RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

63/127,218, filed December 18, 2020, and U.S. Provisional Patent Application No. 63/228,415, filed August 2, 2021, the contents of which are incorporated herein by reference in their entirety.

BACKGROUND

[0002] Medicament delivery devices, like insulin delivery devices, may have associated management devices. The management devices may be dedicated handheld electronic devices or may be smartphones or other mobile electronic devices, upon which software for managing the medicament delivery device is installed. Each management device may provide information to a user, such as medicament delivery history and user metrics, like glucose level history. The management device may also enable the user to control medicament deliveries. For example, the user may be able to cause the delivery of a medicament bolus using a management device. Further, a user may be able set the dosage for medicament deliveries, such as basal medicament deliveries that are delivered on an ongoing basis at periodic intervals, via the management device.

[0003] Such a management device may be cumbersome. The user must carry the management device everywhere. In addition, the management device is not always available for use as there are limitations as to where and when a user may use such a management device. For example, if a user is driving a car, the user cannot easily use the management device, and using the management device while driving poses a driving safety hazard.

SUMMARY

[0004] In accordance with a first inventive aspect, a method is performed by a processor of a smartwatch. Per the method, a user interface element is displayed on a display of the smartwatch to request a bolus of medicament from a medicament delivery device. It is determined that the user interface element has been used to request a bolus of medicament be delivered to a user of the medicament delivery device, and responsive to the determining, the medicament delivery device is instructed to deliver the medicament bolus to the user.

[0005] The medicament may include at least one of insulin, a glucagon-like peptide- 1 (GLP- 1) agonist, or pramlintide, for example. The method may further include determining a dosage of the bolus of medicament for the user. The determining of the dosage may comprise displaying a prompt on the display of the smartwatch to obtain information for the determination of the dosage. The prompt may request a carbohydrates quantity. The method may further include displaying a reminder of when, and in some instances what (or a quantity of carbohydrates), the user should eat on the display of the smartwatch.

[0006] In accordance with another inventive aspect, a method is performed by a processor of a smartwatch having a display. The method includes obtaining measured analyte history and medicament delivery history for the user and displaying on the display at least one of an indication of historical measured analyte values from the measured analyte history and/or information about medicament deliveries in the medicament delivery history.

[0007] The medicament may be insulin, and the measured analyte values may be glucose concentration values. The method may further include displaying a user interface element on the display for accessing information regarding a party under care of the user. The method may further include detecting motion by the user and in response, displaying an option for the user to change a mode of operation to protect the user.

[0008] In accordance with a further inventive aspect, a method is performed by a processor of a vehicle infotainment system. The method includes displaying a user interface element on a display of a vehicle infotainment system to request a bolus of medicament from a medicament delivery device. The method further includes determining that the user interface element has been used to request a bolus of medicament be delivered to a user of the medicament delivery device and responsive to the determining, instructing the medicament delivery device to deliver the medicament bolus to the user.

[0009] The medicament may include at least one of insulin, a glucagon-like peptide- 1 (GLP- 1) agonist, or pramlintide, for example. The method may further include determining a dosage of the bolus of medicament for the user. The determining of the dosage may comprise outputting a prompt to obtain information for the determination of the dosage. The prompt may request a carbohydrates quantity. The user may provide a spoken response to the prompt.

[0010] In accordance with an additional inventive aspect, a method is performed by a processor of a vehicle infotainment system having a display. The method includes obtaining measured analyte history and medicament delivery history for the user and displaying on the display of the vehicle infotainment system at least one of an indication of historical measured analyte values from the measured analyte history and/or information about medicament deliveries in the medicament delivery history.

[0011] The medicament may be insulin and the measured analyte values may be glucose level values. The method may further include outputting alarms, alerts or notifications to the user via the vehicle infotainment system. The outputting may entail outputting the alarms, alerts or notifications by displaying information on the display of the vehicle infotainment system and/or by generating audio output.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 depicts a block diagram of a medicament delivery system suitable for practicing the exemplary embodiments.

[0013] Figure 2 depicts an illustrative home screen of a smartwatch of exemplary embodiments. [0014] Figure 3 depicts a table for explaining illustrative trend icons that may be used in exemplary embodiments.

[0015] Figure 4 depicts illustrative views of glucose viewing screens for varying time intervals on a smartwatch in exemplary embodiments.

[0016] Figure 5 depicts a flowchart showing illustrative steps that may be performed in exemplary embodiments to set glucose level thresholds.

[0017] Figure 6A depicts an illustrative glucose level and bolus history screen on a smartwatch in exemplary embodiments.

[0018] Figure 6B depicts an illustrative insights screen on a smartwatch in exemplary embodiments.

[0019] Figure 7 depicts a flowchart of illustrative steps that may be performed to calculate time range values in exemplary embodiments.

[0020] Figure 8 depicts a flowchart of illustrative steps that may be performed in exemplary embodiments to calculate percentages by type of insulin delivery.

[0021] Figures 9A and 9B depict illustrative screens that may be displayed to confirm whether a user wishes to suspend insulin delivery due to an activity in exemplary embodiments. [0022] Figure 10 depicts a flowchart of illustrative steps that may be performed in exemplary embodiments to identify an activity by the user and to suspend insulin delivery in response.

[0023] Figure 11 depicts an illustrative screen on a smartwatch in exemplary embodiments for use by a caretaker.

[0024] Figure 12 depicts an illustrative screen on a smartwatch in exemplary embodiments for locating a management device.

[0025] Figures 13 and 14 depict a sequence of illustrative screens on a smartwatch in exemplary embodiments for delivering an insulin bolus.

[0026] Figure 15 depicts a sequence of illustrative screens on a smartwatch in exemplary embodiments where a user specifies a meal size rather than a carbohydrate amount in requesting an insulin bolus.

[0027] Figure 16 depicts a sequence of illustrative screens on a smartwatch in exemplary embodiments where a user wishes to schedule a medicament bolus delivery.

[0028] Figure 17 depicts a sequence of illustrative screens on a smartwatch in exemplary embodiments where a user accesses the snooze functionality.

[0029] Figure 18 depicts a sequence of illustrative screens on a smartwatch in exemplary embodiments where a user deletes a scheduled medicament bolus delivery. [0030] Figure 19 depicts an illustrative home screen for a vehicle infotainment system in exemplary embodiments.

[0031] Figure 20 depicts an illustrative screen on a vehicle infotainment system display of exemplary embodiments showing insulin and glucose level information.

[0032] Figure 21 depicts an illustrative glucose viewing screen on a vehicle infotainment system display of exemplary embodiments.

[0033] Figure 22 depicts an illustrative screen that requests a voice command on a vehicle infotainment system display of exemplary embodiments.

[0034] Figure 23 A depicts an illustrative notification on a vehicle infotainment system display of exemplary embodiments.

[0035] Figure 23B depicts an illustrative notification history shown on a vehicle infotainment system display of exemplary embodiments.

[0036] Figure 24 depicts an illustrative sequence of screens on a vehicle infotainment system display of exemplary embodiments for navigating among screens using voice commands.

[0037] Figure 25 depicts an illustrative sequence of screens on a vehicle infotainment system display of exemplary embodiments for delivering a bolus of insulin responsive to voice commands. [0038] Figure 26 depicts an illustrative screen from a voice assistant on a vehicle infotainment system display of exemplary embodiments requesting confirmation that the user is going to exercise and requesting whether to enter an insulin delivery mode in response.

[0039] Figure 27 depicts a flowchart of illustrative steps that may be performed to use geolocation information in exemplary embodiments to determine what action is taken.

DETAILED DESCRIPTION

[0040] The exemplary embodiments may overcome the above-described problems encountered with conventional management devices for medicament delivery systems. In some exemplary embodiments, the user may wear a smartwatch that provides much of the functionality available with the management device and may also provide additional functionality. With the smartwatch, there is no need to carry a management device since the smartwatch is strapped to the wrist of the user. The smartwatch is inobtrusive, and the user does not need to hold a management device in his/her hand. The user is less likely to lose the smartwatch and is less likely to forget to bring their smartwatch with them than a management device given that the smartwatch is secured to the user’s wrist.

[0041] The exemplary embodiments may also provide management device capabilities in a vehicle infotainment system. Thus, the management device capabilities are available to the user as the user drives. The user may be able to issue voice commands to the vehicle infotainment system to manage the medicament delivery device, including transmitting commands to, and receiving information from, the medicament delivery device. As a result, the user is not required to attempt to access the management device while driving. Instead, the user may issue voice commands that are received by the vehicle infotainment system and passed on to the medicament delivery device in a hands-free fashion. Any information that is displayed may be displayed on the vehicle infotainment system display, which is in the field of view of the user. [0042] The term “vehicle infotainment system” may refer to an information system, an entertainment system or both. Examples of an information system include a navigation system that includes a display, a video display that displays vehicle information, an onboard integrated computing device, etc. An entertainment system may include a radio system, a compact disk system, a video entertainment device like a DVD player, an integrated on-board gaming system, a streaming device for streaming video or audio content, etc. The infotainment system may include output display devices, like video displays, touchscreen display devices, a microphone, etc.

[0043] Figure 1 depicts an illustrative medicament delivery system 100 that is suitable for delivering a medicament, such as insulin, a GLP-1 agonist or other medicament, like those detailed below, to a user 108 in accordance with exemplary embodiments. The medicament delivery system 100 includes a medicament delivery device 102. The medicament delivery device 102 may be a wearable device that is worn on the body of the user 108. The medicament delivery device 102 may be directly coupled to a user (e.g., directly attached to a body part and/or skin of the user 108 via an adhesive or the like) or connected to the user via tubing and an infusion set. In an example, a surface of the medicament delivery device 102 may include an adhesive to facilitate attachment to the user 108.

[0044] The medicament delivery device 102 may include a processor 110. The processor 110 may, for example, be a microprocessor, a logic circuit, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) or a microcontroller coupled to a memory. The processor 110 may maintain a date and time as well as other functions (e.g., calculations or the like). The processor 110 may be operable to execute a control application 116 stored in the storage 114 that enables the processor 110 to implement a control system for controlling operation of the medicament delivery device 102. The control application 116 may control medicament delivery to the user 108 as described herein. The storage 114 may hold histories 111 for a user, such as a history of automated basal medicament deliveries, a history of bolus medicament deliveries, meal event history, activity event history, sensor data, such as glucose level data obtained from a CGM, and the like. In addition, the processor 110 may be operable to receive data or information. The storage 114 may include both primary memory and secondary memory. The storage 114 may include random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like.

[0045] The medicament delivery device 102 may include a reservoir 112 for storing medicament for delivery to the user 108 as warranted. A fluid path to the user 108 may be provided, and the medicament delivery device 102 may expel the medicament from the reservoir 112 to deliver the medicament to the user 108 via the fluid path. The fluid path may, for example, include tubing coupling the medicament delivery device 102 to the user 108 (e.g., tubing coupling a cannula to the reservoir 112).

[0046] There may be one or more communications links with one or more devices physically separated from the medicament delivery device 102 including, for example, a management device 104 of the user and/or a caregiver of the user and/or sensor(s) 106. The communication links may include any wired or wireless communication link operating according to any known communications protocol or standard, such as Bluetooth®, Wi-Fi, a near-field communication standard, a cellular standard, or any other wireless protocol. The medicament delivery device 102 may also include a user interface 117, such as an integrated display device for displaying information to the user 108 and in some embodiments, receiving information from the user 108. The user interface 117 may include a touchscreen and/or one or more input devices, such as buttons, a knob or a keyboard.

[0047] The medicament delivery device 102 may interface with a network 122. The network 122 may include a local area network (LAN), a wide area network (WAN) or a combination therein. A computing device 126 may be interfaced with the network, and the computing device 126 may communicate with the medicament delivery device 102.

[0048] The medicament delivery system 100 may include sensor(s) 106 for sensing the levels of one or more analytes. The sensor(s) 106 may be coupled to the user 108 by, for example, adhesive or the like and may provide information or data on one or more medical conditions and/or physical atributes of the user 108. The sensor(s) 106 may, in some exemplary embodiments provide periodic glucose concentration measurements and may be a continuous glucose monitor (CGM), or another type of device or sensor that provides glucose measurements, such as glucose concentrations in interstitial fluid that accurately estimates blood glucose levels. The sensor(s) 106 may be physically separate from the medicament delivery device 102 or may be an integrated component thereof. The sensor(s) 106 may provide the processor 110 with data indicative of one or more measured or detected analyte levels of the user 108. The information or data provided by the sensor(s) 106 may be used to adjust medicament delivery operations of the medicament delivery device 102.

[0049] The medicament delivery system 100 may also include a management device 104. In some embodiments, no management device 104 is needed; rather the medicament delivery device 102 may manage itself. The management device 104 may be a special purpose device, such as a dedicated personal diabetes manager (PDM) device. The management device 104 may be a programmed general-purpose device, such as any portable electronic device including, for example, a device with a dedicated controller, such as a processor, a micro-controller or the like. The management device 104 may be used to program or adjust operation of the medicament delivery device 102 and/or the sensor 106. The management device 104 may also be used to view data and other information relating to medicament delivery and analyte levels. The management device 104 may be any portable electronic device including, for example, a dedicated device, a smartphone, a smartwatch or a tablet. In the depicted example, the management device 104 may include a processor 119 and a storage 118. The processor 119 may execute processes to manage and control the delivery of the medicament to the user 108. The processor 119 may also be operable to execute programming code stored in the storage 118. For example, the storage 118 may be operable to store a control application 120 for execution by the processor 119. The control application 120 may be responsible for controlling the medicament delivery device 102, e.g., the automatic insulin delivery (AID) of insulin to the user 108. The storage 118 may store the control application 120, histories 121 like those described above for the medicament delivery device 102 and other data and/or programs. [0050] The management device 104 may include a user interface (UI) 123 for communicating with the user 108. The user interface 123 may include a display, such as a touchscreen, for displaying information. The touchscreen may also be used to receive input when it is a touch screen. The user interface 123 may also include input elements, such as a keyboard, button, knobs, or the like.

[0051] The management device 104 may interface with a network 124, such as a LAN or WAN or combination of such networks. The management device 104 may communicate over network 124 with one or more servers or cloud services 128.

[0052] The medicament delivery system 100 may include a smartwatch 130 worn by the user 108. The smartwatch 130 includes a processor 140, like a microprocessor, for executing computer programming instructions such as an application 148 for performing the functionality described herein. The smartwatch 130 also includes a display 142 for displaying content. The display 142 may be a touchscreen for receiving input as well. The smartwatch 130 may include audio output/input 144, such as a speaker and a microphone. The smartwatch 130 may include storage, such as described above for the management device 104, for holding data and software, like the application 148.

[0053] The smartwatch 130 has a wireless communication connection with the management device 104. The smartwatch 130 may issue commands to the medicament delivery device 102 and obtain information from the medicament delivery device 102 by way of wireless communications sent to the management device 104 over the connection. In some embodiments, the smartwatch may have a direct communication link with the medicament delivery device 102 to obtain information and issue commands as shown in Figure 1. In other embodiments, the smartwatch 130 may forward an instruction to the management device 104, which then issues the command to the medicament delivery device 102. Similarly, the smartwatch 130 may request information. This request may be received by the management device 104 and then forwarded to the medicament delivery device 102. The medicament delivery device 102 provides the requested information to the management device 104, which returns the requested information to the smartwatch 130. The functional capabilities of the smartwatch 130 in relation to the medicament delivery system 100 will be described in more detail below. The application 148 facilitates communications with the management device 104 and provides the functionality of the smartwatch 130, which is described in more detail below.

[0054] A vehicle infotainment system 150 may be part of the medicament delivery system 100. The vehicle infotainment system 150 may be like those found in many vehicles to enable a user to listen to the radio, play music or other audio content from a portable device like a smartphone, thumb drive or the like. The vehicle infotainment system 150 may provide navigation assistance via displayed maps and audio output. The vehicle infotainment system may include a processor, like a microprocessor, microcontroller or ASIC, for executing computer programming instructions, such as application 158. The vehicle infotainment system 150 includes a display 154, such as a touch screen display, and audio output/input 160, such as loudspeakers and a microphone. The vehicle infotainment system 150 includes storage 156, which may comprise memory devices like those discussed above relative to storage 114. The storage 156 may store the application 158. The application 158 facilitates functionality described herein. In some embodiments, the management device 104 include an application and the vehicle infotainment system 150 may communicate with the management device 104 to realize the functionality described herein.

[0055] The vehicle infotainment system 150 may issue commands to the medicament delivery device 102 and obtain information from the medicament delivery device 102 by way of wireless communications sent to the management device 104 over the connection. Technologies, such as Apple CarPlay or Android Auto, may be used to integrate the management device 104 and the vehicle infotainment system 150. The vehicle infotainment system 150 may forward an instruction to the management device 104, which then issues the command to the medicament delivery device 102. Similarly, the vehicle infotainment system 150 may request information. This request is received by the management device 104 and forwarded to the medicament delivery device 102. The medicament delivery device 102 provides the requested information to the management device 104, which returns the requested information to the vehicle infotainment system 150. The functional capabilities of the vehicle infotainment system 150 in relation to the medicament delivery system 100 will be described in more detail below. The application 158 facilitates communications with the management device 104 and provides the functionality of the vehicle infotainment system 150, which is described in more detail below. In some alternative embodiments, the vehicle infotainment system 150 may have a direct wireless connection with the medicament delivery device 102 as shown in Figure 1 by the connecting lines.

[0056] As was mentioned above, the medicament delivery system 100 may include a smartwatch 130, such as the Apple® Watch, the Fitbit® Versa smartwatch, the Samsung® Galaxy watch, etc. The smartwatch 130 may execute the application 148 on the processor 142 to provide the functionality described herein. Figure 2 depicts an example of an illustrative smartwatch 200 that is suitable for use with exemplary embodiments. In this example, the smartwatch 200 is used to control the medicament delivery device 102 in the form of an insulin delivery device. The smartwatch 200 includes straps 202 for securing the smartwatch to the wrist of the user 108. The smartwatch 200 includes a display 204. In some exemplary embodiments, the display 204 may be a touchscreen display. The smartwatch 200 may include a rotatable wheel 206. The rotatable wheel 206 may be used to cycle through a list of displayed items as will be discussed below. The home screen shown in Figure 2 may display a current analyte level for the user. In Figure 2, the analyte level is the current glucose level reading 208 (“110”) for the user 108. The current glucose level reading may be obtained from the management device 104 or the medicament delivery device 102 in some embodiments. The insulin on board (IOB) 210 is also displayed on the home screen (“1.05”). The home screen displays an icon 212 that may be selected to request the delivery of an insulin bolus to the user 108. Another icon 214 displays a trend icon for the analyte level. In this exemplary case, the analyte level is the glucose level of the user 108.

[0057] There are a variety of different trend icons other than the trend icon 214 shown in Figure 2 that may be displayed to provide a visual cue of the trend of the analyte level of the user 108. Figure 3 depicts a table 300 showing a list of illustrative trend icons that may be displayed. The table 300 is organized by row. Row 302 depicts a sideways pointing arrow icon, which means that the glucose level of the user 108 is increasing or decreasing less than 1 mg/dL each minute. Row 304 depicts an upward facing arrow icon and a downward facing arrow icon that are each oriented at 45°. These icons in row 304 indicate that the glucose level of the user 108 is increasing (upward-oriented arrow icon) or decreasing (downward-oriented icon) at a rate of 30- 60 mg/dL per 30 minutes. Row 306 shows an upward facing arrow icon and a downward facing arrow icon. These icons indicate that the glucose level of the user 108 is increasing or decreasing respectively at a rate of 60-90 mg/dL per 30 minutes. Lastly, row 308 depicts an icon with two upward facing arrows and an icon of two downward facing arrows. These icons indicate that the glucose level of the user 108 is increasing or decreasing at a rate of more than 90 mg/dL.

[0058] With reference to Figure 2 again, a status view 216 specifies the insulin delivery mode as being a manual mode (open loop), limited mode where connectivity with a sensor is limited (such as when there is limited connectivity with a CGM, or when a connection with a CGM is currently in progress ) or an automated mode (hybrid closed loop) or any other mode that might need to be communicated to the user, such as a hypo-protect mode where insulin delivery to the user is reduced or stopped temporarily to protect against hypoglycemia. In the example depicted in Figure 2, the status view indicates that the current insulin delivery mode is the automated insulin delivery mode.

[0059] The smartwatch 130 may provide information to the user 10 regarding analyte level history and trends. Figure 4 shows exemplary displays for the case where the smartwatch 130 is used with an insulin delivery device. The user 108 may select the duration of the view shown on the display 405 of the smartwatch 401. Figure 4 shows a graph 411 for a six-hour view 402, a graph 412 for a three-hour view 404 and a graph 414 for a one-hour view 406. It should be appreciated that these time intervals are merely illustrative and are not intended to be limiting. Other time intervals may be used. Each graph 411, 412, and 414 shows glucose level values 410 over the specified time interval. These views 402, 404, and 406 enable a user to understand the trend in the glucose level over respective time intervals. User-adjustable high or low glucose concentration thresholds 408 are shown in each of the views 402, 404, and 406. The most recent glucose concentration reading 403 is displayed along with the trend icon 407. The user for which the data is being displayed is identified by text 422 shown at the top of the display 405. This is helpful for caretakers that may need to view the data for another party or multiple parties. Graphical bar 416 illustrates the period in which insulin delivery was suspended during the specified time interval. Icon 418 shows where during the time interval a bolus was delivered.

[0060] The user 108 may set the glucose concentration thresholds 408 as mentioned above. Specifically, as depicted in the flowchart 500 of Figure 5, the user 108 may set the upper glucose concentration threshold at 502, and the user may set the lower glucose concentration threshold at 504. Once these thresholds are set, the thresholds may be displayed on the display of the smartwatch 130 with the glucose level history in graphical form, such as shown in Figure 4.

[0061] In the exemplary embodiments, the smartwatch 600 may show historical glucose level and medicament bolus information on the display 602 as depicted in Figure 6A. The smartwatch 600 may, for instance, obtain insulin delivery information 604, glucose level history and recent medicament bolus delivery history from the management device 104 and then display the information on the display 602. The displayed information 604 may include the time that the bolus delivery was made, the glucose level of the user 108 at the time of the bolus delivery and the amount of the bolus delivery. The smartwatch 600 may show a graphical depiction 606 that indicates by color and magnitude the number of recent glucose level readings that were above the target value range, below a target value range, or within the range. The percentage of the recent glucose level readings that are above the range 608 may be displayed along with the percentage of recent glucose readings that are below the range 612. The percentage of recent glucose level readings that are within range 610 may be displayed. The average of the recent glucose level readings 614 may also be displayed. The smartwatch 600 may perform calculations that are needed to determine these percentages prior to the display of the percentages.

[0062] The smartwatch 600 may also show insights regarding the insulin deliveries by the user and the total carbohydrates ingested by the user over a period of time. The insights are obtained by processing the gathered data regarding the user 108. Figure 6B shows a display like that of Figure 6A but with information regarding the insights and the last bolus delivery. The insights 620 includes a depiction 624 of the total insulin delivered for a time interval, such as a day or a past hour. In the depicted example case, the recent glucose level readings include ten readings. The percentage of insulin deliveries that were basal insulin deliveries 626 is displayed along with a percentage of insulin deliveries that were bolus insulin deliveries 628. The total carbohydrates ingested during the time interval 630 is also displayed. The dosage and time of the last bolus delivery 622 is shown on the display 602.

[0063] The time in range values that are displayed in the insights section shown in Figure 6B need to be calculated by the application 148. Figure 7 depicts a flow chart 700 showing illustrative steps that may be performed by exemplary embodiments to calculate the time in range values. First, the application 148 must calculate the percentage of glucose level values for the time interval that are in range at 702. The range may be bounded by the threshold values that are set by the user. The application 148 determines how many of the values fall within the defined range, and then determines what percentage of the total those values constitute. The application 148 also calculates the percentage of glucose level values for the time interval that are above the upper threshold of the range at 704. This entails determining how many of the values are above the upper threshold of the range, dividing that number of values by the total number of values, and converting the results to a percentage. At 706, the percentage of glucose level values for the time interval that are below the lower threshold of the range is determined. This entails determining how many values are below the lower threshold of the range, dividing that number by the total number of values and converting the result to a percentage.

[0064] Figure 8 depicts a flowchart 800 of illustrative steps that may be performed to determine a breakdown of insulin delivery to the user for a time interval by type of insulin delivery. Initially, at 802, the application 148 determines the total amount of insulin that has been delivered to the user 108 for the time interval. This entails summing the amounts of insulin delivered to the user 108 at basal rates for the time interval and summing the amounts of bolus insulin delivered to the user 108 for the time interval. The resulting sum constitutes the total insulin delivered for the time interval. The percentage of insulin that is utilized for basal rates may be determined at 804 by dividing sum of total bolus insulin delivered for the time interval by the total amount of insulin that was delivered for the time interval. The percentage of insulin that is not bolus insulin is calculated at 806 by dividing the sum of the insulin that is delivered at basal rates for the time interval with the total insulin delivered for the time interval. A ratio may be determined by dividing the bolus insulin by the total insulin (which may yield a value around 0.5). Alternative methods may be used to determine this ration

[0065] The application 148 may exploit features provided by the smartwatch 900 (Figure 9 A) to aid in controlling medicament delivery to the user 108 and for interacting with the user 108. For example, the smartwatch may contain an accelerometer that detects movement by the user 108. The smartwatch 900 may have intelligence, such as found in a fitness application on the smartwatch 900 to match the detected activity by the accelerometer with patterns of movement found with exercise, or eating, or driving in a car, for example. Alternatively, motions, like hand motions, may signal activities, like eating. Figure 10 depicts a flowchart 1000 of illustrative steps that may be performed in exemplary embodiments to detect an activity, such as exercise, eating, or driving, and adjust medicament delivery accordingly. At 1002, the smartwatch 900 detects activity that may be exercise (or eating, or driving, for example) or signal an activity (e.g., through hand motions) via the accelerometer. If the activity pattern matches that of exercise (or other activity), the smartwatch 900 may confirm with the user that the user is exercising (or engaged in another activity) at 1004. Figure 9A shows an example of the user interface that may be displayed on the smartwatch 900 in response to detecting activity that may be exercising. The display 902 contains a prompt 904 for asking the user 108 if the user 108 is exercising. The prompt 904 may be combined with an audible sound, a light emission, or a vibration, for example. The user 108 has the option of responding to the prompt 904 by selecting a “Yes” button 906 or a “No” button 908. If the user 108 does not confirm the exercising, the processing may stop. If the user 108 confirms the exercising, the user 108 may be asked if the user 108 wants to take an action that may benefit their insulin management, such as entering a different insulin management mode that may suspend delivery of insulin, at 1006. The suspension of insulin delivery is a precautionary measure to prevent the user 108 from becoming hypoglycemic during the exercising. The exercising reduces the glucose level of the user. When combined with an insulin delivery, the exercising may reduce the glucose level of the user more than desired. Figure 9B depicts an illustrative user interface that may be shown on the display 902 of the smartwatch 900. A prompt 910 asks the user 108 if the user would like to temporarily suspend insulin delivery. The user may select a “Yes” button 912 or a “No” button 914 in response to the prompt 910. At 1008, a check is made whether to suspend insulin delivery or not based upon which button 912 or 914 the user chooses. If the user chooses the “Yes” button 912, insulin delivery is suspended for an interval, such as 30 minutes or one hour. If the user chooses the “No” button 914, no further activity regarding this suspension is taken.

[0066] As was mentioned above, the smartwatch 130 may be used by caretakers that need to have access to information for those they are assisting and need to be able to deliver medicament as needed for those the caretakers are assisting. To that end, as shown in Figure 11, the smartwatch 1100 may show on its display 1102 a prompt 1104 that asks the caretaker which user they would like to view information regarding. In the example shown in Figure 11, an icon and a textual name 1106 is shown for “Matt” and an icon in a textual name 1108 is shown for “Sarah”. The caretaker needs only select one of the icons 1106 or 1108 to view information regarding that user or for selecting an icon with their own name where the user is a caregiver as well as a patient.

[0067] Sometimes it is easy for a user to misplace a management device 104. The smartwatch 1200 (Figure 12) provides an ability to help locate the management device 104. Specifically, the display 1202 of the smartwatch 1200 may contain an icon 1206 and a prompt that when selected or activated causes the management device 104 to produce an audio output, such as a ringing or beeping. This audio output helps the user 108 to locate the management device 104. In this example, the management device 104 is a personal diabetes manager (PDM).

[0068] The smartwatch 130 provides the ability to calculate an insulin bolus size and to deliver the insulin bolus of the specified size to the user 108. The user 108 may initiate the process of calculating a bolus and delivering an insulin bolus by selecting the option to deliver an insulin bolus, such as by selecting icon 212 (Figure 2). Figure 13 shows a sequence of screens that may be displayed on the display 1302 of the smartwatch 1300 to facilitate calculation of an insulin bolus and delivery of the insulin bolus to the user 108. The user 108 may be prompted initially to enter a glucose value. The user 108 may enter a value in text box 1306 or may scroll through displayed value options 1308 to select among displayed value options 1308, such as value 1310, using the rotating knob 1304. The glucose value may also be automatically populated by a continuous glucose monitor (CGM) that is paired with the insulin controller system. The entered glucose value may be a glucose concentration value expressed in terms of mg/dL or mmol/L. The user 108 is then prompted to enter the amount of carbohydrates as shown in Figure 13. The user may manually enter the grams of carbohydrates in text box 1312 or may scroll through options to select a value such as the highlighted value 1314. In the next screen, the display 1302 of the smartwatch 1300 shows the entered glucose concentration value 1316 representing the most recent value for the user 108 and the amount of carbohydrates to be ingested in a meal 1318 that was entered by the user 108. A correction factor 1320 is also displayed. The correction factor is the number/formula used to correct a user’s high or low blood sugar that is out of range. This is managed in his or her settings in the control software. The correction factor indicates how much insulin is required to correct for a gram of carbohydrates ingested. The correction bolus may be populated if a user’s blood glucose level is out of range and needs to be factored into an execution of a bolus. This may be a correction for a high blood glucose value by adding to the total bolus amount or a reverse correction for a low blood glucose value that would subtract from the overall bolus value. The application 148 then calculates using the provided information and correction factor and displays the appropriate correction bolus dosage to compensate for the indicated number of carbohydrates given the current glucose concentration (see 1322). In the example case, it will take 2.5 units of insulin to compensate for 25 grams of carbohydrates (i.e., 25 x 0.1). The user 108 may be prompted to confirm the formulation of the bolus by physical action, such as swiping right, or verbal action, such as verbally confirming the bolus. In the next screen, the user 108 is prompted to select either option by selecting a normal bolus by selecting element 1326, or an extended bolus by selecting element 1328. In this example, the user 108 selects by swiping the element 1326 or 1328 to the right. In the example of Figure 13, the user 108 has selected the extended bolus as indicated by text at 1330 on display 1302. The user 108 enters percentage values to specify how the extended bolus is to be distributed over time. In text box 1332, the user 108 enters the percentage of the bolus to be delivered now. In text box 1334 the user 108 enters the percentage of the bolus to be delivered in an extended fashion. In text box 1336, the user 108 enters the duration over which the extended portion is to be delivered. The smartwatch 130 may also prompt the user to review the insulin amount to be distributed rather than using percentages for extended boluses. Once the user 108 has entered the appropriate values, the user 108 may confirm the extended bolus delivery by selecting element 1338, such as by swiping to the right.

[0069] Figure 14 shows a next sequence of screens after the user 108 has selected to have an extended bolus delivered. The user 108 has initially selected an extended bolus as shown in screen 1404 on display 1402. The user 108 is then prompted 1414 to confirm delivery of the number of units as shown by display 1412. If the user accepts the delivery of the 2.5 units, the user enters a confirmatory code via screen 1416 to initiate the delivery. The confirmatory code may be established with the user during user on-boarding. The smartwatch 1400 then displays the screen 1418 on display 1402 to remind the user 108 that they will be notified when it is ok to eat. This time parameter will be set by the user 108 in the insulin controller system application, whether that is a controller or smartphone application. The goal of the mealtime reminder is to improve user’s pre-bolus activity by giving insulin before a meal in order to stay in target glycemic range. In the example shown, the user is reminded to eat in 15 minutes. After the 15 minutes has elapsed, the smartwatch 1400 displays a screen 1406 on display 1402 reminding the user 108 that it is time for the user 108 to eat. This helps the user 108 to avoid a problem by having the insulin bolus delivered without ingesting the carbohydrates for which the insulin bolus is intended, in addition to knowing ample time has passed for the user to ingest the carbohydrates.

[0070] The smartwatch 130 may also enable the user to simply choose the size of meal that is to be ingested to determine the insulin bolus dosage rather than specifying the amount of carbohydrates to be ingested in grams. The application 148 may have categories of meal sizes, such as a regular meal and a large meal. A regular meal is presumed to include a first amount of carbohydrates, whereas a large meal is presumed to include a second amount of carbohydrates that is larger than the first amount. A “small meal” or “snack” may also be presented as an option, which may correspond to a lower amount of carbohydrates than the regular meal option. These carbohydrate amounts may be defined by either the user 108 or health care provider by programming such amounts into the insulin controller system. Custom meal names (and carbohydrate amounts) may also be set up by the user in the insulin controller system. As shown in Figure 15, the smartwatch 1500 may show on display 1502 a regular meal option 1504 and a large meal option 1506 for selection by the user 108. The user 108 may then be prompted to confirm which of the meal sizes the user 108 selected in screen 1506. The screen 1506 may include a “Yes” button 1508 to confirm the selected meal size or a “No” button 1510 to not confirm the selected meal size. If the user 108 confirms the meal size by selecting the “Yes” button 1508, the user 108 is prompted to enter a confirmatory code to initiate the delivery of the insulin bolus using display 1512. The user 108 may also be prompted by a voice command on the smartwatch 1500 to confirm the meal, by which the user 108 may confirm verbally. As was described previously above, screen 1514 provides a reminder of when the user 108 should eat. This screen 1514 is followed by a follow up reminder screen 1516 when the time to eat arrives. Screen 1516 reminds the user 108 that it is time for the user 108 to eat.

[0071] The user 108 may also schedule a drug delivery, such as a bolus of insulin, via the smartwatch 130. Figure 16 depicts a screen 1600 on the smartwatch 130 that provides the user 108 with options regarding bolus delivery. A bolus now button 1602 may be selected, such as by touching the touchscreen of the smartwatch 130, to deliver the bolus immediately, such as described above. A schedule bolus button 1604 may be selected by the user 108 to schedule a future date and time for the delivery of the bolus. A back button 1606 may be selected to navigate back to the previous screen. If the user 108 selects the schedule now button, screen 1610 may be displayed. The screen 1610 contains user interface elements for that facilitate scheduling of the medicament bolus delivery. User interface element 1616 enables the user 108 to enter or edit the bolus amount to be delivered. User interface elements 1618 may be used to by the user to specify the month and day for the date of the scheduled medicament bolus delivery. User interface elements 1620 may be used by the user 108 to specify the time of the scheduled bolus delivery in hours and minutes. The confirm button 1624 may be selected by the user 108 to confirm the bolus amount and the date and time of the scheduled medicament bolus delivery. Upon the confirm button 1624 being selected, a confirmation screen 1630 may be displayed that shows the bolus amount 1632, date 1634 and time 1636 for the scheduled bolus delivery. [0072] The user 108 may then determine, by using the smartwatch controls, such as a dial or a touchscreen user interface, the amount, the date and time when the application 148 will prompt a scheduled bolus reminder. Screen 1700 in Figure 17 depicts an illustrative scheduled bolus reminder. Screen 1700 depicts the bolus amount 1701 that is scheduled to be delivered. A confirm button 1702 is provided for selection to confirm the scheduled bolus. If the user 108 selects the confirm button 1702, a number pad 1710 may be displayed to enter a password or PIN as an additional layer of security.

[0073] A snooze button 1704 also is displayed. Selection of the snooze button 1704 delays the scheduled bolus by a determined amount of time. When the user 108 selects the snooze button 1704, screen 1712 may be displayed. The user 108 is presented with buttons 1716 that may be selected to choose among the options for the magnitude of the snooze (e.g., 5, 10, 15, 20, 25 or 30 minutes). The user 108 may effectuate the delay by selecting snooze button 1714.

[0074] When the user 108 selects the edit or cancel button 1706, screen 1718 may be displayed. Screen 1718 includes an editable text box 1722 in which the user 108 may modify the bolus amount. User interface elements 1724 enable the editing of the date for the scheduled bolus, and user 108 interface elements 1726 enable the editing of the time of the scheduled bolus. After editing the bolus amount, date and/or time, the user 108 may select button 1728 to confirm the modified particulars of the scheduled bolus delivery. If the user 108 wishes to cancel the scheduled bolus, the user 108 needs to only select the cancel button 1730. If the user 108 confirms the edited scheduled bolus delivery, screen 1740 may be displayed to show the bolus amount 1742, the scheduled date 1746 and the scheduled time 1748 for the edited scheduled bolus delivery.

[0075] As shown in Figure 18, a user 108 may view when multiple boluses are scheduled to be delivered in a list view. Screen 1800 may be displayed, for example. In this illustrative case, the information 1802 for a first scheduled bolus is displayed, and information 1804 for a second scheduled bolus is displayed. A button 1806 for scheduling a new bolus also is displayed. When the displayed information 1804 for the second scheduled bolus is selected by swiping left.

Arrow icon 1812 is displayed to evidence the swipe. In addition, an edit button 1814 may be displayed to cause editing of the second scheduled bolus. A delete button 1816 is displayed for deleting the second scheduled bolus. When the delete button 1816 is selected, a button 1822 may be displayed on screen 1820 to confirm the deletion, and a cancel button 1824 may be displayed for canceling the deletion. If the user 108 selects the edit button 1816, an edit screen 1830 is displayed. The edit screen 1830 includes user interface elements 1831, 1832 and 1834 for editing the bolus amount, the date and time, respectively, of the second scheduled bolus. The edited particulars for the second scheduled bolus may be accepted by selecting button 1836 or may be rejected by selecting button 1838.

[0076] The user 108 may also use the vehicle infotainment system 150 when driving or in a vehicle, such as a car, a truck, a motorcycle or another type of vehicle, to interact with the medicament delivery device 102 and the management device 104. Figure 19 depicts an example of the display 1900 for the vehicle infotainment system 150. The display 1900 is typically positioned in the dash of the vehicle in the field of view of the driver. A group of icons 1902 are displayed for selection by the user 108. Each icon is associated with a particular application. Icon 1904 is for the application 158 that controls and interacts with the medicament delivery device 102. The user 108 may select the icon 1904 via touch on the touchscreen display or by way of spoken command. The management device 104 may support voice commands and the application 158 may leverage that capability.

[0077] Once the icon 1902 has been selected, the home screen 2002, like that shown in Figure 20, may be displayed on display 2000 of the vehicle infotainment system. The home screen includes a display 2004 of the last glucose level reading and text 2006 specifying the time of the last glucose reading. In addition, the home screen 2002 may display an arrow icon 2008 indicating the current trend in glucose level values for the user 108. The home screen 2002 may display the insulin on board 2010 for the user 108. The home screen 2002 may show a plot 2016 of glucose level values for the user 108, which may be driven by a paired CGM sensor. A curve 2024 of the values over a specified time interval is depicted in the plot 2016. The user-selected lower threshold 2026 and upper threshold 2028 are depicted in the plot 2016. As with the smartwatch 130, the application 158 may obtain the data regarding glucose level history and insulin delivery history from the management device 104 or even from the medicament delivery device 102. A notifications icon 2020 may be selected to display notifications that have been generated by the medicament delivery system 100. To use voice commands, the user 108 may select icon 2022 to activate the voice recognition agent.

[0078] If the user 108 wishes to view more information regarding the history and trends of the glucose concentration values for the user 108, the user 108 may select to view the glucose viewing screen. Figure 21 depicts an illustrative glucose viewing screen 2102 shown on the display 2100. Three buttons 2104 are displayed to allow the user 108 to select whether to view a one-hour view, a three-hour view or a six-hour view. In the example shown in Figure 21, the user 108 has selected the three-hour view. The user 108 may be able to adjust the viewing window options displayed on the application in the medicament device settings. A plot 2112 is displayed that includes a curve 2110 of the glucose level readings over the three-hour interval. The lower threshold 2108 and the upper threshold 2106 are displayed. The glucose viewing screen 2102 also displays the most recent glucose level value 2118 and the trend icon 2120. A home button 2116 is provided to return to the home screen. A button 2114 is provided to invoke the use of voice commands. When the user selects the icon 2114, a screen 2202 like that shown in Figure 22 is displayed on the display 2200. A prompt 2204 is provided to prompt the user to provide voice commands.

[0079] As was mentioned above, the medicament delivery system 100 may generate alerts alarms and other notifications. These notifications may appear on the display of the vehicle infotainment system in some embodiments. The notifications are generated by the application 158 or by the management device 104. Figure 23A depicts an example notification 2304 shown on the display 2302 for the vehicle infotainment system 2300. The notification 2304 contains textual content. In this example, the notification 2304 informs the user 108 that the medicament delivery device has less than 50 units of insulin remaining. Once the user 108 has read the notification, the user 108 may dismiss the notification by selecting the “Dismiss” button 2306. The notification may also disappear after a set time period depending on the priority of the message.

[0080] The user 108 may also see a history of the most recent notifications. Figure 23B depicts a display 2312 for the vehicle infotainment system 2300 showing a history of notifications organized in list form in chronological order from most recent to oldest but may be sorted based on user 108 preference in the medicament device. Each notification includes a time and a description of the notification. For example, notification 2310 was issued at 9 AM and informs the user 108 that the medicament delivery device expires in four hours. Notification 2308 was issued at 9:25 AM and informs user 108 of the delivery of a bolus of insulin of 3.5 units. The term “Bolus” is highlighted to indicate a user or system action. The screen 2312 also includes a home button 2314 to return to the home screen.

[0081] The user 108 may use voice commands to navigate to the glucose viewing screen and to make selections on that screen to operate hands free. This is helpful to a driver of a vehicle. A voice assistant may be provided as part of application 158 or the voice assistant of the management device 104 may be used. Figure 24 depicts a sequence of screens that may be displayed in an illustrative instance. Initially, at step one, screen 2400 is displayed to indicate that the voice commands have been activated. In this example the user asks for his/her most recent glucose level reading as indicated by 2402. The voice assistant generates screen 2404 at step two to confirm receipt of the voice command. Next, the view of the glucose viewing screen 2406 is displayed at step three. In the example of Figure 24, at step four, the user 108 may use the buttons to select the time interval of the view, as has been discussed above. In step five, as shown in screen 2410, a prompt that the voice assistant is waiting for a voice command is displayed after the user has initiated the voice assistant by selecting the “Ask Omnipod” button on the system. The user 108 issues a voice command to go to the home screen as indicated by 2412. At step six, the voice assistant generates a screen 2414 to confirm receipt of the voice command. At step seven, the home screen 2416 is displayed. [0082] As was mentioned above, a user 108 may use voice commands to cause the delivery of a bolus of medicament. Figure 25 illustrates a sequence of screens organized into eight steps for a voice-assisted bolus sequence. Initially, at screen 2500, the user has activated the use of voice commands and submits a request 2502 to calculate a bolus using a carbohydrate value of 25 grams. At step two, the voice assistant in screen 2504 acknowledges the voice command provided by the user 108. At step three, screen 2506 is displayed to illustrate how the application 158 calculates the insulin bolus. The calculation is performed as discussed above. At step four, the voice assistant asks the user 108 to confirm the bolus value that is calculated using voice commands or on-screen buttons (see message 2510 on screen 2508). After the user 108 has confirmed the bolus value that was calculated in step four, the voice assistant in screen 2512, as part of step five, asks the user 108 to provide a confirmatory code to confirm delivery of the insulin bolus. In the example the user provides a pass code “1234” (see 2514). In step six, as indicated by screen 2516, the voice assistant provides an indication that the bolus has been confirmed with the proper pass code. In step seven, screen 2518 is displayed to indicate that the bolus is in process and specifies the bolus dosage. A status bar 2520 is displayed in the example shown. The user 108 may have the ability to cancel the bolus by selecting a cancellation button. Lastly, in step eight, upon successful bolus delivery the system returns to a home screen 2522. The insulin on board value is updated to reflect the insulin bolus that has been delivered.

[0083] The application 158 may use geo-location or geo-positioning information, such as GPS data, to aid in helping the user. The information may be used with a smartwatch 130 or a vehicle infotainment system. For example, in a vehicle infotainment system, as shown in Figure 26, the application 158 may note that the user 108 is on a routine route where the user is on their way to exercise based on geolocation services. A voice assistant then displays the message 2604 on screen 2602 that is shown on display 2600. The message 2604 notes that it appears that the user is on the way to exercise, prompting the system to request of the user if they would like to enter a mode of insulin delivery that is suitable for exercising to avoid an excursion in glucose level. The user 108 may accept or reject the protective insulin delivery mode via voice command or via the touchscreen. [0084] More generally, the application 158 may leverage geolocation information, such as GPS and map information, to assist the user 108. As shown in Figure 27, at 2702 in the flowchart 2700, the application may receive GPS information regarding the current location of the car and user 108 via either the vehicle or via the management device 104. The GPS information is compared to known GPS data at 2704 to see if there is a match. For example, the sequence of the GPS data may correspond to a route that the user takes to a restaurant. The application 158 may then ask the user 108 if the user is going to eat and wished to shift to an insulin delivery mode suitable for a meal. Similarly, the GPS data could indicate instead that the car is no longer moving and corresponds to a restaurant location. The same prompt can be produced as before regarding whether the user is eating. In general, the application may take action if there is a location match that is associated with an action at 2706. Otherwise, no action is taken. The application 158 may also leverage other smartphone applications that have given permission to use information to make insulin controller decisions. For example, if a user decides to order food and beverage via a mobile application ordering platform, the application 158 may read relevant information such as carbohydrates, calories, fat, or other values that may automatically be added in the user’s insulin management bolus calculation. The user may decide to use this information immediately to deliver a bolus or delay treatment based on a set time. If the bolus execution is delayed, the system will prompt the user to confirm bolus delivery once the timer has expired.

[0085] While exemplary embodiments have been described herein, various changes in form and detail may be made relative to the exemplary embodiments without departing from the intended scope of the attached claims.