Drug delivery system with a graphical user interface

Abstract

To disclose a system for automatically delivering medication to a user.SOLUTION: A sensor worn by a user can collect information regarding the user. A user device, for example, a smartphone, executes a user application that uses the collected information to determine the amount of medication to be provided to the user. The user application includes a graphical user interface that allows the user to easily interact with the user application to specify various aspects of the delivery of the medication. The user application controls a wearable drug delivery device to dispense the medication to the user.SELECTED DRAWING: Figure 4

Description

TECHNICAL FIELD

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 132,694, filed on December 31, 2020, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] Embodiments of the present specification 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 ART

[0003] Wearable drug delivery systems, particularly systems 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 administering insulin to the user. The advanced control algorithms required for such systems generally require powerful computing resources and high-capacity power supplies. As a result, conventional drug delivery systems do not provide wireless communication between system components, fully autonomous operation, an enhanced user experience involving ubiquitous electronic devices such as smartphones, and improved security features. Accordingly, there is a need for an insulin management system that includes such functionalities.

SUMMARY OF THE INVENTION

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

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] [Figure 1] A functional block diagram of an exemplary system is shown. [Figure 2a]An exemplary medical device suitable for performing the systems and methods disclosed herein is shown in a front-facing perspective view and a rear-facing perspective view. [Figure 2b] An exemplary medical device suitable for performing the systems and methods disclosed herein is shown in a front-facing perspective view and a rear-facing perspective view. [Figure 2c] Figures 2a and 2b show the first and second devices illustrating the add-on module. [Figure 2d] Figures 2a and 2b show the first and second devices illustrating the add-on module. [Figure 3] This indicates the system components located in specific positions on the user's system. [Figure 4] This shows the default home screen of the user application. [Figure 5a] This is an example of the information page displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5b] This is an example of the information page displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5c] This is an example of the information page displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 5d] This is an example of the information page displayed in the main area of ​​the home screen when the "Dashboard" tab is selected. [Figure 6a] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6b] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6c] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6d] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6e] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 6f] This is an example of the information page displayed in the main area of ​​the home screen when the "Insulin" tab is selected. [Figure 7a] This is an example of the information page displayed in the main area of ​​the home screen when the "Pod Info" tab is selected. [Figure 7b] This is an example of the information page displayed in the main area of ​​the home screen when the "Pod Info" tab is selected. [Figure 8a] This shows an example of a page that appears overlaid on the main area of ​​the home screen when a user application is delivering an immediate bolus or a persistent bolus. [Figure 8b] This shows an example of a page that appears overlaid on the main area of ​​the home screen when a user application is delivering an immediate bolus or a persistent bolus. [Figure 9a] This is an example of the information page displayed in the "Recent Bolas" area on the home screen. [Figure 9b] This is an example of the information page displayed in the "Recent Bolas" area on the home screen. [Figure 10a] This is an example of an information page displayed in the "CGM Info" area on the home screen. [Figure 10b] This is an example of an information page displayed in the "CGM Info" area on the home screen. [Figure 10c] This is an example of an information page displayed in the "CGM Info" area on the home screen. [Figure 11a] This shows an example of a screen that provides a bolus calculator, which is displayed when the bolus button on the default home screen is selected, as well as an example of a screen where the user can specify persistent bolus delivery. [Figure 11b]This shows an example of a screen that provides a bolus calculator displayed when a bolus button on the default home screen is selected, and further an example of a screen that allows a user to specify extended bolus delivery. [Figure 11c] This shows an example of a screen that provides a bolus calculator displayed when a bolus button on the default home screen is selected, and further an example of a screen that allows a user to specify extended bolus delivery. [Figure 11d] This shows an example of a screen that provides a bolus calculator displayed when a bolus button on the default home screen is selected, and further an example of a screen that allows a user to specify extended bolus delivery. [Figure 11e] This shows an example of a screen that provides a bolus calculator displayed when a bolus button on the default home screen is selected, and further an example of a screen that allows a user to specify extended bolus delivery. [Figure 11f] This shows an example of a screen that provides a bolus calculator displayed when a bolus button on the default home screen is selected, and further an example of a screen that allows a user to specify extended bolus delivery. [Figure 12] This is an example of a screen showing a list of notifications displayed when a user selects a notification indicator from the default home screen. [Figure 13a] This shows an example of a main menu that appears when a menu button is selected from the home screen. [Figure 13b] This shows an example of a main menu that appears when a menu button is selected from the home screen. [Figure 14a] This shows an example of a modal message for providing a user with information related to a special situation or an error state. [Figure 14b] This shows an example of a modal message for providing a user with information related to a special situation or an error state. [Figure 15] This shows an example of a screen presenting detailed information related to a wearable drug delivery device. [Figure 16a]This example shows an instruction screen that provides step-by-step instructions for the user to set up a new drug delivery device and attach it to their body. [Figure 16b] This example shows an instruction screen that provides step-by-step instructions for the user to set up a new drug delivery device and attach it to their body. [Figure 16c] This example shows an instruction screen that provides step-by-step instructions for the user to set up a new drug delivery device and attach it to their body. [Figure 16d] This example shows an instruction screen that provides step-by-step instructions for the user to set up a new drug delivery device and attach it to their body. [Figure 17a] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 17b] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 17c] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 17d] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 17e] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 17f] This shows an example of a screen where a user can view, create, edit, and start a basic program. [Figure 18a] This shows an example of a screen where a user can create or select a temporary base profile. [Figure 18b] This shows an example of a screen where a user can create or select a temporary base profile. [Figure 18c] This shows an example of a screen where a user can create or select a temporary base profile. [Figure 18d]This shows an example of a screen where a user can create or select a temporary base profile. [Figure 18e] This shows an example of a screen where a user can create or select a temporary base profile. [Figure 18f] This shows an example of a screen where a user can create or select a temporary base profile. [Figure 19a] This shows an example of a screen where users can manually enter blood glucose levels. [Figure 19b] This shows an example of a screen where users can manually enter blood glucose levels. [Figure 19c] This shows an example of a screen where users can manually enter blood glucose levels. [Figure 19d] This shows an example of a screen where users can manually enter blood glucose levels. [Figure 20a] This example shows a screen that runs a food library, which can be used by the user to select foods to add to their meal for the purpose of calculating the total carbohydrate intake during the meal. [Figure 20b] This example shows a screen that runs a food library, which can be used by the user to select foods to add to their meal for the purpose of calculating the total carbohydrate intake during the meal. [Figure 20c] This example shows a screen that runs a food library, which can be used by the user to select foods to add to their meal for the purpose of calculating the total carbohydrate intake during the meal. [Figure 20d] This example shows a screen that runs a food library, which can be used by the user to select foods to add to their meal for the purpose of calculating the total carbohydrate intake during the meal. [Figure 21a] This shows an example of a screen used for the initial setup of a user application. [Figure 21b] This shows an example of a screen used for the initial setup of a user application. [Figure 21c]This shows an example of a screen used for the initial setup of a user application. [Figure 21d] This shows an example of a screen used for the initial setup of a user application. [Figure 21e] This shows an example of a screen used for the initial setup of a user application. [Figure 21f] This shows an example of a screen used for the initial setup of a user application. [Figure 21g] This shows an example of a screen used for the initial setup of a user application. [Figure 22a] Examples of information and error screens displayed by a graphical user interface are shown. [Figure 22b] Examples of information and error screens displayed by a graphical user interface are shown. [Figure 22c] Examples of information and error screens displayed by a graphical user interface are shown. [Figure 23a] An example of a screen showing the operation history of user applications and drug delivery devices is shown. [Figure 23b] An example of a screen showing the operation history of user applications and drug delivery devices is shown. [Figure 23c] An example of a screen showing the operation history of user applications and drug delivery devices is shown. [Figure 24a] An example of a screen showing information about user applications and associated devices is shown. [Figure 24b] This shows the screen used to send log files to the customer care center. [Figure 24c] This shows the screen used to send log files to the customer care center. [Figure 25a] This displays a menu that provides general setup for the application. [Figure 25b] This screen shows how to change the time zone used to calculate insulin delivery. [Figure 25c] This screen shows how to change the time zone used to calculate insulin delivery. [Figure 26a] This shows an example of a screen that allows the user to interrupt and start drug delivery. [Figure 26b] This shows an example of a screen that allows the user to interrupt and start drug delivery. [Figure 27a] This shows an example of a screen where the user can start and cancel HypoProtect® mode. [Figure 27b] This shows an example of a screen where the user can start and cancel HypoProtect® mode. [Figure 28a] This example shows a screen that allows the user to switch between automatic and manual modes for operating a user application. [Figure 28b] This example shows a screen that allows the user to switch between automatic and manual modes for operating a user application. [Figure 29a] This shows an example screen where a user can connect a new drug delivery device to a user application. [Figure 29b] This shows an example screen where a user can connect a new drug delivery device to a user application. [Figure 30a] This example shows a screen where a user can configure the parameters of a reminder provided by a user application. [Figure 30b] This example shows a screen where a user can configure the parameters of a reminder provided by a user application. [Figure 31a] This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Figure 31b]This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Figure 31c] This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Figure 31d] This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Figure 31e] This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Figure 31f] This example shows a screen that displays a list of people ("viewers") who are permitted to view data generated by user app 160, and allows the user to add new viewers to that list. [Modes for carrying out the invention]

[0006] Various embodiments of the present invention include systems and methods for delivering a drug to a user automatically or in accordance with a radio signal received from an electronic device, using a wearable drug device (which may also be referred to herein as a “pod”). In various embodiments, the electronic device may be a user device, which includes any other type or kind of electronic device that is worn on or carried on the user’s body and runs an algorithm that calculates the time and dosage of drug delivery. For example, the user device may run 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, which collects data about the user’s physical attributes or condition, such as glucose levels. The sensor may be located inside or on the user’s body and may be part of the drug delivery device or 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. Communication may be direct (e.g., if the sensor is integrated with the drug delivery device or otherwise part of the drug delivery device) or remote / wireless (e.g., if the sensor is located in a housing separate from the medical device). In these embodiments, the sensor and / or drug delivery device has computing hardware (e.g., processor, memory, firmware, etc.) that executes some or all of the algorithms for calculating the time and dosage of drug delivery.

[0007] Figure 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 functions for) drug delivery algorithms for managing or controlling the automated delivery of drugs or medications, such as insulin, to a user (e.g., to maintain normal blood glucose levels). The drug delivery system 100 may be an automated drug delivery system that includes a wearable drug delivery device 102, an analyte sensor 108, and a user device 105.

[0008] The drug delivery system 100 may also include, as may be selected, accessory devices 106 such as smartwatches, personal digital assistants, or similar devices, which can communicate with other components of the system 100 via 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 similar. For example, the user device 105 may include a processor 151, device memory 153, user interface 158, and communication interface 154. The user device 105 may also have analog and / or digital circuits that can be implemented as a processor 151 for executing processes based on program code stored in the device memory 153, such as a user application 160 for managing the user's blood glucose levels and controlling the delivery of drugs, medications, or therapeutic agents to the user, and further, as discussed below, for calculating carbohydrate-compensation dosages, correction bolus dosages, and similars. The user device 105 may be used to program, adjust settings, and / or control the operation of the wearable drug delivery devices 200a, 200b and / or the analyte sensor 103, and, optionally, the smart accessory device 106.

[0010] The processor 151 may also be configured to execute program code stored in the device memory 153, such as a user application 160. The user application 160 may be a computer application that can be operated to deliver a drug based on information received from the analyte sensor 103, the cloud service 111, and / or the user device 105 or an 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 touchscreen device, camera, or the like), a communication interface 154, and the like. When the processor 151 is running the user application 160, it may be configured to perform displays and notifications related to meal 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 enables input of meal reporting, adjustment of setting options, and the like as described herein.

[0011] In a specific example, if the user application 160 is an insulin delivery application, the processor 151 is also configured to execute a diabetes treatment plan managed by the user application 160 (which may be stored in memory). In addition to the functions described above, if the user application 160 is an insulin delivery application, it may also provide functions for determining carbohydrate compensation doses, corrected bolus doses, and basal doses according to the diabetes treatment plan. Furthermore, as an insulin delivery application, the user application 160 provides a function for outputting signals to wearable drug delivery devices 200a and 200b via the communication interface 154 to deliver the determined bolus and basal doses.

[0012] The communication interface 154 may include one or more transceivers operating according to one or more radio frequency protocols. In one embodiment, the transceivers may include cellular transceivers and Bluetooth® transceivers. The communication interface 154 may be configured to receive and transmit signals containing information that the user application 160 is available.

[0013] The user device 105 may further include one or more output devices 155, which may be, for example, speakers or vibration transducers, to provide the user with various signals.

[0014] A preferred embodiment of the wearable drug delivery device 102 may include a storage unit 124 and a drive mechanism 125, which are controllable by a controller 121 that runs a drug delivery algorithm (MDA) 129 stored in memory 123. Alternatively, the controller 121 may operate to control the storage unit 124 and the drive mechanism 125 based on signals received from a user application 160 running on a 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, a device sensor 184, and a power supply 128.

[0016] In an alternative embodiment, the wearable drug delivery device 102 may include a second storage unit 124-2 and a second drive mechanism 125-2, which may be present as desired, thereby enabling the independent delivery of two different liquid drugs. For example, storage unit 124 may be filled with insulin, while storage unit 124-2 may be filled with plumlintide or GLP-1. In some embodiments, each of storage units 124, 124-2 may be configured with separate drive mechanisms 125, 125-2, which may be independently controllable by the controller 121 under the command of the MDA 129. Both storage units 124, 124-2 may be connected to a common patient interface 186.

[0017] The wearable drug delivery device 102 may optionally be configured with a user interface 127 that provides means for receiving input from the user and means for outputting information to the user. The user interface 127 may include, for example, a light-emitting diode, a button on the housing of the wearable drug delivery device 102, a sound transducer, a microdisplay, a microphone, an accelerometer for detecting the movement of the device by the user's gestures (e.g., tapping the housing of the device), or any other type of interface device configured to allow the user to input information and / or for the wearable drug delivery device 102 to output information (e.g., an alarm signal or the like) for the user to present to the user.

[0018] The wearable drug delivery device 102 includes a patient interface 186 for interconnecting with the user to deliver liquid drugs. 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 means for inserting the patient interface 186 into the user's body, which in one embodiment may include an actuator for inserting the needle / cannula under the user's skin and then withdrawing the needle to leave the cannula in the correct position.

[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 similar. 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 pressure sensors, power sensors, or similar, which are coupled in communication with the controller 121 and provide various signals. For example, a pressure sensor may be configured to provide an index of fluid pressure detected in the fluid path between the patient interface 186 and the reservoir 124. The pressure sensor may be coupled to or integrated with an actuator for inserting the patient interface 186 into the user. For example, the controller 121 may be operable to determine the drug infusion rate based on the fluid pressure index. The drug infusion rate may be compared to an infusion rate threshold, and the result of the comparison may be used to determine the amount of residual insulin (IOB) or total daily insulin (TDI) amount.

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

[0022] The communication link 115 connecting the cloud service 111 to each of the devices 102, 105, 106, and 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 that stores anonymized data such as blood glucose measurements, IOB or TDI history, previous carbohydrate compensation doses, and other forms of data. In addition, the cloud service 111 may process anonymized data from multiple users to provide generalized information related to TDI, insulin sensitivity, IOB, and similar data.

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

[0024] The wearable drug delivery device 102 may be configured to perform and execute the processes necessary to deliver a drug dose to the 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, IOB, insulin remaining amount, and similar items, and to actuate the controller 121 to operate the drive mechanism 125 to deliver the drug from the storage unit 124. The MDA 129 may utilize data received from the analyte sensor 108 or from the user application 160 as input.

[0025] Storage units 124 and 124-2 may be configured to store drugs, medications, or therapeutic agents suitable for automated delivery, such as insulin, pramulintide, GLP-1, insulin and GLP-1 combinations, morphine, blood pressure drugs, chemotherapy agents, ovulation inducers, or similar substances.

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

[0027] When configured to communicate with an external device such as a user device 105 or an 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 signals from each external device and may also perform drug delivery to the user in accordance with a diabetes treatment plan or other drug delivery plan executed by the MDA 129 or user application 160.

[0028] In an example of operation, the controller 121 may generate and output control signals that can be operated to move the drive mechanism 125 to deliver a carbohydrate-compensated dose of insulin, a corrected bolus, a modified basal dose, a co-formulation of various liquid drugs, or similar substances during the execution of the MDA 129.

[0029] The accessory device 106 could be, for example, an Apple Watch®, other wearable smart devices such as eyeglasses, smart jewelry, a wearable global positioning system, a wearable fitness device, smart clothing, or the same. Similar to the user device 105, the accessory device 106 may be configured to perform various functions, including controlling 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 memory 173. The user interface 178 may be a graphic user interface presented on the 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 the user app 160, or pared-down versions of the user app 160 with reduced functionality.

[0030] The analyte sensor 108 may include a controller 131, a memory 132, a detection / measurement device 133, an optional user interface 137, a power / energy harvesting circuit 134, and a communication interface 135. The analyte sensor 108 may be coupled by communication to the processor 151 of the management device 105 or the controller 121 of the wearable drug delivery devices 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 multiple different analytes, such as lactate, ketones, uric acid, sodium, potassium, alcohol levels, or similar substances, and to output the results of the measurements or detections, such as similar substances. In a preferred embodiment, the analyte sensor 108 may be configured to measure blood glucose levels at predetermined time intervals, such as every 5 minutes or at similar intervals. The communication interface 135 of the analyte sensor 108 may have a circuit that acts as a transceiver for communicating the measured blood glucose levels to a user device 105 via a wireless link 195, or to wearable drug delivery devices 200a, 200b via a wireless communication link 108. The sensing / measuring device 133 of the analyte sensor 108, referred to herein as 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 similar substances. The controller 131 may include an independent, dedicated logic circuit and / or component, application-specific integrated circuit, microcontroller, or processor that executes software instructions, firmware, program instructions, or any combination thereof stored in memory (such as memory 132).

[0032] Similar to the controllers 221 of the wearable drug delivery devices 200a and 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 detection and measurement device 133.

[0033] Although the analyte sensor 108 is shown separately from the wearable drug delivery device 102 in Figure 1, in various embodiments the analyte sensor 108 and the wearable drug delivery device 102 may be integrated into the same unit. That is, in various examples the analyte sensor 108 may be part of the wearable drug delivery device 102, integrated with it, and housed in the same housing as the wearable drug delivery device 102. In such embodiments the controller 221 may be able to perform the functions required for proper drug delivery on its own, without any external input from the user device 105, cloud service 111, another sensor (not shown), optional accessory device 106, or any of the same kind.

[0034] User app 160 (or MDA129) can provide periodic insulin microboluses based on predicted glucose over a 60-minute prediction interval. Optimal postprandial control requires the user to administer meal boluses in the same manner as current pump therapy, but normal operation of user app 160 compensates for missed meal boluses and mitigates persistent hyperglycemia. User app 160 employs a control-to-target strategy that attempts to achieve and maintain a set target glucose level, thereby shortening the duration of persistent hyperglycemia and hypoglycemia.

[0035] The user application 160 is the primary interface with the user and runs a graphical user interface used for controlling the wearable drug delivery devices 200a and 200b, programming the basic and bolus computer settings for manual mode, and programming settings specifically 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 volumes and also has the option to set a temporary basal profile. The controller 121 also has the ability to function as a sensored pump in manual mode, adding data to the bolus calculator using sensor glucose data provided by the analyte sensor 108.

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

[0038] The user app 160 can guide the user through the setup process and use the system 100 using large text, graphics, and on-screen instructions. It is also used to program a personalized basal insulin delivery profile, check the status of wearable drug delivery devices 200a and 200b, initiate insulin bolus administration, change the patient's insulin delivery profile, handle 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 do not need to communicate directly with each other. Instead, data from the analyte sensor (e.g., blood glucose records) may be communicated to wearable drug delivery devices 200a, 200b via link 196 and then relayed to the user device 105 via link 194. In some embodiments, the serial number of the analyte sensor must be entered into the user application 160 to enable communication between the analyte sensor 108 and the user device 105.

[0040] User app 160 may provide the ability to calculate a proposed bolus dose using a bolus calculator. The bolus calculator is provided for user convenience to assist in determining a proposed bolus dose based on ingested carbohydrates, the most recent blood glucose record (or, if using a fingerstick, the blood glucose record), programmable correction factors, insulin-to-carbohydrate ratio, target glucose value, and residual insulin (IOB). IOB is estimated by user app 160, taking into account both manually delivered boluses and insulin delivered by algorithms.

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

[0042] Software-related executions of the technologies described herein may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instruction that can be executed by one or more processors. Computer-readable instructions may be provided via non-temporary computer-readable media. Hardware-related executions of the technologies described herein may include, but are not limited to, integrated circuits (ICs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the technologies described herein, and / or any system or component described herein, may be executed using a processor that executes computer-readable instructions stored in one or more memory components.

[0043] Figure 2a shows a perspective view of the drug delivery device 102 with the front side facing upwards, showing one or more housings of the drug delivery device 102. Figure 2b is a perspective view of the drug delivery device 102 from the back side, showing the adhesive backing 206 and 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 user's skin. The needle / cannula cap 208 protects the needle / cannula until use of the device and should be removed as shown before adhering the device to the user's skin to expose the needle / cannula. The adhesive should be strong enough to adhere the drug delivery device 102 to the user's skin, but also allow for easy removal of the drug delivery device 102.

[0044] As shown in Figures 2c to 2d, the drug delivery device 102 may include a module 202 attached to or coupled to one or more housings of the drug delivery device 102. Alternatively, the module 202 may be located within the main housing of the drug delivery device 102, or in close proximity to another housing of the drug delivery device 102, so as to allow for a seamless transition between the housing of the drug delivery device 102 and the module 202.

[0045] Module 202 may include some or all of the features described above with reference to the user device 105, or other electronic components, durable components, or semi-durable components. In various embodiments, module 202 may include a transceiver that enables the drug delivery device 102 to communicate wirelessly with any other device or component shown in Figure 1. 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 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 module 202.

[0046] Module 202 may include a motor for driving a pump that delivers the drug into the user's body, at least one battery and / or supercapacitor, a printed circuit board, 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, and sensors such as a temperature sensor, an accelerometer, a barometric pressure sensor, and / or a light sensor. Module 202 may also include an optical output unit such as one or more LEDs, a vibration transducer, and / or an audio output unit such as a speaker for providing 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 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 memory. The memory may include, but is not limited to, one or more types of storage such as random access memory (RAM), flash memory, read-only memory (ROM), computer-readable memory storage, and similar types. The memory may also hold data and other useful information for the operation of the drug delivery device 102. The drug delivery device 102 mounted on the electronic module 202 may have other components of the drug delivery system, including, for example, a reservoir for storing the drug, a needle, cannula, and / or microneedle array for delivering the drug to the user's body, and a pump for transferring the drug from the reservoir to the user's body through the needle, cannula, or microneedle array. The drug delivery device 102 may also include a power source, such as a battery, for supplying power to the pump and / or other components of the drug delivery device 102.

[0047] Module 202 may be removably attached to a drug delivery device 102 so that it can be used with multiple drug delivery devices 102, some of which may be disposable, and so that Module 202 may be reusable. This avoids the need to remanufacture all components of the drug delivery device 102, which may be disposable after the drug in the storage unit 124 has been used up, thereby reducing the cost of the drug delivery device 102. Module 202 may be sealed and waterproof. Module 202 may have a battery that may be rechargeable using wireless or wired charging.

[0048] In various embodiments, the drug delivery device 102 and / or module 202 described herein include 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 module 202, an accelerometer for detecting the movement of the drug delivery device 102 or module 202, or any other such input device. The user output device may be a speaker for producing sound, a vibration generator (e.g., a motorized gear with an off-center weight) for producing vibration, a metal terminal for delivering an electric shock to the user's body, a display and / or one or more colored lights for emitting a visual alarm, or any other such output device.

[0049] In various embodiments, when the drug delivery device 102 receives a command from the user device 105, the action associated with the command (e.g., bolus delivery) will not be performed until input from the user is received. Possible inputs 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 the accelerometer), tapping the drug delivery device 102 or electronic module 202 one or more times (as detected by the accelerometer), 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 described above. If no input is 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 will be unable to perform the drug delivery action. That is, the determined insulin dose may not be delivered, and the user may receive a warning accordingly. In some embodiments, the output device alerts the user that a command has arrived at the drug delivery device 102 or module 202, for example by sounding an alarm, vibrating, or emitting a visual signal. The output device may also alert the user after the action has been performed and / or if the action is canceled due to a lack of user input.

[0050] A preferred embodiment of system 100 is shown in Figure 3, which shows the system components in a predetermined location on the 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 the user device 105 or other devices such as a cloud device or service 111. As described above, the analyte sensor 108 may be incorporated into the drug delivery device 102 or mounted therein in an adjacent housing.

[0051] Next, we will consider the graphic user interface for user application 160. Figure 4 shows the default home screen 400. When user application 160 is 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 several pages showing various information, the currently displayed page varies depending on the user's selection of one of several tabs displayed in the tab bar 402. In one embodiment of the present 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, the details of which will be discussed later.

[0053] In one embodiment, the "Dashboard" tab may be the default tab displayed when the user app 160 is launched. As shown in Figure 4, the tab bar 402 indicates that the "Dashboard" tab is selected, as indicated by the underline of the "Dashboard" tab, the different color of the word "Dashboard," and the highlighting of the leftmost dot on 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, it 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 can be changed by selecting one of the tabs in the tab bar 402 or by swiping left or right within the information area 404. By selecting one of the tabs or swiping left or right within area 404, the content displayed in the information area 404 is changed without affecting the content displayed in areas 406 or 408 of the screen. The information area 404 consists of a border 404a whose color may change depending on the operating mode. For example, the boundary line may be light gray if the user application 160 is in manual mode, or if there are no active pods or no pod communication. If the user application is in automatic mode, the boundary line 404a may be purple or another color if the pod reports that it is operating in a fully automatic state, or dark gray if the pod reports that it is operating in a limited automatic state.

[0054] The variations of the home screen 400 that appear when the user application 160 is launched or when the user navigates to the home screen 400 differ depending on the current state of the user application 160. In one embodiment, for example, when an immediate bolus is delivered, the default home screen appears as shown in Figure 8a. When a persistent bolus is delivered, the home screen appears as shown in Figure 8b.

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

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

[0057] Examples of various pages that may be displayed in information area 404 are shown in Figures 5 to 10, and will be discussed in detail later.

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

[0059] The CGM area 408 of the default home screen 400 provides an option to display information related to the user's continuous glucose monitoring. In a particular embodiment, the CGM area 408 may display, for example, the reading of the most recent glucose record, or a graph of a predetermined number of recent glucose record values ​​from continuous glucose monitoring. The information displayed in the CGM area 408 may be automatically selected based on the current status of the user app 160, or it may be selected by the user by tapping within the CGM area 408 with a finger. Examples of pages displayed in the CGM area 408 are shown in Figures 10a to 10c.

[0060] The default home screen 400 includes a mode indicator 410, which shows the current mode of the user app 160. Various modes may be indicated by different icons, words indicating the mode, and / or the color of the mode indicator 410. In a preferred embodiment of the present invention, the mode indicator 410 may show one of the following four modes: (1) “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, and this mode may only be displayed after the CGM and / or IOB values ​​have expired; (2) “Restricted” mode indicator, which is displayed when the drug delivery device 102 reports being in a restricted state in automatic mode; (3) “Manual” mode indicator, which is displayed when the user app 160 is operating in manual mode; and (4) “Automatic” mode, which is displayed when the drug delivery device 102 reports operating in a fully automatic or hybrid automatic state.

[0061] The default home screen 400 includes a menu button 414, which, when activated by the user tapping the menu icon, displays a vertical menu superimposed on the left side of the home screen 400 in one embodiment of the present invention. Examples of the displayed menu 1300 are shown in Figures 13a and 13b.

[0062] Figures 5a to 5d show pages that may appear in the information area 404 of the default home screen 400 when the "Dashboard" tab is selected. Figure 5a shows the default page, which includes a residual insulin indicator 502, the most recent recorded value 504 from the connected CGM 108, and an arrow 506 indicating the trend of the recorded value from the CGM 108. In some cases, the arrow 506 may not be present, which indicates 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 various colors that show the CGM recorded value compared to the desired value. For example, in a preferred embodiment, blue indicates that the CGM record value 502 is within the user-set CGM / BG target range and the user application 160 is operating in manual mode; red indicates that the latest CGM record value 504 is lower than the user-set CGM / BG target range (both manual and automatic modes); yellow indicates that the latest CGM record value 504 is higher than the user-set CGM / BG target range (both manual and automatic modes); and purple indicates that the latest CGM record value 504 is within the user-set CGM / BG target range and the user application 160 is operating in automatic mode. In other embodiments, other colors may be used as indicators of other states.

[0063] Figure 5b is an example of a page displayed in the information area 404 when the CGM monitor 108 is not registered with the user application 160 and a wearable drug delivery device 102 is in operation. In this case, the latest CGM record value 504 does not need to be available, and therefore only the remaining insulin is displayed. Figure 5c shows a screen indicating that the CGM 108 has returned a "high" status. The "high" status is displayed in yellow and indicates that the latest CGM record value 504 is higher than the user-set CGM / BG target. Similarly, this type of page may also show a "low" indicator (not shown), which is displayed in red and indicates that the latest CGM record value 504 is lower than the user-set CGM / BG target range. Figure 5d shows a page similar to the page shown in Figure 5a, but with the addition of a button 508 that allows the user to initiate the 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] Figures 6a to 6f show the pages that may appear in the information area 404 of the default home screen 400 when the "Insulin" tab is selected. Figure 6a shows the default page that appears when a basal program is running. The basal program icon 602 is displayed in the upper left corner of the screen. Different basal programs may have different icons. When a basal program is running, the basal program icon 602 is shown in green, and when a basal program is not running, the basal program icon 602 may be grayed out. The name and status 604 of the basal program are shown next to the basal program icon 602. The basal graph 606 shows a full 24-hour graph showing the total number of units of insulin to be delivered over a 24-hour period by the currently running basal program. The current basal rate 608 is shown in the box above the basal graph 606 according to the current time of day. Below the basal graph 606 is the total insulin indicator 610, which shows the total insulin to be delivered by the currently running basal program during the day. When button 612 is selected by the user tapping on it, the screen transitions to the page shown in Figure 6b, where a list of saved base programs 614 is displayed overlaid on the bolus display area 406 and CGM area 408 on the default home screen 400. The currently running base program 613 is shown in the information area 404. Button 616 allows the user to create a new base program, which will be saved in list 614. Screens for creating, editing, and starting base programs are shown in Figures 17a to 17f.

[0065] Figure 6d shows the page displayed in 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 dose 610 is replaced with the change in basal delivery 618 due to the temporary basal program. In addition, this page includes a cancel button 620, which, when selected by the user, cancels the temporary basal program. When the temporary basal program is running, the "Insulin" tab in tab bar 402 changes to the "Temporary On" button 618 shown in Figure 6c. Once the temporary basal program is complete, the "Insulin" tab will reappear in tab bar 402.

[0066] Figure 6f shows the page displayed in information area 404 when HypoProtect® mode is selected by the user. HypoProtect® mode may be invoked by the user when the user has experienced a negative response to insulin, when the user is about to start an activity or time frame in which insulin sensitivity will increase, or when the user simply wants to interrupt or reduce insulin delivery for a predetermined period of time. In one preferred embodiment, when HypoProtect mode is selected, automated basal insulin delivery is reduced by 75%, and the user's target blood glucose level is increased. Information area 404 includes an icon 624 indicating that HypoProtect® mode is in progress, as well as a time indicator 626 showing the remaining time until normal operation can be resumed. It also includes a button 628 ("Cancel") which the user may select to immediately cancel HypoProtect® mode. When in HypoProtect® mode, the "Insulin" tab in tab bar 402 changes to the "Protect" button 622 shown in Figure 6e. Once HypoProtect™ mode is exited, the "Insulin" tab will reappear on tab bar 402.

[0067] When the "Insulin" tab is selected, other status pages (not shown) may also be displayed in 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 Figure 6f appears, indicating the current mode.

[0068] Figures 7a and 7b show the 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 is shown in Figure 7a and includes the Pod Status 702, which is displayed at the top of the page. The Pod Status 702 can be changed. For example, if the drug delivery device 102 is nearing its expiration date, the Pod Status 702 may be changed to "Replace Pod Soon" or "Please Replace Pod," and may be displayed in a different color, such as 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 showing the amount of insulin remaining in the drug delivery device 102 (in units), and an expiration indicator 708 showing the date and time when the drug delivery device 102 will expire. This page also includes a Pod Details button 710, which, when selected by the user, displays more detailed information about the drug delivery device 102. Figure 7b shows a page on which a user can set up a new drug delivery device 102. This page may appear, for example, if the user app 160 loses communication with the wearable drug delivery device 102 for a predetermined period of time. This page includes a "Set up new pod" button 714 that allows the user to initialize the new wearable drug delivery device 102.

[0069] Figures 8a and 8b show the default home screen 400 when a bolus is being delivered. Figure 8a shows the delivery and status of an immediate bolus. Note that during the delivery of an immediate bolus, the menu button 414, alarm icon 416, and mode indicator 40 are hidden (and disabled). A progress bar 802 is included that shows what percentage of the total bolus has been delivered (e.g., including a percentage) and changes as the bolus is delivered. Figure 8b shows the default home screen 400 during the delivery of a sustained bolus. Since a sustained 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 sustained bolus.

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

[0071] In the CGM area 408 of Figure 4, information about CGM can be accessed. The default page of the CGM area 408 is shown in Figure 10a. The default page includes a graphic and a "Display" button 1002, which, when selected by the user, displays the graph shown in Figure 10c in the information area 404 of the default home screen 400. The page shown in Figure 10b is displayed when the "Insulin" or "Pod Info" tab is selected from the tab bar 402, or when the "Dashboard" tab is selected and the information area 404 is hidden by the immediate bolus or sustained bolus graphics shown in Figures 8a and 8b. The information displayed in area 1004 is very similar to the information displayed on the default dashboard page shown in Figure 5a. The page shown in Figure 10b also includes a graph display button 1006, which, when selected by the user, displays the graph shown in Figure 10c in area 404.

[0072] The graph shown in Figure 10c appears in the information area 404 of the default home screen 400. The default graph 1010 shows CGM recorded values ​​for more than 3 hours prior to the current time. Each dot in graph 1010 represents a CGM recorded value received from CGM 108. The grayed-out area 1012 in graph 1010 indicates the target range of CGM / BG set by the user, and the dotted line 1014 is a target BG that can also be set by the user. The timeline 1016 shows the time scale of the recorded values. Below the timeline 1016 is the event area, which in one embodiment, for example, shows 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, when there was no active wearable drug delivery device 102, or when there was no communication with the wearable drug delivery device 102; a dark gray background when the user app 160 was delivering insulin in a limited automatic mode; a blue background when transient basal delivery was in progress; a red line for times when insulin delivery was interrupted; an orange line for times when the maximum permissible basal insulin was being delivered; a green line for when HypoProtect® mode was in progress; and a bolus icon (see 412 in Figure 4) for times when the user initiated a bolus delivery of insulin. Different colors may be used and different events may be shown in this area, as will be recognized by those skilled in the art.

[0073] The user can change the graph display 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 latest CGM record value along with a trend arrow, as well as the current remaining insulin.

[0074] A notification indicator 416 on the home screen 400 indicates to the user that there are available notifications. In some embodiments, the appearance of the notification indicator 416 may change, for example, by changing color, flashing, or changing the shape it displays. When the user selects the notification indicator 416 by tapping an icon, the screen shown in Figure 12 is displayed, which shows a list of notifications 1202 including a predetermined 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] Figures 13a and 13b show examples of variations of the menu 1300 that appear when the user selects the menu button 414 on the default home screen 400. Depending on the mode of the user app 160, various functions can be enabled or disabled on the menu 1300. Figure 13a shows the menu 1300 as it appears when the user app 160 is in "Automatic" mode. Buttons 1302 ("Temporary Basic Settings"), 1310 ("Insulin Interruption"), and all buttons in section 1306 ("Program & Preset Management") are disabled. If HypoProtect® mode is running, button 1308 ("HypoProtect® Mode") is also disabled. Figure 13b shows the menu 1300 as it appears when the user app 160 is in "Manual" mode. In this mode, button 1308 ("HypoProtect® Mode") is disabled. Button 1602 ("Temporary Basis Setting") is enabled unless a temporary basis program is in progress, insulin delivery is interrupted, or there is no active wearable drug delivery device 102. Button 1310 ("Insulin Interruption") is disabled if there is no active wearable drug delivery device 102. If button 1302 is selected and insulin delivery is interrupted, button 1310 is replaced by the "Insulin Start" button. The functions of the buttons in menu 1300 will be described later in this specification.

[0076] Any abnormal situation or error condition resulting from the operation of the user application 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 and 14b. Each modal message may have an "OK" button 1402, which, when selected by the user, dismisses the modal message and returns to the home screen 400.

[0077] Bolas screen The bolus button 412 on the home screen 400, when selected by the user, replaces the default home screen 400 with the bolus calculator shown in Figures 11a to 11f. The bolus button 412 may appear in different colors. For example, the bolus button 412 may appear gray to indicate that the button is disabled if immediate bolus delivery is in progress or insulin delivery is interrupted. The bolus button 412 may appear blue when the user app 160 is in manual mode, and purple when 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 input the total carbohydrates consumed during a meal. When field 1102 is selected, a modal keyboard appears overlaid on the screen, where the user can input the amount of carbohydrates. When the user exits the modal keyboard, the entered amount is transferred to field 1102. The amount of insulin for the bolus based on the amount of carbohydrates 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 record value. Field 1104 allows the user to enter the current blood glucose record value. Selecting field 1104 brings up a modal keyboard, allowing the user to manually enter the current blood glucose record value. Alternatively, pressing button 1106 will use the latest record value from CGM 108 and enter it into field 1104. The correction bolus will be displayed as "Corrected Bolus" in 1116. Note that the correction bolus can be a positive or negative number.

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

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

[0082] Users may wish to specify the delivery of a bolus as a sustained bolus. When the user selects button 1124 ("Sustained Bolus") in Figure 11b, the screen shown in Figure 11e appears, allowing the user to input the percentage of the bolus to be delivered immediately and the percentage of the bolus to be delivered over a sustained period of time. The user can input into either field 1128 ("Immediately") or field 1130 ("Sustained"). 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 moved to the field with the current focus (i.e., field 1128 or 1130). Regardless of which field is entered by the user, the other field is automatically populated by the user application 160 by subtraction from 100%. In field 1132 ("Duration"), the user can specify the duration over which the sustained portion of the bolus is delivered. Selecting field 1132 brings up a modal menu with options for various time intervals. When the user selects a time interval value from the modal menu, that time interval is moved to field 1132. A summary of the bolus appears in area 1134 of the screen. When the user selects button 1136 ("Confirm"), the screen shown in Figure 11f appears, which displays a summary of the bolus 1138, including the percentage to be delivered immediately and the percentage to be delivered over the duration. When the user selects button 1140 ("Start"), the delivery of the bolus begins.

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

[0084] Figure 15 shows an information screen 1500 that provides details about the current status of the pod. Screen 1500 can be reached by selecting the "Pod Info" tab from the home screen 500, and then selecting button 1010 ("Show Pod Details") from the information page shown in Figure 7a. Section 1502 of the screen shows the remaining amount of insulin in the wearable drug delivery device 102. This information is transmitted wirelessly from the wearable drug delivery device 102 to the user app 160. In certain embodiments, when the amount of insulin in the wearable drug delivery device 102 falls below a predetermined 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. 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 appear after the user selects button 1508 in Figure 14. Figures 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 can 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 can begin operating the drug delivery device 102 by selecting button 1604 in Figure 16b. During the setup process, the user may be presented with one or more modal screens, an example of which is shown in Figure 16d, which prompt the user to confirm that the cannula of the drug delivery device 102 has been correctly inserted, as indicated by a pink status light visible on the housing of the drug delivery device 102 body. The user can respond by pressing the "Yes" or "No" button on the screen. Some instruction pages may include hyperlinks, such as hyperlink 1608 shown in Figure 16b, which can take the user to other instruction pages. When hyperlink 1608 in Figure 16b is pressed, the user is taken to the screen in Figure 16c, where the user can record the physical location where the drug delivery device 102 will be placed. This page may also display 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) can also be reached via hyperlinks on the instruction pages.

[0086] Basic Program Screen This section relates to a screen that allows the user to view, select, edit, and create base programs to be executed by the user application 160. Figure 17a shows the screen of Figure 6b with a modal menu 1704 superimposed on top. The modal menu 1704 for either the base programs or the list 614 can be invoked by touching the 3-dot menu call control 1703 located next to each base program in the list 914. The modal menu 1704 contains menu items that allow the user to start, edit, or delete the currently selected base program. The user can create a base program by selecting the "New" button 616.

[0087] Figure 17b shows the screen used when creating a basic program. The user can give the program a name 1709, which is displayed near the top of the screen. For each segment of the basic program, the user must specify the start time of the segment, the end time or duration of the segment, and the base rate to be delivered between the specified segments. Following the name 1709 is an indicator of the currently specified segment. When the user specifies the start and end times of a segment in field 1708, vertical lines 1706 indicating the start and end times of the segment appear in area 1707 of the screen. In some embodiments, the start time may be a pre-filled field, and the user only specifies the end time. In some embodiments, the user may manually type the end time into field 1708, or select the end time from a modal menu (not shown), or select the duration from a modal menu (not shown). When 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 fill in the start time field.

[0088] Figure 17c shows a basal rate modal menu 1710 that the user can use to select a basal rate for the current segment. This menu can be invoked by the user selecting the basal rate field 1705 shown in Figure 17b. Once the user has selected a basal rate, the selected basal rate is used to input into field 1705, as shown in Figure 17d. In addition, a bar 1712 showing 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. Figure 17e shows a nearly completed basal program, while Figure 17f shows a completed program, with each segment of the program listed in list 1722. Any segment of the program can 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 can be saved by selecting button 1726 ("Save"). The creation of the basic program can be canceled at any time by pressing button 1728 ("Cancel").

[0089] Temporary basic screen The temporary basal function of user app 160 allows the user to temporarily modify their basal rate for a predetermined period of time. For example, the user may have exercised or gone to bed early, and therefore the amount of basal required will decrease during that period. To access this function, the user simply selects the menu button 414 on the home screen 400. When the menu appears as shown in Figures 13a and 13b, the user selects the menu button 1302 ("Temporary Basal Settings"), which displays the screen shown in either Figure 18a or Figure 18c. The user has the option of entering the basal rate to be delivered during the temporary basal profile as a percentage of the basal rate delivered as part of the currently running basal program, or as an absolute value in units. The options can be configured in the "Settings" section of user app 160, which will be discussed later.

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

[0091] Alternatively, the user may choose not to specify a base rate and duration, but instead select a temporary base profile from a list of saved temporary base profiles by selecting button 1810 ("Select from Presets"). The user can cancel the creation of the temporary base profile at any time by selecting button 1814 ("Cancel"). After the user enters the base rate in field 1806 and the duration in field 1808, they can confirm their selection by selecting button 1812 ("Confirm"), which brings up the screen shown in Figure 18b.

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

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

[0094] Users can either create a temporary base profile or configure a temporary base profile. As shown in Figures 18c to 18d, if a temporary base profile has been created, selecting button 1822 ("Confirm") will navigate the user to a screen where they can save the temporary base profile. As shown in Figures 18a to 18b, if a temporary base profile has been configured, selecting button 1820 ("Confirm") will navigate the user to a screen where they can start the temporary base profile.

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

[0096] By selecting the menu indicator 1828 located next to any of the saved temporary base profiles listed in List 1824, a modal menu 1830 appears, as shown in Figure 18f. From the modal menu 1830, the user can choose to start, edit, or delete each temporary base profile.

[0097] Blood glucose screen The user application 160 provides means for the user to manually input blood glucose records. When the user selects button 1312 ("BG Input") from the menu shown in Figures 13a and 13b, the user application 160 displays the blood glucose input 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 record, which is shown in the field 1904 at the center of the circle. Alternatively, the user may select field 1904, which brings up a modal keyboard, allowing the user to input a blood glucose record. When the modal keyboard is dismissed, the blood glucose record is moved to field 1904. As will be recognized by those skilled in the art, many other means of manually inputting blood glucose levels are possible and are intended to be within the scope of the present invention.

[0098] The color of the circular graphic 1902 may change depending on the blood glucose record value displayed in field 1904. For example, the circular graphic 1903 may appear yellow, as shown in Figure 19b, if the blood glucose level is higher than the user's target range but lower than a pre-selected upper threshold. If the blood glucose level record value 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 pre-selected lower threshold, the circular graphic 1902 may appear red, as shown in Figure 19c. If the blood glucose level record value displayed in field 1904 falls below the lower threshold, the "Low" indicator may appear in field 1904. Once the blood glucose level has been entered into field 1904 and confirmed by the user, the user can save the record value by pressing button 1906 ("Save"). In the first variant of this embodiment shown in Figure 19d, the graphics may be modified by adding plus and minus signs for a few seconds after the user lifts their finger from the cursor 1903, thereby allowing the user to increase or decrease the blood glucose record value displayed in field 1904 by 1, enabling finer control. In the second variant, the blood glucose input screen may be displayed directly from the bolus calculator shown in Figure 11a by tapping field 1104. As shown in Figure 19d, button 1906 ("Save") is replaced with button 1912 ("Add to Calculator"), which, when selected by the user, adds the blood glucose value displayed in field 1904 to the blood glucose field 1104 of the bolus calculator shown in Figure 11a.

[0099] Food Library Screen User app 160 can provide a food library to help users determine the amount of carbohydrates in their meals, and this amount is used by a bolus calculator to calculate the bolus dose of Isrin.

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

[0101] The "My Foods" screen also includes button 2004 ("Add Custom Food"), which allows the user to add a customized food option, for example, if that food does not currently exist in the food library. Selecting button 2004 replaces the button portion of the "My Foods" screen with the screen shown in Figure 20b, which allows the user to enter details about the custom food. In field 2014, the user can name the food. Selecting field 2014 brings up a modal alphanumeric keyboard, which the user can use to enter the name of the custom food. When the modal alphanumeric keyboard is dismissed, the food name is moved to field 2014. In field 2016, the user can enter the carbohydrate value of the food via a modal numeric keyboard, and in field 2018, the user can (optionally) enter the fiber content of the custom food via a modal numeric keyboard. In area 2020 of the screen, the user can select various tags for the custom food. Once the user has entered all the details of the custom food item, they can add it to 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 tab bar 2002, the user can browse the food library by category. The initial list of categories is shown in list 2024. When one of the categories, for example, the "Bars, Breakfast Cereals" tab, is selected, secondary categories are shown in Figure 20d as list 2026. By repeating the category selection, the user eventually reaches individual food items, which they can select and add to the total carbohydrates for a meal and / or to the "My Foods" list 2006. The user can return to the previously viewed category by pressing button 2028, which displays the screen shown in Figure 20c. Each screen in the food library is configured with button 2009 ("Cancel"), which, when selected, returns the user to either the home screen 400 or the bolus calculator screen shown in Figure 11a.

[0103] Initial setup screen The user application 160 provides a series of screens that allow the user to perform the initial setup of the user application 160. The functions provided on these screens are performed only once, typically when the user first launches the user application 160. When the user application 160 is first launched, the user may be presented with a "Welcome" screen 2100 similar to the screen shown in Figure 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 prompted to enter certain information online. Figure 21b shows a screen where the user can log in to an online center, where the user can enter certain information necessary to operate the wearable drug delivery device 102. To access the user account on the online center, the user may be prompted to enter a username 2106 and a password 2108.

[0104] Certain aspects of setting up the user application 160 can be done locally. For example, Figure 21c shows a screen where the user can set a security PIN 2110 to restrict access to the user application 160. The user may be provided with a modal keyboard 2112 on which they can enter the PIN. This may be followed by an additional screen where the user can confirm the PIN entry by re-entering it. Figure 21d shows a screen on which the user can enter Wi-Fi settings to enable connection to a wireless access point for accessing the internet. The user can access a screen (not shown) on which they can enter Wi-Fi settings by selecting a button 2113. In some cases, selecting button 2113 may take the user to the native Wi-Fi settings screen for the user device 105 on which the user application 160 is running. In some cases, the user device 105 on which the user application 160 is running may already be connected to a wireless access point, in which case the screen shown in Figure 21d would be unnecessary.

[0105] During the setup process, the user app 160 may determine that it needs access to the location information of the user device 105. For example, the user app 160 may attempt to track the current location of the user device 105 to identify the time zone in which the user device 105 is currently located, and to adjust the time zone if the user moves between time zones. The time zone can be used as a basis for calculating the time for insulin delivery. The user may be presented with a modal screen, as shown in Figure 21e, which allows the user to grant the user app 160 access to the location information of the user device 105. The screens shown in Figures 21a to 21e are illustrative in nature, and as recognized, 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 can set up a message to be displayed when the user app 160 is locked, for example, to confirm the user's contact information, which could be used if the user device 105 is lost. In addition, the user can set up a background containing personal information that is displayed on the lock screen. Many other user-configurable features may be available to the user.

[0106] In addition to general setup items, users may be prompted to set up parameters for the delivery of basal and bolus doses of liquid drugs. For example, a user can set up a basal profile. Figure 21f shows an exemplary screen in which a user can set the maximum basal rate by entering the number of units per hour in field 2114. Figure 21g shows an exemplary screen in which a user can set up a bolus. Field 2116 indicates the name of the bolus, while in field 2118 the user can generate the start and end times of the bolus. The user can also enter the target blood glucose level in field 2120 and the "correct if exceeded" value in field 2122. Many other parameters for the delivery of liquid drugs, including basal and bolus doses, can be entered on other screens, similar to those already discussed above regarding bolus and basal doses.

[0107] Alarm and warning screen The user application 160 may provide the user with screens displaying alarms, warnings, and / or error screens at various points during its operation. In some cases, alarms or warnings may be accompanied by an exclamation mark ("!") icon, which may be displayed on a background of a specific color, such as a yellow background, as shown in the example of icon 2202 in Figure 22a. The specific screen shown in Figure 22a warns the user that insulin delivery should be resumed. A message 2204 indicating the reason for the warning may also be displayed, along with one or more buttons 2006 that the user can take action in response to the warning. More serious errors or warnings may be provided by an icon, for example, an excavation point on a red background, as shown in Figure 22b as icon 2208. In addition, a message describing the error and the action the user should take to resolve the error may also be provided, as shown by message 2210 in Figure 22b. Warnings and errors may be provided as a full screen, as shown in Figure 22a, or as a modal popup, as shown in Figure 22b. Figure 22c shows yet another example of a common error.

[0108] History screen The user application 160 has a function to display the history of its operations. The user can access the history information by selecting button 1314 ("History Details") on menu 1300. The default history screen appears as a vertical modal popup 2300, superimposed on or replacing menu 1300, as shown in Figure 23a. By default, the history screen displays the history information for the current day. However, history information for other days can be displayed by the user selecting button 2302 ("<"). The history screen 2300 includes tab buttons with two tabs, the "List" tab 2304 and the "Automatic Events" tab 2305. The screen showing the display when the List tab 2304 is selected is shown in Figure 23a. The display includes the CGM history 2306, which includes the average CGM recorded value, as well as information on the percentage of time the user's blood glucose level was within the user-specified range, above the range, and below the range. Additionally, if the list tab 2304 is selected, insulin and carbohydrate information 2308 will also be displayed. This area of ​​screen 2300 shows the total insulin delivered on that day, the percentage delivered as basal insulin, the percentage delivered as bolus insulin, and the total carbohydrates consumed by the user during that day.

[0109] Area 2310 of the history screen 2300 displays a timeline showing individual events and the times when those individual events occurred. Further details about each individual event can be displayed, for example, by selecting the downward arrow 2312, thereby expanding the area to display details about the individual timeline event. As shown in Figure 23b, the graph shown in area 2314 is displayed as a result of the user selecting the downward arrow 2312 on the "Temporary Base Start" area of ​​timeline 2314. Different types of information may be displayed when different timeline events are expanded. Timeline events can be collapsed by selecting button 2316, thereby hiding the graph shown in area 2314.

[0110] Selecting the "Automatic Events" tab 2305 results in the screen shown in Figure 23c, which displays event banners and data columns. Event banners 2316 and 2320 indicate mode switching events and time zone switching events. Event banners 2316 and 2320 may be displayed in different colors; for example, a purple banner may be displayed when automatic mode starts, and a blue banner may be displayed when automatic mode ends. This screen also includes a data column 2318, which shows CGM recorded values ​​and delivered microbolus doses.

[0111] Settings screen All user-configurable options and settings for the user application 160 can be accessed via button 1316 ("Settings"), as shown in Figure 13a. Button 1316 can be extended to display an extended settings menu 1318. Figure 13a shows the extended settings menu.

[0112] When the user selects button 1320 ("About the App"), the main menu 1300 is replaced with a screen displaying 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, and information about recent communications with the wearable drug delivery device 102 or the cloud 111.

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

[0114] When button 2402 is selected, the screen shown in Figure 24b is displayed. In some embodiments, the user must have a Personal Identification Number (PIN) in order to send a log file. Therefore, the screen shown in Figure 24b may also include instructions for obtaining the PIN 2406. The user can receive the PIN, for example, through communication via user application 160 or through communication independent of user application 160. If the user already has a PIN, the user may select button 2404 ("Next"), which displays the screen shown in Figure 24c. The user then enters the PIN in field 2408 using the keypad 2410, and after completion, selects button 2412 ("Send File") to begin sending the log file to the customer care center. When button 2412 is selected, the screen shown in Figure 24c disappears, and the user returns to the operation of the previously displayed screen.

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

[0116] In addition, by selecting button 2502 in Figure 25a, the user can set the default time zone and language, as well as the time zone on which to calculate the time for insulin delivery. This brings up the screen shown in Figure 25b, which first alerts the user that insulin delivery must be interrupted before the time zone can be changed. When the user interrupts insulin delivery by pressing button 2504 ("Interrupt Insulin"), the screen changes as shown in Figure 25c, displaying a banner 2506 indicating that insulin delivery has been interrupted, and enabling a selection menu 2508 that the user can use to select a time zone. Once a time zone is selected, the user may select button 2510 ("Save"), which saves the time zone selection, the screen shown in Figure 25c disappears, and insulin delivery resumes if it was interrupted. If the user allowed access to the device's location information during the setup process, the time zone may be automatically changed when the user moves 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 used by the system for drug delivery. If there is a time zone discrepancy, the user may be alerted and asked whether they should update their time zone. Updating the time zone results in corresponding changes being made to insulin delivery. For example, a baseline profile that can deliver different amounts or rates of insulin at different times of the day may subsequently be adapted to the updated time zone. In addition, instead of the user having to set the time zone (either by default or otherwise), the user device 105 can 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.Furthermore, if the time and / or time zone of the user device 105 is automatically updated (for example, 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 can 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 the user moves to a new location.

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

[0118] Insulin interruption screen When the user selects button 1310 ("Insulin Interruption") from the main menu 1300 shown in Figures 13a and 13b, the user can temporarily suspend insulin delivery for a specified period of time. Note that button 1310 may only be available when certain conditions are met. For example, button 1310 may be disabled when a temporary basal profile or continuous bolus program is running. Selecting button 1310 can display the screen shown in Figure 26a, where the user can specify the length of time to interrupt insulin delivery. In some embodiments, selecting field 2602 may present the user with a modal keypad from which they can manually enter the time. In other embodiments, selecting field 2602 may provide the user with a menu from which they can select a duration menu item. When the modal screen is dismissed, the specified time for the interruption is moved to field 2602. The user can start the interruption by pressing button 2604. If insulin delivery is interrupted, button 1310 on the main menu 1300 may change from "Interrupt Insulin" to "Start Insulin," and selecting this allows the user to resume insulin delivery. When the user selects button 1310 ("Start Insulin"), the screen shown in Figure 26b appears, allowing the user to resume insulin delivery using the most recently active basal program. Resumption is achieved by the user selecting button 2606. Once insulin delivery is resumed, button 1310 on the menu 1300 returns to displaying the words "Interrupt Insulin," and is considered active if all other conditions are met.

[0119] HypoProtect (trademark) mode screen The user can initiate "HypoProtect® mode" by selecting button 1308 on the main menu 1300 shown in Figures 13a and 13b. HypoProtect® mode can stop basal insulin delivery, or in some embodiments, reduce it 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 the range of 150-200 mg / dL, such as 200 mg / dL). HypoProtect® mode is typically used during times when the risk of hypoglycemia is high, such as during exercise, during sleep, or upon first waking in the morning. Selecting button 1308 brings up the screen shown in Figure 27a, which allows the user to set the duration of HypoProtect® mode. Selecting field 2702 may present the user with a modal keypad to manually enter the time. In other embodiments, selecting field 2702 may provide the user with a menu to select a menu item for the duration. When the modal screen is dismissed, the time specified for the duration of HypoProtect® mode is moved to field 2702. Selecting button 2704 ("Confirm") starts HypoProtect® mode and displays the screen shown in Figure 27b. This screen shows the remaining time 2706 and 2708 for running HypoProtect® mode and the exact date and time when HypoProtect® mode will end. The user can cancel HypoProtect® mode at any time by selecting button 2710 ("Cancel"). When HypoProtect® mode is active, the information area 404 of the home screen 400 may appear as shown in Figure 6f.

[0120] Mode switching screen The user can switch between automatic and manual modes using button 1324 ("Mode Switching") on the main menu 1300 shown in Figures 13a and 13b. If the user is currently in manual mode, selecting button 1324 will display the screen shown in Figure 28a. This screen shows information block 2802, which indicates to the user when they can enter automatic mode. A green checkmark indicates that the stated conditions are met. If any of the conditions are not met, a red "X" may be displayed next to that condition. If all conditions are met, the user can enter automatic mode by selecting button 2804 ("Switch"). If the user application 160 is currently in automatic mode, selecting button 1324 will bring up the screen shown in Figure 28b, 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 when 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 and 13b, the user can display and / or change the serial number of the CGM 108. The diagram shown in Figure 29a is initially displayed when button 1326 is selected. 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 can enter a new CGM serial number using buttons 3204 and 3206. Selecting 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. In addition, selecting field 2910 presents the user with a modal keyboard, allowing the user to enter a serial number from the CGM 108. Once the user has finished entering the serial number, they can save it by selecting button 2912 ("Save"), which returns them to the screen shown in Figure 29a, where the new serial number is moved to field 2902.

[0122] Reminders screen The user can enable / disable and / or set parameters regarding when reminders are provided from the user app 160. Selecting button 1328 ("Reminders") in the "Settings" submenu of the main menu 1300 shown in Figures 13a and 13b displays the screen shown in Figure 30a. This screen shows a list of reminders. The current setting 3002 for each reminder is shown below the reminder name. For example, in the exemplary screen shown in Figure 30a, the user has set a "Pod Expiry" reminder four hours before the drug delivery device 102 expires, which indicates that the user will be provided with a reminder from the user app 160 four hours before the drug delivery device 102 expires. A particular reminder can be enabled or disabled by the user by selecting a slider 3004. Tapping the slider 3004 switches the state between "On" and "Off". The exemplary screen shows that three reminders are enabled. Figure 30b shows an example of a screen that can be used to set one of the parameters of a reminder. In the example screen, the "Pod Expired" reminder is being set. In one particular embodiment, when the user selects field 3006, a modal numeric keyboard appears, and the user can enter the number of hours until the reminder expires. In other embodiments, a modal menu may appear with menu items for various number of hours. When the modal menu is dismissed, the specified number of hours is moved to field 3006. The user can save the setting by selecting button 3008.

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

[0124] By pressing button 3104 ("New Visitor"), the screen shown in Figure 31b is displayed, allowing a new visitor to be added. This screen provides field 3104, where the user can enter various necessary or optional information about the new visitor, 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 visitor.

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

[0126] As those skilled in the art will recognize, a user interface comprises many screens that offer a wide variety of functions, most of which are not shown herein. To illustrate the various functions of user application 160, a selection of exemplary screens that make up the user interface have been presented herein. The present invention is not intended to be limited to a strict description of each individual screen, including, for example, the specific text displayed on each screen, the arrangement of functions on each screen, the colors used to display various functions on the screen, and the flow from one screen to the next. As will be recognized, any of these embodiments of the user interface may vary considerably while still providing the same functionality. Instead, the scope intended by the present invention is contained in the following claims. The inventions disclosed herein include the following embodiments: <Aspect 1> A drug delivery system, Drug delivery devices and A user device that communicates wirelessly with the drug delivery device, The system comprises a user application having a graphical user interface, running on the user device, and controlling the delivery of a drug by the drug delivery device, The graphic user interface includes a default screen that is displayed when the user application is launched, The default screen includes an information area that displays the user's latest blood glucose level, a trend indicator showing the trend of the user's blood glucose level based on multiple past blood glucose records, and an indicator of estimated remaining insulin. A bolus display area equipped with an indicator for the most recent bolus delivered by the drug delivery device, When selected, the CGM area displays a graph of blood glucose records within a period selected by the user, and The system includes a mode indicator that shows whether the user application is operating in automatic mode or manual mode. Drug delivery system. <Aspect 2> The aforementioned startup screen further includes 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 the basal program currently running by the user application in a graph, and the CGM area displays the user's latest blood glucose level. The system according to embodiment 1, wherein when the pod info tab is selected, the information area displays status information about the drug delivery device, including the number of drug units remaining in the drug delivery device, and the CGM area displays the user's latest blood glucose level. <Aspect 3> The system according to embodiment 1, wherein when the bolus display area of ​​the default screen is selected by the user, the graphic user interface displays an indicator of the estimated amount of remaining insulin in the bolus display area. <Aspect 4> The system according to embodiment 1, wherein the startup screen further includes a bolus button that initiates the delivery of a bolus dose of the drug when selected by the user. <Aspect 5> The system according to embodiment 4, wherein when the bolus button is selected, the graphic user interface displays a bolus calculator screen for calculating the total bolus dose of the drug to be delivered based on the amount of carbohydrates ingested by the user, the user's most recent blood glucose record, and the estimated amount of remaining insulin. <Aspect 6> The system according to embodiment 4, wherein the user can initiate delivery of the bolus dose as an immediate bolus dose or as a sustained bolus dose. <Aspect 7> The system according to embodiment 6, wherein the graphical user interface includes a screen on which the user can specify the parameters for the sustained bolus delivery of the drug. <Aspect 8> The system according to embodiment 6, wherein, when a bolus dose or sustained bolus dose is being delivered, the graphic user interface displays the status of the bolus dose or sustained bolus dose in the information area of ​​the default screen. <Pattern 9> The system according to embodiment 2, wherein when the insulin tab is selected, the graphic user interface displays a list of basal programs. <Aspect 10> The system according to embodiment 9, wherein the basic program determines the timing and amount of delivery of the basic dose of the drug on that day. <Aspect 11> The system according to embodiment 9, wherein the graphic user interface provides a screen on which the user can create a new basic program. <Aspect 12> The system according to embodiment 11, wherein the screen on which the user can create a new basic program includes a graph display showing one or more time ranges and the basic rate for drug delivery during each time range. <Aspect 13> The system according to embodiment 9, wherein the list of basal programs includes one or more temporary basal programs that specify the timing and amount of delivery of basal doses for a portion of the day, and the temporary basal programs increase or decrease the amount of the drug specified by the currently running basal program. <Aspect 14> The system according to embodiment 1, wherein the graphic user interface further includes a menu button that, when selected, displays a menu having multiple menu items superimposed on the currently displayed screen of the graphic user interface. <Aspect 15> The system according to embodiment 14, wherein when one of the menu items is selected, a HypoProtect mode is initiated that temporarily suspends the delivery of the drug for a duration specified by the user. <Aspect 16> The system according to 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> The system according to embodiment 1, wherein the graphic user interface includes a screen that provides instructions for replacing the drug delivery device. <Aspect 18> The system according to embodiment 1, wherein the graphic user interface includes a screen that provides an interface to a food library, and the food library includes at least the amount of carbohydrates contained in each food in the food library. <Aspect 19> The system according to embodiment 1, wherein access to the user application requires the input of a user PIN, and the graphical user interface further includes a screen on which the user can set and input the PIN. <Aspect 20> The system according to embodiment 14, wherein when one of the menu items is selected, the graphical user interface displays the delivery history of the drug and a timeline of events. <Aspect 21> The system according to embodiment 14, wherein when one of the menu items is selected, the graphical user interface displays a screen that allows the user to switch between the automatic mode and the manual mode. <Aspect 22> The system according to embodiment 1, further comprising a continuous glucose monitor that wirelessly communicates with the user device, wherein the continuous glucose monitor provides periodic blood glucose recordings from the user. <Aspect 23> The system according to embodiment 1, wherein the graphic user interface includes a screen that can display a list of persons who are permitted to view data generated by the user application, and a screen that can add newly permitted persons. <Aspect 24> The system according to embodiment 1, wherein the user application generates one or more log files, and the graphical user interface includes a screen that allows the user to send the one or more log files to a customer care center.

Claims

1. A drug delivery system, Drug delivery devices and A user device that communicates wirelessly with the drug delivery device, The system comprises a user application having a graphical user interface, running on the user device, and controlling the delivery of a drug by the drug delivery device, The graphic user interface of the user application is A default screen displayed when the user application is launched, comprising an information area that displays the user's latest blood glucose level, a trend indicator showing the trend of the user's blood glucose level indicated by multiple past blood glucose records, and an indicator of estimated remaining insulin, A viewer screen that can display a list of persons who are permitted to view data generated by the user application that controls the delivery of the drug, and can add newly permitted persons, wherein each person on the list of the viewer screen is associated with a status indicator that shows whether the person is a valid viewer or awaiting approval, A drug delivery system in which requests to add views are sent via the user application, and the status indicator is updated based on information received on the user device.

2. The system according to claim 1, wherein the viewer screen is displayed in response to receiving a selection of the viewer button on the default screen.

3. The system according to claim 2, wherein the list of persons who are permitted to view the data is stored in a cloud-based service and downloaded in response to receiving a selection of the viewer button.

4. The system according to claim 1, wherein adding a newly authorized person to the aforementioned list includes sending an invitation to the newly added user to view the aforementioned data.

5. The default screen further includes a tab bar with a dashboard tab, an insulin tab, and a pod info tab. When the insulin tab is selected, the information area displays a graph of the baseline program currently running by the user application, and the CGM area displays the user's latest blood glucose level. The system according to 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 drug units remaining in the drug delivery device, and the CGM area displays the user's latest blood glucose level.

6. The system according to claim 1, wherein when the bolus display area of ​​the default screen is selected by the user, the graphic user interface displays an indicator of the estimated amount of remaining insulin in the bolus display area.

7. The system according to claim 1, wherein the default screen further comprises a bolus button that, when selected by the user, initiates the delivery of a bolus dose of the drug, the user can initiate the delivery of the bolus dose as an immediate bolus dose or as a sustained bolus dose, and the graphic user interface includes a screen on which the user can specify parameters for sustained bolus delivery of the drug.

8. The system according to claim 7, wherein when the bolus button is selected, the graphic user interface displays a bolus calculator screen for calculating the total bolus dose of the drug to be delivered based on the amount of carbohydrates ingested by the user, the user's most recent blood glucose record, and the estimated amount of remaining insulin.

9. The system according to claim 7, wherein, when a bolus dose or sustained bolus dose is being delivered, the graphic user interface displays the status of the bolus dose or sustained bolus dose in the information area of ​​the default screen.

10. The system according to claim 1, wherein the graphic user interface provides a screen on which the user can create a new basic program.

11. The system according to claim 10, wherein the screen on which the user can create a new basic program includes a graph display showing one or more time ranges and the basic rate for drug delivery during each time range.

12. The system according to claim 1, wherein the graphic user interface includes a screen that provides an interface to a food library, and the food library includes at least the amount of carbohydrates contained in each food in the food library.

13. The system according to claim 1, wherein the graphic user interface further includes displaying the delivery history of the drug and a timeline of events.

14. The system according to claim 1, further comprising a continuous glucose monitor that communicates wirelessly with the user device, wherein the continuous glucose monitor provides periodic blood glucose records from the user.

15. The system according to claim 1, wherein the user application generates one or more log files, and the graphic user interface includes a screen that can send the one or more log files to a customer care center.

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