Medication delivery system with 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 Dec. 31, 2020, the entire contents of which are incorporated herein by reference.

[0002] Embodiments of this specification relate generally to automated drug delivery, and more particularly, to wireless drug delivery systems using wearable drug delivery devices and user applications for controlling wearable drug delivery devices.

Background Art

[0003] Wearable drug delivery systems, particularly systems for delivering insulin, can typically monitor a user's glucose level, determine an appropriate insulin level for the user based on the monitored glucose level, and subsequently administer insulin to the user. The sophisticated control algorithms required for such systems generally require powerful computing resources and large amounts of power. As a result, conventional drug delivery systems do not provide wireless communication between system components, full autonomous operation, an improved 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 features.

Summary of the Invention

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

Brief Description of the Drawings

[0005]

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Mode for Carrying Out the Invention

[0006] Various embodiments of the present invention involve systems and methods for delivering drugs to a user using a wearable drug device (which may also be referred to herein as a "pod") either automatically or in accordance with a wireless signal received from an electronic device. In various embodiments, the electronic device can be a user device including a smartphone, smartwatch, smart necklace, a module attached to a drug delivery device, or any other type or kind of electronic device that is wearable or portable on the user's body and executes an algorithm for calculating the time and dosage of drug delivery. For example, the user device can execute an "artificial pancreas" algorithm for calculating the time and dosage of insulin delivery. The user device can also communicate with sensors such as a glucose sensor that collects data regarding the user's physical attributes or conditions such as glucose levels. The sensors can be placed inside or on the user's body, can be part of the drug delivery device, or can be separate devices. As another option, the drug delivery device can communicate with the sensors instead of or in addition to the communication between the sensors and the user device. The communication can be direct (e.g., when the sensor is integrated with or otherwise part of the drug delivery device) or remote / wireless (e.g., when the sensor is placed in a housing different from the medical device). In these embodiments, the sensor and / or the drug delivery device have computing hardware (e.g., a processor, memory, firmware, etc.) that executes some or all of the algorithm for calculating the time and dosage of drug delivery.

[0007] FIG. 1 shows a functional block diagram of an exemplary drug delivery system 100 suitable for implementing the systems and methods described herein. The drug delivery system 100 may execute (and / or provide functionality for) a drug delivery algorithm for managing or controlling the automatic delivery of a drug or agent, such as insulin, to a user (e.g., for maintaining normal blood glucose, normal blood sugar levels). The drug delivery system 100 may be an automatic drug delivery system that may include a wearable drug delivery device 102, an analyte sensor 108, and a user device 105.

[0008] In an example where it may be optionally selected, the drug delivery system 100 may also include an accessory device 106, such as a smartwatch, a mobile information terminal, or the like, which may communicate with other components of the system 100 via either a wired or wireless communication link 191-193.

[0009] The user device 105 can be a computing device such as a smartphone, tablet, personal diabetes management (PDM) device, dedicated diabetes therapy management device, or the like. For example, the user device 105 can include a processor 151, a device memory 153, a user interface 158, and a communication interface 154. The user device 105 can also 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 level, controlling the delivery of drugs, medications, or therapeutic agents to the user, and further providing other functions such as calculating carbohydrate-compensation dosages, correction bolus dosages, and the like, as discussed below. The user device 105 can also 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 further, if desired, the smart accessory device 106.

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

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

[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 a cellular transceiver and a Bluetooth® transceiver. The communication interface 154 may be configured to receive and transmit signals including information usable by the user app 160.

[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 various signals to the user.

[0014] A preferred embodiment of the wearable drug delivery device 102 may include a reservoir 124 and a drive mechanism 125, which may be controllable by a controller 121 that executes a medication delivery algorithm (MDA) 129 stored in the memory 123. Alternatively, the controller 121 may act to control the reservoir 124 and the drive mechanism 125 based on signals received from a user app 160 that runs on the user device 105 and communicates 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 source 128.

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

[0017] The wearable drug delivery device 102 may be configured with a user interface 127 that provides means for receiving input from the user and means for outputting information to the user, as desired. 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 movement of the device by the user's gesture (e.g., tapping on the housing of the device), or any other type of interface device configured such that the user can input information and / or the wearable drug delivery device 102 can output information (e.g., an alarm signal or the like) for presentation to the user.

[0018] The wearable drug delivery device 102 includes a patient interface 186 for interconnecting with a user to deliver a liquid drug. The patient interface may be, for example, a needle or cannula for delivering the drug to the user's body (which may be made 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 comprise an actuator for inserting a needle / cannula under the user's skin and then withdrawing the needle leaving 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 wireless communication, cellular, or the like. The controller 121 may communicate, for example, with the user device 105 and the analyte sensor 108 via the communication interface 126.

[0020] In some embodiments, the wearable drug delivery device 102 may comprise one or more sensors 184. The sensor 184 is communicatively coupled to the controller 121 and may include one or more of a pressure sensor, a power sensor, or the like that provide various signals. For example, the pressure sensor may be configured to provide an indication of the fluid pressure detected in the fluid path between the patient interface 186 and the reservoir 124. The pressure sensor may be coupled to or integral with the 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 indication of the fluid pressure. 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 insulin on board (IOB) or the total daily insulin (TDI) amount.

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

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

[0023] The wireless communication links 191 - 196 may be any type of wireless link operating using known wireless communication standards or proprietary standards. By way of example, the 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 the respective wireless interfaces 154, 174, 126, and 135.

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

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

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

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

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

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

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

[0031] The analyte sensor 108 can be configured to detect a plurality of different analytes such as lactate, ketones, uric acid, sodium, potassium, alcohol levels, or the like, and output a measurement value or a result of detection such as the like. In a preferred embodiment, the analyte sensor 108 can be configured to measure blood glucose levels at predetermined time intervals such as every 5 minutes or intervals of the like. The communication interface 135 of the analyte sensor 108 has a circuit that operates as a transceiver for communicating the measured blood glucose level to the user device 105 via the wireless link 195 or for communicating with the wearable drug delivery devices 200a, 200b via the wireless communication link 108. Although referred to herein as the analyte sensor 108, the sensing / measurement device 133 of the analyte sensor 108 can include one or more additional sensing elements such as a glucose measurement element, a heart rate monitor, a pressure sensor, or the like. The controller 131 can include an independent dedicated logic circuit and / or component, an application-specific integrated circuit, a microcontroller, or a processor that executes software instructions, firmware, program instructions, or any combination thereof stored in a memory (such as the memory 132).

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

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

[0034] The user app 160 (or MDA 129) may provide periodic insulin microboluses based on predicted glucose over a 60-minute prediction interval. For optimal postprandial control, the user needs to administer a meal bolus in the same way as current pump therapy, but in normal operation of the user app 160, it compensates for missed meal boluses and reduces persistent hyperglycemia. The user app 160 uses a control-to-target strategy to attempt to achieve and maintain a set target glucose value, thereby shortening the duration of persistent hyperglycemia and hypoglycemia.

[0035] The user app 160 is the primary interface with the user and executes a graphical user interface for controlling the wearable drug delivery devices 200a, 200b, programming basal and bolus calculator settings for manual mode, and further programming settings dedicated to automatic mode (hybrid closed loop or closed loop).

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

[0037] In automatic mode, the user app 160 assists with the use of multiple target blood glucose values. For example, in one embodiment, the target blood glucose values can be in the range of 110 - 150 mg / dL in increments of 10 mg / dL, in increments of 5 mg / dL, or other increments, but preferably in increments of 10 mg / dL. What the user experiences reflects the current setup flow, where the healthcare provider assists the user in programming the basal rate, glucose target values, and bolus calculator settings. Subsequently, these 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 each use of the wearable drug delivery devices 200a, 200b. A temporary hypoglycemia protection mode can be executed by the user for various durations in automatic mode. In the hypoglycemia protection mode, the algorithm is one that reduces insulin delivery and is intended to be used for a temporary period when an increase in insulin sensitivity, such as during exercise, is anticipated.

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

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

[0040] The user app 160 may provide the ability to calculate the proposed bolus dose by using a bolus calculator. The bolus calculator is provided for the convenience of the user to assist in determining the proposed bolus dose based on the ingested carbohydrates, the latest blood glucose reading (or, if a fingerstick is used, the blood glucose reading), a programmable correction factor, the insulin-to-carbohydrate ratio, the target glucose value, and the insulin on board (IOB). The IOB is estimated by the user app 160 taking into account both manually administered boluses and insulin delivered by the algorithm.

[0041] The various embodiments described herein include systems and methods for automatically delivering a drug 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 drug to provide to the user. The controller can instruct a drug delivery device to administer the drug to the user. The drug delivery device can be a wearable insulin pump directly coupled to the user. The controller can be implemented, in whole or in part, as a smartphone app. The user may be required to provide a confirmation input in order to administer to the user an amount of insulin determined based on the user's detected glucose level.

[0042] Examples of executions related to the software of the technology described herein include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instructions that can be executed by one or more processors. The computer-readable instructions can be provided via a non-transitory computer-readable medium. Examples of executions related to the hardware of the technology described herein include, but are not limited to, integrated circuits (ICs), application-specific ICs (ASICs), field-programmable gate arrays (FPGAs), and / or programmable logic devices (PLDs). In some examples, the technology described herein, and / or any of the systems or component configurations 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 up, showing one or more housings of the drug delivery device 102. Figure 2b is a perspective view showing a view from the back side of the drug delivery device 102, and the adhesive backing 206 and the needle / cannula cap 208 can be seen. When the adhesive backing 206 is removed, the adhesive pad 204 is exposed and 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 the drug delivery device 102 to be easily removed.

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

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

[0046] Module 202 may contain a motor for driving a pump that extrudes a drug into the user's body, at least one battery and / or supercapacitor, a printed circuit board, a memory, a processor, a Bluetooth transceiver, a Bluetooth low energy transceiver, a body area network (BAN) transceiver, a cellular communication transceiver, or a wireless communication interface such as a WiFi transceiver, at least one antenna, a temperature sensor, an accelerometer, a barometric pressure sensor, and / or a sensor such as a light sensor. Module 202 may also contain a light 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 can 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 chip (SoC). The processor can execute program instructions stored in the memory. The memory can include one or more types of storage including, but not limited to, random access memory (RAM), flash memory, read only memory (ROM), computer readable memory storage, and the like. The memory can also hold data and other useful information for the operation of the drug delivery device 102. The drug delivery device 102 attached to the electronic module 202 can have other components of a drug delivery system, including, for example, a reservoir for storing the drug, a needle, a cannula, and / or a micro needle 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 micro needle array. The drug delivery device 102 can 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] The module 202 can be removably attached to the drug delivery device 102 such that the module 202 can be reusable and can be used with a plurality of drug delivery devices 102 that can be partially or wholly disposable. Thereby, the need to remanufacture all components of the drug delivery device 102, which can be disposable after the agent in the reservoir 124 is depleted, is avoided, thereby reducing the cost of the drug delivery device 102. The module 202 can be hermetically sealed and waterproof. The module 202 can have a battery that can be charged using wireless or wired charging.

[0048] In various embodiments, the drug delivery device 102 and / or the module 202 described herein include a user input device and / or a user output device. The user input device can be a button disposed on the drug delivery device 102 or the module 202, an accelerometer for detecting movement of the drug delivery device 102 or the module 202, or any other such input device. The user output device can be a speaker for emitting sound, a vibration generator for creating vibrations (e.g., a weighted motorized gear), metal terminals 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, an action associated with the command (e.g., delivery of a bolus) is not performed until an input from the user is received. The input can include pressing a button on the drug delivery device 102 or module 202, shaking the drug delivery device 102 or module 202 (as detected by an accelerometer), tapping the drug delivery device 102 or electronic module 202 one or more times (as detected by an 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 operation similar to the operations described above. If the input is not received within a certain time (e.g., 30 seconds, 1 minute, 2 minutes, or any other time), the drug delivery device 102 and / or module 202 cannot perform the drug delivery action. That is, the determined insulin dose cannot be delivered, and the user may receive a warning accordingly. In some embodiments, the output device warns 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 similarly warn the user after the action is executed and / or when the action is canceled due to lack of user input.

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

[0051] Next, consider the graphical user interface for the user application 160. Figure 4 shows the default home screen 400. When the 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 a plurality of pages showing various information, and the currently displayed page varies according to which one of the plurality of tabs displayed in the tab bar 402 the user selects. In one embodiment of the present invention, the tab bar 402 has three tabs, a "Dashboard" tab, an "Insulin" tab, and a "Pod Info" tab, which provide various page display options, and these will be considered in more detail later.

[0053] In one embodiment, the "Dashboard" tab may be the default tab displayed when the user app 160 is launched. As shown in FIG. 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 of the page indicator 403. The page indicator 103 has three dots corresponding to the "Dashboard", "Insulin", and "Pod Info" tabs in the tab bar 402, although 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. Selecting one of the tabs or swiping left or right within area 404 changes the content displayed in the information area 404 without affecting the content displayed in the screen areas 406 or 408. The information area 404 is composed of a boundary line 404a that can change color according to the operation mode. For example, the boundary line can be light gray when the user application 160 is in manual mode, or when there is no active pod or no pod communication. When the user application is in automatic mode, the boundary line 404a can be purple or another color when the pod reports being in a full automatic state of operation, and dark gray when the pod reports being in a limited automatic state of operation.

[0054] Variations of the home screen 400 that appear when the user app 160 is launched or when the user navigates to the home screen 400 vary according to the current state of the user app 160. In one embodiment, for example, when an immediate bolus is being delivered, the default home screen appears as shown in FIG. 8a. When a sustained bolus is being delivered, the home screen appears as shown in FIG. 8b.

[0055] Under certain circumstances, the "Pod Info" tab will be selected after startup, and the appropriate information page will be displayed in the information area 404. Examples include when there is no valid connection to the wearable drug delivery device 102, when the insulin in the reservoir 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 - 12 hours, and / or when the user has set a reminder for the pod expiration. Other circumstances may also cause the selection of the "Pod Info" tab and the display of other information screens.

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

[0057] Examples of the various pages that can be displayed in the information area 404 are shown in FIGS. 5 - 10 and will be discussed in detail later.

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

[0059] The CGM area 408 of the default home screen 400 provides an option to display information regarding a user's continuous glucose monitoring. In certain embodiments, the CGM area 408 may display, for example, the reading of the latest glucose record or a graph of a predetermined number of the latest glucose record values from continuous glucose monitoring. The information displayed in the CGM area 408 may be automatically selected based on the current situation of the user app 160 or may be selected by the user by tapping within the CGM area 408. Examples of the pages displayed in the CGM area 408 are shown in FIGS. 10a - 10c.

[0060] The default home screen 400 includes a mode indicator 410, which indicates the current mode of the user app 160. Various modes can 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 indicate one of the following four modes. (1) The "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 be displayed only after the CGM and / or IOB values have expired; (2) the "Restriction" mode indicator, which is displayed when, in the automatic mode, the drug delivery device 102 reports being in a restricted state; (3) the "Manual" mode indicator, which is displayed when the user app 160 is operating in the manual mode; and (4) the "Automatic" mode, which is displayed when the drug delivery device 102 reports being operating in the fully automatic state or the hybrid automatic state.

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

[0062] Figures 5a - 5d show pages that can be displayed 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 an indicator 502 of residual insulin, the latest recorded value 504 from the connected CGM 108, and an arrow 506 indicating the trend of the recorded values from the CGM 108. In some cases, the arrow 506 may not be present, indicating that the CGM 108 does not yet have sufficient data to identify a trend. Both the latest CGM recorded value 502 and the trend arrow 506 can be displayed in various colors indicating how the CGM recorded value compares to a desired value. For example, in a preferred embodiment, blue indicates that the CGM recorded value 502 is within the CGM / BG target range set by the user and the user app 160 is operating in manual mode, red indicates that the latest CGM recorded value 504 is lower than the CGM / BG target range set by the user (both in manual and automatic modes), yellow indicates that the latest CGM recorded value 504 is higher than the CGM / BG target range set by the user (both in manual and automatic modes), and purple indicates that the latest CGM recorded value 504 is within the CGM / BG target range set by the user and the user app 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 app 160 and when an operating wearable drug delivery device 102 is present. In this case, the most recent CGM recorded value 504 may not be available, and thus only the remaining insulin is displayed. Figure 5c shows a screen indicating that the CGM 108 has returned a status of "High". The status of High is displayed in yellow and indicates that the most recent CGM recorded value 504 is higher than the CGM / BG target set by the user. Similarly, this type of page may also indicate a "Low" indicator (not shown), which is shown in red and indicates that the most recent CGM recorded value 504 is lower than the CGM / BG target range set by the user. Figure 5d shows a page similar to the page shown in Figure 5a, but with a button 508 added that allows the user to initiate the delivery of a bolus dose of insulin. Other screens are also available, for example, a screen indicating the connection status of the CGM 108 may be displayed in the information area 404.

[0064] Figures 6a-6f show pages that can be displayed in the information area 404 of the default home screen 400 when the "Insulin" tab is selected. Figure 6a shows the default page displayed when the basal program is in progress. The basal program icon 602 is displayed in the upper left corner of the screen. Different basal programs may have different icons. When the basal program is running, the basal program icon 602 is shown in green, and when the 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 24-hour graph indicating the total number of insulin units to be delivered over a 24-hour period by the currently running basal program. The current basal rate 608 is shown in a box above the basal graph 606 according to the current time of day. Below the basal graph 606 is a total insulin indicator 610, which shows the total insulin to be delivered by the currently running basal program during the day. Button 612, when selected by the user tapping on it, transitions the screen to the page shown in Figure 6b, where a list 614 of saved basal programs is displayed overlapping the bonus display area 406 and the CGM area 408 on the default home screen 400. The currently running basal program 613 is shown in the information area 404. Button 616 allows the user to create a new basal program, which will be saved in the list 614. The screens for creating, editing, and starting basal programs are shown in Figures 17a-17f.

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

[0066] FIG. 6f shows the page displayed in the information area 404 when the HypoProtect™ mode is selected by the user. The HypoProtect™ mode can be invoked by the user when the user experiences a negative reaction to insulin, when the user is about to start an activity or time frame in which insulin sensitivity increases, or when the user simply wants to interrupt or reduce insulin delivery for a predetermined period of time. In one preferred embodiment, when the HypoProtect mode is selected, the automatic basal insulin delivery is reduced by 75% and the user's target blood glucose level increases. The information area 404 includes an icon 624 indicating that the HypoProtect™ mode is in progress, and a time indicator 626 indicating the remaining time until normal operation resumes. It also includes a button 628 ("Cancel") that the user can select to cancel the HypoProtect™ mode immediately. When in the HypoProtect™ mode, the "Insulin" tab in the tab bar 402 changes to the "Protect" button 622 shown in FIG. 6e. When the HypoProtect™ mode ends, the "Insulin" tab will be displayed in the tab bar 402 again.

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

[0068] FIGS. 7a-7b show pages that may be displayed in the information area 404 of the default home screen 400 when the "Pod Info" tab is selected. The default pod info page is shown in FIG. 7a and includes a pod status 702 shown at the top of the page. The pod status 702 can be changed. For example, when the drug delivery device 102 is approaching its expiration date, the pod status 702 can be changed to "Pod replacement soon" or "Please replace the pod" and can be displayed in a different color, for example, yellow or red to indicate the urgency of the status. In addition, the default pod info page includes a graphic 704 of the drug delivery device 102 in use, an amount indicator 706 indicating the amount of insulin remaining in the drug delivery device 102 (in units), and an expiration indicator 708 indicating 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, shows more detailed information about the drug delivery device 102. FIG. 7b shows a page on which the user can set up a new drug delivery device 102. This page can be displayed, for example, when the user app 160 has lost communication with the wearable drug delivery device 102 over a predetermined period of time. This page includes a "Set up new pod" button 714 that enables the initialization of a new wearable drug delivery device 102.

[0069] Figures 8a - 8b show the default home screen 400 when a bolus is being delivered. Figure 8a shows the delivery of an immediate bolus and its status. Note that during the delivery of an immediate bolus, the menu button 414, the alarm icon 416, and the mode indicator 410 are hidden (and disabled). A progress bar 802 is included that shows what extent of the total bolus has been delivered (e.g., including the percentage amount) and changes as the bolus is being delivered. Figure 8b shows the default home screen 400 during the delivery of a sustained bolus. Since a sustained bolus continues over a longer period of time, during a sustained bolus, the menu button 414, the alarm icon 416, and the mode indicator 410 are not hidden and are not disabled either.

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

[0071] In the CGM area 408 of FIG. 4, information regarding the CGM can be accessed. The default page of the CGM area 408 is shown in FIG. 10a. The default page includes a graphic and a "Display" button 1002, and when this is selected by the user, a graph shown in FIG. 10c appears in the information area 404 of the default usage home screen 400. The page shown in FIG. 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 with the graph of the immediate bolus or sustained bolus shown in FIGS. 8a - 8b. The information displayed in the area 1004 is very similar to the information displayed on the default dashboard page shown in FIG. 5a. The page shown in FIG. 10b also includes a graph display button 1006, and when this is selected by the user, a graph shown in FIG. 10c appears in the area 404.

[0072] The graph shown in FIG. 10c appears in the information area 404 of the default home screen 400. The default graph 1010 shows CGM recorded values for more than 3 hours going back from the current time. Each dot in the graph 1010 represents a CGM recorded value received from the CGM 108. The grayed-out area 1012 in the graph 1010 indicates the CGM / BG target range set by the user, and the dotted line 1014 is also the target BG that can be set by the user. The timeline 1016 indicates the time scale of the recorded values. Below the timeline 1016 is the event area, which, in one embodiment, has a purple background, for example, for the time when the user app 160 was in the automatic mode; a white background for the time when the user app 160 was in the manual mode, when the wearable drug delivery device 102 was not operating, 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 the restricted automatic mode; a blue background when a temporary basal delivery was in progress; a red line for the time when insulin delivery was interrupted; an orange line for the time when the maximum allowable basal insulin was being delivered; a green line when the HypoProtect™ mode was in progress; and a bolus icon (see 412 in FIG. 4) for the time when the user started a bolus delivery of insulin. As will be recognized by those skilled in the art, different colors may be used and different events may be shown in this area.

[0073] The user can change the display of the graph to a 6-hour, 12-hour, or 24-hour timeline by selecting one of the buttons shown in area 1020. The status area 1008 shows the latest CGM recorded value along with a trend arrow and also the current remaining insulin.

[0074] The 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, blinking, or changing the shape shown. When the user selects the notification indicator 416 by tapping on the icon, the screen shown in FIG. 12 is presented, which displays a list 1202 of notifications including a predetermined number of past notifications along with the time at which the notifications were issued. The user can return to the default home screen 400 by tapping on the back arrow 1204.

[0075] FIGS. 13a - 13b show examples of variations of a menu 1300 that is presented 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. FIG. 13a shows the menu 1300 as it appears when the user app 160 is in the "Automatic" mode. All of the buttons in button 1302 ("Temporary Settings"), 1310 ("Insulin Interruption"), and section 1306 ("Program & Preset Management") are disabled. If the HypoProtect (trademark) mode is in operation, the button 1308 ("HypoProtect (trademark) mode") is also disabled. FIG. 13b shows the menu 1300 as it appears when the user app 160 is in the "Manual" mode. In this mode, the button 1308 ("HypoProtect (trademark) mode") is disabled. The button 1602 ("Temporary Settings") is enabled unless a temporary program is in progress, insulin delivery is interrupted, or there is no wearable drug delivery device 102 in operation. The button 1310 ("Insulin Interruption") is disabled if there is no wearable drug delivery device 102 in operation. If the button 1302 is selected and insulin delivery is interrupted, the button 1310 is replaced with an "Insulin Start" button. The functions of the buttons in the menu 1300 are described later in this specification.

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

[0077] Bolus 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 FIGS. 11a-11f. The bolus button 412 may appear in different colors. For example, the bolus button 412 may appear in a gray color indicating that the button is disabled when immediate bolus delivery is in progress or when insulin delivery is interrupted. The bolus button 412 may appear in blue when the user app 160 is in manual mode and in purple when the user app 160 is in automatic mode.

[0078] The bolus calculator is shown in FIG. 11a. The screen includes a field 1102 where the user can enter the total carbs consumed during a meal. Selecting the field 1102 causes a modal keyboard to appear overlaid on the screen, where the user can enter the amount of carbs. When exiting the modal keyboard, the entered amount is transferred to the field 1102. The amount of insulin for the bolus based on the amount of carbs consumed during the meal is displayed as the "meal bolus" 1114.

[0079] Based on the user's current blood glucose recorded value, a correction bolus may be required. In field 1104, the current blood glucose recorded value can be entered. When field 1104 is selected, a modal keyboard appears and the user can manually enter the current blood glucose recorded value. As another option, by pressing button 1106, the latest recorded value from CGM108 is used and entered into field 1104. The correction bolus is displayed as "Correction Bolus" at 1116. Note that the correction bolus can be a positive or negative number.

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

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

[0082] The user may wish to specify the delivery of a bolus as a continuous bolus. When the user selects button 1124 ("Continuous Bolus") in Figure 11b, the screen shown in Figure 11e is displayed, whereby the user can enter the percentage of the bolus to be delivered immediately and the percentage of the bolus to be delivered over a continuous period of time. The user can enter in either field 1128 ("Immediate") or field 1130 ("Continuous"). By selecting either field 1128 or 1130, a modal menu with menu items for various percentages appears. When the user selects one of the percentages, the selected percentage is moved to the currently focused field (i.e., field 1128 or 1130). Whichever field is entered by the user, the other field is automatically entered by user app 160 by subtracting from 100%. In field 1132 ("Duration"), the user can specify the duration over which the continuous portion of the bolus is to be delivered. Selecting field 1132 brings up a modal menu containing options for various time intervals. When the user selects a value for a time interval in the modal menu, that time interval is moved to field 1132. An overview of the bolus appears in area 1134 of the screen. When the user selects button 1136 ("Confirm"), the screen shown in Figure 11f is displayed, which shows an overview 1138 of the bolus 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 is initiated.

[0083] Pod-related Screens This section pertains to all screens dealing with 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 state of the pod. The screen 1500 can be reached by selecting the "Pod Info" tab from the home screen 500 and then selecting the button 1010 ("Pod Details Display") from the information page shown in FIG. 7a. Section 1502 of the screen shows the remaining amount of insulin in the wearable drug delivery device 102. This information is wirelessly communicated from the wearable drug delivery device 102 to the user app 160. In certain embodiments, when the remaining amount of insulin in the wearable drug delivery device 102 drops below a predetermined threshold, the display indicates "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 elapsed since the drug delivery device 102 was activated, the display indicates "Expired" instead of showing the time and date when the drug delivery device 102 expires. The screen 1500 may include a button 1508 that enables 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. The 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 that provide step-by-step instructions for replacing the drug delivery device 102. These screens may be displayed after the user selects the button 1508 in FIG. 14. FIGS. 16a-16d show four examples of a series of screens. Each screen includes a button (1602) that moves the user to the next instruction screen of the procedure. The user can cancel the operation at any time by pressing the cancel button 1606 on any of the instruction pages. When the drug delivery device 102 is properly set up and positioned, the user can start the operation of the drug delivery device 102 by selecting the button 1604 in FIG. 16b. During the setup process, the user may be presented with one or more modal screens, an example of which is shown in FIG. 16d, which shows a screen that asks the user to confirm that the cannula of the drug delivery device 102 is 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 of the instruction pages may include hyperlinks, such as the hyperlink 1608 shown in FIG. 16b, that can take the user to other instruction pages. Pressing the hyperlink 1608 in FIG. 16b takes the user to the screen in FIG. 16c, where the user can record the body location where the drug delivery device 102 is placed. This page can also display the past locations and dates of different spots where the drug delivery device 102 was attached, so that the user can select a new location each time the 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 enables a user to display, select, edit, and create a basic program to be executed by the user application 160. FIG. 17a shows the screen of FIG. 6b with an overlaid modal menu 1704. The modal menu 1704 for either the basic program or the list 614 can be invoked by touching the three-dot menu call control 1703 located next to each basic program in the list 914. The modal menu 1704 includes menu items that allow the user to start, edit, or delete the currently selected basic program. The user can create a basic program by selecting the "New Creation" button 616.

[0087] FIG. 17b shows a 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 basic rate to be delivered during the specified segment. Next to the name 1709 is an indicator for the currently specified segment. When the user specifies the start time and end time of the segment in the field 1708, vertical lines 1706 indicating the start time and end time of the segment appear in the area 1707 of the screen. In some embodiments, the start time may be an already-entered field, and the user only specifies the end time. In some embodiments, the user may manually type the end time into the 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 mark the start time field as entered.

[0088] Figure 17c shows a base rate modal menu 1710 that a user can use to select a base rate for the current segment. This menu can be invoked by the user selecting the base rate field 1705 shown in Figure 17b. When the user selects a base rate, the selected base rate is used for the input in field 1705 as shown in Figure 17d. Additionally, a bar 1712 indicating the base rate for that time segment is placed between the vertical lines indicating the start time and end time of the segment in area 1707 of the screen. Figure 17e shows a substantially completed base 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 selecting the edit button 1724 next to that segment. The total amount of insulin to be delivered by the base program 1720 is shown below the graph. If the user is satisfied with the base program, the base program can be saved by selecting button 1726 ("Save"). Creation of the base program can be cancelled at any time by pressing button 1728 ("Cancel").

[0089] Temporary base screen In the temporary basic function of the user app 160, the user can temporarily modify the basic rate over a predetermined period of time. For example, the user may have performed some exercise or gone to bed early, so during that period, the basic requirement decreases. To invoke this function, the user can select the menu button 414 on the home screen 400. When the menu is displayed as shown in FIGS. 13a - 13b, the user can select the menu button 1302 ("Temporary Basic Setting"), which will display the screen shown in either FIG. 18a or FIG. 18c. The user has the option to enter the basic rate to be delivered during the temporary basic profile either as a percentage of the basic rate being delivered as part of the currently running basic program or as an absolute numerical value in units. The options can be set in the "Settings" section of the user app 160, which will be discussed later.

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

[0091] As another option, instead of specifying a base rate and duration, the user may choose to 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 a temporary base profile at any time by selecting button 1814 ("Cancel"). When the user enters a base rate in field 1806 and a duration in field 1808, the user can confirm the selection by selecting button 1812 ("Confirm"), whereupon the screen shown in FIG. 18b appears.

[0092] FIG. 18b shows the screen displayed after the user has confirmed the specifications of the temporary base profile. In the information area 404 of the screen, the base profile 1802 from the currently running base program is displayed, and the temporary base profile 1814 is overlaid thereon. Preferably, the temporary base profile 1814 is shown in a color different from the base profile from the currently running base program. The dotted line 1816 indicates 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, the profile can be confirmed by pressing button 1820 ("Confirm").

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

[0094] The user can either create a temporary base profile or set a temporary base profile. As shown in FIGS. 18c to 18d, when a temporary base profile has been created, if the user selects button 1822 (“Confirm”), the user is navigated to a screen where the temporary base profile can be saved. As shown in FIGS. 18a to 18b, when a temporary base profile has been set, if the user selects button 1820 (“Confirm”), the user is navigated to a screen where the temporary base profile can be started.

[0095] Selecting button 1810 from the screen shown in either FIG. 18a or FIG. 18c navigates the user to the screen shown in FIG. 18e, which shows a list 1824 of saved temporary base profiles. This page also has a back arrow 1826, which, when selected, navigates the user back to the home screen 400. Further, a button 1806 (“New Creation”) is also provided, which, when selected, navigates the user to the screen shown in either FIG. 18a or FIG. 18c, enabling the user to create a new temporary base profile.

[0096] Selecting the menu indicator 1828 next to any of the saved temporary base profiles listed in list 1824 causes a modal menu 1830 to appear as shown in FIG. 18f. The user can select to start, edit, or delete each temporary base profile from the modal menu 1830.

[0097] Blood glucose screen The user app 160 provides means for the user to manually enter blood glucose recorded values. When the button 1312 ("BG input") is selected from the menu shown in FIGS. 13a - 13b, the user app 160 displays a blood glucose input screen as shown in FIG. 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. When the cursor 1903 is moved in the clockwise direction, the blood glucose recorded value increases, which is shown in the field 1904 at the center of the circle. As another option, the user may select the field 1904, whereby a modal keyboard appears and the user can enter the blood glucose recorded value. When the modal keyboard is dismissed, the blood glucose recorded value is moved to the field 1904. As will be recognized by those skilled in the art, many other means of manually entering blood glucose levels are possible and are also contemplated to be within the scope of the present invention.

[0098] The color of the circular graphic 1902 can change according to the value of the blood glucose recorded value displayed in the field 1904. For example, when the blood glucose level is higher than the user's target range but lower than the preselected upper threshold value, the circular graphic 1903 can appear yellow as shown in FIG. 19b. When the blood glucose level recorded value displayed in the field 1904 rises above the upper threshold value, the graphic displays "High" in the field 1904. Similarly, when the input value is lower than the user's target range but higher than the preselected lower threshold value, the circular graphic 1902 can be displayed in red as shown in FIG. 19c. When the blood glucose level recorded value displayed in the field 1904 drops below the lower threshold value, an indicator of "Low" can appear in the field 1904. When the blood glucose level is entered into the field 1904 and confirmed by the user, the user can save the recorded value by pressing the button 1906 ("Save"). In the first variant of this embodiment shown in FIG. 19d, the graphic may be modified by adding plus and minus signs for a few seconds after the user removes a finger from the cursor 1903, whereby the user can increase or decrease the blood glucose recorded value displayed in the field 1904 by one at a time, enabling more fine-grained control. In the second variant, the blood glucose input screen can be directly displayed by tapping the field 1104 from the bolus calculator shown in FIG. 11a. As shown in FIG. 19d, the button 1906 ("Save") is replaced by a button 1912 ("Add to Calculator"), which, when selected by the user, adds the blood glucose value shown in the field 1904 to the blood glucose field 1104 of the bolus calculator shown in FIG. 11a.

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

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

[0101] The "My Foods" screen also includes button 2004 ("Add Custom Food"), which allows the user to add options for customized foods, for example, if the 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 enables 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 that the user can use to enter the name of the custom food. Dismissing the modal alphanumeric keyboard moves the name of the food 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 for the custom food, selecting button 2022 ("Save to My Foods") allows the custom food to be added to the list in "My Foods" list 2006 shown in Figure 20a.

[0102] When the "Browse" tab is selected from the 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 "Bar, Breakfast Cereal" tab is selected, secondary categories are shown as list 2026 in FIG. 20d. Repeating the category selection eventually leads to individual food items, which the user can select and add to the total carbs for the meal and / or add to the "My Foods" list 2006. The user can return to the previously browsed category by pressing the button 2028 that displays the screen shown in FIG. 20c. Each screen in the food library is configured with a button 2009 ("Cancel"), which, when selected, returns the user to either the home screen 400 or the bonus calculator screen shown in FIG. 11a.

[0103] The first setup screen The user app 160 provides a series of screens that allow the user to perform the initial setup of the user app 160. The functions provided on this screen will only be performed once, typically when the user launches the user app 160 for the first time. When the user app 160 is launched for the first time, a "Welcome" screen 2100 similar to the screen shown in FIG. 21a may be provided to the user. The welcome screen 2100 may include a welcome message 2102 and a button 2104 ("OK") to move the user to the next screen. As part of the setup, the user may be asked to enter certain information online. FIG. 21b shows a screen where the user can log in to the 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 required to enter a username 2106 and password 2108.

[0104] Certain aspects of the setup of the user application 160 can be performed locally. As an example, FIG. 21c shows a screen where a 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 where the PIN can be entered. An additional screen may follow where the user can confirm the PIN entry by re-entering the PIN. FIG. 21d shows a screen where 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) where the Wi-Fi settings can be entered by selecting a button 2113. In some cases, selecting the button 2113 may cause the user to be taken 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 FIG. 21d may be unnecessary.

[0105] During the setup process, user app 160 may determine that access to the location information of user device 105 is required. For example, user app 160 may attempt to track the current location of user device 105 to identify the time zone in which user device 105 is currently located and adjust the time zone when 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 the modal screen shown in FIG. 21e, whereby the user can grant user app 160 access to the location information of user device 105. The screens shown in FIGS. 21a-21e are of an exemplary nature, and as will be appreciated, many other setup screens may be provided through which the user can set up various other aspects of user app 160. For example, the user can set up the message that is displayed when user app 160 is locked, which, for example, checks the user's contact information and can be used if user device 105 is lost. Additionally, the user can set up the background with personal information displayed on the lock screen. Many other functions that are configurable by the user may be available to the user.

[0106] In addition to general setup items, the user may be prompted to set up parameters for the delivery of basal and bolus doses of liquid medication. As an example, the user can set up a basal profile. FIG. 21f shows an exemplary screen where the user can set the maximum basal rate by entering the number of units per hour in field 2114. FIG. 21g shows an exemplary screen where the 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. Similar to what has already been discussed above regarding bolus and basal doses of liquid medication, many other parameters for the basal and bolus delivery of liquid medication can be entered on other screens.

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

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

[0109] The area 2310 of the history screen 2300 shows a timeline indicating individual events and the times at which those individual events occurred. Further details about each individual event can be displayed, for example, by selecting the downward arrow 2312, whereby the area expands to show details about the individual timeline events. As shown in Fig. 23b, the graph shown in the area 2314 is displayed as a result of the user selecting the downward arrow 2312 on the "Temporary Basal Start" area of the timeline 2314. Different types of information can be shown when different timeline events are expanded. The timeline events can be folded by selecting the button 2316, whereby the graph shown in the area 2314 will disappear.

[0110] When the "Automatic Event" tab 2305 is selected, the screen shown in FIG. 23c is displayed, which shows an event banner and data columns. The event banners 2316, 2320 indicate a mode switching event and a time zone switching event. The event banners 2316, 2320 may be displayed in different colors. For example, a purple banner may be displayed at the start of the automatic mode, and a blue banner may be displayed at the end of the automatic mode. This screen also has a data column 2318, which shows CGM recorded values and the delivered microbolus dosage.

[0111] Setting screen All the options and settings that can be set by the user of the user app 160 can be accessed from the button 1316 ("Settings") as shown in FIG. 13a. The button 1316 can be expanded to show an extended settings menu 1318. FIG. 13a shows the settings menu in an expanded form.

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

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

[0114] When button 2402 is selected, the screen shown in FIG. 24b is displayed. In some embodiments, to send a log file, the user must have a personal identification number (PIN). For this reason, the screen shown in FIG. 24b may also include an instruction to obtain the PIN 2406. The user can receive the PIN, for example, through communication via the user app 160 or communication independent of the user app 160. If the user already has a PIN, the user may select button 2404 ("Next"), whereby the screen of FIG. 24c is displayed. The user then uses the keypad 2410 to enter the PIN in field 2408, and after completion, selects button 2412 ("Send File") to start sending the log file to the customer care center. When button 2412 is selected, the screen shown in FIG. 24c disappears and 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 by the menu shown in FIG. 25a, whereby the user can set various aspects of the operation and display of the user device 105 on which the user app 160 is running. For example, the user can switch on or off the in-flight mode, change Wi-Fi settings, screen timeout, screen brightness, lock screen message, background image, and security PIN, etc.

[0116] In addition, the user can also set the default time zone and language, as well as the time zone that serves as the basis for calculating the time for insulin delivery, by selecting the button 2502 in FIG. 25a. As a result, the screen shown in FIG. 25b appears, first alerting the user that it is necessary to interrupt insulin delivery before the time zone can be changed. When the user interrupts insulin delivery by pressing the button 2504 ("Insulin Interrupt"), the screen changes as shown in FIG. 25c, a banner 2506 indicating that insulin delivery has been interrupted is shown, and a selection menu 2508 that the user can use to select the time zone becomes available. When the time zone is selected, the user may select the button 2510 ("Save"), whereby the selection of the time zone is saved, the screen shown in FIG. 25c disappears, and if it was interrupted, insulin delivery resumes. If the user has permitted 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 where the user is currently located. The system may periodically check that the time zone where the user is currently located is the same as the time zone currently being used by the system for drug delivery. If there is a discrepancy in the time zone, the user may receive a warning and be asked whether to update the time zone. When the time zone is updated, it results in corresponding changes to insulin delivery. For example, a basal profile that can deliver different amounts or rates of insulin at different times of the day may subsequently correspond 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 enter the time or time zone.Furthermore, when the time and / or time zone of the user device 105 is automatically updated (e.g., in the case of a smartphone), the time and / or time zone used by the user app 160 and the wearable drug delivery device 102 can also be automatically updated. The user app 160 can periodically send queries to the user device 105 to determine, for example, whether the time and / or time zone has been changed by the user or automatically updated by the user device 105 when moving to a new location.

[0117] In addition, the user can select a language, perform a diagnosis, or reset the user app 160. Selecting any menu item on the "PDM Settings" menu can result in the display of another screen for setting specific settings. Depending on the current mode in which the user app 160 is running, some 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 FIGS. 13a - 13b, the user can temporarily stop the delivery of insulin for a specified time. It should be noted that button 1310 may be available only when certain specific conditions are met. For example, when a temporary basal profile or a sustained bolus program is in execution, button 1310 may be made invalid. When button 1310 is selected, a screen as shown in FIG. 26a can be displayed, where the user can specify the length of time to interrupt insulin delivery. In some embodiments, when field 2602 is selected, a modal keypad may be presented to the user where the user can manually enter time. In other embodiments, when field 2602 is selected, a menu may be provided to the user where the user can select menu items for the duration. When the modal screen is dismissed, the specified time for interruption is moved to field 2602. The user can start the interruption by pressing button 2604. When insulin delivery is interrupted, button 1310 on the main menu 1300 may be changed from “Insulin Interruption” to “Insulin Start”, and selecting this allows the user to resume insulin delivery. When the user selects button 1310 (“Insulin Start”), the screen of FIG. 26b appears, by which the user can resume insulin delivery using the most recently valid basal program. Resumption is accomplished when the user selects button 2606. When insulin delivery is resumed, button 1310 on menu 1300 returns to display the text “Insulin Interruption” and is made valid if all other conditions are met.

[0119] HypoProtect (trademark) mode screen The user can initiate the "HypoProtect (trademark) mode" by selecting button 1308 of the main menu 1300 shown in FIGS. 13a - 13b. The HypoProtect (trademark) mode can stop basal insulin delivery or, in some embodiments, reduce it by 25 - 95% (such as 50% or 75%), and set the target blood glucose level of basal delivery to a predetermined amount (e.g., within the range of 150 - 200 mg / dL such as 200 mg / dL). The HypoProtect (trademark) mode is typically used during times when the risk of hypoglycemia increases, such as during exercise, during sleep, or when waking up in the morning for the first time. Selecting button 1308 will present the screen shown in FIG. 27a, by which the user can set the duration of the HypoProtect (trademark) mode. Selecting field 2702 may present a modal keypad to the user where the time can be manually entered. In other embodiments, selecting field 2702 may provide a menu to the user where menu items for the duration can be selected. Dismissing the modal screen will move the time specified for the duration of the HypoProtect (trademark) mode to field 2702. Selecting button 2704 ("Confirm") will initiate the HypoProtect (trademark) mode and display the screen shown in FIG. 27b. This screen shows the remaining time 2706 to execute the HypoProtect (trademark) mode and the exact date and time when the HypoProtect (trademark) mode will end. The user can cancel the HypoProtect (trademark) mode at any time by selecting button 2710 ("Cancel"). When in the HypoProtect (trademark) mode, the information area 404 of the home screen 400 may appear as shown in FIG. 6f.

[0120] Mode Switching Screen By pressing the button 1324 ("Mode Switch") of the main menu 1300 shown in FIGS. 13a - 13b, the user can switch between the automatic mode and the manual mode. When the user is currently in the manual mode, if the user selects the button 1324, the screen shown in FIG. 28a is displayed. An information block 2802 is shown on this screen, which indicates to the user when they can enter the automatic mode. The green check mark indicates that the described conditions are met. If any of the conditions are not met, a red "X" may be shown next to that condition. When all the conditions are met, the user can enter the automatic mode by selecting the button 2804 ("Switch"). When the user app 160 is currently in the automatic mode, by selecting the button 1324, the screen shown in FIG. 28b appears and the user can switch to the manual mode. This screen shows an information block 2806, which notifies the user of the basic program that will be executed when the switch is made. The user can confirm the switch by pressing the button 2808 ("Switch").

[0121] CGM Transmitter Screen By selecting button 1326 from menu 1300 shown in FIGS. 13a - 13b, the user can display and / or change the serial number of CGM 108. The figure shown in FIG. 29a is first shown when button 1326 is selected. Serial number 2902 is displayed. In certain cases where the CGM has expired, the serial number may be displayed in red and a "Expired" label may also be displayed on the screen. The user can enter the serial number of the new CGM using buttons 3204 and 3206. When button 2906 is selected, the screen shown in FIG. 29b is displayed. This screen shows an information block 2908 that indicates to the user the location of the serial number on CGM 108. Additionally, when field 2910 is selected, a modal keyboard is presented to the user and the user can enter the serial number from CGM 108. When the user finishes entering the serial number, the user can save the serial number by selecting button 2912 ("Save"), thereby returning to the screen shown in FIG. 29a and the new serial number is moved to field 2902.

[0122] Reminder Screen The user can enable / disable and / or set parameters regarding at what point a reminder is provided from the user app 160. Selecting button 1328 ("Reminder") in the "Settings" sub-menu of main menu 1300 shown in FIGS. 13a-13b displays the screen shown in FIG. 30a. This screen shows a list of reminders. The current settings 3002 for each reminder are shown under the reminder name. For example, in the exemplary screen shown in FIG. 30a, the user has set a "Pod Expiration" reminder 4 hours before the expiration of drug delivery device 102, which indicates that a reminder will be provided to the user from user app 160 4 hours before the expiration of drug delivery device 102. A particular reminder can be enabled or disabled by the user selecting slider 3004. Tapping slider 3004 toggles the state between "On" and "Off". The exemplary screen shows that three reminders are enabled. FIG. 30b shows an example of a screen that can be used to set a parameter for one of the reminders. In the exemplary screen, the "Pod Expiration" reminder is set. In a 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 is displayed until expiration. In other embodiments, a modal menu with menu items for various numbers of hours may appear. Dismissing the modal menu moves the specified number of hours to field 3006. The user can save the settings by the user selecting button 3008.

[0123] Viewer screen The user app 160 may have a function that allows a specified person to view the data generated by the user app 160. To display a list of viewers who have permission to view the user data, the user may select the button 1330 ("Viewers") from the main menu 1300 shown in FIGS. 13a to 13b. When the button 1330 is selected, the screen shown in FIG. 31a is displayed, showing the list of viewers 3102. The list of viewers who have permission to view the user data can be held in the cloud service 111 and can be downloaded to the user device 105 by selecting the button 1330. Each viewer in the list 3102 has an associated modal option 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 attempts to edit a viewer, the user may select "Edit" from the menu options in the modal menu 3105, and the screen shown in FIG. 31e is displayed, and the viewer's information can be edited as described below.

[0124] By pressing the button 3104 ("New Viewer"), the screen of FIG. 31b is displayed, and a new viewer can be added. This screen provides a field 3104, where the user can enter various necessary or optional information about the new viewer, such as name, email address, and relationship to the user. In various embodiments, other fields may also be required or desired to identify the new viewer.

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

[0126] As will be recognized by those skilled in the art, the user interface comprises many screens that provide a wide variety of functions, most of which are not shown herein. To illustrate the various functions of the user application 160, exemplary selected ones of the screens that make up the user interface have been presented herein. The present invention is not intended to be limited to an exact description of each individual screen, including, for example, the specific text sentences displayed on each screen, the arrangement of functions on each screen, the colors in which the various functions are displayed on the screen, and the flow from one screen to the next. As will be recognized, any of these aspects of the user interface may vary widely while still providing the same functionality. Instead, the intended scope of the present invention is set forth in the following claims. The invention disclosed herein includes the following aspects. <Aspect 1> A drug delivery system comprising a drug delivery device, a user device that wirelessly communicates with the drug delivery device, a user application having a graphical user interface, executed on the user device, and controlling the delivery of a drug by the drug delivery device, wherein the graphical user interface includes a default screen displayed when the user application is launched, the default screen including an information area that displays the user's latest blood glucose level, a trend indicator indicating the trend of the user's blood glucose level as indicated by a plurality of previous blood glucose recorded values, and an indicator of estimated remaining insulin, a bolus display area having an indicator of the latest bolus delivered by the drug delivery device, a CGM area that, when selected, displays a graph of blood glucose recorded values within a period selectable by the user, and a mode indicator indicating that the user application is operating in an automatic mode or a manual mode. Drug delivery system. <Aspect 2> The startup screen further includes a tab bar having a dashboard tab, an insulin tab, and a pod info tab. When the insulin tab is selected, the information area displays a graph of the basal program currently being executed by the user application, and the CGM area displays the user's latest blood glucose level. When the pod info tab is selected, the information area displays status information about the drug delivery device including the number of units of drug remaining in the drug delivery device, and the CGM area displays the user's latest blood glucose level. The system according to aspect 1. <Aspect 3> When the bolus display area of the default screen is selected by the user, the graphical user interface displays an indicator of the estimated amount of remaining insulin in the bolus display area. The system according to aspect 1. <Aspect 4> The startup screen further includes a bolus button for starting the delivery of the bolus dose of the drug when selected by the user. The system according to aspect 1. <Aspect 5> When the bolus button is selected, the graphical 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 latest recorded blood glucose value, and the estimated value of the remaining insulin. The system according to aspect 4. <Aspect 6> The system according to aspect 4, wherein the user can start the delivery of the bolus dose as an immediate bolus dose or as a continuous bolus dose. <Aspect 7> The system according to aspect 6, wherein the graphic user interface includes a screen on which the user can specify parameters for the sustained bolus delivery of the drug. <Aspect 8> The system according to aspect 6, wherein when a bolus dose or a sustained bolus dose is being delivered, the graphic user interface displays the status of the bolus dose or the sustained bolus dose in the information area of the default screen. <Aspect 9> The system according to aspect 2, wherein when an insulin tab is selected, the graphic user interface displays a list of basal programs. <Aspect 10> The system according to aspect 9, wherein the basal program determines the timing and amount of delivery of the basal dose of the drug for the day. <Aspect 11> The system according to aspect 9, wherein the graphic user interface provides a screen on which the user can create a new basal program. <Aspect 12> The system according to aspect 11, wherein the screen on which the user can create a new basal program includes a graphical display showing one or more time ranges and a basal rate for the delivery of the drug during each time range. <Aspect 13> The system according to aspect 9, wherein the list of basal programs includes one or more temporary basal programs that specify the timing and amount of delivery of the basal dose for a portion of the day, and the temporary basal programs increase or decrease the amount of the drug specified by the currently executing basal program. <Aspect 14> The system according to aspect 1, wherein the graphic user interface further includes a menu button that, when selected, displays a menu with a plurality of menu items overlaid on the currently displayed screen of the graphic user interface. <Aspect 15> The system according to aspect 14, wherein when one of the menu items is selected, a HypoProtect mode is started that temporarily stops the delivery of the drug for a duration specified by the user. <Aspect 16> The system according to aspect 15, wherein when the HypoProtect mode is enabled, the graphic user interface displays a label for the HypoProtect mode in the information area of the default screen. <Aspect 17> The system according to aspect 1, wherein the graphic user interface includes a screen that provides an instruction to replace the drug delivery device. <Aspect 18> The system according to aspect 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 individual foods in the food library. <Aspect 19> The system according to aspect 1, wherein access to the user application requires the input of a user PIN, and the graphic user interface includes a screen through which the user can set and input the PIN. <Aspect 20> The system according to aspect 14, wherein when one of the menu items is selected, the graphic user interface displays the history of the delivery of the drug and the timeline of events. <Aspect 21> The system according to aspect 14, wherein when one of the menu items is selected, the graphic user interface displays a screen through which the user can switch between the automatic mode and the manual mode. <Aspect 22> The system according to aspect 1, further comprising a continuous glucose monitor that wirelessly communicates with the user device, the continuous glucose monitor providing periodic blood glucose readings from the user. <Aspect 23> The system according to aspect 1, wherein the graphical user interface includes a screen capable of displaying a list of persons permitted to view data generated by the user application, and a screen capable of adding newly permitted persons. <Aspect 24> The system according to aspect 1, wherein the user application generates one or more log files, and the graphical user interface includes a screen capable of transmitting the one or more log files to a customer care center.

Claims

**Claim 1** A drug delivery system comprising: a drug delivery device; a user device that wirelessly communicates with the drug delivery device; a user application having a graphical user interface, executed on the user device, and controlling the delivery of a drug by the drug delivery device; the graphical user interface includes a default screen 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 indicating the trend of the user's blood glucose level shown by a plurality of previous blood glucose recorded values, and an indicator of estimated remaining insulin; a bolus display area including an indicator of the latest bolus delivered by the drug delivery device; a CGM area that, when selected, displays a graph of blood glucose recorded values within a period selectable by the user; a mode indicator indicating that the user application is operating in a manual mode in which the drug delivery device delivers the drug using pre-programmed dosing parameters or an automatic mode in which the drug delivery device adapts the dosing parameters over time; A drug delivery system. **Claim 2** The default screen further includes a tab bar including a dashboard tab, an insulin tab, and a pod info tab; when the insulin tab is selected, the information area graphically represents and displays the basal program currently being executed by the user application, and the CGM area displays the user's latest blood glucose level; when the pod info tab is selected, the information area displays status information about the drug delivery device including the number of units of drug remaining in the drug delivery device, and the CGM area displays the user's latest blood glucose level. The system according to claim 1. **Claim 3** When the bolus display area of the default screen is selected by the user, the graphical user interface displays an indicator of the estimated amount of remaining insulin in the bolus display area. The system according to claim 1. **Claim 4** The system according to claim 1, wherein when the default screen is further selected by the user, the default screen includes a bolus button for replacing the bolus calculator, and the user can start the delivery of the bolus dose of the drug by pressing a start button.

5. The system according to claim 4, wherein when the bolus button is selected, 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 latest blood glucose record value, and the estimated value of the remaining insulin is displayed on the graphical user interface.

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

7. The system according to claim 6, wherein the graphical user interface includes a screen on which the user can specify parameters for the delivery of the bolus dose of the drug.

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

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

10. The system according to claim 9, wherein the basal program determines the timing and amount of delivery of the basal dose of the drug on the day.

11. The system according to claim 9, wherein the graphical user interface provides a screen on which the user can create a new basal program.

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

13. The list of the basal programs includes one or more temporary basal programs that specify the timing and amount of delivery of the basal dose for a part of the day, and the temporary basal program increases or decreases the amount of the drug specified by the currently running basal program. The system according to claim 9.

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

15. The system according to claim 14, wherein when one of the menu items is selected, a HypoProtect mode is initiated that temporarily halts the delivery of the drug for a duration specified by the user.

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

17. The system according to claim 1, wherein the graphical user interface includes a screen that provides an instruction for replacing the drug delivery device.

18. The system according to claim 1, wherein the graphical 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 individual foods in the food library.

19. The system according to claim 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.

20. The system according to claim 14, wherein when one of the menu items is selected, the graphical user interface is caused to display the history of the delivery of the drug and the timeline of events.

21. The system according to claim 14, wherein when one of the menu items is selected, the graphical user interface is caused to display a screen on which the user can switch between the automatic mode and the manual mode.

22. The system according to claim 1, further comprising a continuous glucose monitor that wirelessly communicates with the user device, the continuous glucose monitor providing periodic blood glucose record values from the user.

23. The system according to claim 1, wherein the graphical user interface includes a screen capable of displaying a list of persons permitted to view data generated by the user application, and a screen capable of adding newly permitted persons.

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

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