Abstract: Embodiments of the invention provide optimized polymeric surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These polymer surfaces have a constellation of features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a polymer surface with the disclosed constellation of features.

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The first adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.

Abstract: A system includes one or more processors and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: associating a medical device with an intermediate device, obtaining, from the medical device via the intermediate device, measurement data correlative to a condition of a user, determining updated control information for the medical device based at least in part on the measurement data, and streaming the updated control information to the medical device via the intermediate device.

Abstract: Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor comprising an analyte modulating membrane formed from a polymer composition having carbonate and aromatic isocyanate chains, a composition observed to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.

Abstract: Systems, devices and methods are disclosed for a prescription-regulated software application and an associated medical device. In some aspects, a smart medicine-injection device (e.g., smart insulin pen) is configured to be in communication with a patient's companion device (e.g., smartphone) having a software application (prescription app) that serves the patient as a complimentary medical device to the smart medicine-injection device, in which only certain features and functionalities of the prescription app are fully operable based on device pairing with the smart medicine-injection device to unlock medical device capabilities only available to the patient through prescription.

Abstract: Disclosed herein are techniques related to product consumption recommendations. In some embodiments, the techniques may involve receiving activity data from an activity monitoring device. The activity monitoring device may comprise an activity sensor for tracking movement of a user during an activity. The techniques may also involve receiving glucose data from a continuous glucose monitoring device. The techniques may further involve determining a product consumption recommendation based on the glucose data and the activity data. The product consumption recommendation may include a recommendation of when the user should consume a carbohydrate-containing product in order to maintain glucose levels with a specified target range during the activity. Additionally, the technique may involve causing display of the product consumption recommendation on a display device.

Abstract: Disclosed are methods and corresponding systems and devices for controlling which communication interface is used for communication in a wireless body area network of medical devices. In some aspects, a security level for data to be transmitted from a first device to a second device is determined. The first device includes a first communication interface and a second communication interface. Signals communicated over the second communication interface (e.g., a near-field communication interface) have a shorter range compared to the first communication interface (e.g., a far-field communication interface). The data is transmitted using the second communication interface based on determining that the security level for the data is higher than that associated with the first communication interface. In some instances, transmission of the data involves switching to the second communication interface after establishing an initial communication channel using the first communication interface.

Abstract: Electrochemical impedance spectroscopy (EIS) may be used in conjunction with continuous glucose monitoring (CGM) to enable identification of valid and reliable sensor data, as well implementation of Smart Calibration algorithms.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining a current value for a physiological condition of the user influenced by the fluid violates a first threshold value, determining a predicted value for the physiological condition of the user violates a second threshold value, and automatically altering operation of the infusion device to modify delivery of the fluid to the user after determining the predicted value violates the second threshold value when the current value violates the first threshold value.

Abstract: A sensor assembly for sensing a physiological characteristic includes a power source, a power control switch, and a power latch configured to latch an output of the power control switch. The sensor assembly also includes a power converter coupled to the power control switch. The power converter is configured to step down a voltage of the latched output of the power control switch for delivery of the latched output to one or more components of the sensor assembly. The power control switch is configured to inhibit consumption of power from the power source when the sensor assembly is in a pre-deployment state and output the latched output to the power converter in response to transition of the sensor assembly from the pre-deployment state to a deployed state.

Abstract: Techniques disclosed herein relate generally to notification generation in a medical device system. In some embodiments, the techniques involve generating a first notification via a medical application executing on a first device, determining that the first notification was not acknowledged within a predetermined time frame, and causing generation of a second notification at a medical device carried by a user to notify the user that the first notification has not been acknowledged.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes, and associated architectures, as well as methods for making and using such sensors. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: Techniques disclosed herein relate to continuous analyte sensor quality measures. In some embodiments, the techniques may involve obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device. The techniques may further involve obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value. The techniques may further involve causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric.

Abstract: The double layer capacitance of a working electrode of a sensor may be measured with minimal disruption to the sensor equilibrium by open circuiting the working electrode and measuring the voltage drift on a periodic, or as-needed, basis. The values of the double layer capacitance may be monitored over time to determine, e.g., sensor age and condition.

Abstract: A method of operating an insulin infusion device involves: operating the infusion device in an automatic mode to automatically control delivery of insulin to a user, in accordance with a first target glucose setpoint value; receiving user status data that indicates sleeping status of the user, the user status data generated by a sleep detection system; and determining, from the user status data, that the user is sleeping while the insulin infusion device is operating in the automatic mode. In response to the determining, the method transitions from the first target glucose setpoint value to a second (different) target glucose setpoint value for use during the automatic mode, the transitioning occurring without user input. The method continues to operate the infusion device in the automatic mode to automatically control delivery of insulin to the user, in accordance with the second target glucose setpoint value.

Abstract: A medical device may determine an occurrence of an alert condition. The medical device may transmit, to a separate device, data indicative of the occurrence of the alert condition. After transmitting the data indicative of the occurrence of the alert condition to the separate device, the medical device may determine, based on an audio signal generated by a microphone of the medical device, that the separate device has outputted an audible alert. The audio signal may correspond to audio captured by the microphone.

Abstract: A sensor assembly for sensing a physiological characteristic includes a power source configured to deliver power to one or more components of an electrical subsystem upon deployment of the sensor assembly to a user. A power latch is configured to latch an output of a power control switch for delivery to one or more components of the electrical subsystem upon deployment of the sensor assembly to a user. The power control switch is configured to inhibit delivery of power to the electrical subsystem prior to deployment of the sensor assembly to a user and to deliver the latched output to one or more components of the electrical subsystem in response to deployment of the sensor assembly to a user.

Abstract: Techniques related to temporary setpoint values are disclosed. The techniques may involve causing operation of a fluid delivery device in a closed-loop mode for automatically delivering fluid based on a difference between a first setpoint value and an analyte concentration value during operation of the fluid delivery device in the closed-loop mode. Additionally, the techniques may involve obtaining a second setpoint value. The second setpoint value may be a temporary setpoint value to be used for a period of time to regulate fluid delivery, and the second setpoint value may be greater than the first setpoint value. The techniques may further involve causing operation of the fluid delivery device for automatically reducing fluid delivery for the period of time based on the second setpoint value.

Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: One or more processors may be configured to detect whether a patient with diabetes is operating a vehicle based on one or more detected gestures. Based on the detection of operating the vehicle, the one or more processors may cause a patient device to output alerts according to a driving alert protocol. In another example, based on the detection of operating the vehicle, one or more processors may cause an insulin pump to operate according to a driving therapy protocol.