Drug delivery system with graphic user interface - Patents.com

Abstract

A system for automated delivery of medication to a user is disclosed. Sensors worn by the user can collect information about the user. A user device, e.g., a smartphone, executes a user application that uses the collected information to determine an amount of medication to provide to the user. The user application includes a graphical user interface that allows a user to easily interact with the user application to specify various aspects of the medication delivery. The user application controls a wearable drug delivery device to dispense the medication to the user.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 132,694, filed December 31, 2020, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE Embodiments herein relate generally to automated drug delivery, and more particularly to a wireless drug delivery system using a wearable drug delivery device and a user application for controlling the wearable drug delivery device. [Background technology]

[0003] Wearable drug delivery systems, particularly those for delivering insulin, are typically capable of monitoring a user's glucose level, determining an appropriate insulin level for the user based on the monitored glucose level, and subsequently dispensing insulin to the user. The sophisticated control algorithms required for such systems generally require powerful computing resources and large capacity power sources. As a result, conventional drug delivery systems do not provide wireless communication between system components, fully autonomous operation, enhanced user experience involving ubiquitous electronic devices such as smartphones, and improved security features. Thus, there is a need for an insulin management system that includes such capabilities. Summary of the Invention

[0004] In the drawings, like numerals generally refer to the same parts throughout the different drawings.In the following description, various embodiments of the present invention are described with reference to the following drawings, in which: [Brief description of the drawings]

[0005] [Figure 1] FIG. 1 illustrates a functional block diagram of an exemplary system. [Figure 2a]1A-1D show front-up and back perspective views of an exemplary medical device suitable for implementing the systems and methods disclosed herein. [Figure 2b] 1A-1D show front-up and back perspective views of an exemplary medical device suitable for implementing the systems and methods disclosed herein. [Figure 2c] 2a and 2b show a first and second view of the device of FIG. 2a and FIG. 2b showing an add-on module; [Figure 2d] 2a and 2b show a first and second view of the device of FIG. 2a and FIG. 2b showing an add-on module; [Diagram 3] Shows system components in place on the user. [Figure 4] Shows the default home screen for user applications. [Figure 5a] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5b] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5c] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5d] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 6a] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6b] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6c] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6d] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6e] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6f] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 7a] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Pod Info" tab is selected. [Figure 7b] 1 shows an example of an information page that is displayed in the main area of ​​the home screen when the "Pod Info" tab is selected. [Figure 8a] 4 shows an example of a page that is overlaid on top of the main area of ​​the home screen when the user application is delivering an immediate bolus or a sustained bolus. [Figure 8b] 4 shows an example of a page that is overlaid on top of the main area of ​​the home screen when the user application is delivering an immediate bolus or a sustained bolus. [Figure 9a] 1 shows an example of the information page that appears in the "Upcoming Boluses" area of ​​the home screen. [Figure 9b] 1 shows an example of the information page that appears in the "Upcoming Boluses" area of ​​the home screen. [Figure 10a] An example of an information page displayed in the "CGM Info" area of ​​the home screen is shown. [Figure 10b] An example of an information page displayed in the "CGM Info" area of ​​the home screen is shown. [Figure 10c] An example of an information page displayed in the "CGM Info" area of ​​the home screen is shown. [Figure 11a] 13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 11b]13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 11c] 13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 11d] 13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 11e] 13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 11f] 13 shows an example of a screen that provides a bolus calculator that is displayed when the bolus button on the default home screen is selected, as well as an example of a screen that allows the user to specify continuous bolus delivery. [Figure 12] 1 is an example screen showing a list of notifications that are displayed when a user selects the notification indicator from the default home screen. [Figure 13a] An example of the main menu that appears when the menu button is selected from the home screen is shown. [Figure 13b] An example of the main menu that appears when the menu button is selected from the home screen is shown. [Figure 14a] Here are examples of modal messages that are used to provide information to the user about a special status or error condition. [Figure 14b] Here are examples of modal messages that are used to provide information to the user about a special status or error condition. [Figure 15] 13 shows an example of a screen showing detailed information about a wearable drug delivery device. [Figure 16a]13 shows an example of an instruction screen that provides step-by-step instructions for a user to initially set up a new drug delivery device and to wear the drug delivery device on the user's body. [Figure 16b] 13 shows an example of an instruction screen that provides step-by-step instructions for a user to initially set up a new drug delivery device and to wear the drug delivery device on the user's body. [Figure 16c] 13 shows an example of an instruction screen that provides step-by-step instructions for a user to initially set up a new drug delivery device and to wear the drug delivery device on the user's body. [Figure 16d] 13 shows an example of an instruction screen that provides step-by-step instructions for a user to initially set up a new drug delivery device and to wear the drug delivery device on the user's body. [Figure 17a] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Figure 17b] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Figure 17c] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Figure 17d] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Figure 17e] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Fig. 17f] 1 shows examples of screens that allow a user to view, create, edit, and start basic programs. [Figure 18a] 13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Figure 18b] 13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Figure 18c] 13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Figure 18d]13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Figure 18e] 13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Fig. 18f] 13 shows an example of a screen that allows a user to create or select a temporary basal profile. [Figure 19a] 13 shows an example of a screen that allows a user to manually enter a blood glucose recording value. [Figure 19b] 13 shows an example of a screen that allows a user to manually enter a blood glucose recording value. [Figure 19c] 13 shows an example of a screen that allows a user to manually enter a blood glucose recording value. [Figure 19d] 13 shows an example of a screen that allows a user to manually enter a blood glucose recording value. [Figure 20a] 1 shows an example screen implementing a food library that a user can use to select foods to add to a meal for the purposes of calculating the total carbs ingested during the meal. [Figure 20b] 1 shows an example screen implementing a food library that a user can use to select foods to add to a meal for the purposes of calculating the total carbs ingested during the meal. [Figure 20c] 1 shows an example screen implementing a food library that a user can use to select foods to add to a meal for the purposes of calculating the total carbs ingested during the meal. [Figure 20d] 1 shows an example screen implementing a food library that a user can use to select foods to add to a meal for the purposes of calculating the total carbs ingested during the meal. [Figure 21a] An example of a screen used for initial setup of a user application is shown below. [Figure 21b] An example of a screen used for initial setup of a user application is shown below. [Figure 21c]An example of a screen used for initial setup of a user application is shown below. [Figure 21d] An example of a screen used for initial setup of a user application is shown below. [Figure 21e] An example of a screen used for initial setup of a user application is shown below. [Fig. 21f] An example of a screen used for initial setup of a user application is shown below. [Fig. 21g] An example of a screen used for initial setup of a user application is shown below. [Figure 22a] 4 shows examples of information and error screens displayed by the graphic user interface. [Figure 22b] 4 shows examples of information and error screens displayed by the graphic user interface. [Figure 22c] 4 shows examples of information and error screens displayed by the graphic user interface. [Figure 23a] 13 shows an example of a screen showing the operation history of a user application and a medication delivery device. [Figure 23b] 13 shows an example of a screen showing the operation history of a user application and a medication delivery device. [Figure 23c] 13 shows an example of a screen showing the operation history of a user application and a medication delivery device. [Figure 24a] 13 shows an example of a screen showing information about user applications and associated devices. [Figure 24b] 1 shows a screen used to send a log file to a customer care center. [Figure 24c] 1 shows a screen used to send a log file to a customer care center. [Figure 25a] 3 shows a menu that provides the general setup of the application. [Figure 25b] 13 shows a screen that allows the user to change the time zone on which insulin delivery calculations are based. [Figure 25c] 13 shows a screen that allows the user to change the time zone on which insulin delivery calculations are based. [Figure 26a] 13 shows an example of a screen that allows the user to pause and start the delivery of a medication. [Figure 26b] 13 shows an example of a screen that allows the user to pause and start the delivery of a medication. [Figure 27a] 1 shows an example of a screen that allows a user to start and cancel HypoProtect™ mode. [Figure 27b] 1 shows an example of a screen that allows a user to start and cancel HypoProtect™ mode. [Figure 28a] 1 shows an example of a screen that allows a user to switch between automatic and manual modes of operation of a user application. [Figure 28b] 1 shows an example of a screen that allows a user to switch between automatic and manual modes of operation of a user application. [Figure 29a] 13 shows an example of a screen that allows a user to connect a new medication delivery device to the user application. [Figure 29b] 13 shows an example of a screen that allows a user to connect a new medication delivery device to the user application. [Figure 30a] 13 shows an example of a screen that allows a user to set parameters for reminders provided by a user application. [Figure 30b] 13 shows an example of a screen that allows a user to set parameters for reminders provided by a user application. [Figure 31a] An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. [Figure 31b]An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. [Fig. 31c] An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. [Fig. 31d] An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. [Figure 31e] An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. [Fig. 31f] An example of a screen is shown that displays a list of people ("viewers") who are allowed to view data generated by user app 160 and allows the user to add new viewers to that list. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] Various embodiments of the present invention include systems and methods for delivering medication to a user using a wearable drug device (sometimes referred to herein as a "pod"), either automatically or according to a wireless signal received from an electronic device. In various embodiments, the electronic device may be a user device including a smartphone, a smart watch, a smart necklace, a module attached to a drug delivery device, or any other type or kind of electronic device that can be worn or carried on the user's body and executes an algorithm that calculates the time and dosage of medication delivery. For example, the user device may execute an "artificial pancreas" algorithm that calculates the time and dosage of insulin delivery. The user device may also communicate with a sensor, such as a glucose sensor, that collects data regarding a physical attribute or condition of the user, such as glucose levels. The sensor may be located in or on the user's body and may be part of the drug delivery device or may be a separate device. Alternatively, the drug delivery device may communicate with the sensor instead of or in addition to communication between the sensor and the user device. The communication may be direct (e.g., if the sensor is integrated with or otherwise part of the drug delivery device) or remote / wireless (e.g., if the sensor is located in a housing different from the medical device). In these embodiments, the sensor and / or drug delivery device has computing hardware (eg, processor, memory, firmware, etc.) that executes some or all of the algorithms that calculate the time and dosage of drug delivery.

[0007] 1 shows a functional block diagram of an exemplary drug delivery system 100 suitable for implementing the systems and methods described herein. The drug delivery system 100 may execute (and / or provide functionality for) drug delivery algorithms to manage or control the automated delivery of a drug or medication, such as insulin, to a user (e.g., to maintain euglycemia, normal glucose levels in the blood). The drug delivery system 100 may be an automated drug delivery system that may include a wearable drug delivery device 102, an analyte sensor 108, and a user device 105.

[0008] The drug delivery system 100 may also include accessory devices 106, such as a smart watch, personal digital assistant, or the like, in examples which may be selected as desired, which may communicate with other components of the system 100 via either wired or wireless communication links 191-193.

[0009] The user device 105 may be a computing device such as a smartphone, tablet, personal diabetes management (PDM) device, dedicated diabetes therapy management device, or the like. For example, the user device 105 may include a processor 151, a device memory 153, a user interface 158, and a communication interface 154. The user device 105 may also have analog and / or digital circuitry that may be implemented as the processor 151 for executing processes based on program code stored in the device memory 153, such as user applications 160 for managing the user's blood glucose levels and for controlling delivery of drugs, medications, or therapeutic agents to the user, as well as for providing other functions such as calculating carbohydrate-compensation dosage, correction bolus dosage, and the like, as discussed below. The user device 105 may be used to program, adjust settings, and / or control the operation of the wearable drug delivery device 200a, 200b and / or the analyte sensor 103, as well as smart accessory devices 106 that may be used as desired.

[0010] The processor 151 may also be configured to execute program code stored in the device memory 153, such as the user app 160. The user app 160 may be a computer application operable to deliver medication based on information received from the analyte sensor 103, the cloud service 111, and / or the user device 105 or the accessory device 106, which may be used as desired. The memory 153 may also store program code for operating, for example, a user interface 158 (e.g., a touch screen device, a camera, or the like), a communication interface 154, and the like. When the processor 151 executes the user app 160, it may be configured to perform displays and notifications related to food intake, blood glucose measurements, and the like. The user interface 158 may be under the control of the processor 151 and may be configured to present a graphical user interface that allows for input of food reports, adjustment of setting options, and the like, as described herein.

[0011] In a specific example, when the user app 160 is an insulin delivery application, the processor 151 is also configured to execute a diabetes treatment plan (which may be stored in the memory) managed by the user app 160. In addition to the functions described above, when the user app 160 is an insulin delivery application, the user app 160 may further provide functionality for determining a carbohydrate compensation dose, a correction bolus dose, and determining a basal dose according to the diabetes treatment plan. In addition, as an insulin delivery application, the user app 160 provides functionality for outputting a signal to the wearable drug delivery device 200a, 200b via the communication interface 154 to deliver the determined bolus dose and basal dose.

[0012] Communications interface 154 may include one or more transceivers operating according to one or more radio frequency protocols. In one embodiment, the transceivers may include a cellular transceiver and a Bluetooth transceiver. Communications interface 154 may be configured to receive and transmit signals containing information usable by user apps 160.

[0013] The user device 105 may further include one or more output devices 155, which may be, for example, a speaker or a vibration transducer, for providing various signals to the user.

[0014] A preferred embodiment of the wearable drug delivery device 102 may include a reservoir 124 and a drive mechanism 125, which are controllable by a controller 121 executing a drug delivery algorithm (MDA) 129 stored in memory 123. Alternatively, the controller 121 may act to control the reservoir 124 and the drive mechanism 125 based on signals received from a user app 160 executing on the user device 105 and communicating with the wearable drug delivery device 102 via a communication link 194.

[0015] The wearable drug delivery device 102 may further include a user interface 127, a patient interface 186, a communication interface 126, device sensors 184, and a power source 128.

[0016] In alternative embodiments, the wearable drug delivery device 102 may include an optional second reservoir 124-2 and a second drive mechanism 125-2, allowing for independent delivery of two different liquid drugs. By way of example, the reservoir 124 may be filled with insulin, while the reservoir 124-2 may be filled with pramlintide or GLP-1. In some embodiments, each of the reservoirs 124, 124-2 may be configured with a separate drive mechanism 125, 125-2, respectively, which may be separately controllable by the controller 121 under the command of the MDA 129. Both reservoirs 124, 124-2 may be connected to a common patient interface 186.

[0017] The wearable drug delivery device 102 may be configured with a user interface 127 that provides a means for receiving input from a user and a means for outputting information to a user, as desired. The user interface 127 may include, for example, light emitting diodes, buttons on the housing of the wearable drug delivery device 102, a sound transducer, a microdisplay, a microphone, an accelerometer for detecting movement of the device due to a user gesture (e.g., tapping the housing of the device), or any other type of interface device configured to allow a user to input information and / or for the wearable drug delivery device 102 to output information for presentation to a user (e.g., an alarm signal or the like).

[0018] The wearable drug delivery device 102 includes a patient interface 186 for interfacing with a user to deliver a liquid drug. The patient interface may be, for example, a needle or cannula for delivering the drug to the user's body (this may be done subcutaneously, intraperitoneally, or intravenously). The wearable drug delivery device 102 further includes a means for inserting the patient interface 186 into the user's body, which in one embodiment may comprise an actuator for inserting the needle / cannula under the user's skin and then retracting the needle to leave the cannula in place.

[0019] In one embodiment, the wearable drug delivery device 102 includes a communication interface 126, which may be a transceiver operating according to one or more radio frequency protocols, such as Bluetooth, Wi-Fi, near field communication, cellular, or the like. The controller 121 may communicate with the user device 105 and the analyte sensor 108, for example, via the communication interface 126.

[0020] In some embodiments, the wearable drug delivery device 102 may include one or more sensors 184. The sensors 184 may include one or more of a pressure sensor, a power sensor, or the like, coupled in communication with the controller 121 to provide various signals. For example, the pressure sensor may be configured to provide an indication of fluid pressure detected in a fluid path between the patient interface 186 and the reservoir 124. The pressure sensor may be coupled to or integral with an actuator for inserting the patient interface 186 into a user. For example, the controller 121 may be operable to determine a drug infusion rate based on the indication of fluid pressure. The drug infusion rate may be compared to an infusion rate threshold, and the results of the comparison may be usable to determine an amount of remaining insulin (IOB) or a total daily insulin (TDI) amount.

[0021] The wearable drug delivery device 102 further includes a power source 128, such as a battery, a piezoelectric device, an energy harvesting device, or the like, for powering the controller 121, the memory 123, the drive mechanism 125, and / or other components of the wearable drug delivery device 102.

[0022] The communications link 115 coupling the cloud service 111 with each of the devices 102, 105, 106, 108 of the system 100 may be a cellular link, a Wi-Fi link, a Bluetooth link, or a combination thereof. The services provided by the cloud service 111 may include data storage for storing anonymized data such as blood glucose measurements, IOB or TDI history, previous carbohydrate compensation doses, and other forms of data. Additionally, the cloud service 111 may process anonymized data from multiple users to provide generalized information related to TDI, insulin sensitivity, IOB, and the like.

[0023] Wireless communication links 191-196 may be any type of wireless link operating using known wireless communication standards or proprietary standards. By way of example, wireless communication links 191-196 may provide, via respective air interfaces 154, 174, 126, and 135, communications links based on Bluetooth, Zigbee, Wi-Fi, short-range wireless communication standards, cellular standards, or any other wireless protocol.

[0024] The wearable drug delivery device 102 may be configured to implement and execute the processes required to deliver a dose of medication to a user without input from the user device 105 or an accessory device 106, which may be used as desired. As will be described in more detail, the MDA 129 may be operable to determine, for example, the amount of insulin to be delivered, the IOB, the insulin remaining amount, and the like, and to actuate the drive mechanism 125 to the controller 121 to deliver the medication from the reservoir 124. The MDA 129 may utilize data received from the analyte sensor 108 or from a user app 160 as input.

[0025] The reservoirs 124, 124-2 may be configured to store drugs, agents, or therapeutic agents suitable for automated delivery, such as insulin, pramlintide, GLP-1, co-formulations of insulin and GLP-1, morphine, blood pressure medications, chemotherapy agents, fertility drugs, or the like.

[0026] The wearable drug delivery device 102 can be attached to a body attachment location on a user, such as a patient or diabetic, and can deliver any therapeutic agent, including any drug or medication, such as insulin or the like, to the user at or around the attachment location. One side of the wearable drug delivery device 102 can include an adhesive to facilitate attachment to the skin of a user.

[0027] When configured to communicate with an external device, such as the user device 105 or the analyte sensor 108, the wearable drug delivery device 102 may receive signals from the user device 105 via link 194 or from the analyte sensor 108 via link 196. The controller 121 of the wearable drug delivery device 102 may receive and process the signals from the respective external devices and may further execute drug delivery to the user according to a diabetes treatment plan or other drug delivery regime executed by the MDA 129 or user application 160.

[0028] In an example of operation, the controller 121, upon execution of the MDA 129, may generate and output control signals that are operable to move the drive mechanism 125 to deliver a carbohydrate compensation dose of insulin, a correction bolus, a modified basal dose, co-formulations of various liquid drugs, or the like.

[0029] The accessory device 106 may be, for example, an Apple Watch®, other wearable smart devices, such as eyeglasses, smart jewelry, wearable global positioning systems, wearable fitness devices, smart clothing, or the like. Like the user device 105, the accessory device 106 may be configured to perform various functions, including controlling the wearable drug delivery devices 200a, 200b. For example, the accessory device 106 may include a communication interface 174, a processor 171, a user interface 178, and a memory 173. The user interface 178 may be a graphical user interface presented on a touchscreen display of the smart accessory device 106. The memory 173 may store program code for operating different functions of the smart accessory device 106, as well as instances of user apps 160 or pared-down versions of the user apps 160 with reduced functionality.

[0030] The analyte sensor 108 may include a controller 131, a memory 132, a sensing / measuring device 133, an optional user interface 137, a power / energy harvesting circuit 134, and a communication interface 135. The analyte sensor 108 may be communicatively coupled to a processor 151 of the management device 105 or the controller 121 of the wearable drug delivery device 200a, 200b. The memory 132 may be configured to store information and program code 136.

[0031] The analyte sensor 108 may be configured to detect a number of different analytes, such as lactate, ketones, uric acid, sodium, potassium, alcohol levels, or the like, and output a result of the detection, such as a measurement or the like. The analyte sensor 108 may be configured in a preferred embodiment to measure blood glucose values ​​at predetermined time intervals, such as every 5 minutes, or the like. The communication interface 135 of the analyte sensor 108 may have circuitry that operates as a transceiver to communicate the measured blood glucose values ​​to the user device 105 via the wireless link 195, or to communicate with the wearable drug delivery device 200a, 200b via the wireless communication link 108. Although referred to herein as the analyte sensor 108, the sensing / measuring device 133 of the analyte sensor 108 may include one or more additional sensing elements, such as a glucose measuring element, a heart rate monitor, a pressure sensor, or the like. Controller 131 may include separate dedicated logic circuitry and / or components, application specific integrated circuits, microcontrollers, or processors that execute software instructions, firmware, program instructions, or any combination thereof stored in a memory (such as memory 132).

[0032] Similar to the controller 221 of the wearable drug delivery device 200a, 200b, the controller 131 of the analyte sensor 108 may be operable to perform many functions. For example, the controller 131 may be configured by program code 136 to manage the collection and analysis of data detected by the sensing and measuring device 133.

[0033] 1 as being separate from the wearable drug delivery device 102, in various embodiments, the analyte sensor 108 and the wearable drug delivery device 102 may be incorporated into the same unit. That is, in various examples, the analyte sensor 108 may be part of, integral with, and housed in the same housing as the wearable drug delivery device 102. In such embodiments, the controller 221 may be capable of performing the functions required for proper delivery of medication alone, without any external input from the user device 105, the cloud service 111, another sensor (not shown), an accessory device 106 that may be used as desired, or the like.

[0034] The user app 160 (or MDA 129) may provide periodic insulin microboluses based on predicted glucose over a 60 minute prediction horizon. Optimal post-prandial control requires the user to administer meal boluses in the same manner as current pump therapy, but normal operation of the user app 160 compensates for missed meal boluses and reduces persistent hyperglycemia. The user app 160 employs a control-to-target strategy that attempts to achieve and maintain set target glucose values, thereby reducing the duration of persistent hyperglycemia and hypoglycemia.

[0035] The user app 160 is the primary interface with the user and implements a graphical user interface used to control the wearable drug delivery device 200a, 200b, program basal and bolus calculator settings for manual mode, as well as program dedicated settings for automatic mode (hybrid closed-loop or closed-loop).

[0036] In manual mode, the user app 160 delivers insulin at programmed basal rates and bolus amounts and also has the option to set a temporary basal profile. The controller 121 also has the ability to function as a sensor pump in manual mode, populating the bolus calculator with sensor glucose data provided by the analyte sensor 108.

[0037] In the automatic mode, the user app 160 supports the use of multiple target blood glucose values. For example, in one embodiment, the target blood glucose values ​​may be in the range of 110-150 mg / dL in 10 mg / dL increments, 5 mg / dL increments, or other increments, but preferably in 10 mg / dL increments. The user experience reflects a current setup flow, where the healthcare provider assists the user in programming the basal rate, glucose target, and bolus calculator settings. These then inform the user app 160 about insulin dosing parameters. The insulin dosing parameters are adapted over time based on the total daily insulin (TDI) delivered during the course of each use of the wearable drug delivery device 200a, 200b. A temporary hypoglycemic protection mode may be implemented by the user in the automatic mode for various durations. In the hypoglycemic protection mode, the algorithm reduces insulin delivery and is intended to be used for temporary periods when increased insulin sensitivity is expected, such as during exercise.

[0038] The user app 160 can use large text, graphics, and on-screen instructions to guide the user through the set-up process and use of the system 100. It can also be used to program a personalized basal insulin delivery profile, check the status of the wearable drug delivery devices 200a, 200b, initiate an insulin bolus, change the patient's insulin delivery profile, address system warnings and alarms, and allow the user to switch between automatic and manual modes.

[0039] In some embodiments, the user device 105 and the analyte sensor 108 may not communicate directly with each other. Instead, data from the analyte sensor (e.g., blood glucose readings) may be communicated to the wearable drug delivery devices 200a, 200b via link 196 and then relayed to the user device 105 via link 194. In some embodiments, the analyte sensor serial number must be entered into the user app 160 to enable communication between the analyte sensor 108 and the user device 105.

[0040] The user app 160 may provide the ability to calculate a suggested bolus dose using a bolus calculator. The bolus calculator is provided as a convenience to the user to aid in determining a suggested bolus dose based on ingested carbohydrates, the most recent blood glucose reading (or blood glucose reading if a fingerstick is used), a programmable correction factor, insulin to carbohydrate ratio, target glucose value, and residual insulin (IOB). The IOB is estimated by the user app 160, taking into account both manual boluses and insulin delivered by an algorithm.

[0041] Various embodiments described herein include systems and methods for automatically delivering medication to a user. A sensor coupled to a user can collect information about the user. A controller can use the collected information to determine an amount of medication to provide to the user. The controller can command a drug delivery device to dispense the medication to the user. The drug delivery device can be a wearable insulin pump directly coupled to the user. The controller can be implemented, in whole or in part, as a smartphone app. The user can be required to provide a confirmation input to cause the user to dispense an amount of insulin determined based on the user's detected glucose level.

[0042] Software-related implementations of the techniques described herein may include, but are not limited to, firmware, application specific software, or any other type of computer-readable instructions that may be executed by one or more processors. The computer-readable instructions may be provided via a non-transitory computer-readable medium. Hardware-related implementations of the techniques described herein may include, but are not limited to, integrated circuits (ICs), application specific ICs (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the techniques described herein and / or any system or configuration components described herein may be implemented using a processor executing computer-readable instructions stored in one or more memory components.

[0043] FIG. 2a shows a perspective view of the drug delivery device 102, facing up, showing the housing or housings of the drug delivery device 102. FIG. 2b shows a perspective view of the drug delivery device 102, showing the adhesive backing 206 and the needle / cannula cap 208. Removing the adhesive backing 206 exposes the adhesive pad 204, which is used to adhere the drug delivery device 102 to the skin of a user. The needle / cannula cap 208 protects the needle / cannula until use of the device and should be removed as shown to expose the needle / cannula before adhering the device to the skin of a user. The adhesive should be strong enough to adhere the drug delivery device 102 to the skin of a user, but also allow the drug delivery device 102 to be easily removed.

[0044] 2c-d, the drug delivery device 102 may include a module 202 attached or coupled to one or more housings of the drug delivery device 102. Alternatively, the module 202 may be disposed within a main housing of the drug delivery device 102 or may be located proximate to another housing of the drug delivery device 102 such that there is a seamless transition between the housing of the drug delivery device 102 and the module 202.

[0045] The module 202 may include some or all of the features described above with reference to the user device 105, or other electronic or durable or semi-durable components. In various embodiments, the module 202 may include a transceiver that enables the drug delivery device 102 to wirelessly communicate with any other device or component shown in FIG. 1. The module 202 and the drug delivery device 102 may communicate over any known wireless or wired communication standard or protocol. In some embodiments, for example, short-range wireless communication is used for communication between the drug delivery device 102 and the module 202. In other embodiments, a wired connection, such as a Universal Serial Bus connection, is used for communication between the drug delivery device 102 and the module 202.

[0046] The module 202 may contain a motor for driving a pump that pushes the drug into the user's body, at least one battery and / or supercapacitor, a printed circuit board, a memory, a processor, a wireless communication interface such as a Bluetooth transceiver, a Bluetooth low energy transceiver, a body area network (BAN) transceiver, a cellular communication transceiver, or a WiFi transceiver, at least one antenna, sensors such as a temperature sensor, an accelerometer, a barometric pressure sensor, and / or a light sensor. The module 202 may also contain a light output such as one or more LEDs, a vibration transducer, and / or an audio output such as a speaker to provide feedback to the user. The pump may be housed within the drug delivery device 102 and may be, for example, a positive displacement pump or a reciprocating pump. The processor in the module 202 may take many different forms, including a central processing unit (CPU), a graphics processing unit (GPU), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a special purpose controller chip, or a system on a chip (SoC). The processor may execute program instructions stored in the memory. The memory may include one or more types of storage, including but not limited to random access memory (RAM), flash memory, read only memory (ROM), computer readable memory storage, and the like. The memory may also hold data and other useful information for the operation of the drug delivery device 102. The drug delivery device 102 attached to the electronic module 202 may have other components of a drug delivery system including, for example, a reservoir for storing a medication, a needle, cannula, and / or a microneedle array for delivering the medication to the user's body, and a pump for transferring the medication from the reservoir through the needle, cannula, or microneedle array to the user's body. The drug delivery device 102 may also include a power source, such as a battery, for powering the pump and / or other components of the drug delivery device 102.

[0047] The module 202 may be removably attached to the drug delivery device 102 such that the module 202 may be reusable such that the module 202 may be used with multiple drug delivery devices 102, which may be partially or entirely disposable. This avoids the need to remanufacture all components of the drug delivery device 102, which may be disposable, after the drug in the reservoir 124 is depleted, thereby reducing the cost of the drug delivery device 102. The module 202 may be sealed and waterproof. The module 202 may have a battery, which may be rechargeable using wireless or wired charging.

[0048] In various embodiments, the drug delivery device 102 and / or the module 202 described herein includes a user input device and / or a user output device. The user input device may be a button located on the drug delivery device 102 or the module 202, an acceleration sensor for detecting the movement of the drug delivery device 102 or the module 202, or any other such input device. The user output device may be a speaker for playing a sound, a vibration generator (e.g., a gear with a motor with an off-center of gravity) for creating vibrations, a metal terminal for administering an electric shock to the user's body, a display and / or one or more colored lights for issuing a visual alarm, or any other such output device.

[0049] In various embodiments, when a command is received at the drug delivery device 102 from the user device 105, the action associated with the command (e.g., delivery of a bolus) is not performed until an input is received from the user. The input may include pressing a button on the drug delivery device 102 or module 202, shaking the drug delivery device 102 or module 202 (as detected by an acceleration sensor), tapping the drug delivery device 102 or electronic module 202 one or more times (as detected by an acceleration sensor), scanning an RFID or NFC tag, key card, or fob, or any other such input, or pressing a button on the user device 105, or performing an action similar to those mentioned above. If the input is not received within a certain time (e.g., 30 seconds, 1 minute, 2 minutes, or any other time), the drug delivery device 102 and / or module 202 cannot perform the drug delivery action. That is, the determined insulin dose may not be delivered, and the user may be alerted accordingly. In some embodiments, the output device alerts the user about an arriving command at the drug delivery device 102 or module 202, such as by sounding an alarm, vibrating, or emitting a visual signal. The output device may also alert the user after an action has been performed and / or if the action has been cancelled due to lack of user input.

[0050] A preferred embodiment of the system 100 is shown in Figure 3, which shows the system components in place on a user. In this embodiment, the drug delivery device 102 and the analyte sensor 108 may communicate directly, and one or both may communicate directly with other devices, such as the user device 105 or a cloud device or service 111. As noted above, the analyte sensor 108 may be integrated into the drug delivery device 102 or attached thereto in an adjacent housing.

[0051] Consider next the graphical user interface for user apps 160. Figure 4 shows a default home screen 400. When user apps 160 are launched, the default home screen 400, or a variation thereof, is displayed.

[0052] Home Screen The default home screen 400 includes an information area 404 that displays one of a number of pages showing various information, with the currently displayed page varying depending on the user's selection of one of a number of tabs displayed in a tab bar 402. In one embodiment of the invention, the tab bar 402 has three tabs that provide various page display options, a "Dashboard" tab, an "Insulin" tab, and a "Pod Info" tab, which are discussed in more detail below.

[0053] In one embodiment, the "Dashboard" tab may be the default tab displayed upon launch of the user app 160. As shown in FIG. 4, the tab bar 402 indicates that the "Dashboard" tab is selected, as indicated by an underline on the "Dashboard" tab, a different color for the word "Dashboard," and a highlight on the leftmost dot of the page indicator 403. The page indicator 103 has three dots corresponding to the "Dashboard," "Insulin," and "Pod Info" tabs in the tab bar 402, but in other embodiments may have a different number of dots depending on the number of options displayed in the tab bar 402. The page displayed in the information area 404 may be changed by selecting one of the tabs in the tab bar 402 or by swiping left or right within the information area 404. Selecting one of the tabs or swiping left or right within the area 404 changes the content displayed in the information area 404 without affecting the content displayed in areas 406 or 408 of the screen. The information area 404 is comprised of a border 404a that may change color depending on the mode of operation. For example, the border may be light gray when the user application 160 is in manual mode or if there are no pods active or no pod communication, and when the user application is in automatic mode, the border 404a may be purple or another color if the pod reports full automatic operation, or dark gray if the pod reports limited automatic operation.

[0054] The variation of home screen 400 that appears when user apps 160 are launched or when a user navigates to home screen 400 depends on the current state of user apps 160. In one embodiment, for example, if an immediate bolus is being delivered, the default home screen appears as shown in Figure 8a. If a continuous bolus is being delivered, the home screen appears as shown in Figure 8b.

[0055] Under certain circumstances, the "Pod Info" tab will be selected after launch and an appropriate information page will be displayed in the information area 404. Examples include: when there is no valid connection with the wearable drug delivery device 102, when the insulin in the wearable drug delivery device 102 reservoir is below a certain amount, such as 5 U, when the time until the pod expires is below a certain amount, such as 6 hours, when the time until the pod expires is within a certain range, such as 6-12 hours, and / or when the user has set a pod expiration reminder. Other circumstances may cause the "Pod Info" tab to be selected and other information screens to be displayed.

[0056] Under certain circumstances, the "Insulin" tab will be selected after start-up and the appropriate information page will be displayed in the information area 404. These include, for example, if a temporary basal program is running or if the user app 160 is running in a hypoglycemic protection mode, such as HypoProtect™ mode. Otherwise, the default home screen 400, as shown in FIG. 4, will be displayed.

[0057] Examples of various pages that may be displayed in information area 404 are shown in Figures 5-10 and are discussed in more detail below.

[0058] The bolus display area 406 of the default home screen 400 displays the most recent bolus amount or status and / or remaining insulin (IOB) status. Details of both the most recent bolus dose and remaining insulin status are discussed below. The information displayed in the bolus display area 406 may be automatically selected depending on the current state of the user app 160. Alternatively, the display may be changed by the user by the user tapping within the bolus display area 406. Example pages displayed in the bolus display area 406 are shown in Figures 9a-9b.

[0059] The CGM area 408 of the default home screen 400 provides options to display information about the user's continuous glucose monitoring. In certain embodiments, the CGM area 408 may display, for example, the most recent glucose log reading, or a graph of a predetermined number of the most recent glucose log readings from continuous glucose monitoring. The information displayed in the CGM area 408 may be automatically selected based on the current state of the user app 160, or may be selected by the user by tapping a finger within the CGM area 408. Examples of pages displayed in the CGM area 408 are shown in FIGS. 10a-10c.

[0060] The default home screen 400 includes a mode indicator 410, which indicates the current mode of the user app 160. Various modes may be indicated by different icons, words indicating the mode, and / or colors of the mode indicator 410. In a preferred embodiment of the present invention, the mode indicator 410 may indicate one of four modes: (1) a "no pod communication" mode indicator, which indicates that there is no valid communication between the user app 160 and the wearable drug delivery device 102, which may only be displayed after the CGM and / or IOB values ​​have expired; (2) a "restricted" mode indicator, which is displayed when in automatic mode, the drug delivery device 102 reports that it is in a restricted state; (3) a "manual" mode indicator, which is displayed when the user app 160 is operating in manual mode; and (4) an "automatic" mode, which is displayed when the drug delivery device 102 reports that it is operating in a fully automatic state or a hybrid automatic state.

[0061] The default home screen 400 includes a menu button 414 which, when activated by a user tapping the menu icon, in one embodiment of the invention, displays a vertical menu overlaid on the left side of the home screen 400. An example of the displayed menu 1300 is shown in Figures 13a-b.

[0062] 5a-5d show pages that may be displayed in the information area 404 of the default home screen 400 when the "Dashboard" tab is selected. FIG. 5a shows the default page, which includes an indicator 502 of remaining insulin, the most recent recorded value 504 from a connected CGM 108, and an arrow 506 that indicates a trend of the recorded value from the CGM 108. In some cases, the arrow 506 may not be present, indicating that the CGM 108 does not yet have enough data to identify a trend. Both the most recent CGM recorded value 502 and the trend arrow 506 may be displayed in different colors that indicate the CGM recorded value compared to a desired value. For example, in a preferred embodiment, blue indicates that the CGM recorded value 502 is within the user-set CGM / BG goal range and the user app 160 is operating in manual mode, red indicates that the most recent CGM recorded value 504 is below the user-set CGM / BG goal range (in both manual and automatic modes), yellow indicates that the most recent CGM recorded value 504 is above the user-set CGM / BG goal range (in both manual and automatic modes), and purple indicates that the most recent CGM recorded value 504 is within the user-set CGM / BG goal range and the user app 160 is operating in automatic mode. In other embodiments, other colors may be used as indicators of other conditions.

[0063] FIG. 5b is an example of a page that is displayed in the information area 404 when the CGM monitor 108 is not registered with the user app 160 and when there is an active wearable drug delivery device 102. In this case, the latest CGM recording 504 may not be available, so only remaining insulin is displayed. FIG. 5c shows a screen indicating that the CGM 108 has returned a status of "high." The high status is displayed in yellow, indicating that the latest CGM recording 504 is higher than the CGM / BG goal set by the user. Similarly, this type of page could also show an indication of "low" (not shown), which is displayed in red, indicating that the latest CGM recording 504 is lower than the CGM / BG goal range set by the user. FIG. 5d shows a page similar to the page shown in FIG. 5a, but with the addition of a button 508 that allows the user to initiate delivery of a bolus dose of insulin. Other screens are also available, for example, a screen showing the connection status of the CGM 108 may be displayed in the information area 404.

[0064] 6a-6f show pages that may be displayed in the information area 404 of the default home screen 400 when the "Insulin" tab is selected. FIG. 6a shows the default page that is displayed when a basal program is in progress. A basal program icon 602 is displayed in the top left corner of the screen. Different basal programs may have different icons. If a basal program is running, the basal program icon 602 may be shown in green, and if a basal program is not running, the basal program icon 602 may be grayed out. The name and status 604 of the basal program is shown next to the basal program icon 602. A basal graph 606 shows a full 24 hour graph that shows the total units of insulin to be delivered in a 24 hour period by the currently running basal program. A current basal rate 608 is shown in a box above the basal graph 606 according to the current time of the day. Below the basal graph 606 is a total insulin indicator 610 that shows the total insulin to be delivered by the currently running basal program for the day. Button 612, when selected by a user tapping on it, transitions the screen to the page shown in FIG. 6b where a list of saved basic programs 614 is displayed overlaid on the default home screen 400 above the bolus display area 406 and CGM area 408. The currently running basic program 613 is shown in the information area 404. Button 616 allows the user to create a new basic program, which will be saved in the list 614. Screens for creating, editing, and starting basic programs are shown in FIGS. 17a-17f.

[0065] 6d shows the page that is displayed in the information area 404 when a temporary basal preset program is running. This page is identical to the basal program page except that the total daily insulin 610 is replaced with the change in basal delivery due to the temporary basal program 618. In addition, this page includes a cancel button 620, which, when selected by the user, cancels the temporary basal program. When a temporary basal program is running, the "Insulin" tab in the tab bar 402 changes to a "Temporary On" button 618, shown in FIG. 6c. Once the temporary basal program is completed, the "Insulin" tab will again be displayed in the tab bar 402.

[0066] FIG. 6f shows the page that is displayed in the information area 404 when HypoProtect™ mode is selected by the user. HypoProtect™ mode may be invoked by the user if the user experiences a negative reaction from insulin, if the user is about to begin an activity or time window during which sensitivity to insulin is increased, or if the user simply wishes to suspend or reduce insulin delivery for a predetermined period of time. In one preferred embodiment, when HypoProtect mode is selected, automatic basal insulin delivery is reduced by 75% and the user's target blood glucose level is increased. The information area 404 includes an icon 624 that indicates that HypoProtect™ mode is in progress, as well as a time indicator 626 that indicates the time remaining before normal operation resumes. It also includes a button 628 ("Cancel") that the user may select to immediately cancel HypoProtect™ mode. When in HypoProtect™ mode, the "Insulin" tab in the tab bar 402 changes to a "Protect" button 622, shown in FIG. 6e. When HypoProtect™ mode is exited, the “Insulin” tab will once again be displayed in the tab bar 402.

[0067] When the "Insulin" tab is selected, other status pages (not shown) may also be displayed in the information area 404. For example, when the "Insulin" tab is selected while the user app 160 is running in automatic or restricted mode, a status screen similar to the HypoProtect™ mode status page shown in FIG. 6f appears indicating the current mode.

[0068] 7a-7b show pages that may be displayed in the information area 404 of the default home screen 400 when the "Pod Info" tab is selected. The default pod info page includes a pod status 702 shown in FIG. 7a and shown at the top of the page. The pod status 702 may be changed. For example, if the drug delivery device 102 is close to expiring, the pod status 702 may be changed to "Pod Replacement Soon" or "Replace Pod" and may be displayed in a different color, for example, yellow or red, to indicate the urgency of the status. In addition, the default pod info page includes a graphic 704 of the drug delivery device 102 in use, a quantity indicator 706 that indicates the amount of insulin (in units) remaining in the drug delivery device 102, and an expiration indicator 708 that indicates the date and time when the drug delivery device 102 will expire. The page also includes a pod details button 710, which when selected by a user, shows more detailed information about the drug delivery device 102. 7b shows a page that allows a user to set up a new drug delivery device 102. This page may be displayed, for example, if the user app 160 loses communication with the wearable drug delivery device 102 for a predetermined period of time. The page includes a "Setup New Pod" button 714 that allows initialization of a new wearable drug delivery device 102.

[0069] 8a-8b show the default home screen 400 when a bolus is being delivered. FIG. 8a shows the delivery of an immediate bolus and its status. Note that the menu button 414, alarm icon 416, and mode indicator 410 are hidden (and disabled) during the delivery of an immediate bolus. A progress bar 802 is included that shows how much of the total bolus has been delivered (e.g., including a percentage amount) and changes as the bolus is delivered. FIG. 8b shows the default home screen 400 during the delivery of a continuous bolus. Because a continuous bolus lasts for a longer period of time, the menu button 414, alarm icon 416, and mode indicator 410 are not hidden or disabled during a continuous bolus.

[0070] FIG. 9a shows a screen that may be displayed in the bolus display area 406 of the default home screen 400. This screen includes a quantity indicator 902 of the most recent bolus dose of insulin delivered, including both the immediate bolus dose and the sustained bolus dose. During bolus delivery, the quantity indicator 902 is grayed out, indicating that the bolus dose delivery is not yet complete. A caution icon 906 is displayed when the user app 160 assumes that the bolus delivery is complete, but has not yet received confirmation from the wearable drug delivery device 102. Once the bolus dose delivery is complete, the caution icon 906 disappears and the quantity indicator 902 is shown in a non-grayed format (not shown). Also included is a date and time stamp 906 indicating the time and date the bolus dose was delivered. FIG. 9b shows another alternative screen that may be displayed in the bolus display area 406 of the default home screen 400, which shows remaining insulin 908. During delivery of the bolus dose, a remaining insulin indicator 908 is continually updated to show remaining insulin, which rises as the bolus is administered. The display may also include a caution icon 906, which has the same meaning as the caution icon shown in FIG. 9a. The user can toggle between the screen shown in FIG. 9a and the screen shown in FIG. 9b by tapping on the bolus display area 406 of the default home screen 400. Note that if the bolus was not delivered, a message may appear in area 406 indicating that the bolus was not delivered.

[0071] The CGM area 408 of FIG. 4 allows access to information about the CGM. The default page of the CGM area 408 is shown in FIG. 10a. The default page includes a graphic and a "View" button 1002 which, when selected by the user, causes the graph shown in FIG. 10c to appear in the information area 404 of the default use home screen 400. The page shown in FIG. 10b is displayed when the "Insulin" or "Pod Info" tabs are selected from the tab bar 402, or when the "Dashboard" tab is selected and the information area 404 is obscured by the immediate bolus or continuous bolus graphics shown in FIGS. 8a-8b. The information displayed in area 1004 is similar to the information displayed in the default dashboard page shown in FIG. 5a. The page shown in FIG. 10b also includes a View Graph button 1006 which, when selected by the user, causes the graph shown in FIG. 10c to appear in area 404.

[0072] The graph shown in Fig. 10c appears in the information area 404 of the default home screen 400. The default graph 1010 shows CGM recorded values ​​going back more than three hours from the current time. Each dot on the graph 1010 represents a CGM recorded value received from the CGM 108. The greyed out area 1012 in the graph 1010 indicates the CGM / BG goal range set by the user, and the dotted line 1014 is the target BG that may also be set by the user. A timeline 1016 shows the time scale of the recorded values. Below the timeline 1016 is an events area, which in one embodiment shows, for example, a purple background for times when the user app 160 was in automatic mode; a white background for times when the user app 160 was in manual mode or when there was no wearable drug delivery device 102 active or communication with the wearable drug delivery device 102; a dark grey background when the user app 160 was delivering insulin in automatic mode in a restricted state; a blue background when a temporary basal delivery was in progress; a red line for times when insulin delivery was interrupted; an orange line for times when maximum basal insulin allowed was being delivered; a green line for times when a HypoProtect™ mode was in progress; and a bolus icon (see 412 in FIG. 4 ) for times when the user started a bolus delivery of insulin. As one skilled in the art will recognize, different colors may be used and different events may be shown in this area.

[0073] The user can change the graph view to a 6 hour, 12 hour, or 24 hour timeline by selecting one of the buttons shown in area 1020. Status area 1008 shows the most recent CGM recorded values ​​along with trend arrows, as well as the current remaining insulin.

[0074] A notification indicator 416 on the home screen 400 indicates to the user that there is a notification available. In some embodiments, the notification indicator 416 may change its appearance, for example by changing color, blinking, or changing the shape it is shown. When the user selects the notification indicator 416 by tapping on the icon, the screen shown in FIG. 12 is shown, which displays a list 1202 of notifications including a predefined number of past notifications along with the time the notification was issued. The user can return to the default home screen 400 by tapping the back arrow 1204.

[0075] 13a-b show example variations of the menu 1300 that are displayed when the user selects the menu button 414 on the default home screen 400. Depending on the mode of the user apps 160, various features can be enabled or disabled on the menu 1300. FIG. 13a shows the menu 1300 as it appears when the user apps 160 are in "Auto" mode. Buttons 1302 ("Temporary Basal Settings"), 1310 ("Insulin Interruption"), and all of the buttons in section 1306 ("Manage Programs & Presets") are disabled. If HypoProtect™ mode is active, button 1308 ("HypoProtect™ Mode") is also disabled. FIG. 13b shows the menu 1300 as it appears when the user apps 160 are in "Manual" mode. In this mode, button 1308 ("HypoProtect™ Mode") is disabled. Button 1602 ("Set Temporary Basal") is enabled unless a temporary basal program is in progress, insulin delivery is paused, or there is no active wearable drug delivery device 102. Button 1310 ("Pause Insulin") is disabled if there is no active wearable drug delivery device 102. If button 1302 is selected and insulin delivery is paused, button 1310 is replaced with a "Start Insulin" button. The functions of the buttons in menu 1300 are described later in this specification.

[0076] Any abnormal situation or error condition that arises due to operation of the user app 160, the wearable drug delivery device 102, or the CGM 108 may cause a modal message to be displayed overlaid on the home screen 400. Examples of modal messages are shown in Figures 14a-b. Each modal message may include an "OK" button 1402 that, when selected by the user, dismisses the modal message and returns to displaying the home screen 400.

[0077] Bolus Screen A bolus button 412 on the home screen 400, when selected by the user, replaces the default home screen 400 with a bolus calculator, as shown in Figures 11a-11f. The bolus button 412 may appear in different colors. For example, the bolus button 412 may appear gray, indicating that the button is disabled, if an immediate bolus delivery is in progress or if insulin delivery is paused. The bolus button 412 may appear blue if the user app 160 is in manual mode and purple if the user app 160 is in automatic mode.

[0078] The bolus calculator is shown in Figure 11a. The screen includes a field 1102 where the user can enter the total carbs consumed during the meal. Selecting field 1102 brings up a modal keyboard overlaying the screen where the user can enter the amount of carbs. When the modal keyboard is exited, the amount entered is transferred to field 1102. The amount of insulin for the bolus based on the amount of carbs consumed during the meal is displayed as "Meal Bolus" 1114.

[0079] A correction bolus may be required based on the user's current blood glucose reading. The current blood glucose reading may be entered in field 1104. Selecting field 1104 will bring up a modal keyboard allowing the user to manually enter the current blood glucose reading. Alternatively, pressing button 1106 will use the most recent reading from the CGM 108 and enter it into field 1104. The correction bolus is displayed as "Correction Bolus" in 1116. Note that the correction bolus can be a positive or negative number.

[0080] The current remaining insulin is displayed as "IOB" at 1118. The total bolus to be delivered, displayed in field 1110, is the sum of the meal bolus and the correction bolus adjusted for the current amount of remaining insulin. Once the total bolus has been calculated, it appears in field 1120.

[0081] If the user selects button 1108 ("Calculate"), the screen shown in FIG. 11c is displayed, which shows the individual components of the total bolus, including the meal bolus amount, the correction bolus amount, the IOB adjustment amount, and / or the amount entered by the user to increase or decrease the total bolus amount. FIG. 11b shows the bolus calculation completed. In some embodiments, field 1104 may not only show the most recent CGM recording, but may also show a trend arrow (not shown) that shows the trend of the user's blood glucose recordings. If a trend arrow is shown, the "Calculate" screen may also provide further adjustments to correct for the trend. If the user selects button 1122 ("Confirm") in FIG. 11b, the screen shown in FIG. 11d is displayed. From this screen, the user can press button 1126 ("Start") to begin delivery of the bolus.

[0082] The user may wish to specify the delivery of a bolus as a continuous bolus. When the user selects button 1124 ("Continuous Bolus") in FIG. 11b, the screen shown in FIG. 11e is displayed, which allows the user to input the percentage of the bolus to be delivered immediately and the percentage of the bolus to be delivered over a continuous time. The user can input in either field 1128 ("Immediate") or field 1130 ("Continuous"). Selecting either field 1128 or 1130 brings up a modal menu with menu items for various percentages. When the user selects one of the percentages, the selected percentage is transferred to the field that currently has focus (i.e., field 1128 or 1130). Whichever field is filled in by the user, the other field is automatically filled in by the user app 160 by subtracting from 100%. Field 1132 ("Duration") allows the user to specify the duration for which the continuous portion of the bolus is delivered. Selecting field 1132 brings up a modal menu with various time interval options. When the user selects a time interval value in the modal menu, the time interval is transferred to field 1132. A bolus summary appears in area 1134 of the screen. When the user selects button 1136 ("Confirm"), the screen shown in FIG. 11f is displayed, showing a bolus summary 1138, including the percentage to be delivered immediately and the percentage to be delivered over the duration. When the user selects button 1140 ("Start"), delivery of the bolus begins.

[0083] Pod-related screen This section pertains to all screens that deal with the operation, initialization, and status of the wearable drug delivery device 102 (i.e., the “pod”). The pod-related screens typically replace the home screen 400.

[0084] FIG. 15 shows an information screen 1500 that provides details about the current status of the pod. Screen 1500 can be reached after selecting the “Pod Info” tab from the home screen 500, followed by selecting button 1010 (“View Pod Details”) from the information page shown in FIG. 7a. Section 1502 of the screen shows the amount of insulin remaining in the wearable drug delivery device 102. This information is wirelessly communicated from the wearable drug delivery device 102 to the user app 160. In one particular embodiment, when the amount of insulin remaining in the wearable drug delivery device 102 falls below a predefined threshold, the display shows “Low” instead of showing the actual amount. Section 1504 shows the time and date when the currently used drug delivery device 102 will expire. In one embodiment, when 72 hours have passed since the drug delivery device 102 was activated, the display shows “Expired” instead of showing the time and date when the drug delivery device 102 will expire. The screen 1500 may include a button 1508 that allows the user to replace the drug delivery device 102. This button may be disabled, for example, if the user has recently replaced the drug delivery device 102. A back arrow button 1510, when selected by the user, navigates the user back to the home screen 400.

[0085] The user may be presented with a series of screens providing step-by-step instructions for replacing the drug delivery device 102. These screens may be displayed after the user selects button 1508 in FIG. 14. FIGS. 16a-16d show four examples of the series of screens. Each screen includes a button (1602) that moves the user to the next instruction screen in the procedure. The user may cancel the operation at any time on any instruction page by pressing the cancel button 1606. Once the drug delivery device 102 is properly set up and positioned, the user may begin operating the drug delivery device 102 by selecting button 1604 in FIG. 16b. During the course of the set up process, the user may be presented with one or more modal screens, an example of which is shown in FIG. 16d, which asks the user to confirm that the cannula of the drug delivery device 102 is properly inserted, as indicated by a pink status light visible on the housing of the body of the drug delivery device 102. The user may respond by pressing a "yes" or "no" button on the screen. Some instruction pages may include hyperlinks, such as hyperlink 1608 shown in Figure 16b, that take the user to other instruction pages. Pressing hyperlink 1608 in Figure 16b takes the user to the screen in Figure 16c, where the user can record the location on the body where the drug delivery device 102 is to be placed. This page may also display the past locations and dates of different spots where the drug delivery device 102 has been attached, so that the user can select a new location each time a new drug delivery device 102 is activated. Other pages (not shown) may also be reached via hyperlinks on the instruction pages.

[0086] Basic Program Screen This section relates to screens that allow the user to view, select, edit, and create basic programs for execution by the user apps 160. FIG. 17a shows the screen of FIG. 6b with a modal menu 1704 overlaid on it. The modal menu 1704 for both the basic programs and the list 614 can be invoked by touching the three-dot menu invocation control 1703 located next to each basic program in the list 914. The modal menu 1704 contains menu items that allow the user to start, edit, or delete the currently selected basic program. The user can create a basic program by selecting the "New" button 616.

[0087] FIG. 17b shows a screen used when creating a basal program. The user can give the program a name 1709, which is displayed near the top of the screen. For each segment of the basal program, the user must specify a start time for the segment, an end time or duration for the segment, and the basal rate to be delivered during the specified segment. Next to the name 1709 is an indicator of the currently specified segment. Once the user specifies the start and end times for the segment in field 1708, vertical lines 1706 appear in area 1707 of the screen indicating the start and end times of the segment. In some embodiments, the start time may be a pre-populated field and the user specifies only the end time. In some embodiments, the user may manually type the end time in field 1708, or may select the end time from a modal menu (not shown), or may select the duration from a modal menu (not shown). Once the user selects an end time for a segment, this end time is used as the start time for the next segment and is used to populate the start time field.

[0088] FIG. 17c shows a basal rate modal menu 1710 that the user may use to select a basal rate for the current segment. This menu may be invoked by the user selecting the basal rate field 1705 shown in FIG. 17b. Once the user selects a basal rate, the selected basal rate is used to populate field 1705, as shown in FIG. 17d. In addition, a bar 1712 indicating the basal rate for that time segment is positioned in area 1707 of the screen between the vertical lines indicating the start and end times of the segment. FIG. 17e shows a nearly completed basal program, while FIG. 17f shows a completed program, with each segment of the program listed in a list 1722. Any segment of the program may be edited by the user by selecting the edit button 1724 next to that segment. The total amount of insulin to be delivered by the basal program 1720 is shown below the graph. If the user is satisfied with the basal program, the basal program may be saved by selecting button 1726 ("Save"). The creation of the base program can be cancelled at any time by pressing button 1728 ("Cancel").

[0089] Temporary basic screen The temporary basal feature of the user app 160 allows the user to temporarily modify the basal rate for a given period of time. For example, the user may have engaged in some exercise or gone to bed early, which reduces the need for basal during that period. To invoke this feature, the user may select the menu button 414 on the home screen 400. Once the menu is displayed as shown in Figures 13a-13b, the user may select the menu button 1302 ("Set Temporary Basal"), which will display the screen shown in either Figure 18a or Figure 18c. The user has the option of either entering the basal rate to be delivered during the temporary basal profile as a percentage of the basal rate being delivered as part of the currently running basal program, or entering an absolute numerical value in units. The options may be set in the "Settings" portion of the user app 160, and are discussed below.

[0090] FIG. 18a is an example of a screen that allows a user to set a temporary basal rate as a percentage of the basal rate for which a basal program is currently running. A graph 1802 for the currently running basal program is shown in the information area 404 of the screen 400. Also displayed is a vertical line 1804 indicating the current time (i.e., "now"). The basal rate can be set by entering a rate in units per hour in field 1806. In some embodiments, when field 1806 is selected, a modal screen appears providing a list of basal rates that the user can select, and when the user selects a basal rate, field 1806 is populated with the selected basal rate. In field 1808, the user sets the duration of the temporary basal. The user may enter the duration in field 1806, or in some embodiments, when field 1808 is selected, a modal menu with menu items of various durations may appear. If the user selects a duration from the modal menu, field 1808 is populated with the selected duration.

[0091] Alternatively, the user may choose not to specify a basal rate and duration, and instead select a temporary basal profile from a list of saved temporary basal profiles by selecting button 1810 ("Select from Presets"). The user may cancel the creation of the temporary basal profile at any time by selecting button 1814 ("Cancel"). Once the user has entered the basal rate in field 1806 and the duration in field 1808, the user may confirm their selection by selecting button 1812 ("Confirm"), which causes the screen shown in FIG. 18b to appear.

[0092] FIG. 18b shows the screen that is displayed after the user has confirmed the designation of the temporary basal profile. The information area 404 of the screen displays the basal profile 1802 from the currently running basal program with the temporary basal profile 1814 overlaid on top. Preferably, the temporary basal profile 1814 is shown in a different color than the basal profile from the currently running basal program. A dotted line 1816 indicates the basal profile from the currently running basal program so that the difference between the basal profile and the temporary basal profile can be seen. A vertical line 1818 indicates the end of the temporary basal profile. The designated basal rate and duration are shown in fields 1806 and 1808, respectively. If the user is satisfied with the created profile, the profile can be confirmed by pressing button 1820 ("Confirm").

[0093] The screens shown in Figures 18c-18d are similar to those shown in Figures 18a-18b, except that the basal rate is specified in field 1822 as an absolute number of units per hour rather than as a percentage of the basal profile of the currently running basal program. Once the profile is confirmed, the screen shown in Figure 18d is displayed, which shows the temporary basal profile 1816 overlaid on the basal profile of the currently running basal program.

[0094] The user can either create a temporary basal profile or set a temporary basal profile. As shown in Figures 18c-18d, if a temporary basal profile has been created, the user can select button 1822 ("Confirm") and be navigated to a screen where the temporary basal profile can be saved. As shown in Figures 18a-18b, if a temporary basal profile has been set, the user can select button 1820 ("Confirm") and be navigated to a screen where the temporary basal profile can be initiated.

[0095] Selecting button 1810 from the screen shown in either Figure 18a or 18c navigates to the screen shown in Figure 18e showing a list of saved temporary basal profiles 1824. This page also includes a back arrow 1826 which, when selected, navigates the user back to the home screen 400. Additionally, button 1806 ("Create New") is also provided which, when selected, allows the user to create a new temporary basal profile by navigating to the screen shown in either Figure 18a or 18c.

[0096] Selecting the menu indicator 1828 next to any of the saved temporary basal profiles listed in the list 1824 causes a modal menu 1830 to appear, as shown in Figure 18f. From the modal menu 1830, the user can choose to start, edit, or delete the respective temporary basal profile.

[0097] Blood Glucose Screen The user app 160 provides a means for the user to manually input a blood glucose reading. Upon selecting button 1312 ("BG Entry") from the menu shown in Figures 13a-13b, the user app 160 displays the blood glucose entry screen shown in Figure 19a. In one embodiment, the user is provided with a circular graphic 1902 having a circular cursor 1903 that the user can move along the circle 1902. Moving the cursor 1903 in a clockwise direction increases the blood glucose reading, which is shown in a field 1904 at the center of the circle. Alternatively, the user may select field 1904, which will cause a modal keyboard to appear allowing the user to enter the blood glucose reading. Upon dismissing the modal keyboard, the blood glucose reading is transferred to field 1904. As will be appreciated by those skilled in the art, many other means of manually entering blood glucose levels are possible and are contemplated to be within the scope of the present invention.

[0098] The color of the circular graphic 1902 may change depending on the value of the recorded blood glucose value displayed in field 1904. For example, the circular graphic 1903 may appear in yellow, as shown in FIG. 19b, if the blood glucose level is higher than the user's target range, but below a preselected upper threshold. If the recorded blood glucose level displayed in field 1904 rises above the upper threshold, the graphic will display "High" in field 1904. Similarly, if the entered value is lower than the user's target range, but higher than a preselected lower threshold, the circular graphic 1902 may appear in red, as shown in FIG. 19c. If the recorded blood glucose level displayed in field 1904 falls below the lower threshold, an indication of "Low" may appear in field 1904. Once the blood glucose level has been entered in field 1904 and confirmed by the user, the user may save the recorded value by pressing button 1906 ("Save"). In a first variation of this embodiment shown in FIG. 19d, the graphic may be altered by adding plus and minus signs for a few seconds after the user releases cursor 1903, allowing the user to increment or decrement the blood glucose record value displayed in field 1904 by one, providing finer control. In a second variation, the blood glucose entry screen may be displayed directly from the bolus calculator shown in FIG. 11a by tapping field 1104. As shown in FIG. 19d, button 1906 ("Save") has been replaced with button 1912 ("Add to Calculator"), which, when selected by the user, adds the blood glucose value shown in field 1904 to the blood glucose field 1104 of the bolus calculator shown in FIG. 11a.

[0099] Food Library Screen The user app 160 can provide a food library to assist the user in determining the number of grams of carbohydrates in a meal, which is used by the bolus calculator to calculate the insulin bolus dose.

[0100] FIG. 20a shows a screen 2000 that is displayed when a user selects to browse a food library. Screen 2000 includes a tab bar 2002 with two tabs, a "My Foods" tab and a "Browse" tab. When the "My Foods" tab is selected, a list of foods 2006 is displayed. The displayed list of foods 2006 includes, for example, foods that the user has recently selected or foods that the user has designated as being "favorites." Food items in the "My Foods" list 2006 can be added to the carb total for a meal by pressing button 2005 ("+"). When button 2005 is pressed, the carb content of the selected food is added to the food carb total 2008 that is displayed below the list. Food carb total 2008 includes both the number of items selected and the sum of the carbs for each of the selected food items. Once the user has completed their food selections, the food carb total 2008 is added to the carb field 1102 of the bolus calculator shown in FIG. 11a by the user selecting button 2010 ("Add to Calculator").

[0101] The "My Foods" screen also includes a button 2004 ("Add Custom Food"), which allows the user to add a customized food option, for example if the food is not currently in the food library. Selecting button 2004 replaces the button portion of the "My Foods" screen with the screen shown in FIG. 20b, which allows the user to enter details about the custom food. Field 2014 allows the user to name the food. Selecting field 2014 reveals a modal alphanumeric keyboard that the user can use to enter a name for the custom food. Dismissing the modal alphanumeric keyboard transfers the name of the food to field 2014. Field 2016 allows the user to enter the carb value of the food via a modal numeric keyboard, and field 2018 allows the user to (optionally) enter the fiber content of the custom food via a modal numeric keyboard. Area 2020 of the screen allows the user to select various tags for the custom food. Once the user has entered all the details of the custom food, the custom food can be added to the list in the "My Foods" list 2006 shown in Figure 20a by selecting button 2022 ("Save to My Foods").

[0102] When the "Browse" tab is selected from the tab bar 2002, the user can browse the food library by category. An initial list of categories is shown in list 2024. When one of the categories is selected, such as the "Bars, Breakfast Cereals" tab, secondary categories are shown in FIG. 20d as list 2026. Repeated category selection eventually arrives at individual food items that the user can select to add to the carb total for a meal and / or add to the "My Foods" list 2006. The user can return to a previously viewed category by pressing button 2028, which causes the screen shown in FIG. 20c to be displayed. Each screen in the food library is configured with a button 2009 ("Cancel") which, when selected, returns the user to either the home screen 400 or the bolus calculator screen shown in FIG. 11a.

[0103] First setup screen The user app 160 provides a series of screens that allow the user to perform an initial setup of the user app 160. The functions provided in this screen will only be performed once, typically the first time the user launches the user app 160. When the user app 160 is launched for the first time, the user may be provided with a "welcome" screen 2100 similar to the screen shown in FIG. 21a. The welcome screen 2100 may include a welcome message 2102 and a button 2104 ("OK") that moves the user to the next screen. As part of the setup, the user may be asked to enter certain information online. FIG. 21b shows a screen that allows the user to log into an online center where the user can enter certain information required to operate the wearable drug delivery device 102. To access the user account on the online center, the user may be asked to enter a username 2106 and a password 2108.

[0104] Certain aspects of the setup of the user app 160 may be performed locally. By way of example, FIG. 21c shows a screen where a user may set a security PIN 2110 to restrict access to the user app 160. The user may be provided with a modal keyboard 2112 where the user may enter the PIN. An additional screen may follow where the user may confirm the entry of the PIN by re-entering the PIN. FIG. 21d shows a screen where the user may enter Wi-Fi settings that allow connection to a wireless access point for accessing the Internet. The user may access a screen (not shown) where the Wi-Fi settings may be entered by the user selecting button 2113. In some cases, selecting button 2113 may take the user to a Wi-Fi settings screen native to the user device 105 on which the user app 160 is running. In some cases, the user device 105 on which the user app 160 is running may already be connected to a wireless access point, in which case the screen shown in FIG. 21d would not be necessary.

[0105] During the setup process, the user app 160 may determine that access to location information of the user device 105 is required. For example, the user app 160 may wish to track the current location of the user device 105 to determine the time zone in which the user device 105 is currently located and to adjust the time zone if the user travels between time zones. The time zone may be used as a basis for calculating the time for insulin delivery. The user may be presented with a modal screen shown in FIG. 21e, which allows the user to grant the user app 160 access to the location information of the user device 105. It will be appreciated that the screens shown in FIGS. 21a-21e are exemplary in nature, and many other setup screens may be provided that allow the user to set up various other aspects of the user app 160. For example, the user may set up a message that is displayed when the user app 160 is locked, such as one that identifies the user's contact information, which may be used in the event the user device 105 is lost. In addition, the user may also set up a background with personal information that is displayed on the lock screen. Many other user configurable features may be available to the user.

[0106] In addition to the general setup items, the user may be prompted to set up parameters for the delivery of basal and bolus doses of a liquid drug. As an example, the user may set up a basal profile. FIG. 21f shows an exemplary screen where the user may set a maximum basal rate by entering units per hour in field 2114. FIG. 21g shows an exemplary screen where the user may set up a bolus. Field 2116 shows the name of the bolus, while field 2118 allows the user to generate a start time and end time for the bolus. The user may also enter a target blood glucose level in field 2120 and a "correct if exceeded" value in field 2122. Many other parameters for basal and bolus delivery of a liquid drug may be entered in other screens, similar to those already discussed above with respect to bolus and basal doses of a liquid drug.

[0107] Alarm and warning screen At various points during its operation, the user app 160 may provide the user with screens that indicate alarms, warnings, and / or error screens. In some cases, an alarm or warning may be accompanied by an exclamation point ("!") icon, and may be provided on a background of a particular color, such as a yellow background, as shown in the example as icon 2202 in FIG. 22a. The particular screen shown in FIG. 22a warns the user that insulin delivery should be resumed. A message 2204 indicating the reason for the warning may be displayed, as well as one or more buttons 2006 that allow the user to take action in response to the warning. More serious errors or warnings may be provided by an icon indicating, for example, an excavation point on a red background, as shown in FIG. 22b as icon 2208. Additionally, a message may be provided that describes the error and the action the user should take to resolve the error, as shown by message 2210 in FIG. 22b. Warnings and errors may be provided as a full screen, as shown in FIG. 22a, or as a modal pop-up, as shown in FIG. 22b. FIG. 22c shows yet another example of a common error.

[0108] History screen The user app 160 has the ability to show a history of its operations. The history information can be accessed by the user by selecting button 1314 ("History Details") of menu 1300. The default history screen appears as a vertical modal popup 2300 overlaying or replacing menu 1300 as shown in FIG. 23a. By default, the history screen shows the history information for the current day. However, history information for other days can be shown by the user by selecting button 2302 ("<"). The history screen 2300 includes a tab button with two tabs, a "List" tab 2304 and an "Auto Events" tab 2305. The screen showing the display when the List tab 2304 is selected is as shown in FIG. 23a. The display includes CGM history 2306, which includes average CGM recorded values ​​and information about the percentage of time the user's blood glucose level was within, above, and below a user-specified range. Also displayed when the summary tab 2304 is selected is insulin and carb information 2308. This area of ​​the screen 2300 shows the total insulin delivered for the day, the percentage delivered as basal insulin, the percentage delivered as bolus insulin, and the total carbs the user has taken during the day.

[0109] Area 2310 of history screen 2300 shows a timeline showing individual events and the times at which those individual events occurred. Further details about each individual event can be displayed, for example, by selecting down arrow 2312, which causes the area to expand to show details about the individual timeline events. As shown in FIG. 23b, the graph shown in area 2314 is displayed as a result of a user selecting down arrow 2312 on the "Temporal Basis Start" area of ​​timeline 2314. When different timeline events are expanded, different types of information may be shown. Timeline events can be collapsed by selecting button 2316, which causes the graph shown in area 2314 to disappear.

[0110] Selecting the "Auto Events" tab 2305 results in the display of the screen shown in FIG. 23c, which shows event banners and data columns. Event banners 2316, 2320 indicate mode switch events and time zone switch events. The event banners 2316, 2320 may be displayed in different colors, for example, a purple banner may be displayed when auto mode is started and a blue banner may be displayed when auto mode is ended. This screen also has data columns 2318, showing CGM recorded values ​​and micro-bolus doses delivered.

[0111] Setting screen All of the user configurable options and settings of the User App 160 can be accessed through button 1316 ("Settings"), as shown in Figure 13a. Button 1316 can expand to show an expanded settings menu 1318. Figure 13a shows the settings menu in its expanded form.

[0112] When the user selects button 1320 ("About App"), the main menu 1300 is replaced with a screen showing information about the user app 160, as shown in Figure 24. Various information is available here, such as the serial number, the version of the wearable drug delivery device 102, information about the most recent communication with the wearable drug delivery device 102 or the cloud 111, etc.

[0113] In some embodiments, the user app 160 includes a feature that allows a user to send log files to a customer care center for analysis. By selecting button 2402 ("Send files to customer care"), the user can send log files to a customer care center. These may be useful, for example, in diagnosing problems the user encounters while operating the device. A caution icon ("!") indicates that the log files are in the process of being sent, but the sending process is not yet complete.

[0114] When button 2402 is selected, the screen shown in FIG. 24b is displayed. In some embodiments, the user must have a personal identification number (PIN) to send the log file. As such, the screen shown in FIG. 24b may also include instructions for obtaining a PIN 2406. The user may receive the PIN, for example, via communication through the user app 160 or via communication independent of the user app 160. If the user already has a PIN, the user may select button 2404 ("Next"), which causes the screen of FIG. 24c to be displayed. The user then enters the PIN in field 2408 using keypad 2410, and upon completion, selects button 2412 ("Send File") to initiate the sending of the log file to the customer care center. When button 2412 is selected, the screen shown in FIG. 24c disappears, and operation returns to the previously displayed screen.

[0115] When a user selects button 1322 ("PDM Settings") from main menu 1300, main menu 1300 is replaced with the menu shown in Figure 25a, which allows a user to configure various aspects of the operation and display of user device 105 on which user app 160 is running. For example, a user can turn airplane mode on or off, change Wi-Fi settings, screen timeout, screen brightness, lock screen message, background image, security PIN, etc.

[0116] In addition, the user may set a default time zone and language by selecting button 2502 in FIG. 25a, as well as the time zone from which times for insulin delivery will be calculated. This will cause the screen shown in FIG. 25b to appear, which first alerts the user that insulin delivery must be suspended before the time zone can be changed. When the user suspends insulin delivery by pressing button 2504 ("Suspend Insulin"), the screen changes to FIG. 25c, showing banner 2506 indicating that insulin delivery has been suspended and enabling selection menu 2508 that the user may use to select a time zone. Once a time zone has been selected, the user may select button 2510 ("Save"), which will save the time zone selection, dismiss the screen shown in FIG. 25c, and resume insulin delivery if it was suspended. If the user allowed the device to access location information during setup, the time zone may automatically change as the user travels between time zones, and the user may be notified that the time zone has been updated, or may be asked to confirm whether to update the time zone in which the user is currently located. The system may periodically verify that the time zone in which the user is currently located is the same as the time zone currently being used by the system for drug delivery. If there is a time zone discrepancy, the user may be alerted and asked whether to update the time zone. When the time zone is updated, a corresponding change may result in the insulin delivery. For example, a basal profile that may deliver different amounts or rates of insulin at different times of the day may now accommodate the updated time zone. Additionally, instead of the user having to set the time zone (by default or otherwise), the user device 105 may automatically detect and / or provide the time and time zone to the user app 160 and / or the wearable drug delivery device 102, thereby eliminating the need for the user to input the time or time zone.Additionally, if the time and / or time zone of the user device 105 is automatically updated (e.g., in the case of a smartphone), the time and / or time zone used by the user app 160 and the wearable drug delivery device 102 may also be automatically updated. The user app 160 may periodically query the user device 105 to determine whether the time and / or time zone has been changed by the user or automatically updated by the user device 105, for example, when traveling to a new location.

[0117] In addition, the user can select a language, run diagnostics, or reset User Apps 160. Selection of any menu item on the "PDM Settings" menu can result in the display of other screens for configuring specific settings. Depending on the current mode in which User Apps 160 is running, some options may or may not be available.

[0118] Insulin Discontinuation Screen User selection of button 1310 ("insulin interruption") from main menu 1300 shown in Figures 13a-b allows the user to suspend insulin delivery for a specified time. Note that button 1310 may only be available if certain conditions are met. For example, button 1310 may be disabled if a temporary basal profile or continuous bolus program is running. Selection of button 1310 may display a screen shown in Figure 26a, where the user may specify how long to interrupt insulin delivery. In some embodiments, selection of field 2602 may present the user with a modal keypad where the user may manually enter the time. In other embodiments, selection of field 2602 may provide the user with a menu where the user may select a duration menu item. Dismissing the modal screen transfers the specified time for interruption to field 2602. The user may initiate the interruption by pressing button 2604. Once insulin delivery has been interrupted, button 1310 on main menu 1300 may change from "Insulin Interrupted" to "Start Insulin," which, when selected, allows the user to resume insulin delivery. When the user selects button 1310 ("Start Insulin"), the screen of FIG. 26b appears, which allows the user to resume insulin delivery using the most recently active basal program. Resumption is accomplished by the user selecting button 2606. Once insulin delivery has been resumed, button 1310 on menu 1300 reverts to displaying the text "Insulin Interrupted" and is enabled if all other conditions are met.

[0119] HypoProtect™ Mode Screen A user may initiate "HypoProtect™ Mode" by user selection of button 1308 of main menu 1300 shown in Figures 13a-13b. HypoProtect™ Mode may stop or in some embodiments reduce basal insulin delivery by 25-95% (e.g., 50% or 75%) and set the target blood glucose level for basal delivery to a predetermined amount (e.g., within a range of 150-200 mg / dL, such as 200 mg / dL). HypoProtect™ Mode is typically used during times of increased risk of hypoglycemia, such as during exercise or sleep periods or when first waking in the morning. Selection of button 1308 brings up the screen shown in Figure 27a, which allows the user to set the duration of HypoProtect™ Mode. Selection of field 2702 may present the user with a modal keypad where the time may be manually entered. In other embodiments, selection of field 2702 may provide the user with a menu where the duration menu item may be selected. When the modal screen is dismissed, the time specified for the duration of HypoProtect™ mode is transferred to field 2702. Selecting button 2704 ("Confirm") initiates HypoProtect™ mode and displays the screen shown in FIG. 27b. This screen indicates the exact date and time HypoProtect™ mode will end in time remaining 2706 and 2708 to run HypoProtect™ mode. The user may cancel HypoProtect™ mode at any time by selecting button 2710 ("Cancel"). When in HypoProtect™ mode, the information area 404 of the home screen 400 may appear as shown in FIG. 6f.

[0120] Mode switching screen Button 1324 ("Switch Mode") of main menu 1300 shown in Figures 13a-b allows the user to switch between automatic and manual modes. If the user is currently in manual mode, when the user selects button 1324, the screen shown in Figure 28a is displayed. This screen shows information block 2802, which indicates to the user when automatic mode can be entered, with a green check mark indicating that the conditions listed are met. If any condition is not met, a red "X" may be shown next to the condition. If all conditions are met, the user can enter automatic mode by selecting button 2804 ("Switch"). If user app 160 is currently in automatic mode, selecting button 1324 causes the screen shown in Figure 28b to appear, allowing the user to switch to manual mode. This screen shows information block 2806, which informs the user of the underlying program that will be executed if the switch is made. The user can confirm the switch by pressing button 2808 ("Switch").

[0121] CGM transmitter screen By selecting button 1326 from menu 1300 shown in Figures 13a-b, the user can view and / or change the serial number of the CGM 108. The diagram shown in Figure 29a is initially shown upon selection of button 1326. Serial number 2902 is displayed. In certain cases, if the CGM has expired, the serial number may be displayed in red and an "Expired" indicator may also be displayed on the screen. The user may enter a new CGM serial number using buttons 3204 and 3206. Selection of button 2906 displays the screen shown in Figure 29b. This screen shows an information block 2908 that indicates to the user the location of the serial number on the CGM 108. Additionally, selection of field 2910 presents the user with a modal keyboard, allowing the user to enter the serial number from the CGM 108. Once the user has finished entering the serial number, the user may save the serial number by selecting button 2912 ("Save"), which will return the user to the screen shown in FIG. 29a with the new serial number moved into field 2902.

[0122] Reminders screen The user can enable / disable and / or set parameters for when the user app 160 will provide reminders. Selecting the button 1328 ("Reminders") in the "Settings" submenu of the main menu 1300 shown in Figs. 13a-b displays the screen shown in Fig. 30a. This screen shows a list of reminders. The current setting 3002 for each reminder is shown under the reminder name. For example, in the exemplary screen shown in Fig. 30a, the user has set a "Pod Expiration" reminder 4 hours before the expiration of the drug delivery device 102, indicating that the user app 160 will provide a reminder to the user 4 hours before the expiration of the drug delivery device 102. A particular reminder can be enabled or disabled by the user by selecting a slider 3004. Tapping the slider 3004 toggles the state between "on" and "off." The exemplary screen shows three reminders enabled. FIG. 30b shows an example of a screen that can be used to set the parameters of one of the reminders. The example screen is setting a "pod expire" reminder. In one particular embodiment, when a user selects field 3006, a modal numeric keyboard appears allowing the user to enter the number of hours before expiration that the reminder will be displayed. In other embodiments, a modal menu may appear with menu items for various numbers of hours. When the modal menu is dismissed, the specified number of hours is transferred to field 3006. The user can save the settings by the user selecting button 3008.

[0123] Viewer screen The user app 160 may include functionality that allows designated people to view data generated by the user app 160. To view a list of viewers who have permission to view the user data, the user may select button 1330 ("Viewers") from the main menu 1300 shown in Figures 13a-13b. When button 1330 is selected, the screen shown in Figure 31a is displayed, showing a list of viewers 3102. The list of viewers who have permission to view the user data may be maintained in the cloud service 111 and may be downloaded to the user device 105 by selecting button 1330. Each viewer in the list 3102 is associated with a modal options menu 3105 that, when selected, displays various menu items. For example, the menu may include options to edit or delete the viewer. If the user wishes to edit a viewer, they may select the menu option "Edit" from the modal menu 3105, which displays the screen shown in Figure 31e, allowing the viewer's information to be edited, as described below.

[0124] Pressing button 3104 ("New Viewer") displays the screen of Figure 31b, in which a new viewer may be added. This screen provides fields 3104 in which the user may enter various required or optional information about the new viewer, such as name, email address, and relationship to the user. In various embodiments, other fields may also be required or desired to identify the new viewer.

[0125] Once the user selects one of the fields 3106, a modal keyboard 3108 appears on the screen, as shown in FIG. 31c, allowing the user to enter the required information for the new viewer. Once all required fields have been filled in, the screen shown in FIG. 31d appears, listing the new viewer's information. To correct any mistakes in the new viewer's information, the user may select button 3114 ("Edit"), which returns the user to the screen shown in FIG. 31b. Note that the screen shown in FIG. 31d can also be reached by selecting the "Edit" button from the modal menu 3105 next to a viewer from the list 3102 shown in FIG. 31a. This allows the user to edit an existing viewer's information, for example, to change that viewer's email address. Selecting button 3112 ("Send New Invitation") sends the new viewer an invitation to view the user's data. Once the invitation has been sent, the screen shown in FIG. 31e appears. This screen is the same as the screen shown in Figure 31a, except that a new user 3115 has been added to the list and is shown as "Waiting", as indicated by status indicator 3116. If the new viewer accepts the invitation, the screen shown in Figure 31f is displayed, which shows the new user 3115 with an "Active" status, as indicated by status indicator 3118. Note that this is the same screen as shown in Figure 31a, with the new user 3115 added.

[0126] As will be appreciated by those skilled in the art, the user interface comprises many screens providing a wide variety of functionality, most of which are not shown herein. An exemplary selection of screens that make up the user interface have been presented herein to illustrate the various functions of the user app 160. The invention is not intended to be limited to the exact depiction of each individual screen, including, for example, the specific textual text that appears on each screen, the arrangement of the functions on each screen, the colors in which the various functions are displayed on the screen, and the flow from one screen to the next. As will be appreciated, any of these aspects of the user interface may be varied while still providing the same functionality. Instead, the intended scope of the invention is contained in the following claims. The invention disclosed in this specification includes the following aspects. <Aspect 1> 1. A drug delivery system comprising: A drug delivery device; a user device in wireless communication with the drug delivery device; a user application having a graphical user interface, running on said user device and controlling delivery of medication by said drug delivery device; The graphic user interface includes a default screen that is displayed upon launch of the user application; The default screen includes an information area displaying the user's most recent blood glucose level, a trend indicator indicating a trend in the user's blood glucose level as indicated by a number of previous blood glucose records, and an indicator of estimated remaining insulin; a bolus display area with an indicator of the most recent bolus delivered by the drug delivery device; a CGM area that, when selected, displays a graph of blood glucose recordings over a user-selectable time period; a mode indicator that indicates whether the user application is operating in an automatic mode or a manual mode. Drug delivery systems. <Aspect 2> the start-up screen further comprises a tab bar comprising a DASHBOARD tab, an INSULIN tab, and a POD INFO tab; When the Insulin tab is selected, the information area displays a graphical representation of the basal program currently being run by the user application, and the CGM area displays the user's most recent blood glucose level; The system of aspect 1, wherein when the Pod Info tab is selected, the information area displays status information about the drug delivery device including the number of units of medication remaining in the drug delivery device, and the CGM area displays the user's latest blood glucose level. <Aspect 3> 2. The system of claim 1, wherein when the bolus display area of ​​the default screen is selected by the user, the graphical user interface displays an indication of the estimated amount of remaining insulin in the bolus display area. <Aspect 4> The system of claim 1, wherein the start-up screen further comprises a bolus button that, when selected by the user, initiates the delivery of a bolus dose of the medication. <Aspect 5> The system of aspect 4, wherein when the bolus button is selected, the graphical user interface displays a bolus calculator screen for calculating a total bolus dose of the medication to be delivered based on the amount of carbohydrates ingested by the user, the user's most recent blood glucose recording, and the estimated remaining insulin. <Aspect 6> The system of embodiment 4, wherein the user can initiate delivery of the bolus dose as an immediate bolus dose or as a continuous bolus dose. <Aspect 7> The system of embodiment 6, wherein the graphical user interface includes a screen on which the user can specify parameters for the sustained bolus delivery of the medication. <Aspect 8> The system of embodiment 6, wherein when a bolus dose or a continuous bolus dose is being delivered, the graphical user interface displays the status of the bolus dose or the continuous bolus dose in the information area of ​​the default screen. <Aspect 9> The system of embodiment 2, wherein when the insulin tab is selected, the graphical user interface displays a list of basal programs. <Aspect 10> The system of embodiment 9, wherein the basal program determines the timing and amount of delivery of a basal dose of the drug for the day. <Aspect 11> 10. The system of embodiment 9, wherein the graphic user interface provides a screen with which the user can create a new basic program. <Aspect 12> The system of embodiment 11, wherein the screen on which the user can create a new basal program includes a graphical display showing one or more time ranges and the basal rate for delivery of the medication over the course of each time range. <Aspect 13> The system of aspect 9, wherein the list of basal programs includes one or more temporary basal programs that specify the timing and amount of basal dose delivery for a portion of the day, and the temporary basal programs increase or decrease the amount of the medication specified by a currently running basal program. <Aspect 14> 2. The system of claim 1, wherein the graphical user interface further comprises a menu button that, when selected, displays a menu comprising a plurality of menu items overlaid on a currently displayed screen of the graphical user interface. <Aspect 15> A system as described in aspect 14, wherein one of the menu items, when selected, initiates a HypoProtect mode that suspends delivery of the medication for a user-specified duration. <Aspect 16> The system of embodiment 15, wherein when HypoProtect mode is enabled, the graphic user interface displays a HypoProtect mode indicator in the information area of ​​the default screen. <Aspect 17> 2. The system of embodiment 1, wherein the graphical user interface includes a screen providing instructions for replacing the drug delivery device. <Aspect 18> 2. The system of claim 1, wherein the graphical user interface includes a screen that provides an interface to a food library, the food library including at least the amount of carbohydrates contained in each food in the food library. <Aspect 19> The system of embodiment 1, wherein access to the user application requires entry of a user PIN, and further wherein the graphical user interface includes a screen by which the user can set and enter the PIN. <Aspect 20> The system of aspect 14, wherein when one of the menu items is selected, the graphical user interface displays a history of the delivery of the medication and a timeline of events. <Aspect 21> The system of embodiment 14, wherein when one of the menu items is selected, it causes the graphical user interface to display a screen that allows the user to switch between the automatic mode and the manual mode. <Aspect 22> The system of aspect 1, wherein the system further comprises a continuous glucose monitor in wireless communication with the user device, the continuous glucose monitor providing periodic blood glucose recordings from the user. <Aspect 23> The system of aspect 1, wherein the graphical user interface includes a screen capable of displaying a list of people authorized to view data generated by the user application, and a screen capable of adding new authorized people. <Aspect 24> The system of claim 1, wherein the user application generates one or more log files and the graphical user interface includes a screen that enables the one or more log files to be sent to a customer care center.

Claims

1. 1. A drug delivery system comprising: A drug delivery device; a user device in wireless communication with the drug delivery device; a user application having a graphical user interface, running on said user device and controlling delivery of medication by said drug delivery device; the graphical user interface includes a default screen that is displayed upon launch of the user application; The default screen includes an information area displaying the user's most recent blood glucose level, a trend indicator indicating a trend in the user's blood glucose level as indicated by a number of previous blood glucose records, and an indicator of estimated remaining insulin; a bolus display area with an indicator of the most recent bolus delivered by the drug delivery device; a CGM area which, when selected, displays a graph of blood glucose recordings over a user selectable time period; a mode indicator that indicates whether the user application is operating in a manual mode, in which the drug delivery device delivers the medication using preprogrammed dosing parameters, or in an automatic mode, in which the drug delivery device adapts the dosing parameters over time. Drug delivery systems.

2. The default screen further comprises a tab bar having a dashboard tab, an insulin tab, and a pod info tab; When the Insulin tab is selected, the information area displays a graphical representation of the basal program currently being executed by the user application, and the CGM area displays the user's most recent blood glucose level; The system of claim 1, wherein when the Pod Info tab is selected, the information area displays status information about the drug delivery device including the number of units of medication remaining in the drug delivery device, and the CGM area displays the user's most recent blood glucose level.

3. The system of claim 1 , wherein when the bolus display area of ​​the default screen is selected by the user, the graphical user interface displays an indication of the estimated amount of remaining insulin in the bolus display area.

4. The system of claim 1, wherein the default screen further includes a bolus button that, when selected by the user, replaces the default screen with a bolus calculator, and the user can press a start button to initiate the delivery of a bolus dose of the medication.

5. 5. The system of claim 4, wherein when the bolus button is selected, the graphical user interface displays a bolus calculator screen for calculating a total bolus dose of the medication to be delivered based on the amount of carbohydrates ingested by the user, the user's most recent blood glucose recording, and the estimated remaining insulin.

6. The system of claim 4 , wherein the user can initiate delivery of the bolus dose as an immediate bolus dose or as a continuous bolus dose.

7. The system of claim 6 , wherein the graphical user interface includes a screen that allows the user to specify parameters of the delivery of the bolus dose of the medication.

8. The system of claim 6, wherein if a bolus dose or a continuous bolus dose is being delivered, the graphical user interface displays the status of the bolus dose or the continuous bolus dose in the information area of ​​the default screen.

9. The system of claim 2 , wherein when the insulin tab is selected, the graphical user interface displays a list of basal programs.

10. 10. The system of claim 9, wherein the basal program defines the timing and amount of delivery of a basal dose of the drug for the day.

11. 10. The system of claim 9, wherein the graphic user interface provides a screen through which the user can create a new basic program.

12. 12. The system of claim 11, wherein the screen on which the user can create a new basal program includes a graphical display showing one or more time ranges and the basal rate for delivery of the medication over the course of each time range.

13. The system of claim 9, wherein the list of basal programs includes one or more temporary basal programs that specify the timing and amount of basal dose delivery for a portion of the day, the temporary basal programs increasing or decreasing the amount of the medication specified by a currently running basal program.

14. 2. The system of claim 1, wherein the graphical user interface further comprises a menu button that, when selected, displays a menu comprising a plurality of menu items overlaid on a currently displayed screen of the graphical user interface.

15. 15. The system of claim 14, wherein one of the menu items, when selected, initiates a HypoProtect mode that suspends delivery of the medication for a user-specified duration.

16. The system of claim 15, wherein when HypoProtect mode is enabled, the graphical user interface displays a HypoProtect mode indicator in the information area of ​​the default screen.

17. The system of claim 1 , wherein the graphical user interface includes a screen providing instructions for replacing the drug delivery device.

18. The system of claim 1 , wherein the graphical user interface includes a screen that provides an interface to a food library, the food library including at least the amount of carbohydrates contained in each food in the food library.

19. 2. The system of claim 1, wherein access to the user application requires entry of a user PIN, and further wherein the graphical user interface includes a screen that allows the user to set and enter the PIN.

20. The system of claim 14 , wherein one of the menu items, when selected, causes the graphical user interface to display a history of the delivery of the medication and a timeline of events.

21. 15. The system of claim 14, wherein one of the menu items, when selected, causes the graphical user interface to display a screen that allows the user to switch between the automatic mode and the manual mode.

22. 10. The system of claim 1, further comprising a continuous glucose monitor in wireless communication with the user device, the continuous glucose monitor providing periodic blood glucose readings from the user.

23. The system of claim 1 , wherein the graphical user interface includes a screen capable of displaying a list of people authorized to view data generated by the user application and a screen capable of adding new authorized people.

24. The system of claim 1 , wherein the user application generates one or more log files, and the graphical user interface includes a screen that enables the user application to transmit the one or more log files to a customer care center.

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