on the most recent blood glucose data.

[0046] Accessories 102 and 103 may include one or more processors and memory for controlling wireless communication, controlling wireless communication interfaces, controlling user interfaces, and / or identifying recommendations regarding treatment.

[0047] In some embodiments, applications running on accessories 102, 103 may execute one or more algorithms to determine estimated glucose values ​​(EGV) from raw glucose sensor data. In some embodiments, the glucose sensor system 101 may transmit the EGV to the accessories. In some embodiments, the accessories and / or smart electronics provided herein may include memory for storing user-specific dosage parameters (e.g., recommended daily dose or total daily basal dose (TDBD) of long-acting insulin, insulin sensitivity factor (ISF), carbohydrate-to-insulin ratio (CR), correction amount based on blood glucose range, total daily insulin dose (TDD), target glucose value, recommended rapid-acting dose for different meal sizes or categories). In some embodiments, user-specific dosage parameters may be time-dependent, such as time-dependent CR and ISF values. In some embodiments, accessories 102, 103 provided herein may have memory for storing recommended rapid-acting insulin doses for different meals or different meal categories. In some embodiments, user-specific dosage parameters and / or different recommended dosages for different meals may be updated via a mobile application 104 that communicates wirelessly with the accessory. For example, an algorithm in a mobile computing device or the cloud may update these parameters or recommended dosages. In some embodiments, the parameters or recommended dosages may be updated by a healthcare professional or manually by a PWD or caregiver. In some embodiments, the accessory may contain in memory an algorithm executed by a processor that automatically updates user-specific dosage parameters or recommended dosages.

[0048] In some embodiments, the accessories 102 and 103 provided herein can display or otherwise notify the user of the current blood glucose level and / or blood glucose trend data (e.g., rate of change) based on glucose data received from the glucose sensor system 101. The accessories 102 and 103 (or other smart electronics) provided herein may provide a recommended insulin dose based on blood glucose data, user-specific dosage parameters, recommended dose set by the user or a healthcare professional, time, meal data or category, or any other suitable input.

[0049] System 10 is described using two accessories 102 and 103, but is not limited to these, and may include more or fewer accessories. For example, accessory 102 may include a pairing or discoverable mode that broadcasts discoverable information by the mobile application 104. The broadcast may follow a Bluetooth beacon or other suitable communication protocol. In response to a pairing confirmation, such as by keeping accessory 102 and a mobile device hosting the mobile application 104 close together, or by pressing a button on either accessory 102 or the mobile application 104 for a sufficient amount of time, the mobile application 104 may create a profile of a manual delivery device associated with accessory 102. In one embodiment, accessory 102 may be specifically calibrated for a particular type of manual delivery device and may provide the mobile application 104 with an identifier for the delivery device type. In another embodiment, once accessory 102 and the mobile application 104 are paired, setup information may be provided on the interface of the mobile application 104 or the accessory.

[0050] In one embodiment, pairing may also include sharing an encryption key that the devices can use to decrypt / authenticate messages from the devices within the system 10.

[0051] Each accessory paired with system 10 may have a profile created by mobile application 104. In one embodiment, mobile application 104 may query web service 105 to see if a profile for the device already exists for the user, and if so, may request that it be sent. This allows mobile application 104 to avoid setup duplication and to make more of the user's historical data or physiological attributes (e.g., insulin sensitivity), improved by actual glucose measurements and blood glucose response analysis, available to the recommendation algorithm running in mobile application 104.

[0052] Once a profile is created, the mobile application 104 may use this profile to save insulin therapy-related settings. These insulin therapy-related settings may include user-specific dosage parameters, device delivery characteristics, and specific techniques that can be used to identify recommendations for the user.

[0053] In one embodiment, each manual delivery device profile may include, or be part of, a user profile that includes a preset corrective dosage for a specific blood glucose range. In one embodiment, the preset dosage may be entered in a mobile application 104. In another embodiment, the preset dosage may be entered in one of the web services 105 (e.g., by a healthcare provider or parent) and downloaded to the mobile application 104.

[0054] As described in more detail below, in one embodiment, the user may select from available dosages, and the system monitors the administration operation with the associated manual delivery device. As described more fully herein, the administration operation may be specifically detected (e.g., by detecting the drug released from the delivery device's needle) or inferred (e.g., using capping information). In some cases, a corrective dosage may not be available for a certain period after insulin administration or for the detected possible dosage. For example, the methods, systems, and devices provided herein may be able to detect a dosage or possible dosage, but may not be able to identify the dosage, and therefore such systems, methods, and devices may not be able to determine the amount of active insulin (e.g., IOB) remaining with the user. Therefore, such systems may prevent the calculation or suggestion of a corrective dosage for 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 or detected possible dose of rapid-acting insulin.

[0055] Since meal dosage recommendations can be calculated for manual delivery devices with rapid-acting insulin, the profile may also include, or refer to, an algorithm for calculating meal dosages to offset the effects of large, medium, or small meals on blood glucose levels. In one embodiment, the algorithm may first be tailored to the user using physiological information about the user, and then, over time, to the individual using actual glucose sensor data and administration event information.

[0056] The mobile application 104 is configured to record past treatment-related information, such as blood glucose history, dosage, administered medications, and administration timing information.

[0057] System 10 is also configured so that accessories can be removed. For example, on the setup screen of the mobile application 104, the user may select a manual delivery device 107 to be removed / unpaired from System 10. In response to the selection, the manual delivery device 107 may initiate a confirmation prompt to the user. In one embodiment, a confirmation process including a specific user action (e.g., pressing and holding a button on the mobile device and a button on the accessory 104) may be used to confirm removal. In response to the confirmation, the device profile may be stored, the accessory 103 may change to an irrelevant state and power off.

[0058] System 10 is also configured to add and remove the glucose sensor system 101 and other glucose monitoring devices configured to transmit blood glucose data. For example, as described later, a communication link between the accessory 103 and the glucose sensor system 101 may be activated by swiping or shaking the accessory 103 in close proximity to the glucose sensor system 101. In one embodiment, the communication link may be initiated according to a Near Field Communication (NFC) protocol, in which an antenna and reader IC on the accessory queries a tag (typically a chip) on the glucose sensor system 101. Since the belonging / activation data may be shared between systems, other devices (accessories, mobile devices, etc.) may be able to access blood glucose data on the glucose sensor system 101.

[0059] Background activities and synchronization If the necessary equipment is available and online, the following activities may be performed in the background. These activities are described in the following workflow and may change based on the system status. In the following description, the first accessory 102 is related to long-acting insulin delivery, and the second accessory 103 is related to rapid-acting insulin delivery.

[0060] Execution of the program with the first accessory associated with long-acting insulin delivery. In one embodiment, the first accessory 102 or a device communicating with the first accessory 102 may run software to calculate the user's required dose of long-acting insulin. In one embodiment, glucose measurements are sent to a long-acting insulin dosage recommendation service hosted in the cloud. In various embodiments, glucose values ​​may be sent to the cloud service at regular intervals (e.g., via a wireless or cellular connection) as described in the workflow above, resulting in updates to the treatment parameters. In one embodiment, the pen cap 112 may include a wireless or cellular device that can transmit glucose values ​​to the cloud service via a wireless or cellular connection. In another embodiment, the first accessory 102 may piggyback on a wireless or cellular connection of a mobile device running a mobile application 104. The first accessory 102 periodically backs up data to the cloud via the mobile application 104 (e.g., via a local connection such as Bluetooth® or BLE connection).

[0061] The first accessory 102 may receive updated treatment parameters from the cloud service 105 when the cloud service is approved and available. An example of the data flow is described below.

[0062] Execution of the program with the second accessory related to rapid-acting insulin delivery. In one embodiment, a second accessory 103 associated with rapid-acting insulin delivery, or a device communicating with the second accessory 103, runs software including an algorithm to calculate the user's required dose of rapid-acting insulin. Glucose values ​​and meal selections may also be transmitted at regular intervals to a rapid-acting insulin dosage recommendation service (e.g., via a wireless or cellular connection) as described in the workflow above, and as a result, calculations may be performed. In one embodiment, the second accessory 103 may include a wireless or cellular device that can transmit glucose values ​​to a cloud service via a wireless or cellular connection. In another embodiment, the second accessory 103 may piggyback on a wireless or cellular connection of a mobile device on which a mobile application 104 is installed and running. The second accessory 103 periodically backs up data to the cloud via the mobile application 104 (e.g., via a local connection such as Bluetooth® or BLE connection).

[0063] The second accessory 103 receives updated treatment parameters from these when the cloud service is approved and available. This data flow will be discussed in a later section.

[0064] Running a program on a mobile app The mobile application 104 can run in the background and synchronize with BLE devices (e.g., the first accessory 102 and the second accessory 103, glucose sensor system 101) and the cloud, acting as an information conduit. The information is synchronized periodically as described above. In addition, system status configuration, dosage history, and glucose trends and forecasts may be displayed when they are calculated in the cloud and pushed to the mobile application 104.

[0065] Updating treatment parameters As shown in Figure 1A, the cloud service can execute algorithms to update and personalize the user's treatment parameters (ISF, CR, TDBD, glucose target, correction chart, dietary category dosage) over time based on information provided from the local system (e.g., to the cloud). These values ​​may be updated when data is pushed from accessories 102, 103 to the PWD mobile application 104. In one embodiment, when the new values ​​are ready to be pushed to the user's mobile application 104, they may first be pushed to the healthcare provider's (HCP) web portal (e.g., via wireless or cellular connection) for approval.

[0066] In some cases, the portal may alert the HCP that it is ready to review the new parameter set. The clinician can then review the values ​​and approve or reject them. If rejected, the cloud service is notified, and no further action is taken.

[0067] If approved, the cloud service 105 is notified, and the value (e.g., updated parameter) is pushed to the user's mobile application 104 (e.g., via one of the system's local devices, such as accessories 102, 103 and / or a mobile application running on the mobile device) and approved. For example, the value may be sent to the mobile application, which then locally communicates that value to one or both of accessories 102 and 103.

[0068] In some cases, the algorithm can determine if an update is proposed and send a notification to the user suggesting that they update their treatment parameters (perhaps in consultation with their doctor).

[0069] Figure 14 illustrates an exemplary process for updating treatment information according to embodiments of the present disclosure. In operation 502, the user accesses the treatment settings using the mobile application 104. The treatment settings may be stored in the mobile application 104, accessories 102, 103, or both. In operation 504, the new treatment settings are provided by the mobile application 104 and through a user interface configured to receive the new settings. In operation 506, the mobile application 104 may present a notification to the user interface indicating that the settings need to be synchronized to accessories 102, 103. In operations 508 and 510, the mobile application 104 may wirelessly transmit one or more of the new settings to accessories 102, 103. In one embodiment, a treatment setting related to long-acting insulin is transmitted to an accessory related to long-acting insulin delivery, and a treatment setting related to rapid-acting insulin is transmitted to an accessory related to the setting and then to an accessory related to rapid-acting insulin delivery.

[0070] Pen cap and insulin pen system architecture During use, the treatment management system 10 may assist the patient-health worker (PWD) (or their caregiver) in determining the time and amount of insulin to infuse. The system 10 may be configured to assist the PWD (or caregiver) by providing recommendations in determining an appropriate insulin dosage based on current data from a glucose sensor, based on stored treatment parameters, and / or data related to insulin infusion. In some embodiments, accessories 102, 103 are configured to collect and provide data related to insulin infusion events.

[0071] In one embodiment, the manual delivery devices 106 and 107 shown in Figures 1B and 1C may be insulin pens, such as commercially available mechanical insulin pens, containing any suitable insulin, for example, long-acting insulin and rapid-acting insulin (sometimes referred to as rapid-acting insulin or ultra-rapid-acting insulin). Suitable rapid-acting insulins include HUMALOG®, NOVOLOG®, APIDRA®, and FIASP®. Suitable long-acting insulins include LANTUS®, LEVEMIR®, TOUJEO®, and TRESIBA®.

[0072] For example, as shown in Figures 1B and 1C, the manual delivery device 107 may be a long-acting insulin injection pen 110, and the manual delivery device 106 may be a rapid-acting insulin injection pen 120. Figure 1B shows an insulin treatment management system 11, an insulin pen 110, an insulin pen 120, a GCM 130, and a mobile device 140 having a treatment management mobile application running on it. The first accessory 102 may be a pen cap 112, and the second accessory 103 may be a pen cap 122. Figure 1B shows an insulin treatment management system 12, an insulin pen 110 with a pen cap 112, an insulin pen 120 with a pen cap 122, a GCM 130, a BGM 150, and a mobile device 140 having a treatment management mobile application running on it. As shown, system 12 has the components of system 11, but also has a BGM 150 and a mobile application display with different blood glucose levels.

[0073] The insulin pens 110, 120 may include a dial (not shown) which can be used to configure the pen to dispense an insulin dose corresponding to the rotation of the dial. In some embodiments, each insulin injection pen may be a reusable insulin pen including a display or audio and / or input device, such as those disclosed for the pen cap disclosed herein. An example of a reusable insulin pen is an insulin pen including a chamber for removing a used insulin cartridge and loading a new insulin cartridge. The insulin pens 110, 120 may include an interface for wireless and / or wired communication with one or more of the pen cap, glucose sensor, mobile device, and other accessories.

[0074] Pen cap attachment information (i.e., information regarding when the pen cap is attached to the injection pen and / or released from the injection pen (hereinafter also referred to herein as "cap attachment" and "cap removal," respectively)) may include information regarding the current cap attachment period (e.g., time since the last cap attachment), information regarding one or more cap removal periods, and the timing of each cap removal and each cap attachment (e.g., time or elapsed time). In some embodiments, the pen cap attachment information may be displayed to the user via the pen cap interface. In some embodiments, the pen cap attachment information may be communicated by a speaker inside the pen cap. For example, in some embodiments, the pen cap may provide a timer that counts up (or counts down) since the pen cap was last attached to the injection pen. In some embodiments, the pen cap can wirelessly transmit the pen cap attachment information to a mobile device 140 (e.g., a smartphone, tablet, etc., running a mobile application).

[0075] Pen cap wearing information may be used to tailor the user experience. In some embodiments, the pen cap adjusts the presentation of treatment-related information and / or recommendations provided to the user in response to the pen cap wearing information. For example, in some embodiments, the pen cap may provide a bolus recommendation to correct elevated blood glucose levels based on data from the CGM 130, but the presentation of such a corrective bolus recommendation may be limited to a period during which the current pen cap wearing period is longer than a threshold period (e.g., at least 3 hours, at least 4 hours, or at least 5 hours). In some embodiments, pen caps 112 and 122 may provide the user with notifications, alerts, and / or warnings based on the pen cap wearing information (e.g., based on the period during which the pen cap was attached and / or removed). For example, if the pen caps 112 and 122 are removed from the injection pen within a threshold period (e.g., within 30 minutes or 1 hour for rapid-acting insulin, or within 6 to 12 hours for long-acting insulin) since the previous cap attachment, the pen caps may provide visual, audible, and / or tactile notifications indicating that the user may have recently used the pen to administer insulin. In some embodiments, the pen caps 112 and 122 may communicate wirelessly with a mobile computing device 140, and one or more notifications, alerts, or warnings based on the pen cap attachment information may be announced or displayed on the mobile computing device.

[0076] A cap-attachment sensor for detecting possible cap-attachment, cap-removal, and cap-reattachment events may be an analog or digital electronic sensor integrated with the pen cap, or more generally with an accessory, that responds to attachment or removal from the insulin pen. In one embodiment, a piezoelectric material that generates a small current when pressure is applied (e.g., by being securely fixed to the insulin pen) may be incorporated. In another embodiment, it may respond to the relative motion between itself and a small magnetic element fixed to the drug delivery device. In yet another embodiment, it may respond to open and closed circuits (e.g., an open loop when the cap is removed and a closed loop when the cap is attached). Any suitable sensor for detecting cap-attachment and cap-removal may be used.

[0077] Cap attachment / cap removal event and administration event Pen cap placement information can be stored, displayed, and analyzed in conjunction with glucose data to determine whether a person is administering insulin appropriately in response to a meal, and / or to correct elevated blood glucose levels. In some embodiments, pen cap placement information may be presented to the user and / or a healthcare professional on a graph display of the user's blood glucose data. In some embodiments, blood glucose data from the period following each cap placement event may be evaluated to determine whether the user administered insulin appropriately, under-administered, or over-administered in response to that cap placement event.

[0078] In some embodiments, pen cap removal events, pen cap attachment events, or pen cap reattachment events may be ignored if other information indicates that no administration occurred. For example, if no change in insulin pen dosage selection (e.g., dial) is detected, the event may be ignored.

[0079] In one embodiment, the pen caps 112, 122 may be configured to track pen cap attachment events that can be used to infer an administration action. In various embodiments, the systems 11 and / or 12 may be configured to infer that a cap attachment event corresponds to an administration action and to record one or more of the following (e.g., as an administration event): time, type of insulin, and amount of insulin delivered. In one embodiment, the amount of insulin delivered may be captured in the insulin pens 110, 120 and provided to the pen caps 112 and 122. In some embodiments, the pen caps 112, 122 may identify and track the remaining insulin in the insulin pens 110, 120 based on each dose. In another embodiment, the pen caps 112, 122 may track the amount of insulin remaining in the insulin cartridge and, based on the change in the amount of insulin in the insulin cartridge, identify the amount of insulin associated with an administration action. In additional embodiments, a smart pen or pen accessory may detect the set or administered dose using other suitable techniques.

[0080] In some embodiments, the pen caps 112, 122 may include one or more smart sensors that detect substances on the user's finger, such as a temperature sensor that determines (e.g., along with blood glucose data) whether insulin needs to be replaced or is faulty, a touchscreen, and a capacitive touch button. For example, a mobile application or one or more of the pen caps 112, 122 may include a temperature monitor that monitors one of the following experiences: average temperature, high temperature, or low temperature. Such temperature range and / or minimum and maximum temperatures may be due to the treatment (e.g., insulin) attached to the pen caps 112, 122. When exposed to the minimum and / or maximum temperatures (e.g., or a selected period within a selected temperature range), the pen caps 112, 122 may provide the user with an alert and / or warning indicating that the insulin has been exposed to an out-of-range temperature (e.g., a level exceeding the user's and / or insulin storage recommendations).

[0081] In some embodiments, such a temperature sensor may be used in conjunction with a blood glucose sensor that indicates that if insulin is exposed to a selected temperature level, the insulin is not having the expected effect on the subject's blood glucose level. For example, if insulin is exposed to an out-of-range temperature and data from blood glucose monitor data indicates that the insulin is not having the expected effect on the subject's blood glucose level (e.g., the change is smaller or larger than expected), a warning and / or alert may be provided. In some cases, the methods, systems, and apparatus provided herein may adjust notifications regarding temperature exposure based on additional data indicating that the effectiveness of insulin is impaired or may be impaired, in order to alleviate notification fatigue for users experiencing it. In some embodiments, a mobile application or pen cap 112, 122 may trigger a reminder to the user to take a post-infusion reading to determine the effectiveness of insulin recently administered to the subject.

[0082] In some embodiments, a mobile application or pen caps 112, 122 can communicate with a wearable device (e.g., a smartwatch) worn by the PWD to identify actions being performed by the subject (e.g., whether the subject is eating). For example, the wearable application may run on a wearable device that allows the user to interface with one or more of the pen caps 112, 122, insulin pens 110, 120, mobile device 140, and other accessories. In some embodiments, the wearable application may interface with a mobile application running on mobile device 140, such as mobile application 104. The mobile application can perform processing for various features described herein, and the wearable application may provide the user with alerts and recommendations, and may also provide the mobile application with information received from the user on the wearable device, such as instructions for eating, exercising, or administering medication.

[0083] Swipe / Collect glucose information Figure 2 shows a PWD using one or more parts of the diabetes management system 10 of Figure 1. As shown in Figure 2, the PWD 20 may have, for example, a glucose sensor system 101 applied to the arm so that it can detect the blood glucose level of the PWD, and the user can query the glucose sensor system 101 using a pen cap 122 fixed to a rapid-acting insulin pen 120. Before and after the user swipes the pen cap 122 in Figure 2, the pen cap 122 may display treatment-related information.

[0084] Figure 3 shows a display on the pen cap. As shown in Figure 3, for example, the display 124 on the pen cap 122 may show the time 125 of the most recent dose, i.e., the “last dose” (e.g., the time and / or date of the last dose), which can help the user remember whether they have given a bolus dose to a recent meal and help the user avoid unintentionally accumulating boluses. In some embodiments, such as when using a pen cap that can detect the dosage, the display may further show the number of units of the last dose. In some embodiments, the timing of the last dose may be a clock that increases to show how long ago the last dose was given. In some embodiments, the display may show the most recently obtained blood glucose level and the time of acquisition. In some embodiments, the display may be a bistable display, such as an e-paper display. An e-paper display is a display that mimics the appearance of ordinary ink on paper. In some embodiments, the display may include identification information (e.g., a label that identifies the user, such as “Sarah’s Pen”) and / or information about the type of insulin pen to which the pen cap is attached (e.g., the brand of insulin, whether the insulin is fast-acting or long-acting, etc.). As shown in the figure, the pen cap 122 may include a button 123, which may be used to activate the pen cap (change modes), switch screens, and / or provide other functions.

[0085] Figure 4 shows a pen cap 122 displaying blood glucose data 129, which may include the current blood glucose level and a trend arrow. The blood glucose level may be received from the glucose sensor system 101 after scanning the pen cap 122, as shown in Figure 2. In some embodiments, positioning the pen cap 122 close to the glucose sensor system 101 (e.g., scanning the sensor 130) may act to activate the pen cap 122 from idle mode. In some cases, a push button 123 can activate the pen cap 122 to enable scanning of the glucose sensor system 101. In some cases, removing the pen cap 122 from the pen 120 can activate the pen cap 122 to enable scanning of the glucose sensor system 101.

[0086] Immediate delivery recommendation In one embodiment, system 11 and / or system 12 may be configured to provide corrective dosage recommendations and present the recommendations in a user interface. Referring to Figure 4, the display of the pen cap 122 includes a recommended corrective dosage 127d and a corresponding corrective dosage icon 126d. If the user's glucose concentration is within an acceptable range, the pen cap 112 may, in response to the recommendation system, display information indicating that no corrective dosage is necessary. In some embodiments, further input may be entered by or requested by the user, such as a display of meals for the user to select (for example, the pen cap 112 may then display a number of meal options as described below). In some cases, a button 123 may be novelly pressed to increase the meal size, progressively display larger meal sizes, and / or highlight different meal sizes. Dosages for meals, and any optional corrective dosages, may be provided to the user along with the display of meal sizes. The indication of meal size may be based on the size of the icon, the number of carbohydrates displayed, and / or a label (e.g., large or L, medium or M, small or S). In other embodiments, the meal indicator or icon may be based on other characteristics of the meal, such as a preferred meal selection made by the user, a meal with selected nutritional characteristics (e.g., carbohydrates), or a specific meal based on time of day (e.g., breakfast, lunch, dinner, snack).

[0087] Because changes in blood glucose levels are due to factors such as basal metabolism, diet, and exercise, the recommended corrected dose may only be valid for a set period. In one embodiment, the pen cap 122 may be configured to display the recommended corrected dose for a set period (e.g., the period since the last scan event, as shown in Figure 2). The set time may be user-defined or determined based on the timing of the recommendation and a confidence level corresponding to the user's physiological factors. Thus, the recommended corrected dose may have an associated confidence level and a "decrease rate" of that confidence level. After the timer expires (e.g., within the last 5, 10, 15, 20, 30 minutes, or longer), the pen cap 122 may stop and display the recommended corrected dose. In some cases, the pen cap 122 may stop displaying the recommended corrected dose when the received glucose value expires (e.g., more than 10 minutes, more than 15 minutes, more than 20 minutes, or more than 30 minutes have passed). In various embodiments, the glucose data transmitted from the glucose sensor system 101 to the pen cap 122 in a single transmission may include data that can be used by the pen cap to identify at least two estimated glucose values ​​(EGV) over a period of at least 30 minutes. In some embodiments, a single transmission may include at least 1 hour of glucose data, at least 2 hours of glucose data, at least 4 hours of glucose data, at least 6 hours of glucose data, or at least 8 hours of glucose data. For example, a continuous glucose monitor (CGM) and / or flash glucose monitor, such as glucose monitor 130, may transmit glucose data over multiple hours in a single transmission event.

[0088] In one embodiment, in response to the timer expiring, the display 124 on the pen cap 122 may instruct the user that a new blood glucose reading is required before an updated recommendation based on blood glucose data can be made. In some cases, a pen cap without current blood glucose data may provide a recommendation based solely on meal size, but may optionally further include a display indicating that the recommendation does not include any corrective components.

[0089] In one embodiment, the corrected dose may be displayed only if the current blood glucose level (e.g., effective blood glucose level from 10 minutes, 15 minutes, or 30 minutes prior) is available. If the effective blood glucose level is not available, a message may be displayed to the user indicating that the current blood glucose level is required.

[0090] Figure 5 shows a pen cap 122 having meal-related dosage recommendations (hereinafter referred to as “meal recommendations”) 127a–127c, which may be displayed for meals of different sizes identified by meal icons 126a–126c. For example, a user can press button 123 during use to obtain meal recommendations after viewing the screen in Figure 4. In some embodiments, meal recommendations may be based on meal dosages set by a healthcare professional, PWD, and / or caregiver using a mobile application during setup or update by a healthcare professional, PWD, and / or caregiver. In some embodiments, meal recommendations may be based on user-specific dosage parameters that are automatically updated by the system using any preferred algorithm for updating dosage parameters. In some embodiments, if a user has recently obtained a blood glucose reading (e.g., within the last 5, 10, 15, 20, 30 minutes, or more), meal recommendations 127a–127c may include both meal dosages and corrected dosages. In some embodiments, the dietary recommendations 127a-127c may consist only of dietary doses, and the pen cap 122 may not require the user to scan the glucose sensor to receive the dietary recommendations 127a-127c.

[0091] In some embodiments, the pen cap 112 may refuse to provide a corrected dose for a predetermined period after a previous dose and / or over a period after a previous dose, based on the identification of the amount of active insulin (e.g., IOB) in the PWD. In some cases, the corrected dose may be adjusted based on an estimate of active insulin (e.g., an IOB estimate). In some cases, the IOB may not be known, but an estimated percentage of residual active substance from the previous dose may be identified and displayed to the user. In some cases, the corrected dose calculation may be reduced based on an estimated percentage of residual active insulin that is within a predetermined range (e.g., if residual active insulin is identified as 5% to 25%, the recommended corrected dose may be reduced by 25% to 75%). For example, the pen cap 112 may continue to increase the recommended corrected dose over a period of 2 to 4 hours after a previous dose, based on the estimated percentage of active insulin in the subject.

[0092] Warning / alert thresholds for administration actions In some embodiments, if the pen cap 122 identifies another recent dose (e.g., by detecting the capping action of the pen cap within the last 3 hours, last 4 hours, or last 5 hours) even though the dose is unknown, the pen cap may refuse to add a corrective component to avoid unintentionally stacking corrective boluses (e.g., initially refuse and then optionally reverse). In some embodiments, meal icons 126a-126c may indicate whether the recommendation includes a corrective component. In some embodiments, additional icons or displays may indicate whether a recommended corrective dose is included and / or whether a size for the recommended corrective dose exists. In some embodiments, by pressing button 123, the user can obtain a screen displaying the current blood glucose level, trend information (e.g., trend arrow), and the recommended corrective dose. In some embodiments, if a recent insulin dose (e.g., within the last 1, 2, 3, or 4 hours) exists, a warning screen may appear next to or above the recommendation to indicate that a recent dose has been taken, to avoid unintentionally stacking corrective boluses. In some embodiments, a notification icon 128 may appear on the pen cap 122 in a mobile application on a mobile device 140 to indicate to the user that more detailed suggestions, hints, alerts, or warnings are available.

[0093] Recommendations specific to long-acting insulin delivery Figure 6 shows a pen cap 112 that may be used with a long-acting insulin injection pen 110. In some embodiments, caps 112 and 122 may share one or more (e.g., most, all) operational features. As shown in Figures 3 to 6, pen caps 112 and 122 may have distinct visual appearances (e.g., different colors, marks, patterns, etc.) or physical structures (e.g., shape, texture, etc.) to make it easier for the user to distinguish between long-acting insulin and rapid-acting insulin. This is because unintentionally delivering the wrong type of insulin can cause hypoglycemic or hyperglycemic events. The pen cap 112 may include a button 113 and a display 114 (e.g., an e-paper display). When the button 113 is pressed by the user (e.g., to activate the pen cap 112), the display 114 may remind the user (using appropriate icons 116) of the amount of long-acting insulin 117 that the PWD should inject based on stored therapeutic parameters (e.g., even if blood glucose readings have not been received from the associated blood glucose sensor).

[0094] In some embodiments, if the user has recently removed the pen cap 112 from the pen 110, the display may show information about the time the pen cap 112 was removed or other warnings to prevent unintended duplicate delivery of long-acting insulin. In some embodiments, the pen cap 112 may provide a notification sound to indicate to the user that it is time to deliver long-acting insulin based on stored therapeutic parameters. In some cases, the method, apparatus, and system may provide the user with a warning, alert, or notification (e.g., via the pen cap or via a mobile application) if the user fails to administer within a specific threshold period of the planned administration time (i.e., “forgotten administration”). In some embodiments, a suitable therapeutic titration algorithm may suggest that the user modify stored therapeutic parameters and / or automatically update stored therapeutic parameters related to the dosage of long-acting insulin.

[0095] In some embodiments, the long-acting insulin pen cap 112 may use pen cap attachment information to predict an administration action. If an administration action is not predicted at a specific time or within a specific time range, the pen cap 112 may detect a missed administration of long-acting insulin. A warning, alert, and / or notification of the missed administration may be generated and provided to the user. The missed administration notification may include information about the missed administration, such as the scheduled delivery time and amount of long-acting insulin.

[0096] In some embodiments, a time threshold parameter may be provided that defines the period since the last pre-emptive dosing action. The time threshold parameter may be configurable, so the user may set a different period (for example, the value may be entered by the user or selected from a list of recommended periods in the setup screen). If the time since the last pre-emptive dosing action exceeds the time threshold parameter, a missed dose may be inferred, and a missed dose warning, alert, and / or notification may be generated and provided to the user.

[0097] In some embodiments, the pen cap 112 can query the glucose monitor 130 to receive glucose data via the mobile device 140 and / or the pen cap 122, and / or receive blood glucose data. In some embodiments, the display 114 can show recent blood glucose data, the time of such data, and / or glucose trend data (e.g., trend arrows). In some cases, to prevent the user from confusing the pen cap 122 with the rapid-acting pen cap 112, the pen cap 122 may be adapted not to display the current blood glucose level. In some embodiments, the display 114 may include a recommended dose of long-acting insulin 117. In some cases, if a corrective dose is required, the pen cap 112 may indicate that the user should use the pen 120 to deliver a corrective dose of rapid-acting insulin.

[0098] Treatment-related information In some embodiments, one or more of the pen caps 112, 122 may track and display the estimated percentage of administered doses over time. For example, pen caps 112, 122 may track the estimated percentage of active insulin (e.g., IOB) remaining in the subject after each dose has been administered over time. In some cases, the IOB percentage remaining indicator may be displayed based on the most recent capping time (e.g., immediately after capping, the IOB percentage remaining indicator may show that the IOB remaining is 100%, but decreases over time to zero after the last capping). In some cases, cap 112 may include a calculation of the rapid-acting insulin activity rate, which may decrease over 3 to 6 hours. In some cases, cap 122 may include a calculation of the long-acting insulin activity rate, which may decrease over 12 to 36 hours. In some cases, a pen cap fitted to rapid-acting insulin may determine the percentage of intermediate-acting insulin, which may decrease over 6 to 12 hours. In some cases, the pen caps 112 and / or 122 may be adapted to identify the amount of insulin remaining in the insulin injection pen, and thus identify the dosage, and to display a real-time estimate of insulin as the number of units of insulin for each insulin type.

[0099] Exemplary system architecture Figure 7 shows an exemplary communication architecture of a system (e.g., system 11 shown in Figure 1B) illustrating possible communication links between system components. Various components can interface with each other via controlled radio, NFC, or BLE protocols. Each of these components displays, transmits, and receives information based on the system workflow in progress at a given time. As shown, the glucose monitor 130 can communicate via NFC with the fast-acting pen cap 122, communication link 231, and / or the mobile device 140, communication link 232. In some cases, a second BLE communication link 232 may be between the mobile device 140 and the glucose monitor 130, enabling real-time warnings or alerts based on current blood glucose received by the mobile device 140 via BLE communication without requiring user intervention. In some embodiments, the long-acting pen cap 112 can communicate with the glucose monitor 130 via NFC communication. In some embodiments, the long-acting pen cap 112 does not communicate directly with the glucose monitor 130 via NFC (or, in some embodiments, BGM via BLE), thereby preventing user confusion due to the fact that only rapid-acting insulin should be used for correction or meal administration. In some embodiments, the glucose monitor 130 can further communicate with a mobile device via a wireless communication device that transmits glucose values ​​at predetermined intervals. Both pen caps 112 and 122 can communicate with the mobile device 140 via BLE communication. Glucose data, programmed therapeutic parameters (e.g., daily dose of long-acting insulin, dose for different meal sizes (which may vary by time), insulin sensitivity factors, carbohydrate-to-insulin ratio, etc.), pen cap attachment data (and optionally, dose data, if detected by the pen cap) may be communicated between the mobile device 140 and each pen cap 112 and 122, and system data may be communicated to a web service 250 (which may be any remote server) via WiFi or cellular connection 241.In some embodiments, each pen cap 112, 122 may include a processor and memory configured to execute an algorithm that determines a recommended dosage. In some embodiments, a mobile device 140 may execute a treatment recommendation or treatment parameter update algorithm to recommend changes to programmed treatment parameters and / or automatically update programmed treatment parameters. In some embodiments, a web service 250 may execute an algorithm to recommend changes to programmed treatment parameters and / or automatically update programmed treatment parameters. In some embodiments, timing data from cap-attaching and / or cap-removal events of pen caps 112 and 122 (cap-attaching and cap-removal events may be referred to separately herein as “cap-attaching events”; another event that generates cap-attaching information is a cap-removal event, followed by a cap-re-attaching event) may be included in the algorithm to provide treatment recommendations.

[0100] In some embodiments, initial treatment parameters may be programmed into a mobile application on a mobile device 140 and transmitted to pen caps 112 and 122 via BLE communication links 211 and 221. In some embodiments, pen cap 122 can use the treatment parameters received from the mobile application to recommend corrected doses and meal doses. In some embodiments, the treatment parameters may include meal doses for different meal sizes (e.g., small, medium, and large meals). In some embodiments, the treatment parameters may include treatment parameters for correcting glucose values ​​such as insulin sensitivity factors. In some embodiments, the correction may be based on linear slide scale correction as described below. In some embodiments, pen cap 112 can receive treatment parameters indicating a daily dose of long-acting insulin. In some embodiments, pen cap 112 can receive recommended administration times for long-acting insulin from the mobile device mobile application 140 (e.g., 9 a.m. daily, 8 a.m. daily, or twice daily at 8 a.m. and 8 p.m.).

[0101] Delivery of rapid-acting insulin doses Once the user has decided on a rapid-acting insulin dose (e.g., before meals), the system can initiate the following workflow. Some actions are optional and do not need to be called if certain devices are unavailable or if the user chooses not to use them.

[0102] Obtain glucose readings As shown in Figures 2 and 3, the user can initiate NFC transfer from the sensor to the rapid-acting insulin smart cap (RCap) by activating the pen cap and shaking it above the sensor.

[0103] After obtaining a glucose reading, the pen cap presents the user with the current glucose value and trend line, along with a recommended corrected dose or action. If no glucose value is available within the last 10 minutes, the pen cap displays a home screen without a value, and the system proceeds to the next step in the workflow, once initiated by the user. In some embodiments, as described elsewhere, the recommended corrected dose may vary depending on the pen cap attachment information. For example, in some embodiments, the recommended corrected dose for an elevated glucose reading will only be displayed if the pen cap has been on the pen for at least a threshold period (e.g., at least 2 hours, at least 3 hours, or at least 4 hours). The last dosing time may be displayed, which is based on the most recent pen cap attachment.

[0104] Figure 8 shows a corrected dosage recommendation process according to an embodiment of the present disclosure. In operation 402, when removal of the fast-acting pen cap 122 (e.g., by the user) is detected, the recommendation mode is activated. In one embodiment, when the pen cap 122 is then removed from the insulin pen, the pen cap 122 may switch from low-power mode to active mode. In one embodiment, in low-power mode, the pen cap may display information about the last dosing operation, e.g., the amount and / or time of the last insulin dose, as shown in Figure 3. In operation 404, in response to cap removal and shaking near the glucose monitor 130, the pen cap 122 activates intermediate mode to read a glucose measurement from the glucose monitor 130 and prompts the user to swipe the pen cap 122 near the glucose monitor 130. In one embodiment, the pen cap 122 may also activate a reader configured to query the glucose monitor 130 when the pen cap 122 is nearby. In one embodiment, the reader may be an NFC antenna that advertises itself as available for BLE communication. In one embodiment, a Bluetooth tag may be linked to a glucose monitor 130 capable of communicating with a reader in response to an advertisement. In operation 406, the glucose sensor 120 provides a blood glucose measurement to the pen cap 122 in response to an inquiry, and the pen cap 122 decodes the received measurement. In one embodiment, the glucose measurement may be encrypted or coded using a proprietary format. In operation 408, the user presses button 123, and the pen cap 122 activates the corrected dosage recommendation mode in response to the user pressing the button. In operation 410, the pen cap 122 recommends a corrected dosage on the display on the pen cap 122. In one embodiment, the corrected dosage is identified on the pen cap 122. In another embodiment, the corrected dosage is identified on another device, such as a mobile device 130, and communicated to the pen cap 122. In various embodiments, the pen cap 122 may be configured to switch between glucose reading mode and recommendation mode, and the user may be able to receive the current measurement and current recommendation.The pen cap 122 may be configured to return to low-power mode in response to a timeout.

[0105] User evaluation (optional) of the effect of diet on blood glucose levels. If the user intends to administer medication with a meal, the user will proceed to the next screen, where three different dosage recommendations will be presented for meals that will have a large, medium, or small impact on the user's blood glucose. These recommendations may change over time to adapt to the user's habits and physiological function. The recommended dosages will include adjustments based on the user's glucose readings, where applicable.

[0106] A rapid-acting insulin is injected to capture the insulin dose. The user removes the RCap from the insulin pen and attaches the needle to the insulin pen. The needle is primed, and the user then dials the desired dosage and injects the insulin. The user removes the needle and replaces the cap with a rapid-acting insulin pen. The glucose value (if applicable) is transmitted via BLE to a mobile app, which is stored locally on the smartphone. If connectivity to the cloud is available via cellular or WiFi, the data is then synchronized to the cloud. In some embodiments, parts of the system (e.g., the cap, the mobile application) may monitor pen usage (e.g., based on data entered by the user regarding the normal use of the device) to detect priming operations (e.g., two sets of clicks from the pen, and / or input from the user regarding priming or lack thereof), and / or dosage selection. In some cases, the methods, systems, and devices provided herein may detect the presence of a needle and infer priming behavior (i.e., consider priming to occur when the needle is removed and replaced). In some cases, the methods, systems, and apparatus provided herein may be considered priming based on the dosage and the expected effect of glucose.

[0107] Figure 9 shows the infusion process for rapid-acting insulin according to an embodiment of the present disclosure. In operation 422, the user launches the mobile application and enters meal information. In operation 424, the mobile application presents the user with one or more corrected dosage recommendations. In one embodiment, the recommendations are based on an aggressiveness slide scale. In one embodiment, the recommendations may be based on the low, moderate, or hyperglycemic effect of the meal information entered by the user. In another embodiment, the recommendations may be based on glucose readings, and the recommendations may be based on the 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 is still valid. The second recommendation may correspond to a moderate confidence that the last glucose reading is still valid. The third recommendation may correspond to a low confidence that the last glucose reading is still valid. In operation 426, the user removes the cap of the pen cap 122, which is detected by the pen cap 122. In operation 428, the user primes the insulin injection pen 120 to deliver the dosage. In operation 430, the user injects an insulin dose from the insulin injection pen 120. In operation 432, the user replaces the pen cap 122, which is detected by the pen cap 122. In operation 434, the pen cap 122 records the administration operation and the time of the administration operation in response to the detected cap-attaching event. In operation 436, the pen cap 122 returns to low-power mode in response to the cap-attaching event.

[0108] Delivery of long-acting insulin doses Once the user has determined the delivery of a long-acting insulin dose, the system initiates the following workflow. Some steps are optional and do not need to be called if certain devices are unavailable or if the user chooses not to use them.

[0109] Obtain glucose readings The user may initiate NFC transfer from the glucose sensor (typically a CGM) to the long-acting insulin pen cap 112 by activating the pen cap and shaking it above the sensor.

[0110] After obtaining a glucose reading, the pen cap displays the current glucose value and trend line to the user, along with a recommended long-acting insulin dosage. If no glucose value is available within the last 10 minutes, the pen cap displays only the recommended long-acting insulin dosage, which is adjusted to the user's habits and physiological function and may change over time under the supervision and approval of a clinician.

[0111] Figure 10 shows a corrected dosage recommendation process according to an embodiment of the present disclosure. In operation 442, the user removes the pen cap 112 to activate recommendation mode. Once the pen cap 112 is removed from the insulin pen, the pen cap 112 may switch from low-power mode to active mode. In one embodiment, in low-power mode, the pen cap may display information about the last long-acting insulin administration operation, for example, the amount and / or time of the last insulin dose, as shown in Figure 3. In operation 444, in response to the removal of the cap and being shaken near the glucose monitor 130, the pen cap 112 activates intermediate mode to read a glucose measurement from the glucose monitor 130 and prompts the user to swipe the pen cap 112 near the glucose monitor 130. In one embodiment, the pen cap 112 may also activate a reader configured to query the glucose monitor 130 when the pen cap 112 is nearby. In one embodiment, the reader may be an NFC antenna that advertises itself as available for BLE communication. In one embodiment, a Bluetooth tag may be linked to a glucose monitor 130 capable of communicating with a reader in response to an advertisement. In operation 446, the glucose monitor 130 provides a blood glucose measurement to the pen cap 112 in response to an inquiry, and the pen cap 112 decodes the received measurement. In one embodiment, the glucose measurement may be encrypted or coded using a proprietary format. In operation 448, the user presses button 113, and the pen cap 112 activates the corrected dosage recommendation mode in response to the user pressing the button. In operation 450, the pen cap 112 recommends a corrected dosage on the display on the pen cap 112. In one embodiment, the corrected dosage is identified on the pen cap 112. In another embodiment, the corrected dosage is identified on another device, such as a mobile device 130, and communicated to the pen cap 112. In various embodiments, the pen cap 112 may be configured to switch between glucose reading mode and recommendation mode, and the user may be able to receive the current measurement and the current recommendation.The pen cap 112 may be configured to return to low-power mode in response to a timeout.

[0112] Inject the insulin dose. The user removes the pen cap 112 from the insulin pen and attaches the needle to the cartridge. The needle is primed, and the user then dials the desired dosage and injects the insulin. The user removes the needle and replaces the cap with a rapid-acting insulin pen. The glucose value (if applicable) is transmitted via BLE to a mobile app, which is stored locally on the smartphone. If connectivity to the cloud is available via cellular or WiFi, the data is then synchronized to the cloud. In some embodiments, parts of the system (e.g., the cap, the mobile application) may monitor pen usage (e.g., based on data entered by the user regarding the normal use of the device) to detect priming operations (e.g., two sets of clicks from the pen, and / or input from the user regarding priming or lack thereof), and / or dosage selection.

[0113] Figure 11 shows the injection process for rapid-acting insulin according to an embodiment of the present disclosure. In operation 462, the user launches a mobile application and enters meal information. In operation 464, the mobile application presents the user with one or more corrected dosage recommendations. In one embodiment, the recommendations are based on an aggressiveness slide scale. In one embodiment, the recommendations may be based on the low, moderate, or hyperglycemic effect of the meal information entered by the user. In another embodiment, the recommendations may be based on glucose readings, and the recommendations may be based on the 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 is still valid. The second recommendation may correspond to a moderate confidence that the last glucose reading is still valid. The third recommendation may correspond to a low confidence that the last glucose reading is still valid. In operation 466, the user removes the cap of the pen cap 112, which is detected by the pen cap 112. In operation 468, the user primes the insulin injection pen 110 to deliver the dosage. In operation 470, the user injects an insulin dose from the insulin injection pen 105. In operation 472, the user replaces the pen cap 112, which is detected by the pen cap 112. In operation 474, the pen cap 112 records the administration operation and the time of the administration operation in response to the detected cap replacement event. In operation 476, the pen cap 112 returns to low power mode in response to the cap replacement event.

[0114] Checking the status of fast-acting and long-acting pen caps. Figure 12 shows status confirmation on pen caps 112 and 122 according to embodiments of the present disclosure. For example, status information may include the date and time of the last rapid-acting insulin dose, a glucose trend line, the most recent glucose reading and time, and a recommended corrected dose. In operation 482, the user requests status confirmation from pen cap 122 related to rapid-acting insulin delivery. In operation 484, the user requests status confirmation from pen cap 112 related to long-acting insulin delivery. In operation 486, pen cap 122 may display status information in response to the user's request. In some embodiments, pen cap 122 may continuously display the date and time of the last rapid-acting insulin dose when in low-power mode. In operation 488, pen cap 112 may display status information in response to the user's request. In some embodiments, pen cap 112 may continuously display the date and time of the last long-acting insulin dose when in low-power mode.

[0115] Checking system status Users can check the system status in the following locations:

[0116] Figure 13 shows a status check in a mobile application according to an embodiment of the present disclosure. For example, the status information may include system maintenance information (such as remaining power, remaining insulin, and sensor status), the date and time of the last rapid-acting or long-acting dose, a glucose trend line, the most recent glucose reading and time, detailed forecasts and trends, and recommended corrected doses. In operation 492A, the user requests a status check from the mobile application. In operation 494A, the mobile application may display the status information in response to the user's request.

[0117] Figure 15 shows a process for checking the system status according to an embodiment of the present disclosure. In operation 522, the mobile application 104 is started. In operation 524, the mobile application 104 presents a user prompt, which is for scanning the glucose sensor system. In one embodiment, the mobile application 104 may present a prompt to check the system status in response to a request received at the user interface. In operation 526, the mobile device running the mobile application 104 is swiped near one or more glucose sensors. In operation 528, the mobile application 104 receives blood glucose data from one or more glucose sensors. In operation 530, the mobile application 104 identifies and presents glucose data and trends, typically with respect to a recent time window.

[0118] Mobile application user interface The methods and systems provided herein may further include a mobile application running on a mobile device (e.g., a smartphone or tablet) that wirelessly communicates (e.g., via BLE) with one or more pen 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 blood glucose meter 150) either 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 graph of the blood glucose data. In some embodiments, the graph of blood glucose data over time may include an indicator that conveys pen cap wearing information.

[0119] Figure 16 shows an exemplary display of the system (e.g., a mobile device). For example, Figure 16 shows an exemplary user interface of a mobile application that includes a graphical display of blood glucose data using marks along the x-axis (e.g., triangles, circles, wedges, or any other preferred icons or marks for dosage), where these marks indicate the timing of insulin administration and / or other actions, such as the timing of glucose readings, or the timing of reattaching the cap. In some embodiments, if the cap removal is prolonged (e.g., if the pen cap remains off for an extended period before being reattached), the triangle may become wider to indicate the time during which insulin administration is being performed. In some embodiments, the icons may vary depending on the type of insulin associated with the pen cap having a reattaching action (e.g., different colors or shapes). In some embodiments, the graphical display of blood glucose levels may be switched between 3-hour and 12-hour timeframes. In some embodiments, the home screen may include a simplified display of the current EGV, a curve of the EGV shown 30 minutes ago, and a curve showing the predicted EGV for the next 30 minutes.

[0120] A message may be displayed on the home screen to remind the user of recommended actions they can take to improve their treatment. In some embodiments, the mobile app may guide the user based on a combination of glucose data and / or pen cap attachment information. In some embodiments, the guidance provided through the app may be approved by a healthcare professional via a cloud connection before being provided to the user. For example, in some embodiments, blood glucose data after a cap attachment action may indicate that the user is typically under-administering or over-administering insulin for a particular meal. In some embodiments, the methods and systems provided herein can then adjust user-specific treatment parameters or recommended doses of rapid-acting insulin based on the blood glucose data after each cap attachment event. In some embodiments, glucose data after or before each cap attachment event may be transmitted to a healthcare professional to update user-specific dosage parameters or the user's recommended dose (which may be based on time). In some embodiments, data before and after each cap attachment event may indicate that the user typically administers rapid-acting insulin after the start of a meal, and may be adapted to instruct the user to administer a bolus before the meal if the user is about to eat. In some embodiments, data and blood glucose levels before and after each capping event may be used to recommend the timing of infusion in relation to when to start eating after infusion. In some embodiments, data and / or blood glucose levels before and after each capping event may be used to recommend modifications to the insulin dosage taken by the subject. Again, such guidance may be automated, approved by a healthcare professional, and / or developed by a healthcare professional.

[0121] In some embodiments, blood glucose levels may be further used to track the type of insulin being ingested and / or to make recommendations thereon. In some cases, blood glucose levels may be analyzed in conjunction with dose capture data to determine whether the wrong insulin has been ingested. In some cases, blood glucose data may be analyzed in conjunction with temperature sensor data from the pen cap to determine whether the insulin is faulty, whether the wrong insulin has been ingested (e.g., as described above), or whether there are other problems with the treatment or associated device.

[0122] The mobile application may be adapted to provide the user with additional information that can be used to determine how often the user adheres to the recommended dosage. In some embodiments, the user may be provided with the possibility of entering the dosage for each cap-wearing event and / or multiple doses (e.g., the amount of insulin taken over a selected period, such as more than one day) in the mobile application or directly in the pen cap. For example, marks along a graph may be tapped by the user to allow them to enter the dosage they have taken.

[0123] Figure 17 shows another exemplary display 300 of a part of the system (for example, a mobile device such as the mobile device 140 shown in Figure 7). As shown in Figure 9, the display 300 may be somewhat similar to the one shown in Figure 16 and may include a graphical display of blood glucose data using marks along the x-axis (e.g., circles 302), where these marks indicate the timing of events related to the system 10, such as the timing of glucose readings received from a related glucose monitor (e.g., a flash monitor). Circles 302 may be connected by a trend line 304 of the user's blood glucose level (e.g., located above it).

[0124] In embodiments where data is received only intermittently from the blood glucose monitor (for example, segments or blocks of data relating to BGV are downloaded in separate periods on request), data prior to the current data point circle 302 showing the most recent glucose reading (e.g., the area between the current circle 302 and the previous circle 302) may be received from the glucose monitor and added to the trend line 304. In some embodiments, another marker (e.g., the most recent circle 306) may be positioned at the most recent reading (e.g., the most recent circle 302) and may be visually distinguishable 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 of the most recent circle, i.e., marker 306, on the trend line 304 may also be indicated on the display 300 using a marker (e.g., a vertical line 308).

[0125] In some embodiments, the pen cap may query the blood glucose sensor when the device is positioned near the sensor and / or when a button (e.g., a virtual scan sensor button 310) is selected or pressed (e.g., and held) by the user. In some embodiments, the display 300 may include an indicator (e.g., a meter 312 extending around the user button 310) that displays a measurement relevant to the system. For example, the meter 312 may display the remaining lifespan of the blood glucose sensor (e.g., an estimated time until the sensor needs to be replaced). As shown, the meter 312 may increase (e.g., rise) or decrease (e.g., recede) around the button 310 in accordance with changes in the relevant data. For example, the meter 312 may decrease or increase over time as the lifespan of the blood glucose sensor approaches zero (e.g., resulting in either a filled-in meter 312 or an empty, i.e., white meter 312). In some embodiments, the meter 312 may display other metrics, such as the time since the last scan, the time until the next recommended scan, or the percentage of a previously administered dose (e.g., a corrected dose).

[0126] As shown in Figure 18, in some embodiments, the display 300 may allow the user to track previous values ​​on the trend line 304. For example, the user may drag the latest circle, i.e., the marker 306 (along with, for example, the vertical line 308), backward along the trend line to previous periods. As shown, the display 300 may track the position of the latest circle 306 and display the time and blood glucose level for the selected period.

[0127] In some embodiments, the nearest circle 306 (for example, together with the vertical line 308) may be fixed to the nearest data position of the trend line 304 and may return to the nearest position when the nearest circle 306 is released by the user. For example, the vertical line 308 may be transformed into a "slingshot" and may return the circle 306 to the nearest reading position when released by the user.

[0128] In some embodiments, the user may be asked to estimate the number of insulin units remaining in the pen. In some embodiments, the user may be asked to take a picture of the insulin pen, and the app may be adapted to analyze the image of the insulin pen to determine the approximate number of units remaining in the pen. For example, Figure 19 shows an exemplary user interface in which the user may take a picture of the pen using the smartphone camera. In some embodiments, the user interface may overlay a real-time view of the smartphone camera onto guide lines corresponding to the pen's features to help the user align the pen with the smartphone camera. In some embodiments, the mobile app may be adapted to automatically take a snapshot of the pen when the features as seen from the smartphone camera are aligned with the guide lines 150. As shown, the guide lines 150 may include lines indicating a window in the pen that allows the plunger to be seen. In some embodiments, the guide lines may move in relation to the pen's position. In some embodiments, the mobile app may detect whether the pen is too close or too far from the camera and instruct the user to move the pen relative to the smartphone camera. In some embodiments, the camera may automatically zoom in on the pen. In some embodiments, the user may be asked to estimate how often they will follow the recommended dosage. In some embodiments, the device may automatically analyze the amount of insulin when the pen or part thereof is visible to a mobile device (e.g., a camera).

[0129] In one embodiment, the device may automatically analyze an insulin vial and infer meal information based on changes in the image of the insulin vial. For example, based on several consecutive images, meal intake and the number of meals may be inferred based on changes in the amount of insulin in the vial and the type of insulin (i.e., rapid-acting).

[0130] In some embodiments, the pen may include an indicator (e.g., a scale mark) that allows the user to easily identify the position of a part of the pen (e.g., a plunger) and input the relevant value into the application.

[0131] The pen cap may be configured to provide insights into recommended dosages that the user is likely to follow. For example, as described in U.S. Patent Application Publication No. 15 / 717,805, filed September 27, 2017, titled "Medicine Injection And Disease Management Systems, Devices and Methods," and filed September 27, 2017, the pen cap (whether or not any dosage capture features incorporated into the pen cap exist) may include meal notification categories (e.g., S, M, L), and data from each notification may indicate whether the user may have administered an appropriate amount for an S, M, or L meal. In some embodiments, a button on the pen cap 122 may be pressed multiple times to sequentially display recommendations for S, M, and L meals, and the methods and systems provided herein may assume that the user administered insulin based on the last displayed recommendation. In some embodiments, additional information provided via a mobile application showing the amount of insulin remaining in the pen at various intervals (once a day, once every few days, once a week) can indicate whether the user generally follows treatment recommendations or ignores them. In some embodiments, the methods and systems provided herein can analyze glucose data, pen cap attachment information, data on the amount of insulin remaining in one or more pens, and / or answers to questions presented via a mobile app to identify the potential or assessment of the user's suitability for the recommended dosage, which may be used by the methods and systems provided herein to determine whether to adjust the recommended dosage or to instruct the user.

[0132] System Setup The treatment management systems provided herein can be set up using any preferred method. In some embodiments, a medical professional can input initial treatment parameters from a web portal or directly to the user's mobile device (e.g., during a consultation). In some embodiments, the user may input initial treatment parameters based on advice from a physician. The treatment management systems provided herein provide a way for the user to clearly understand their treatment settings, thereby gaining the user's trust in the system.

[0133] Figure 20 shows an exemplary initial screen in a mobile application for a mobile device 140 for a diabetes management system, such as the system shown in Figure 1A, Figure 1B, or Figure 1C. On the initial screen, the user can click the Start button and enter their settings, which may be instructed by a healthcare professional. The user may be given the opportunity to enter information about their insulin treatment (e.g., brand names and / or generic names of long-acting and / or rapid-acting insulin, average dose information, etc.). In some embodiments, the user may be asked to select a brand of long-acting and / or rapid-acting insulin from a list of known brands. In some cases, the user may also be asked whether they will use two insulin pens or one insulin pen, and the product configuration may be done on the fly during setup. For example, some treatment settings may be automatically set according to the selected insulin brand. In some embodiments, prescription information may be associated with the pen cap (e.g., downloaded from the treatment management system or entered by a healthcare provider), and the list of insulin brands may be supervised based on the prescription information. Furthermore, treatment settings may be automatically set according to the prescription information.

[0134] The mobile application may present a screen as shown in Figure 21, on which the user is prompted to enter the daily dose of a long-acting insulin pen (e.g., full unit, half unit, or other resolution based on the resolution of the user's long-acting insulin pen 110). The user interface may use, for example, a sliding wheel or a numeric keypad as shown. In some embodiments, the user may be prompted to enter the time of day when the long-acting insulin is typically infused. In another screen, as shown in Figure 22, the user may be able to enter standard doses for different meal sizes. In some embodiments, each of these fields may be pre-filled with recommended amounts based on the user's daily dose of long-acting insulin, and these values ​​may be obtained based on a population model. For example, the pre-set amounts may be pre-filled based on relationships as described in U.S. Patent Application No. 15 / 717,805, but the user interface may allow the user to enter their own dose for each meal size by pressing within the field to override these pre-filled numbers. In some embodiments, the mobile application can show the user examples of meals that fit each category, thereby allowing the user to compare their mental model of what constitutes a small, medium, and large meal with the system's hypotheses. Figure 23 shows an exemplary user interface for showing exemplary meals with serving sizes that fit different categories. For example, in the case of a “small carbohydrate” meal, each meal shown has a similar effect on blood glucose (e.g., similar amount of carbohydrates). Similarly, “medium carbohydrate” and “large carbohydrate” meals also have a similar effect on blood glucose (e.g., identical amount of carbohydrates) to the meals shown in each category. For example, a meal shown in “small carbohydrate” may contain approximately 15-20 grams of carbohydrates, a meal shown in “medium carbohydrate” may contain 35-45 grams of carbohydrates, and a meal shown in “large carbohydrate” may contain 60-80 grams of carbohydrates. After setting the meal dosage, the user can then select a glucose target or glucose target range.

[0135] Figure 24 shows an exemplary user interface in which the user can adjust the glucose target value up or down. In some embodiments, the glucose target value can be set to a default value of a number of preset values ​​(e.g., 100 mg / dl, 80 mg / dl, 120 mg / dl, etc.).

[0136] In the screen shown in Figure 25, the user can review the settings (and optionally further adjust them).

[0137] In some embodiments, the diabetes management systems provided herein can customize one or more modified dosages using data about the user.

[0138] In some embodiments, a user interface accessible on a mobile device 140 or via the cloud from a remote server allows a healthcare professional or PWD to set the ISF or input other data to determine the corrected dosage. In some embodiments, the glucose target value set in Figure 24 may be used in conjunction with the ISF (or increment value) entered by the healthcare professional or at the healthcare professional's instruction to generate a linear slide scale correction chart. For example, an equation that may define the linear slide scale correction chart is as follows: Corrected dosage = rounddown(current blood glucose - glucose target) / ISF.

[0139] In some embodiments, the glucose target set in Figure 24 can define an intermediate range of the glucose target range, and the formula can calculate a corrected dose using the lower limit of the glucose target range. In some embodiments, the ISF can be inferred from the mathematical relationship between the user's daily doses of long-acting insulin. Figure 26 shows how the slide scale chart may be determined by the ISF or interval and the glucose target or target. In some embodiments, a user interface on a mobile application or in a web portal can generate a slide scale chart for the PWD, caregiver, or healthcare professional before approving the summary shown in Figure 24. In some embodiments, the slide scale chart may be included in the treatment summary. The slide scale chart can simplify the user's understanding of how the system adjusts its treatment based on real-time blood glucose readings from a glucose sensor. In some embodiments, the user interface may allow the user to update the increment or start and dynamically update the generated slide scale correction chart to allow a healthcare professional or PWD to match the generated slide scale correction chart to a desired treatment setting (e.g., shown in Figure 33).

[0140] Figures 27–30 illustrate different options that may be presented to the user via a user interface that enable a mobile application to create a slide scale (for example, as shown in Figure 18). As shown in Figure 27, the mobile application may, as a first option, prompt the user (e.g., subject and / or caregiver) to input values ​​(e.g., based on past use) regarding actions taken by the subject during blood glucose management. For example, historical data regarding the amount (e.g., units) of insulin (e.g., rapid-acting insulin) taken in accordance with a particular blood glucose range. As shown in Figure 28, two or more ranges may be input to create a user-input scale, which may (e.g., consequently) be a nonlinear scale.

[0141] As shown in Figure 29, the mobile application may, as a second option, prompt the user to directly input values ​​related to the subject's ISF. For example, the user may input the average droplet value of blood glucose measured in milligrams per deciliter (mg / dl), caused by each unit of insulin ingested by the subject. In some embodiments, the mobile application may allow the user to input a target blood glucose level.

[0142] In either option, the mobile application may display a confirmation of the scale manually entered by the user under the first option (e.g., a nonlinear scale), or a confirmation of the scale generated using the ISF value entered by the user under the second option (e.g., a linear scale).

[0143] The methods, apparatus, and systems provided herein may detect blood glucose patterns and / or infusion patterns so that the apparatus or system can understand the effects of administration, determine changes to recommended treatment settings, and improve blood glucose outcomes. In some embodiments, a mobile device may determine appropriate treatment changes. In some embodiments, a remote server may determine appropriate treatment settings. In some embodiments, the methods, apparatus, and systems may automatically incrementally adjust dosages for different meal sizes, as described in U.S. Patent Application No. 15 / 717,805, incorporated herein by reference. In some embodiments, an algorithm may update the ISF or corrected dosage based on the detected pattern. In some embodiments, the methods, apparatus, and systems may determine whether there are treatment-related change recommendations and then use that information to inform the user about this pattern, or use a trigger, hint, or suggestion to the user (e.g., a message in a mobile application) to inform the user about this pattern. Examples of these are shown in Figure 31. For example, a message may be as shown in Figure 31 and / or displayed on a mobile device as shown in Figure 32. As shown in Figure 32, the message may include a screen showing the user how to make the appropriate changes (e.g., in-app training) and / or a button that moves the user to a screen where they can actually make the changes. By pressing this button, the user may move to a screen shown in Figure 33, which includes multiple sliders for each meal size. In some embodiments, the user may choose to change only one meal size, or they may want to change across the entire board by changing the bottom slider. In some embodiments, the ISF value may be changed by changing the bottom slider. In some embodiments, the settings may be based on time (e.g., breakfast time, lunch time, dinner time), and the user may adjust the settings for one of these meal times in particular or all of these meal times.

[0144] Alerts and warnings In some embodiments, the diabetes management systems, devices, and methods provided herein may provide notifications, warnings, and / or alerts. In some embodiments, notifications, warnings, and / or alerts may be automatically triggered by one or more parts of the system, such as a mobile device, a pen cap, and / or one or more separate alert accessories. In some embodiments, the treatment management systems, devices, and methods provided herein may include a smart pen or pen accessory adapted to provide notifications, treatment recommendations, and / or alerts when a user performs an operation to acquire blood glucose data (e.g., an accessory adapted to be attached to the pen, e.g., a pen cap, and / or another accessory that is integrated with the pen, or can be applied to the pen, and / or can be connected to the pen). In some embodiments, the treatment management systems, devices, and methods provided herein may include both one or more alert accessories and one or more smart pens or pen accessories, each capable of wirelessly receiving blood glucose data (e.g., from a continuous glucose monitor). In some embodiments, the treatment management systems, devices, and methods provided herein may include 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 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 for communicating blood glucose data to the alert accessories is broader than the communication technology for communicating blood glucose data to the smart pens or pen accessories. In some embodiments, the treatment management systems, devices, and methods provided herein may include one or more alert accessories that passively receive blood glucose data (e.g., via wireless communication) as long as they are within communication range, and one or more smart pens or pen accessories that are configured to wirelessly receive blood glucose data only when the user performs an action to cause the smart pens or pen accessories to receive blood glucose data (e.g., pressing a button, swiping the pen or pen accessory adjacent to a glucose sensor).In some embodiments, the power consumption of the smart pen or pen accessory can be reduced by having a smart pen or pen accessory that receives blood glucose data only when operated by the user, thus reducing the burden on the user of charging or replacing the battery of the smart pen or pen accessory. In some embodiments, by having an alert accessory such as those provided herein, the user can determine when and where to receive disruptive alarms, alerts, and notifications, and furthermore, the user may not feel the need to carry an insulin pen between administrations.

[0145] The methods, systems, and apparatus provided herein may include one or more alert accessories, which may take any preferred form. In some embodiments, the alert accessory may include one or more illuminable icons. In some embodiments, the alert accessory may include a digital display screen. In some embodiments, the alert accessory may include one or more speakers and / or vibration motors. In some embodiments, the alert accessory contemplated herein may be attached to a smartphone (e.g., as a phone case). In some embodiments, the alert accessory contemplated herein may be attached to a keychain. In some embodiments, the alert accessory contemplated herein may be adapted to function as a bedside alarm clock. In some embodiments, the alert accessory contemplated herein is...

[0146] In some embodiments, the methods, systems, and apparatus provided herein may provide guidance regarding an appropriate insulin dosage. In some embodiments, the insulin dosage may be administered using an insulin delivery pen or syringe. In some embodiments, the insulin may be long-acting insulin. In some embodiments, the insulin may be rapid-acting insulin. In some embodiments, the insulin delivery pen or its accessories (e.g., a cap) may be able to detect the amount of insulin being delivered from the pen (or the amount of insulin ready for delivery). In some embodiments, the insulin pen or its accessories may include a user interface that displays data or recommendations to the user and / or allows the user to input data into the insulin pen or accessories.

[0147] The following exemplary treatment management systems include an insulin delivery pen having a dose-capturing pen cap, but other embodiments are also conceivable in which the functions disclosed herein are incorporated into other accessories of the insulin delivery pen or into the insulin delivery pen itself. Furthermore, the following exemplary treatment management systems include a single alert accessory (e.g., a CGM fob), but other embodiments are also conceivable in which multiple alert accessories are included, or in which the functions of the alert accessories are integrated into a smartphone or other web-connected mobile computing device (e.g., using Wi-Fi or cellular communication).

[0148] In some embodiments, one or more parts of the system (e.g., a pen, a mobile application, an alert accessory) may be configured to present one or more of the following warnings or alerts:

[0149] Glucose alert: Low glucose, high glucose, likely to experience low glucose in the future, likely to experience high glucose in the future, hyperglycemia fluctuations

[0150] • Timing alerts: Alerts prompting blood glucose monitoring (e.g., for specific daytime time intervals), meal timing, pen cap removal during specific periods, and duplicate dosing (e.g., removing the pen cap twice in a short period).

[0151] • Rapid-acting insulin alerts: Correction dose intake, forgotten rapid-acting insulin dose, dangerous rapid-acting insulin dose, dose exceeding threshold.

[0152] • Long-acting insulin alerts: Intake of long-acting insulin, missed dose of long-acting insulin, dangerous long-acting insulin administration, dose exceeding the threshold.

[0153] • Insulin switching alert: Dangerous dosage intake - switching dosages, misuse of pen cap

[0154] • Temperature alert: As mentioned above, the detected insulin is outside the specified range.

[0155] • Maintenance alerts: Insulin out, low power, sensor malfunction, sensor expiration.

[0156] Upgradable system The diabetes management systems provided herein may be adapted to add or remove components and / or be configured based on the needs of persons with diabetes mellitus (PWD). For example, Figures 34A–34D show various systems and associated communication architectures that can be used by PWDs with different types of diabetes (including, as shown, type 1 or type 2, or gestational diabetes or other types of diabetes), different stages of diabetes progression, and / or different preferences for methods of monitoring and / or treating diabetes. In some cases, the methods and apparatus provided herein may be adapted to identify when additional treatment is needed and when additional treatment or addition of devices to the treatment and / or system is recommended.

[0157] Figure 34A shows a system 3410 comprising only the BGM 150, a mobile device 140 with a mobile application, a long-acting insulin pen 110, and a long-acting pen cap 112. System 3410 can communicate with the cloud service 250 via the mobile device 140, as described above. System 3410 may be suitable for use by PWDs who do not require mealtime insulin (e.g., early-stage progressive type 2 diabetes and / or gestational diabetes) or PWDs who do not wish to track their rapid-acting insulin dosage. The BGM 150 is a blood glucose meter adapted to determine estimated glucose values ​​(EGV) by using a test strip that analyzes an in vitro blood sample. As shown in the figure, the BGM 150 can transmit a single-point EGV to the pen cap 112 via a BLE communication link 3401. The EGV from the BGM 150 can then be transmitted from the pen cap 112 to the mobile application 140 via a BLE communication link 3405, and to the cloud service 250 via the mobile application 140 for analysis via network communication 3409. The BLE communication link 3405 can also transmit pen cap attachment data to the mobile application 140, which may also be transmitted to the web service 250 via link 3409. The mobile application 140 can display graphs of the most recent EGV and / or collected EGV. The recommended dose of long-acting insulin may be displayed on the pen cap 112 in a manner similar to that shown in Figures 6 and 35A. The system 3410 may prompt the user to collect fasting EGV using the BGM 150. The system 3410 may use the fasting EGV to recommend a change to the displayed recommended dose of long-acting insulin, or it may automatically change the recommended dose using standard long-acting insulin titration techniques or any other suitable algorithm. In some cases, the system 3410 may use an algorithm to determine whether PWD should add rapid-acting insulin to its treatment.

[0158] Figure 34B shows system 3420, which includes components of system 3410 but adds a rapid-acting insulin pen 120 and a rapid-acting pen cap 122. System 3420 may be adapted for use by PWDs who require both long-acting and rapid-acting insulin but wish to monitor EGV with BGM instead of a continuous or flash glucose monitor. When the rapid-acting pen cap is added to the system, the communication link 3401 is removed, and the long-acting pen cap 112 does not receive EGV from BGM 150. This is because the BGM value is not used to determine the immediate dose of long-acting insulin, although this value may be used to determine the corrected dose of rapid-acting insulin. As shown, BGM 150 can transmit a single-point EGV to the pen cap 122 via the BLE communication link 3402. Subsequently, EGV from BGM150 can be transmitted from the pen cap 122 to the mobile application 140 via BLE communication link 3406, and to the cloud service 250 via the mobile application 140 for analysis via network communication 3409. BLE communication links 3405 and 3406 can also transmit pen cap attachment data to the mobile application 140, and this data can also be transmitted to the web service 250 via link 3409. The mobile application 140 can display graphs of the most recent EGV and / or collected EGV. Recommended dosages of rapid-acting and long-acting insulin can be displayed on the pen cap 112 in a manner similar to that shown in Figures 3-6, 35A, and 35B. The system 3420 can prompt a user to collect fasting EGV and / or postprandial EGV using BGM150. For example, system 3420 may, in some cases, trigger a reminder to the user to check the EGV at a predetermined time after the pen cap attachment event and collect post-meal EGV.System 3420 can use fasting EGV to recommend a change in the displayed recommended dose of long-acting insulin, or it can automatically change the recommended dose using standard long-acting insulin titration techniques or any other suitable algorithm. System 3420 can use postprandial EGV to recommend a change in the displayed recommended dose of rapid-acting insulin, or it can automatically change the recommended dose using standard insulin titration techniques or any other suitable algorithm. In some cases, System 3420 may use an algorithm to determine whether the patient (PWD) should add a continuous glucose monitor to help the PWD achieve better glycemic control.

[0159] Figure 34C shows the components of system 3420, but also shows system 3430 with the addition of a continuous glucose monitor 130. The CGM 130 enables both broadcast data via BLE or UHF radio and user-initiated data transfer via NFC communication, and one or both of these communication methods may be used to transmit EGV from the CGM 130 to the pen cap 122 and / or mobile application 140. Since no corrective components are used in long-acting insulin administration, direct communication between the CGM 130 and the pen cap 112 is not required. For example, the NFC communication link 3403 allows the pen cap 122 to receive EGV from the CGM 130, for example, by using the method shown in Figure 2 and described above, once the user decides to acquire EGV. The BLE communication link 3402 still allows the transfer of EGV from the BGM 150 to the pen cap 122. Subsequently, EGVs from BGM150 and / or CGM130 can be transmitted from the pen cap 122 to the mobile application 140 via BLE communication link 3406, and to the cloud service 250 via the mobile application 140 for analysis via network communication 3409. In addition, EGVs from CGM130 may be received by the mobile application 140 via communication link 3404, which may include both BLE and NFC communication. BLE EGV broadcasts may be used to trigger EGV-based warnings or alerts notified by the mobile application 140. Missing EGVs may be filled in by scanning the CGM130, mobile application 140, or pen cap 122 to obtain data from multiple hours prior to the EGV (e.g., 4 hours, 6 hours, 8 hours, or 10 hours). BLE communication links 3405 and 3406 can also transmit pen cap attachment data to the mobile application 140, which may also be transmitted to the web service 250 via link 3409. The recommended dosages of rapid-acting and long-acting insulin can be indicated on the pen cap 112 in a manner similar to that shown in Figures 3-6, 35A, and 35B.System 3430 can use EGV in combination with dosage data (e.g., timing data) to recommend changes to the displayed recommended dosage of rapid-acting insulin, or it can automatically change the recommended dosage using standard insulin titration techniques or any other suitable algorithm.

[0160] Figure 34C also shows that system 3440 may include the same components. System 3440 differs from system 3430 in that it includes pen caps 112 and 122 adapted to detect the amount of insulin remaining in insulin pens 110 and 120, which can be used to determine the insulin dosage. Other methods may be used, and are therefore intended herein, to detect the dosage in the cap or other accessories, or as part of the smart pen or smart inhaler. In addition, system 3440 can use the captured dosage data to more aggressively automate user-specific dosage parameters.

[0161] Figure 34D illustrates a series of care procedures and how systems 3410-3440 can be upgraded by adding components. In addition, system 3450 is an automated insulin delivery system using an insulin pump. In some cases, using systems 3440 or 3430 may help detect candidates for switching to pump therapy, such as system 3450. In some cases, system 3450 may include pen caps 112 and / or 122, which may allow the user to selectively switch between injection therapy (e.g., MDI therapy) and pump therapy (e.g., infusion pump therapy).

[0162] Figure 35A shows exemplary displays 114A-114C of the pen cap 112. Figure 25B shows exemplary displays 124A-124E of the pen cap 122. In the pen cap 112, display 114A may be a standard display when the pen cap is not in use. As described above, display 114 may be a bistable display capable of holding an image without having an excessive power supply. Display 114A may include an insulin type label so that the user can immediately know the insulin type by looking at the pen cap 112. When a button is pressed or the cap 112 is removed, the time of the last dose may be displayed on display 114B. In some cases, if the time since the last dose is less than a threshold (e.g., less than 12 hours), a warning may be displayed and / or the pen cap may refuse to provide the recommended dose. Display screen 114C shows the recommended dose.

[0163] In the pen cap 122, display 124A may be a standard display when the pen cap is not in use. As described above, display 124 may be a bistable display capable of holding an image without having an excessive power supply. Display 124A may include an insulin type label so that the user can immediately know the insulin type by looking at the pen cap 122. When a button is pressed or the cap 122 is removed, the time of the last administration may be displayed on display 124B. When the EGV is obtained (e.g., via a scan of the CGM 130), display 124C may be displayed. As shown in the figure, display 124C includes a corrected dose obtained based on the EGV (and optionally trend data) using any preferred technique. In some cases, the corrected dose may only be displayed if the time since the last administration exceeds a predetermined number of hours and the pen cap 122 is still on the pen 120. In some cases, if the time since the last dose is less than a threshold (e.g., less than 1 hour, less than 30 minutes), a warning may be displayed and / or the pen cap may refuse to dispense the recommended dose. Display screen 124D shows the meal dose recommendation. Display screen 124E shows the meal + corrected dose. In some cases, display 124 can be used to sequentially cycle through display screens 124C to 124E by pressing buttons in succession.

[0164] The embodiments described herein may include the use of a dedicated computer or a general-purpose computer, such as various computer hardware or software modules, as will be discussed in more detail below.

[0165] Embodiments described herein may be carried out using computer-readable media for holding or having computer-executable instructions or stored data structures. Such computer-readable media may be any available media accessible by a general-purpose computer or a dedicated computer. Dedicated computers are intended to be interpreted broadly and include embedded systems, microcontrollers, application-specific integrated circuits, digital signal processors, and general-purpose computers programmed for a particular purpose. A segment (e.g., a code segment or a data segment) may refer to a portion of memory, virtual memory, or an object file (e.g., an address).

[0166] Examples of such computer-readable media include, but are not limited to, 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 disc storage devices, magnetic disc storage devices or other magnetic storage devices, flash memory devices (e.g., solid-state memory devices), or any other storage medium that can be used to hold or store desired program code in the form of computer-executable instructions or data structures and can be accessed by a general-purpose computer or a dedicated computer. The above combinations may be included within the scope of computer-readable media.

[0167] Computer executable instructions include, for example, instructions and data that cause a general-purpose computer, a dedicated computer, or a dedicated processing unit (e.g., one or more processors) to perform a specific function or a set of functions. While the subject matter has been described in language specific to structural features and / or methodological effects, it should be understood that the subject matter defined in the attached "Claims" is not necessarily limited to the specific features or effects described above. Rather, the specific features and effects described above are disclosed as exemplary forms of implementing the "Claims."

[0168] Any scope expressed herein (including the “Claims”) is intended to be interpreted as broadly as possible. For example, unless expressly stated otherwise, scope includes its endpoints (e.g., the scope “between X and Y” includes X and Y). In addition, scopes described using the terms “approximately” or “about” should be understood to have the broadest meaning consistent with the understanding of those skilled in the art. Furthermore, the terms “approximately” or “substantially” include anything within 10% or 5%, or within the tolerances of manufacture or typical tolerances.

[0169] The features of the various embodiments described herein are not mutually exclusive, and various combinations or permutations may exist without departing from the scope of this disclosure, even if they are not explicitly described herein. Indeed, variations, modifications, and other embodiments of those described herein will be conceivable to those skilled in the art without departing from the scope of this disclosure. Accordingly, the present invention should not be defined solely by the above exemplary description, but solely by the following claims and their legal equivalents.

[0170] Further, non-limiting embodiments of this disclosure generally relate to caps for insulin injection pens, as well as related methods and systems.

[0171] Embodiment 1: A pen cap for a manual insulin delivery device, comprising: a wireless communication interface configured to receive blood glucose data from a glucose sensor system; at least one detection circuit configured to detect one or more cap attachments and one or more cap removals of the pen cap from the manual insulin delivery device; at least one user interface configured to present one or more of the following: treatment-related information, treatment recommendations, and timing information related to the detected cap attachment or detected cap removal of the pen cap; a processor and memory, wherein the memory comprises a data segment configured to store at least one of the following: at least one user-specific dosage parameter and one or more recommended dosages; and a code segment configured to store instructions adapted so that, during execution by the processor, the processor can identify content that can be presented by at least one user interface in response to the timing information related to the detected cap attachment or detected cap removal of the pen cap.

[0172] Embodiment 2: The pen cap according to Embodiment 1, wherein the user interface is configured to present a recommended corrected insulin dose in response to a determination that the replacement cap has been attached to a manual insulin delivery device for at least a threshold period, and the recommended corrected insulin dose is based on an insulin sensitivity factor and a target glucose value stored in a memory data segment.

[0173] Embodiment 3: The pen cap according to any one of Embodiments 1 to 2, wherein the wireless communication interface is configured to communicate with the glucose sensor system via a short-range wireless communication protocol when in close proximity to at least a portion of the glucose sensor system.

[0174] Embodiment 4: A pen cap according to any one of Embodiments 1 to 3, wherein the wireless communication interface is configured to transmit messages related to insulin therapy.

[0175] Embodiment 5: A pen cap according to any one of Embodiments 1 to 4, wherein the message includes an indicator, and the indicator relates to insulin therapy.

[0176] Embodiment 6: A pen cap according to any one of Embodiments 1 to 5, wherein the message is configured to be received by one or more insulin therapy applications running on one or more mobile computing devices.

[0177] Embodiment 7: A pen cap according to any one of Embodiments 1 to 6, wherein the wireless communication interface is configured to transmit a message by broadcasting an advertising message.

[0178] Embodiment 8: A pen cap according to any one of Embodiments 1 to 7, wherein the wireless communication interface is configured to transmit a message using data transmission.

[0179] Embodiment 9: The pen cap according to any one of Embodiments 1 to 8, wherein the wireless communication interface is configured to automatically transmit data to an insulin therapy application running on a mobile device.

[0180] Embodiment 10: A pen cap according to any one of Embodiments 1 to 9, wherein the wireless communication interface is configured to communicate automatically with a mobile application.

[0181] Embodiment 11: A pen cap according to any one of Embodiments 1 to 10, wherein the wireless communication interface is adapted to communicate with a glucose sensor system using a first wireless communication technology having a first communication range, and the wireless communication interface is adapted to communicate with a mobile computing device using a second wireless communication technology having a second communication range, the second communication range being greater than the first communication range.

[0182] Embodiment 12: A pen cap according to any one of Embodiments 1 to 11, wherein the glucose sensor system comprises a flash glucose monitor.

[0183] Embodiment 13: A pen cap according to any one of Embodiments 1 to 12, wherein the content includes the presentation of the percentage of active insulin remaining in the user based on the time of previous cap attachment and cap removal of the replacement pen cap and the current time.

[0184] Embodiment 14: A pen cap according to any one of Embodiments 1 to 13, wherein the code segment is configured to store instructions adapted so that, during execution by the processor, the processor can identify the amount of insulin remaining in the manual insulin delivery device and the dosage at a previous capping or cap removal time, and at least one user interface is configured to display the current time and an estimate of the amount of active insulin remaining in the user in response to one or more administration events.

[0185] Embodiment 15: A pen cap according to any one of Embodiments 1 to 14, wherein the memory segment is configured to store administration events over a first period, the period comprising a separate time unit of a first block, a start time unit of the separate time unit of the first block, and an end time of the separate time unit of the first block, the end time corresponding to the current time, and at least one of the separate time units relating to one of the administration events.

[0186] Embodiment 16: The pen cap according to any one of Embodiments 1 to 15, wherein the code segment is configured to store instructions adapted so that, during execution by the processor, the processor records an administration event in response to detected cap attachment and / or detected cap removal, and so that the administration event can be associated with one or more distinct time units of distinct time units.

[0187] Embodiment 17: A pen cap according to any one of Embodiments 1 to 16, wherein the code segment is configured, during execution by the processor, to store instructions that, in response to the active insulin estimation request and the current time, the processor selects a separate block of time units that form a first period, selects one or more administration events associated with the first period, and identifies an estimate of the amount of active insulin remaining in the user in response to the current time and the one or more administration events.

[0188] Embodiment 18: A pen cap according to any one of Embodiments 1 to 17, wherein at least one user interface is configured to display an estimate of the remaining active insulin as a percentage of the dose associated with the most recent administration action.

[0189] Embodiment 19: A pen cap according to any one of Embodiments 1 to 18, further comprising an inner sleeve and an outer housing, wherein the inner sleeve and outer housing define a watertight cavity.

[0190] Embodiment 20: A pen cap according to any one of Embodiments 1 to 19, wherein at least a portion of one or more of the at least one detection circuit, processor, memory, and wireless communication interface is held within a watertight cavity.

[0191] Embodiment 21: A pen cap according to any one of Embodiments 1 to 20, further comprising an adapter configured to be reversibly connected to a corresponding adapter in a manual insulin delivery device.

[0192] Embodiment 22: An insulin delivery system comprising an insulin injection pen for delivering insulin and a pen cap adapted to be reversibly fixed to the insulin injection pen, wherein the pen cap comprises a wireless communication interface adapted to receive blood glucose data from a glucose sensor system, at least one circuit adapted to detect whether the pen cap is fixed to the insulin injection pen, at least one user interface for communicating treatment-related information, treatment recommendations, or previous cap attachment or cap removal times of the pen cap from the insulin injection pen, a memory for storing at least one user-specific dosage parameter or recommended dosage, and at least one processor adapted to identify content presented by the user interface, the processor identifying the content using information regarding one or more cap attachments or cap removals, the insulin delivery system.

[0193] Embodiment 23: The insulin delivery system according to Embodiment 22, wherein the user interface is adapted to display a recommended corrected insulin dose based on an insulin sensitivity factor and a target glucose value stored in memory, when the pen cap has been capped onto the insulin injection pen for at least a threshold period.

[0194] Embodiment 24: An insulin delivery system according to any one of Embodiments 1 to 23, wherein the content includes the presentation of the percentage of active insulin remaining in the user, based on the time of previous cap attachment and cap removal of the pen cap and the current time.

[0195] Embodiment 25: The insulin delivery system according to any one of Embodiments 1 to 24, wherein the replacement pen cap is fitted to identify the amount of insulin remaining in the insulin injection pen and to identify the dose at the time of previous cap attachment or cap removal, and the pen cap displays an estimate of the amount of active insulin remaining in the user based on the current time, as well as the time and dose associated with one or more previous cap attachments or cap removals of the pen cap.

[0196] Embodiment 26: Diabetes management system comprising: a mobile computing device configured to receive one or more user-specific dosage parameters or predetermined dosages from a user; a glucose sensor system configured to collect and wirelessly transmit blood glucose data; and a pen cap adapted to be reversibly attached to an insulin injection pen, wherein the pen cap comprises: a wireless communication interface adapted to receive blood glucose data from the glucose sensor system and one or more user-specific dosage parameters or predetermined dosages from the mobile computing device; at least one circuit adapted to detect whether the pen cap is attached to the insulin injection pen; at least one user interface for communicating treatment-related information, treatment recommendations, or previous cap attachment or cap removal times of the pen cap from the insulin injection pen; a memory for storing at least one user-specific dosage parameter or recommended dosage received from the mobile computing system; and at least one processor adapted to identify content presented by the user interface, the processor identifying content using information about one or more cap attachments or cap removals.

[0197] Embodiment 27: The diabetes management system according to Embodiment 26, further comprising an insulin injection pen adapted to be reversibly fixed to a pen cap.

[0198] Embodiment 28: The diabetes management system according to any one of Embodiments 1 to 27, wherein the user interface is adapted to display a recommended corrected insulin dose based on an insulin sensitivity factor and a target glucose value stored in memory when a replacement pen cap has been capped onto the insulin injection pen for at least a threshold period.

[0199] Embodiment 29: A diabetes management system according to any one of Embodiments 1 to 28, further comprising a long-acting insulin pen, a rapid-acting insulin pen, and at least two pen caps, wherein at least two of the pen caps include a first pen cap adapted to be fixed to the long-acting insulin pen and a second pen cap adapted to be fixed to the rapid-acting insulin pen.

[0200] Embodiment 30: The diabetes management system according to any one of Embodiments 1 to 29, wherein the wireless communication interface is configured to communicate with the glucose sensor system via a short-range wireless communication protocol when the pen cap is in close proximity to at least a portion of the glucose sensor system.

[0201] Embodiment 31: The diabetes management system according to any one of Embodiments 1 to 30, wherein the wireless communication interface is adapted to communicate with a glucose sensor system using a first wireless communication technology having a first communication range, and the wireless communication interface is adapted to communicate with a mobile computing device using a second wireless communication technology having a second communication range, the second communication range being greater than the first communication range.

[0202] Embodiment 32: The diabetes management system according to any one of Embodiments 1 to 31, wherein the glucose sensor system comprises a flash glucose monitor.

[0203] Embodiment 33: A smart electronics module that can be integrated with a manual insulin delivery device, comprising: a wireless communication interface configured to receive blood glucose data from a glucose sensor system; at least one detection circuit configured to detect one or more cap attachments and one or more cap removals of a pen cap from the manual insulin delivery device; at least one user interface configured to present one or more of the following: treatment-related information, treatment recommendations, and timing information related to the detected cap attachment or detected cap removal of the pen cap; a processor and memory, wherein the memory comprises a data segment configured to store at least one of the following: at least one user-specific dosage parameter and one or more recommended dosages; and a code segment adapted so that, during execution by the processor, the processor can identify content that can be presented by the at least one user interface in response to the timing information related to the detected cap attachment or detected cap removal of the pen cap.

[0204] Embodiment 33: A system, method, or apparatus according to any one of Embodiments 1 to 32, wherein the blood glucose data is either the interstitial fluid glucose concentration or is based on the interstitial fluid glucose concentration.

[0205] Embodiment 34: The system, method, or apparatus according to any one of Embodiments 1 to 33, wherein the blood glucose data is a blood glucose value correlated with the interstitial fluid glucose concentration.

[0206] Embodiment 35: The system, method, or apparatus according to any one of Embodiments 1 to 34, wherein the blood glucose data is a blood glucose level.

[0207] Additional, non-limiting embodiments of this disclosure generally relate to treatment management systems, methods, and apparatus.

[0208] Embodiment 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 detect administration events related to administration operations in the manual drug delivery device and to store a record for each of one or more administration events, the record including the administration time of the administration event; a recommendation system configured to provide one or more drug dosage recommendations in response to one or more of the analyte measurement data and administration events; and an adapter configured to be reversibly connected to a predetermined part of the manual drug delivery device.

[0209] Embodiment 2: The reusable accessory according to claim 1, wherein the manual drug delivery device is a drug injection pen, the reusable accessory is a reusable pen cap for the drug injection pen, the administration event associated with one or more administration operations is one or more of a cap attachment event or a cap removal event, and the detection circuit is configured to detect a cap attachment event or a cap removal event in response to a sensor signal.

[0210] Embodiment 3: A reusable accessory according to any one of Embodiments 1 to 2, further comprising a timer configured to count the number of time units from a cap removal event to a subsequent cap attachment event, wherein the circuit is configured to record the administration time in response to a specific count exceeding a threshold number of time units.

[0211] Embodiment 4: A reusable accessory according to any one of Embodiments 1 to 3, wherein the wireless communication interface is configured to receive analyte measurement data via a first wireless connection when the wireless communication interface is positioned in close proximity to at least a portion of the analyte sensor system.

[0212] Embodiment 5: A reusable accessory according to any one of Embodiments 1 to 4, wherein the wireless communication interface is configured to communicate administration events, therapeutic parameters, and analyte measurement data with a mobile computing device via a second wireless connection.

[0213] Embodiment 6: A reusable accessory according to any one of Embodiments 1 to 5, wherein the wireless communication interface is configured to receive therapeutic parameters from a mobile computing device.

[0214] Embodiment 7: A reusable accessory according to any one of Embodiments 1 to 6, wherein the first wireless connection has a first communication range, and the second wireless connection has a second communication range, the second communication range being greater than the first communication range.

[0215] Embodiment 8: A reusable accessory according to any one of Embodiments 1 to 7, wherein the wireless communication interface includes an NFC chip, and the first wireless connection consists of NFC communication between the reusable accessory and the analyte sensor system.

[0216] Embodiment 9: A reusable accessory according to any one of Embodiments 1 to 8, wherein the wireless communication interface comprises a wireless communication device adapted to enable Bluetooth Low Energy communication between the reusable accessory and one or more mobile computing devices.

[0217] Embodiment 10: The analyte detection system is a reusable accessory according to any one of Embodiments 1 to 9, comprising a blood glucose meter adapted to provide blood glucose data.

[0218] Embodiment 11: The analyte sensor system is a flash glucose monitor adapted to provide glucose data via short-range wireless communication, a reusable accessory according to any one of Embodiments 1 to 10.

[0219] Embodiment 12: The analyte sensor system is a reusable accessory according to any one of Embodiments 1 to 11, which is a continuous glucose monitor adapted to provide blood data via wireless communication (e.g., Bluetooth Low Energy) and optionally near-field communication (NFC).

[0220] Embodiment 13: The reusable accessory according to any one of Embodiments 1 to 12, further comprising at least one button for enabling and disabling operating modes of the reusable accessory, such as triggering the reception of analyte measurement data, changing the display, stopping or snoozing a warning, or a combination thereof.

[0221] Embodiment 14: Diabetes management system comprising: a glucose sensor system adapted to wirelessly transmit blood glucose data; an insulin dosage monitor adapted to be reversibly connectable to an insulin delivery device, the insulin dosage monitor comprising a display, memory, and a processor, the memory storing insulin therapeutic dosage parameters; the insulin dosage monitor adapted to detect insulin delivery from the insulin delivery device; the insulin dosage monitor adapted to wirelessly receive blood glucose data from the glucose sensor system; and a mobile computing device including the processor, the mobile computing device configured to intermittently connect to and receive at least one characteristic relating to the insulin monitor, blood glucose data, or a combination thereof via wireless communication.

[0222] Embodiment 15: The system according to Embodiment 14, wherein the insulin dosage monitoring device comprises a pen cap, the insulin delivery device is an insulin injection pen, and the pen cap is adapted to detect insulin delivery from the insulin injection pen by detecting a cap-on event of the pen cap, which can be inferred to be an administration event.

[0223] Embodiment 16: The system according to any one of Embodiments 1 to 15, wherein the insulin dose monitoring device comprises a pen cap, and the insulin delivery device is an insulin injection pen, the pen cap being adapted to detect the amount of insulin remaining in the insulin injection pen after each administration and to optionally determine the timing and dose.

[0224] Embodiment 17: The insulin dosage monitoring device is a system according to any one of Embodiments 1 to 16, comprising an accessory capable of detecting the operation of a plunger or associated mechanical element operating during insulin injection from an insulin injection pen.

[0225] Embodiment 18: The system according to any one of Embodiments 1 to 17, wherein the mobile computing device is configured to receive data relating to at least one characteristic over a selected period of time, including from historical data values ​​to substantially current values.

[0226] Embodiment 19: A method for managing drug therapy by a manual drug delivery device, comprising: receiving analyte measurement data from an analyte sensor system; detecting an administration action event in an accessory configured to be reversibly attached to a manual drug delivery device; storing a record for each of one or more administration action events, the record including the time of administration of the administration action; and providing one or more drug dosage recommendations in response to the analyte measurement data.

[0227] Embodiment 20: The method according to Embodiment 19, further comprising receiving analyte measurement data via a first wireless connection in response to a wireless communication interface located in close proximity to at least a portion of the analyte sensor system.

[0228] Embodiment 21: The method according to any one of Embodiments 1 to 20, further comprising communicating administration events, therapeutic parameters, and analyte measurement data to a mobile computing device via a second wireless connection.

[0229] Embodiment 22: The method according to any one of Embodiments 1 to 21, further comprising receiving therapeutic parameters from a mobile computing device via a second wireless connection.

[0230] Embodiment 23: The method according to any one of Embodiments 1 to 22, wherein the manual drug delivery device is a drug injection pen, the reusable accessory is a reusable pen cap for the drug injection pen, the administration operation events associated with one or more administration operations are one or more of a cap attachment event and a cap removal event, and the detection circuit is configured to detect a cap attachment event and a cap removal event in response to a sensor signal.

[0231] Embodiment 24: A smart electronics module that can be integrated with 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 detect administration operation events, store a record including the administration time of each administration operation, and receive analyte measurement data received from an analyte sensor system; a recommendation system configured to provide one or more drug dosage recommendations in response to the analyte measurement data; and an adapter configured to be reversibly connected to a predetermined part of the manual drug delivery device.

[0232] Embodiment 25: A system, method, or apparatus according to any one of Embodiments 1 to 24, wherein blood glucose data and / or glucose data are interstitial fluid glucose concentrations, or are based on interstitial fluid glucose concentrations.

[0233] Embodiment 26: The system, method, or apparatus according to any one of Embodiments 1 to 25, wherein the blood glucose data and / or glucose data are blood glucose values ​​correlated with interstitial fluid glucose concentration.

[0234] Embodiment 27: The system, method, or apparatus according to any one of Embodiments 1 to 26, wherein blood glucose data and / or glucose data are blood glucose levels.

[0235] Further, non-limiting embodiments of this disclosure generally relate to user interfaces for diabetes management systems, including flash glucose monitors.

[0236] Embodiment 1: A diabetes management system comprising a flash glucose monitor adapted to be fixed to a person with diabetes (PWD), the flash glucose monitor comprising: a sensing part adapted to detect blood glucose data at regular time intervals, the regular time interval being 15 minutes or less; and a wireless communication interface adapted to transmit blood glucose data when the wireless communication interface is activated by a user, the blood glucose data transmitted with each wireless communication transmission includes blood glucose data collected over a data transmission window of at least 1 hour; and a user interface device adapted to receive blood glucose data transmitted at irregular intervals that are at least partially controlled by user actions. A diabetes management system comprising: a user interface device having a face; a display having a touchscreen; a processor and memory, wherein the processor executes instructions in memory and is adapted to display a glucose presentation having a time along the bottom of a graph display and a curve of glucose values ​​for each reception time, the current time being presented on the graph display and indicating whether there is a gap between the most recent glucose value and the current time; and adjacent to the graph display, a single numerical value representing a single blood glucose measurement, wherein the single numerical value is the most recent glucose value when the user is not touching the screen; and the processor and memory is configured to change the single numerical value to a previous glucose value when the user touches the portion of the screen corresponding to a previous time on the graph display.

[0237] Embodiment 2: The diabetes management system according to Embodiment 1, wherein the graph display includes point indicators positioned along a time axis, where a single numerical value corresponds to the time at which it was detected.

[0238] Embodiment 3: The diabetes management system according to any one of Embodiments 1 to 2, wherein the display is configured to allow the user to change the position of a point indicator by pressing a portion of the screen corresponding to a position along the time axis at a time prior to the most recent glucose value.

[0239] Embodiment 4: The diabetes management system according to any one of Embodiments 1 to 3, wherein the portion of the screen corresponding to a position along the time axis is part of the screen indicating the time axis.

[0240] Embodiment 5: The diabetes management system according to any one of Embodiments 1 to 4, wherein the portion of the screen corresponding to a position along the time axis is part of the screen showing a curve of glucose values.

[0241] Embodiment 6: A diabetes management system according to any one of Embodiments 1 to 5, wherein the point indicator needs to be pressed and slid along the graph display in order to move the point indicator.

[0242] Embodiment 7: A diabetes management system according to any one of Embodiments 1 to 6, wherein the point indicator returns along the glucose value curve after the user stops pressing on a portion of the graph display.

[0243] Embodiment 8: The diabetes management system according to any one of Embodiments 1 to 7, wherein the display further shows a trend arrow adjacent to a single number indicating the rate of change of glucose value at a given time.

[0244] Embodiment 9: The diabetes management system according to any one of Embodiments 1 to 8, further comprising a reusable accessory adapted to be reversibly attached to an insulin injection pen, the reusable accessory having a wireless communication interface adapted to be used by the user to query a flash glucose monitor and receive blood glucose data.

[0245] Embodiment 10: The diabetes management system according to any one of Embodiments 1 to 9, wherein the accessory wireless communication interface is adapted to automatically transmit blood glucose data to a user interface device.

[0246] Embodiment 11: The diabetes management system according to any one of Embodiments 1 to 10, wherein a reusable accessory is adapted to detect events related to the administration of insulin from an insulin injection pen.

[0247] Embodiment 12: The diabetes management system according to any one of Embodiments 1 to 11, further comprising displaying an injection indicator along the time axis of a graph display for each detected event.

[0248] Embodiment 13: The diabetes management system according to any one of Embodiments 1 to 12, wherein the infusion indicator displays the amount of insulin administered.

[0249] Embodiment 14: A diabetes management system according to any one of Embodiments 1 to 13, wherein the infusion indicator displays the type of insulin administered.

[0250] Embodiment 15: A diabetes management system according to any one of Embodiments 1 to 14, further comprising a second reusable attachment adapted to be reversibly fixed to a second insulin injection pen, the second insulin injection pen holding a second type of insulin, and a graph display including different infusion indicators along the time axis for each reusable attachment.

[0251] Embodiment 16: The diabetes management system according to any one of Embodiments 1 to 15, wherein the reusable accessory is a replacement pen cap, and the events related to the administration of insulin from the insulin injection pen are the attachment of the replacement pen cap or the removal of the cap from the insulin injection pen.

[0252] Embodiment 17: A diabetes management system according to any one of Embodiments 1 to 16, wherein the reusable accessory comprises an accessory display, the accessory display showing the most recent glucose value received from a flash glucose monitor.

[0253] Embodiment 18: The diabetes management system according to any one of Embodiments 1 to 17, wherein the user interface device is adapted to receive insulin treatment settings and to wirelessly transmit the insulin treatment settings to a reusable accessory, and the accessory display is adapted to provide a recommended insulin dose based on the received insulin treatment settings and the most recent glucose value.

[0254] Embodiment 19: A diabetes management system according to any one of Embodiments 1 to 18, further comprising a blood glucose meter that wirelessly communicates with one or more components of the system, and a graph display also including a BGM indicator that represents blood glucose measurements from the blood glucose meter.

[0255] Embodiment 20: The diabetes management system according to any one of Embodiments 1 to 19, wherein a single numerical value representing a single blood glucose measurement is adapted to represent a blood glucose measurement or blood glucose level from a blood glucose meter, or a glucose level from a flash glucose monitor.

[0256] Embodiment 21: A system, method, or apparatus according to any one of Embodiments 1 to 20, wherein blood glucose data and / or glucose values ​​are interstitial fluid glucose concentrations, or are based on interstitial fluid glucose concentrations.

[0257] Embodiment 22: The system, method, or apparatus according to any one of Embodiments 1 to 21, wherein the blood glucose data and / or glucose value is a blood glucose value correlated with the interstitial fluid glucose concentration.

[0258] Embodiment 23: The system, method, or apparatus according to any one of Embodiments 1 to 22, wherein blood glucose data and / or glucose values ​​are blood glucose values.

[0259] Additional non-limiting embodiments of the present disclosure generally relate to devices, systems, and methods for estimating an active agent from an injection.

[0260] Embodiment 1: A reusable accessory for a drug injection pen, the reusable accessory being adapted to be reversibly attached to the drug injection pen, the reusable accessory detecting events associated with the injection of the drug from the drug injection pen and configured to identify the percentage of the drug remaining active for the injection of the drug based on the current time and the time of the event associated with the injection.

[0261] Embodiment 2: The reusable accessory is a replacement pen cap fixed to the drug injection pen and thus adapted such that when the replacement pen cap is fixed to the drug injection pen, the drug cannot be injected into the user, wherein the event associated with the injection of the drug is a cap attachment event or a cap removal event detected in response to the attachment or removal of the replacement pen cap on the drug injection pen.

[0262] Embodiment 3: The reusable accessory includes a display, the display indicating, as a percentage, a visual indicator of the amount of the remaining active drug.

[0263] Embodiment 4: The reusable accessory is adapted to identify a dosage for each detected event associated with the injection of the drug, and the reusable accessory identifies the amount of the drug remaining active for multiple injections of the drug based on the current time and the time of each of the multiple injections.

[0264] Embodiment 5: The reusable accessory does not detect or identify a dosage for each detected event associated with the injection of the drug.

[0265] Embodiment 6: The drug injection pen is an insulin injection pen, a reusable accessory as described in any one of Embodiments 1 to 5.

[0266] Embodiment 7: The reusable accessory according to any one of Embodiments 1 to 6, wherein the reusable accessory comprises a processor and memory, the memory storing one or more user-specific dosage parameters, and the processor is adapted to identify a recommended dosage of the drug based at least in part on the user-specific dosage parameters and a calculated value of the active drug for one or more previous drug infusions.

[0267] Embodiment 8: A reusable accessory according to any one of Embodiments 1 to 7, comprising a wireless communication interface adapted for transmitting or receiving wireless communication.

[0268] Embodiment 9: The reusable accessory according to any one of Embodiments 1 to 8, wherein the reusable accessory is adapted to receive analyte measurement data from an analyte sensor system via a wireless communication interface, and the reusable accessory is adapted to identify a recommended dosage of a drug based at least in part on the received analyte measurement data.

[0269] Embodiment 10: The reusable accessory according to any one of Embodiments 1 to 9, which is adapted to transmit data relating to each drug infusion event to a mobile computing device via wireless communication.

[0270] Embodiment 11: The reusable accessory according to any one of Embodiments 1 to 10, wherein the reusable accessory is adapted to receive user-specific dosage parameters from a mobile computing device via wireless communication.

[0271] Embodiment 12: A reusable accessory according to any one of Embodiments 1 to 11, wherein the wireless communication interface is configured to receive analyte measurement data from an analyte sensor system.

[0272] Embodiment 13: The reusable accessory according to any one of Embodiments 1 to 12, comprising a recommendation system configured to provide one or more drug dosage recommendations in response to analyte measurement data.

[0273] Embodiment 14: The reusable accessory according to any one of Embodiments 1 to 13, wherein the wireless communication interface comprises a first wireless connection having a first communication range and a second wireless connection having a second communication range, the first wireless connection being between the reusable accessory and the analyte sensor system, and the second wireless connection being between the reusable accessory and a mobile application on a remote computing device, the second communication range being greater than the first communication range.

[0274] Embodiment 15: A reusable accessory according to any one of Embodiments 1 to 14, wherein the wireless communication interface includes an NFC chip, and the first wireless connection consists of NFC communication between the reusable accessory and the analyte sensor system.

[0275] Embodiment 16: A reusable accessory according to any one of Embodiments 1 to 15, wherein the wireless communication interface comprises a wireless communication device adapted to enable Bluetooth Low Energy communication between the reusable accessory and one or more mobile computing devices.

[0276] Embodiment 17: The analyte sensor system is a flash glucose monitor adapted to provide glucose data via short-range wireless communication, a reusable accessory according to any one of Embodiments 1 to 16.

[0277] Embodiment 18: Diabetes treatment management system comprising: a mobile computing device adapted to receive one or more user-specific dosage parameters or predetermined dosages from a user; a glucose sensor system adapted to collect and wirelessly transmit blood glucose data; and a reusable accessory adapted to be reversibly attached to an insulin injection pen, wherein the reusable accessory comprises: a wireless communication interface adapted to receive blood glucose data from the glucose sensor system and one or more user-specific dosage parameters or predetermined dosages from the mobile computing device; an infusion detection mechanism adapted to detect events related to insulin infusion; a processor that identifies the percentage of insulin that remains active with each insulin infusion; and a display adapted to display the amount of active insulin remaining in the user as the percentage of the last insulin injection.

[0278] Embodiment 19: The system according to Embodiment 18, wherein a reusable accessory detects or identifies the insulin dose for each event related to insulin infusion, and the display shows the amount of active insulin remaining in the user as units of insulin, and optionally includes multiple insulin doses at different times.

[0279] Embodiment 20: The system according to any one of Embodiments 1 to 19, wherein the reusable accessory does not detect or specify the insulin dose for each event related to insulin infusion.

[0280] Embodiment 21: A method for managing diabetes treatment, comprising: detecting an event related to the injection of a drug from a drug injector in response to the attachment or removal of a reusable accessory to a drug injector pen; and identifying a percentage of the drug that remains active for drug injection based on the current time and the time of the injection-related event, wherein the event is related to the attachment or removal of a reusable accessory to a drug injector pen.

[0281] Embodiment 22: A smart electronics module that can be integrated with an injection pen, wherein the reusable accessory is adapted to be reversibly attached to a drug injection pen, and the reusable accessory is configured to detect events related to the injection of a drug from the drug injection pen and to identify the proportion of the drug that remains active for the injection of the drug based on the current time and the time of the event related to the injection.

[0282] Embodiment 23: The system, method, or apparatus according to any one of Embodiments 1 to 22, wherein the blood glucose data and / or glucose data is an interstitial fluid glucose concentration or is based on an interstitial fluid glucose concentration.

[0283] Embodiment 24: The system, method, or apparatus according to any one of Embodiments 1 to 23, wherein the blood glucose data and / or glucose data is a blood glucose value that correlates with an interstitial fluid glucose concentration.

[0284] Embodiment 25: The system, method, or apparatus according to any one of Embodiments 1 to 24, wherein the blood glucose data and / or glucose data is a blood glucose value.

[0285] Additional non-limiting embodiments of the present disclosure generally relate to insulin infusion assistance systems, methods, and apparatuses.

[0286] Embodiment 1: A system for assisting manual insulin administration, the system comprising: at least a first glucose sensor system adapted to wirelessly transmit glucose data; at least a first reusable insulin dose detector configured to detect first insulin delivery events associated with the first insulin manual delivery assembly, reversibly connectable to at least a first disposable component having a chamber for a first insulin type and adapted to form at least a portion of a first insulin manual delivery assembly; a mobile application; and a remote computing device from the first reusable insulin dose detector, the system comprising: a mobile application configured to receive insulin treatment settings, including a first insulin type setting, while running on the computer device; identify first timing data corresponding to the time of one or more of the first insulin delivery events; analyze glucose data in combination with the first timing data; and determine adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis.

[0287] Embodiment 2: The system according to Embodiment 1, further comprising a remote server adapted to receive glucose data and first timing data via an Internet connection between a mobile computing device and the remote server.

[0288] Embodiment 3: The system according to any one of Embodiments 1 to 2, wherein the remote server is configured to analyze first timing data and glucose data and to determine adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis.

[0289] Embodiment 4: The system according to any one of Embodiments 1 to 3, wherein the mobile application is configured to analyze first timing data and glucose data and to determine adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis.

[0290] Embodiment 5: The system according to any one of Embodiments 1 to 4, wherein the first reusable insulin dose detector is the first reusable accessory, the first disposable component is the first insulin injection pen or the first insulin inhaler, the first insulin delivery event is related to insulin infusion or insulin inhalation, and the first reusable accessory is adapted to be reversibly connected to the first insulin injection pen or the first insulin inhaler.

[0291] Embodiment 6: The system according to any one of Embodiments 1 to 5, wherein the first reusable accessory is a first replacement cap adapted to be positioned over the needle of a first insulin injection pen or over the inhalation path of a first insulin inhaler, and the first replacement cap is configured to detect a cap attachment event and / or a cap removal event.

[0292] Embodiment 7: The system according to any one of Embodiments 1 to 6, wherein the first reusable accessory is configured to detect a first insulin delivery event in response to one or more capping and / or capping events.

[0293] Embodiment 8: The system according to any one of Embodiments 1 to 7, wherein the first reusable insulin dosage detector is a first reusable smart pen or a first smart inhaler, the first disposable component comprises a first insulin cartridge, and the first reusable smart pen or first smart inhaler is configured to receive the first insulin infusion cartridge and to be activated by the user to deliver a first insulin type from the first insulin cartridge.

[0294] Embodiment 9: The system according to any one of Embodiments 1 to 8, further comprising at least a second reusable insulin dose detector, which is reversibly connectable to a second disposable component having a chamber for a second insulin type and adapted to form at least a portion of a second insulin manual delivery assembly, wherein the second reusable accessory comprises a second wireless communication interface configured to wirelessly receive a second insulin type setting of an insulin delivery setting from a mobile application, the second reusable insulin dose detector is configured to detect a second insulin delivery event associated with the second insulin manual delivery assembly, and the recommendation system is configured to identify second timing data corresponding to the time of one or more second insulin delivery events of one or more second insulin delivery events, analyze glucose data in combination with first and second timing data, and determine an adjustment recommendation or an automatic change to an insulin delivery setting in response to the analysis.

[0295] Embodiment 10: The system according to any one of Embodiments 1 to 9, wherein a second reusable insulin dose detector is configured to wirelessly receive glucose data from the first glucose sensor system.

[0296] Embodiment 11: The system according to any one of embodiments 1 to 10, wherein while the first glucose sensor system is wirelessly communicating with the second reusable insulin dose detector, the system disables wireless communication of glucose data from the first glucose sensor system to the first reusable insulin dose detector.

[0297] Embodiment 12: The system according to any one of Embodiments 1 to 11, wherein the second reusable insulin dosage detector is selected from the group consisting of a second smart pen configured to receive a second disposable pen cartridge containing a second insulin type, a second smart inhaler configured to receive a second disposable inhalable insulin cartridge containing a second insulin type, and a second replacement pen cap adapted to be fixed onto the needle of the second disposable insulin injection pen containing a second insulin type, or a second replacement inhaler cap adapted to be fixed onto the inhalation path of the second insulin inhaler.

[0298] Embodiment 13: The system according to any one of Embodiments 1 to 12, wherein the first insulin type is selected from the group consisting of long-acting insulin, rapid-acting insulin, and combinations of long-acting insulin and rapid-acting insulin.

[0299] Embodiment 14: The system according to any one of Embodiments 1 to 13, wherein the first glucose sensor system is a blood glucose meter adapted for analyzing blood in vitro.

[0300] Embodiment 15: The system according to any one of Embodiments 1 to 14, wherein the recommendation system is adapted to analyze timing data and glucose data of one or more insulin delivery events and recommend the addition of a second glucose sensor system selected from the group consisting of a continuous glucose monitor and a flash glucose monitor.

[0301] Embodiment 16: The system according to any one of Embodiments 1 to 15, wherein the first glucose sensor system is a flash glucose monitor.

[0302] Embodiment 17: The system according to any one of Embodiments 1 to 16, wherein the first glucose sensor system is configured to communicate a limited glucose dataset to a mobile application via a first communication technology having a first communication range, and to communicate a reliable glucose dataset to a first or second reusable insulin dose detector via a second communication technology having a second communication range, the first communication range being greater than the second communication range.

[0303] Embodiment 18: The system according to any one of Embodiments 1 to 17, wherein the mobile application can directly receive glucose data from the first glucose sensor system via the first and second communication technologies.

[0304] Embodiment 19: The system according to any one of Embodiments 1 to 18, wherein the first reusable insulin dose detector comprises a display, the display configured to provide a recommended first insulin dose of a first insulin type based on a first insulin setting.

[0305] Embodiment 20: The system according to any one of Embodiments 1 to 19, wherein the first reusable insulin dosage detector or mobile application is configured to issue an alert if the detected dosage of a first insulin type does not conform to a first insulin setting.

[0306] Embodiment 21: The system according to any one of Embodiments 1 to 20, wherein the system is adapted to identify one or more insulin doses of a first insulin type associated with each detected first insulin delivery event.

[0307] Embodiment 22: A method for assisted manual insulin administration, comprising: receiving a first insulin delivery event associated with a first insulin manual delivery assembly, the first insulin manual delivery assembly comprising a first reusable insulin dose detector reversibly connected to a first disposable component and adapted to detect the first insulin delivery event; identifying first timing data corresponding to the time of one or more of the first insulin delivery events; analyzing glucose data in combination with the first timing data; and determining adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis.

[0308] Embodiment 23: The method according to Embodiment 22, further comprising receiving a first insulin delivery event via a communication interface configured to wirelessly communicate with a first reusable insulin dose detector.

[0309] Embodiment 24: The method according to any one of Embodiments 1 to 23, further comprising receiving a second insulin delivery event related to a second insulin manual delivery assembly, the second insulin manual delivery assembly comprising a second reusable insulin dose detector reversibly connected to a second disposable component and adapted to detect the second insulin delivery event, and determining a second adjustment recommendation or an automatic change of a second insulin treatment setting in response to the second insulin delivery event.

[0310] Embodiment 25: The method according to any one of Embodiments 1 to 24, further comprising receiving glucose data from a first reusable dose detector.

[0311] Embodiment 26: The system according to any one of Embodiments 1 to 25, further comprising receiving glucose data from a first glucose sensor system.

[0312] Embodiment 27: A system for remotely specifying a manual insulin dosage, the system comprising: receiving a first insulin delivery event associated with a first manual insulin delivery assembly, the insulin delivery event being received via a communication interface configured to communicate with a reusable insulin dosage detector; identifying first timing data corresponding to one or more first insulin delivery event times of one or more first insulin delivery events; analyzing glucose data in combination with the first timing data; determining adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis; and providing the adjustment recommendations or automatic changes to insulin treatment settings to the communication interface and transmitting them to the reusable insulin dosage detector.

[0313] Embodiment 28: An insulin manual administration support system, the system comprising a recommendation system having a mobile application running on a computing device, the mobile application configured to determine insulin delivery adjustment recommendations and changes to insulin treatment settings in response to glucose data associated with one or more insulin delivery events, the recommendation system further configured to detect a first reusable insulin dose detector, and in response to the detection, create an insulin manual delivery assembly profile associated with the insulin manual delivery assembly of the first reusable insulin dose detector, and to specify one or more insulin treatment settings in the insulin manual delivery assembly profile.

[0314] Embodiment 29: The system according to Embodiment 28, wherein the recommendation system is configured to load one or more insulin treatment settings from memory or create one or more insulin treatment settings in response to one or more physiological parameters related to the user of the recommendation system.

[0315] Embodiment 30: The recommendation system is configured to provide a user prompt on the display of a computing device, the user prompt including one approval for pairing with a first reusable insulin dosage detector, as described in any one of Embodiments 1 to 29.

[0316] Embodiment 31: The system according to any one of Embodiments 1 to 30, wherein the recommendation system is configured to transmit one or more of the following to a reusable insulin dosage detector: an insulin delivery adjustment recommendation and a change to the insulin treatment setting.

[0317] Embodiment 32: The system according to any one of Embodiments 1 to 31, wherein the recommendation system is further configured to receive an unpairing command with a second insulin dosage detector and, in response to the unpairing command, delete or disable a second insulin manual delivery assembly profile associated with the second insulin dosage detector.

[0318] Embodiment 33: The system according to any one of Embodiments 1 to 32, further configured to detect a second reusable insulin dose detector, and in response to the detection, create a second insulin manual delivery assembly profile associated with a second insulin manual delivery assembly of the second reusable insulin dose detector, and to specify one or more second insulin therapeutic settings to the second insulin manual delivery assembly profile.

[0319] Embodiment 34: The system according to any one of Embodiments 1 to 33, wherein the recommendation system is configured to transmit insulin delivery adjustment recommendations and changes in insulin treatment settings to first and second reusable insulin dosage detectors.

[0320] Embodiment 35: The system according to any one of Embodiments 1 to 34, wherein the recommendation system is configured to receive glucose data related to one or more insulin delivery events of first and second reusable insulin dose detectors.

[0321] Embodiment 36: The system according to any one of Embodiments 1 to 35, wherein the first reusable insulin dose detector and the second reusable insulin dose detector are each different from a reusable accessory, a smart insulin pen, and smart insulin.

[0322] Embodiment 37: A system for assisting manual insulin administration, comprising: at least a first glucose sensor system adapted to wirelessly transmit glucose data; smart electronics connected to one or more parts of a first manual insulin delivery assembly, the smart electronics operably connected to at least a first disposable component having a chamber for a first insulin type, forming at least a part of the first manual insulin delivery assembly, the first reusable insulin dose detector configured to detect a first insulin delivery event associated with the first manual insulin delivery assembly; a mobile application; and a remote computing device from the first reusable insulin dose detector, the mobile application configured, while running on the computer device, to receive insulin treatment settings including a first insulin type setting; to identify first timing data corresponding to one or more first insulin delivery event times for one or more first insulin delivery events; to analyze glucose data in combination with the first timing data; and to determine adjustment recommendations or automatic changes to insulin treatment settings in response to the analysis.

[0323] Embodiment 38: The system, method, or apparatus according to any one of Embodiments 1 to 37, wherein the glucose data is either the interstitial fluid glucose concentration or is based on the interstitial fluid glucose concentration.

[0324] Embodiment 39: The system, method, or apparatus according to any one of Embodiments 1 to 38, wherein the glucose data is a blood glucose level correlated with the interstitial fluid glucose concentration.

[0325] Embodiment 40: The system, method, or apparatus according to any one of Embodiments 1 to 39, wherein the glucose data is blood glucose level.

[0326] Further, non-limiting embodiments of this disclosure generally relate to pen caps for drug injection pens having a temperature sensor.

[0327] Embodiment 1: A replacement pen cap for a drug injection pen comprising at least one temperature sensor, wherein at least one temperature sensor is configured to monitor the temperature of the drug in the drug injection pen while the replacement pen cap is associated with the drug injection pen cap, the replacement pen cap is adapted to detect possible administration events, the replacement pen cap is adapted to receive analyte measurement data from an analyte sensor system, and the replacement pen cap is adapted to determine whether the drug in the drug injection pen has denatured based on a combination of data from at least one temperature sensor and analyte measurement data received following each of the detected possible administration events.

[0328] Embodiment 2: A replacement pen cap according to Embodiment 1, wherein at least one temperature sensor is configured to monitor a temperature range when the pen cap is associated with an insulin pen.

[0329] Embodiment 3: A replacement pen cap according to any one of Embodiments 1 to 2, wherein the pen cap is configured to provide the user with at least one of a warning or alert when a selected threshold temperature value is detected, the alert being presented as a visual indication when the threshold is exceeded, and an audible warning being triggered when the threshold is exceeded and the pen cap receives a glucose value indicating that one or more previous insulin doses were ineffective.

[0330] Embodiment 4: The pen cap according to any one of Embodiments 1 to 3, wherein the pen cap is configured to provide the user with data related to the temperature exposure of insulin.

[0331] Embodiment 5: A smart electronics module that can be integrated with a drug injection pen comprising at least one temperature sensor, wherein at least one temperature sensor is configured to monitor the temperature of the drug in the drug injection pen while the smart electronics module is active, the smart electronics module is configured to detect possible administration events, the smart electronics module is configured to receive analyte measurement data from an analyte sensor system, and the smart electronics module is configured to determine whether the drug in the drug injection pen has denatured based on a combination of data from at least one temperature sensor and analyte measurement data received following each of the detected possible administration events.

[0332] Embodiment 6: The system, method, or apparatus according to any one of Embodiments 1 to 5, wherein the glucose data is either the interstitial fluid glucose concentration or is based on the interstitial fluid glucose concentration.

[0333] Embodiment 7: The system, method, or apparatus according to any one of Embodiments 1 to 6, wherein the glucose data is a blood glucose level correlated with the interstitial fluid glucose concentration.

[0334] Embodiment 8: The system, method, or apparatus according to any one of Embodiments 1 to 7, wherein the glucose data is blood glucose level.

[0335] Further, non-limiting embodiments of this disclosure generally relate to user interfaces for diabetes management systems and devices.

[0336] Embodiment 1: A diabetes management system comprising a computing device including memory and a processor configured to receive at least one data point relating to a subject's previous insulin use and to calculate a slide-scale glucose-corrected dataset based at least in part on the at least one data point relating to the subject's previous insulin use.

[0337] Embodiment 2: The system according to Embodiment 1, further comprising an insulin pen assembly, wherein a computing device is configured to provide at least some data from slide-scale glucose correction data set in the insulin pen assembly, and the insulin pen assembly is configured to display at least some data as a recommended corrected insulin dose.

[0338] Embodiment 3: The insulin pen assembly comprises an insulin pen and a reusable accessory for a disposable insulin pen, as described in any one of Embodiments 1 to 2.

[0339] Embodiment 4: The system according to any one of Embodiments 1 to 3, wherein the reusable accessory is a replacement pen cap for a disposable insulin pen.

[0340] Embodiment 5: The system according to any one of Embodiments 1 to 4, wherein the insulin pen assembly is a reusable insulin injection pen adapted to receive a pre-filled insulin cartridge for administering insulin.

[0341] Embodiment 6: The system according to any one of Embodiments 1 to 5, wherein the insulin pen assembly is adapted to receive blood glucose data from a glucose sensor system, and the recommended corrected insulin dose is based on the received blood glucose data and a slide-scale glucose corrected dataset.

[0342] Embodiment 7: The system according to any one of Embodiments 1 to 6, wherein the slide-scale glucose-corrected dataset is a linear scale based on at least one data point containing an insulin sensitivity factor.

[0343] Embodiment 8: The system according to any one of Embodiments 1 to 7, wherein the slide-scale glucose-corrected dataset is a nonlinear scale based on at least one data point, which includes multiple data points input to a computing device.

[0344] Embodiment 9: The system according to any one of Embodiments 1 to 8, wherein multiple data points each include a range of glucose values ​​and an associated corrected dosage.

[0345] Embodiment 10: The system according to any one of Embodiments 1 to 9, wherein the glucose value range and associated corrected dosage are based on the subject's insulin use history.

[0346] Embodiment 11: A diabetes management system comprising a computing device including a memory and processor configured to display multiple photographs of meals categorized into multiple categories, each having a similar effect on blood glucose, and to receive user input for the number of units of insulin that the user would normally administer for meals included in each of the multiple categories, and an insulin pen assembly having a pen display, wherein the computing device is configured to provide category-specific user input to the insulin pen, and the pen display provides at least one recommended insulin dose based at least in part on the user input received for each category.

[0347] Embodiment 12: The insulin pen assembly is the system according to Embodiment 11, which displays recommended insulin dosages for multiple categories.

[0348] Embodiment 13: The system according to any one of Embodiments 1 to 12, wherein the computing device receives user input defining a correction factor based on blood glucose levels, the insulin pen assembly is adapted to receive blood glucose data from a glucose sensor system, the insulin pen assembly receives the correction factor from the computing device, and each recommended insulin dose is based on the correction factor and blood glucose data.

[0349] Embodiment 14: The system according to any one of Embodiments 1 to 13, wherein the correction factor is a slide-scale glucose correction dataset.

[0350] Embodiment 15: The insulin pen assembly comprises an insulin pen and a reusable accessory for a disposable insulin pen, as described in any one of Embodiments 1 to 14.

[0351] Embodiment 16: The system according to any one of Embodiments 1 to 15, wherein the reusable accessory is a replacement pen cap for a disposable insulin pen.

[0352] Embodiment 17: The system, method, or apparatus according to any one of Embodiments 1 to 16, wherein the glucose data is either the interstitial fluid glucose concentration or is based on the interstitial fluid glucose concentration.

[0353] Embodiment 18: The system, method, or apparatus according to any one of Embodiments 1 to 17, wherein the glucose data is a blood glucose level correlated with the interstitial fluid glucose concentration.

[0354] Embodiment 19: The system, method, or apparatus according to any one of Embodiments 1 to 18, wherein the glucose data is blood glucose level.

[0355] Additional, non-limiting embodiments of this disclosure generally relate to warnings and alerts in diabetes management systems.

[0356] Embodiment 1: A diabetes management system comprising: at least a first glucose sensor system adapted to wirelessly transmit glucose data via a first wireless communication method having a first communication range and a second wireless communication method having a second communication range, wherein the first wireless communication method requires user operation and the second wireless communication method is automatic, and the second communication range is greater than that of the first communication range; at least a first reusable accessory adapted to be reversibly connected to at least a first insulin injection pen, and adapted to wirelessly receive glucose data from the first glucose sensor system via the first wireless communication method when moving within the first communication range; and a mobile application on a remote computing device adapted to automatically receive glucose data via the second wireless communication method, which issues a warning on one or more signal outputs in at least a partial response to the received glucose data.

[0357] Embodiment 2: The diabetes management system according to Embodiment 1, further comprising an insulin type detector configured to detect the type of insulin in the chamber of a manual insulin delivery device, wherein the first reusable accessory is configured to issue a warning in one or more signal outputs in response to the detector, the warning indicating an incorrect insulin type.

[0358] Embodiment 3: The diabetes management system according to any one of Embodiments 1 to 2, further comprising an insulin type detector configured to detect the type of insulin in the chamber of an insulin manual delivery device, wherein a mobile application is configured to issue a warning in one or more signal outputs in response to the detector, the warning indicating an incorrect insulin type.

[0359] Embodiment 4: The diabetes management system according to any one of Embodiments 1 to 3, wherein the mobile application is configured to compare the detected insulin type with a predicted insulin type and to output an error signal in response to the comparison.

[0360] Embodiment 5: The diabetes management system according to any one of Embodiments 1 to 4, wherein the mobile application is configured to identify a predicted insulin type in response to an administration action or based on parameters provided by the user.

[0361] Embodiment 6: The diabetes management system according to any one of Embodiments 1 to 5, further comprising a user confirmation system configured to prompt the user in response to an administration operation and one or more diabetes management system modes.

[0362] Embodiment 7: The diabetes management system according to any one of Embodiments 1 to 6, wherein the user confirmation system is configured to prompt for physiological parameters in response to a hypersystem monitoring mode and a high-correction dose associated with a recent administration operation.

[0363] Embodiment 8: The diabetes management system according to any one of Embodiments 1 to 7, further comprising a user confirmation system configured to prompt for glucose measurement in response to the current time or period.

[0364] Embodiment 9: The diabetes management system according to any one of Embodiments 1 to 8, wherein the first reusable accessory does not receive glucose data from the first glucose sensor system via the first wireless communication method.

[0365] Embodiment 10: The diabetes management system according to any one of Embodiments 1 to 9, wherein the first reusable accessory is adapted to receive glucose data from a mobile application via a second wireless communication method.

[0366] Embodiment 11: The diabetes management system according to any one of Embodiments 1 to 10, wherein the first communication method is short-range wireless communication and the second communication method is Bluetooth Low Energy.

[0367] Embodiment 12: The diabetes management system according to any one of Embodiments 1 to 11, wherein the warning is based on a received glucose level below a threshold.

[0368] Embodiment 13: The diabetes management system according to any one of Embodiments 1 to 12, wherein the warning is based on a predicted future glucose level below a threshold.

[0369] Embodiment 14: The diabetes management system according to any one of Embodiments 1 to 13, wherein the first accessory is adapted to detect insulin administration from a first insulin injection pen and communicate the administration data to a mobile application via a second wireless communication method.

[0370] Embodiment 15: A diabetes management system according to any one of Embodiments 1 to 14, wherein the warning is based at least partially on administration data.

[0371] Embodiment 16: The diabetes management system according to any one of Embodiments 1 to 15, wherein the first insulin injection pen is a long-acting insulin injection pen, and the warning is a missed dose warning.

[0372] Embodiment 17: A diabetes management system according to any one of Embodiments 1 to 16, wherein the warning responds to a high corrected dose, a detected administration event, and a timeout.

[0373] Embodiment 18: A diabetes management system according to any one of Embodiments 1 to 17, wherein the warnings respond to a forgotten administration event, an overcorrected dose, and a timeout.

[0374] Embodiment 19: A diabetes management system comprising: at least a first glucose sensor system adapted to wirelessly transmit glucose data via a first wireless communication method having a first communication range and a second wireless communication method having a second communication range, the first wireless communication method requiring user operation and the second wireless communication method being automatic, the second communication range being greater than the first communication range; at least a first smart electronics module configured to be integrated with a first insulin injection pen, the first smart electronics module configured to wirelessly receive glucose data from the first glucose sensor system via the first wireless communication method when moving within the first communication range; and a mobile application on a remote computing device adapted to automatically receive glucose data via the second wireless communication method, the mobile application issuing warnings on one or more signal outputs in at least partial response to the received glucose data.

[0375] Embodiment 20: The system, method, or apparatus according to any one of Embodiments 1 to 19, wherein the glucose data is either the interstitial fluid glucose concentration or is based on the interstitial fluid glucose concentration.

[0376] Embodiment 21: The system, method, or apparatus according to any one of Embodiments 1 to 20, wherein the glucose data is a blood glucose level correlated with the interstitial fluid glucose concentration.

[0377] Embodiment 22: The system, method, or apparatus according to any one of Embodiments 1 to 21, wherein the glucose data is blood glucose level.

[0378] Additional, non-limiting embodiments of this disclosure generally relate to monitoring devices for diabetes management systems.

[0379] Embodiment 1: A diabetes management system comprising an insulin delivery device and a monitoring device for detecting at least one characteristic of the insulin delivery device.

[0380] Embodiment 2: The system according to Embodiment 1, wherein the insulin delivery device comprises an insulin pen and the monitoring device comprises a pen cap.

[0381] Embodiment 3: The system according to Embodiment 2, wherein the pen cap is configured to detect at least one of the following: a cap attachment event in which the pen cap is fixed onto the therapeutic delivery portion of the insulin pen, or a cap removal event in which the pen cap is at least partially removed from the therapeutic delivery portion of the insulin pen.

[0382] Embodiment 4: The system according to any one of Embodiments 1 to 3, wherein the monitoring device is configured to provide the user with at least one alert or warning regarding the previous and / or future use of the insulin delivery device.

[0383] Embodiment 5: The system according to any one of Embodiments 1 to 4, wherein the monitoring device is configured to provide the user with at least one alert or warning regarding the past or future use of the insulin delivery device.

[0384] Embodiment 6: The system according to any one of Embodiments 1 to 5, wherein the monitoring device is configured to display data relating to the previous or future use of the insulin delivery device.

[0385] Embodiment 7: The system according to any one of Embodiments 1 to 6, wherein the monitoring device is configured to display data relating to the user's blood glucose level.

[0386] Embodiment 8: The system according to any one of Embodiments 1 to 7, wherein the monitoring device is configured to display data relating to the dosage.

[0387] Embodiment 9: The system according to any one of Embodiments 1 to 8, wherein the monitoring device is configured to allow the user to select the dosage.

[0388] Embodiment 10: The system according to any one of Embodiments 1 to 9, wherein the monitoring device is configured to allow the user to select one of a number of predetermined dosages.

[0389] Embodiment 11: The system according to Embodiment 10, wherein the monitoring device is configured to display a predetermined number of doses based on the suggested doses for each selected meal size.

[0390] Embodiment 12: The system according to any one of Embodiments 1 to 11, wherein the monitoring device is configured to display data relating to the time since the previous dose was administered.

[0391] Embodiment 13: The system according to any one of Embodiments 1 to 12, wherein the time relative to a previous dose is assumed based on a previous event detected by a monitoring device.

[0392] Embodiment 14: The system according to Embodiment 13, wherein the time relating to a previous dose is based on a cap removal event detected by a monitoring device equipped with a pen cap.

[0393] Embodiment 15: A diabetes management system comprising a device including a processor, wherein the device is configured to detect an image of an insulin delivery device and to identify the remaining amount of insulin contained in the insulin delivery device.

[0394] Embodiment 16: A method for managing drug therapy, comprising: removing a monitoring device from an insulin delivery device; replacing a monitoring device on an insulin delivery device; and identifying at least one characteristic relating to an insulin delivery device in response to at least one of removing a monitoring device from an insulin delivery device or replacing a monitoring device on an insulin delivery device.

[0395] Embodiment 17: The method according to Embodiment 16, further comprising providing the user with at least one therapeutic suggestion relating to an insulin delivery device based on at least one characteristic, using a monitoring device.

[0396] Embodiment 18: The method according to Embodiment 16 or 17, further comprising providing the user with at least one alert or warning regarding past or future use of an insulin delivery device based on at least one characteristic, using a monitoring device.

[0397] Embodiment 19: The method according to any one of Embodiments 1 to 18, further comprising displaying data relating to past or future use of an insulin delivery device based on at least one characteristic using a monitoring device.

[0398] Embodiment 20: The method according to any one of Embodiments 1 to 19, further comprising using a monitoring device to provide a number of predetermined doses selected by the user. [Explanation of Symbols]

[0399] 10,12 Insulin Therapy Management Systems 20. People with diabetes (PWD) 101 Glucose Sensor System 102 First accessory 103 Second accessory 104 Mobile Applications 105 Web Services 106,107 Manual delivery device 108 Network 110 Long-acting insulin injection pen 112 Long-acting pen cap 113 buttons 114 displays 116 icons 117 Long-acting insulin 120 Rapid-Acting Insulin Injection Pens 122 Instant-acting pen cap 123 buttons 124 displays 125 Time 126a, 126b, 126c Meal icons 126d Correction Dosage Icon 127a, 127b, 127c Diet-related dosage recommendations (dietary recommendations) 127d Recommended corrected dose 128 Notification icons 129 Blood glucose data 130 Glucose Monitor (GCM) 140 Mobile devices or mobile applications 150 Blood sugar meter (BGM) 211,221 Bluetooth Low Energy (BLE) communication links 231 Near Field Communication (NFC) Link 232 NFC and BLE communication links 241 WiFi or cellular connection 250 Web Services

Claims

1. This is a pen cap for an insulin pen. At least one input device configured to receive user glucose data, At least one circuit configured to detect an insulin pen administration event, wherein the administration event is inferred based on an event of the cap removal of the pen cap from the insulin pen and an event of the cap being attached to the insulin pen, At least one user interface configured to display at least one of the following: treatment-related information, treatment recommendations, or the time of the administration action event; A memory configured to store at least one of the user-specific dosage parameters or recommended dosages, The system comprises at least one processor configured to identify content presented by the user interface, and at least one processor configured to use information regarding the administration action event, The pen cap is configured to prevent the display of the recommended corrected dose of insulin for a period of time following the administration action event. The recommended corrected dose is determined by a pen cap, at least in part, based on the insulin sensitivity factor and target glucose value stored in the memory.

2. The pen cap according to claim 1, wherein the recommended corrected dose includes the dose of rapid-acting insulin.

3. The pen cap according to claim 1 or 2, wherein the period is at least 3 hours.

4. The pen cap according to any one of claims 1 to 3, wherein the at least one circuit comprises a sensor configured to detect when the pen cap is applied to or removed from the insulin pen.

5. The pen cap according to claim 4, wherein the sensor includes a leaf spring, an optical sensor, a mechanical sensor, an electronic sensor, a magnetic sensor, or a combination thereof.

6. The pen cap according to any one of claims 1 to 5, wherein the treatment-related information includes the current estimated glucose value, the current glucose trend, the glucose change rate, or a combination thereof.

7. The pen cap according to any one of claims 1 to 6, wherein the treatment recommendation includes a recommended dietary dose, a recommended corrected dose, or a combination thereof.

8. The pen cap according to any one of claims 1 to 7, wherein the user-specific dosage parameters include total daily basal dose, insulin sensitivity factor, carbohydrate-to-insulin ratio, corrected dose based on glucose value range, total daily insulin dose, target glucose value, recommended dietary dose, or a combination thereof.

9. The pen cap according to any one of claims 1 to 8, wherein the recommended corrected dose is at least partially based on the current glucose level.

10. The pen cap according to any one of claims 1 to 9, wherein the pen cap is configured to display the elapsed time since the administration action event.

11. The pen cap according to any one of claims 1 to 10, wherein the pen cap is configured to communicate with a glucose sensor system, and the glucose sensor system comprises a glucose sensor configured to come into contact with the user's bodily fluids.

12. The pen cap according to any one of claims 1 to 11, wherein the content includes a display of active insulin remaining in the user based on the time of the administration action event and the current time.

13. The pen cap according to any one of claims 1 to 12, wherein the content includes a notification indicating that the user has recently administered insulin using the insulin pen, based on the time of the administration action event and the current time.

14. The pen cap according to any one of claims 1 to 13, wherein the pen cap is configured to display the recommended corrected dosage after the period.

15. The pen cap according to claim 14, wherein the pen cap is configured to continue displaying the recommended corrected dosage over a second period.

16. The pen cap according to any one of claims 1 to 15, wherein the aforementioned period is based on the identification of the amount of active insulin remaining in the user.

17. The pen cap according to any one of claims 1 to 16, wherein the aforementioned period is based on the detection of a subsequent administration action event.

18. A method for managing drug therapy using a manual drug delivery device, Receiving user glucose data from a glucose sensor, The pen cap, which is detachably attached to the manual drug delivery device, detects the administration action event. Recording the aforementioned administration action event, This includes providing one or more drug dosage recommendations in response to the glucose data, A method wherein the pen cap is configured to prevent the display of a drug dosage recommendation for a period of time following the administration action event.

19. The method according to claim 18, wherein the drug dosage recommendation includes a recommendation for the dosage of rapid-acting insulin.

20. The method according to claim 18 or 19, wherein the period is at least 3 hours.

21. The method according to any one of claims 18 to 20, further comprising the step of displaying a recommended corrected dose on the pen cap after the aforementioned period.

22. The manual drug delivery device includes a drug injection pen. The method according to any one of claims 18 to 21, wherein the administration action event includes an event of removing the cap from the drug injection pen and an event of attaching the cap to the drug injection pen.

23. The method according to any one of claims 18 to 22, wherein the aforementioned period is based on the identification of the amount of active insulin remaining in the user.

24. The method according to any one of claims 18 to 23, wherein the aforementioned period is based on the detection of a subsequent administration action event.

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