An infusion pump system providing therapy to a patient in a closed-loop or semi-closed loop mode can safely automatically revert to open-loop therapy. The system stores a default open-loop basal rate profile in memory. The system also continually tracks the insulin on board for the patient over a plurality of closed-loop therapy intervals. When an error or event occurs requiring reversion to open-loop therapy, the system automatically provides therapy according to the open-loop basal rate profile and the tracked insulin on board amount.

A priming valve includes a fluid flow path, a fluid inlet configured to couple to a fluid outlet of a fluid channel including at least one sensor configured to characterize at least one attribute of a fluid, a fluid outlet, a valve seat, and a connector. The connector engages the valve seat to prevent fluid flow via the fluid flow path. The connector is configured to move relative to the valve seat in response to a threshold pressure within the fluid flow path to allow the fluid to flow via the fluid flow path. A flow sensor sub-assembly for sensing flow of a fluidic medicament may include a priming valve and at least one sensor of a fluid port configured to characterize at least one attribute of a fluid within an administrable fluid source. A method for readying a fluid sensor may use a priming valve.

A priming valve includes a fluid flow path, a fluid inlet configured to couple to a fluid outlet of a fluid channel including at least one sensor configured to characterize at least one attribute of a fluid, a fluid outlet, a valve seat, and a connector. The connector engages the valve seat to prevent fluid flow via the fluid flow path. The connector is configured to move relative to the valve seat in response to a threshold pressure within the fluid flow path to allow the fluid to flow via the fluid flow path. A flow sensor sub-assembly for sensing flow of a fluidic medicament may include a priming valve and at least one sensor of a fluid port configured to characterize at least one attribute of a fluid within an administrable fluid source. A method for readying a fluid sensor may use a priming valve.

A wearable drug delivery device, techniques, and computer-readable media that provide an application that implements a diabetes treatment plan for a user are described. The drug delivery device may include a controller operable to direct operation of the wearable drug delivery device. The controller may provide a selectable activity mode of operation for the user. Operation of the drug delivery device in the activity mode of operation may reduce a likelihood of hypoglycemia during times of increased insulin sensitivity for the user and may reduce a likelihood of hyperglycemia during times of increased insulin requirements for the user. The activity mode of operation may be manually activated by the user or may be activated automatically by the controller. The controller may automatically activate the activity mode of operation based on a detected activity level of the user and/or a detected location of the user.

Methods and systems for delaying alarms that include detecting an analyte level using an analyte sensor; and delaying the annunciation of an analyte alarm after the analyte level crosses an analyte threshold, wherein the delay is based on one or both of (1) a magnitude of difference between the analyte level and the analyte threshold and (2) a duration of time in which the analyte level has crossed the analyte threshold.

Medical devices and related guidance systems and methods for interactive patient guidance are provided. An exemplary method of interactively providing guidance facilitating operation of a medical device involves identifying, at a computing device communicatively coupled to the medical device, a user objective associated with the medical device, obtaining, at the computing device from the medical device, user interface status information corresponding to a current state of a user interface of the medical device, and providing, on a display associated with the computing device, guidance information influenced by the user interface status information and the user objective. Subsequently, updated user interface status information for the infusion device responsive to a user input with respect to the infusion device may be provided to the computing device, with the guidance information being dynamically updated in response to the updated status information.

Medical devices and related guidance systems and methods for interactive patient guidance are provided. An exemplary method of interactively providing guidance facilitating operation of a medical device involves identifying, at a computing device communicatively coupled to the medical device, a user objective associated with the medical device, obtaining, at the computing device from the medical device, user interface status information corresponding to a current state of a user interface of the medical device, and providing, on a display associated with the computing device, guidance information influenced by the user interface status information and the user objective. Subsequently, updated user interface status information for the infusion device responsive to a user input with respect to the infusion device may be provided to the computing device, with the guidance information being dynamically updated in response to the updated status information.

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

A device for delivering a medication to a patient in a drug infusion system is disclosed. The device is configured as a fully autonomous and integrated wearable apparatus for managing the medication delivery. The device comprises: a reservoir for storing the medication to be delivered to the patient; a continuous glucose monitoring device for monitoring glucose levels in the patient to set flow rates for medication delivery; a needle for delivering the medication from reservoir into the patient; and a pumping unit including one or more MEMS devices configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle at set flow rates and/or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle.

A device for delivering a medication to a patient in a drug infusion system is disclosed. The device is configured as a fully autonomous and integrated wearable apparatus for managing the medication delivery. The device comprises: a reservoir for storing the medication to be delivered to the patient; a continuous glucose monitoring device for monitoring glucose levels in the patient to set flow rates for medication delivery; a needle for delivering the medication from reservoir into the patient; and a pumping unit including one or more MEMS devices configured to function as (a) a pump for pumping the medication from the reservoir through a flow path for medication to the needle at set flow rates and/or (b) a valve for regulating flow of the medication in the flow path from the reservoir through the needle.