Abstract: An amount of glycemic dysfunction associated with mis-timing (e.g., delay) of meal boluses based on replay analysis is determined. The amount of dysfunction of historical or estimated bolusing as compared to an optimally timed bolus based on the replay analysis is quantified and visualized. Inferences may be made about diabetes meal management regarding inputs from a patient.

Abstract: Systems and methods described provide dynamic and intelligent ways to change the required level of user interaction during use of a monitoring device. The systems and methods generally relate to real time switching between a first or initial mode of user interaction and a second or new mode of user interaction. In some cases, the switching will be automatic and transparent to the user, and in other cases user notification may occur. The mode switching generally affects the user’s interaction with the device, and not just internal processing. The mode switching may relate to calibration modes, data transmission modes, control modes, or the like.

Abstract: Systems and methods for analyte monitoring, particularly systems and methods for monitoring and managing life of a battery in an analyte sensor system worn by a user, are provided.

Abstract: An analyte sensor system is provided. The system includes a base configured to attach to a skin of a host. The base includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host, a battery, and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to make electrical contact with a respective one of the first plurality of contacts, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. The system includes a first sealing member configured to provide a seal around the first and second plurality of contacts within a first cavity. Related analyte sensor systems, analyte sensor base assemblies and methods are also provided.

Abstract: Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Systems and methods for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor, are disclosed. In an embodiment, a method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide user access to sensor-related information comprises: activating a transceiver of a first communication device associated with an analyte sensor at a first time; and establishing a two-way communication channel with the second communication device; wherein the activating comprises waking the transceiver from a low power sleep mode using a forced wakeup from the second communication device.

Abstract: The subject matter disclosed herein provides methods for presenting glucose level data. Glucose data for a patient may be received. A current glucose level and a rate of change of the current glucose level may be determined based on the received glucose data. A first interface may be displayed on a screen of a device. The first interface may include a unitary icon. The unitary icon may display the current glucose level and a visualization of the rate of change. Related apparatus, systems, techniques, and articles are also described.

Abstract: Applicators for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. An applicator includes an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host, a housing configured to house the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass, an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host, and a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.

Abstract: Systems and methods are provided that address the need to frequently calibrate analyte sensors, according to implementation. In more detail, systems and methods provide a preconnected analyte sensor system that physically combines an analyte sensor to measurement electronics during the manufacturing phase of the sensor and in some cases in subsequent life phases of the sensor, so as to allow an improved recognition of sensor environment over time to improve subsequent calibration of the sensor.

Abstract: Recommendations based on continuous glucose monitoring (CGM) are described. Given the number of people that wear CGM systems and because CGM systems produce measurements continuously, a platform that provides a CGM system may have an enormous amount of data. This amount of data is practically, if not actually, impossible for humans to process. In implementations, a CGM platform includes a data analytics platform that obtains glucose measurements provided by a CGM system and also obtains additional data associated with a user. The data analytics platform processes these measurements and the additional data to predict a health indicator by using models. This prediction serves as a basis for generating a recommendation, such as a message recommending the user take action or adopt a behavior to mitigate a predicted negative health condition.

Abstract: Applicators for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. An applicator includes an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host, a housing configured to house the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass, an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host, and a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.

Abstract: Systems for applying a transcutaneous monitor to a person can include a telescoping assembly, a sensor, and a base with adhesive to couple the sensor to skin. The sensor can be located within the telescoping assembly while the base protrudes from a distal end of the system. The system can be configured to couple the sensor to the base by compressing the telescoping assembly.

Abstract: In some aspects, an apparatus for a biosensor includes a sensor wire and a rigid member. The rigid member may be coupled to the sensor wire and include a contact surface. The contact surface may be sized to enable a suction head of a robotic placement device to create a vacuum seal on the contact surface for lifting the sensor wire and rigid member.

Abstract: An analyte sensor system is provided. The system includes a base configured to attach to a skin of a host. The base includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host, a battery, and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to make electrical contact with a respective one of the first plurality of contacts, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. The system includes a first sealing member configured to provide a seal around the first and second plurality of contacts within a first cavity. Related analyte sensor systems, analyte sensor base assemblies and methods are also provided.

Abstract: Systems and methods for detecting and reporting patterns in analyte concentration data are provided. According to some implementations, an implantable device for continuous measurement of an analyte concentration is disclosed. The implantable device includes a sensor configured to generate a signal indicative of a concentration of an analyte in a host, a memory configured to store data corresponding at least one of the generated signal and user information, a processor configured to receive data from at least one of the memory and the sensor, wherein the processor is configured to generate pattern data based on the received information, and an output module configured to output the generated pattern data. The pattern data can be based on detecting frequency and severity of analyte data in clinically risky ranges.

Abstract: Glucose level measurements and additional data regarding a user are obtained over time, such as from a wearable glucose monitoring device being worn by the user. This additional data identifies events or conditions that may affect glucose of the user, such as physical activity engaged in by the user. A glucose prediction system analyzes, for example, activity data of the user and determines when a bout of physical activity occurs. The glucose prediction system predicts what the glucose measurements of the user would have been had the physical activity not occurred, and takes various actions based on the predicted glucose measurements (e.g., provides feedback to the user indicating what their glucose would have been had they not engaged in the physical activity).

Abstract: Glucose level measurements of a user are obtained over time, such as from a wearable glucose monitoring device being worn by the user. These glucose level measurements can be produced substantially continuously, such that the device may be configured to produce the glucose level measurements at regular or irregular intervals of time, responsive to establishing a communicative coupling with a different device, and so forth. These glucose level measurements are analyzed to detect deviations from past glucose measurements, such as glucose measurements received earlier in the day or glucose measurements received at corresponding times of one or more preceding days. Indications of detected deviations are provided to the user or communicated elsewhere, such as to a healthcare professional.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.

Abstract: Disclosed are devices for determining an analyte concentration (e.g., glucose). The devices comprise a sensor configured to generate a signal associated with a concentration of an analyte and a sensing membrane located over the sensor. The sensing membrane comprises an enzyme layer, wherein the enzyme layer comprises an enzyme and a polymer comprising polyurethane and/or polyurea segments and one or more zwitterionic repeating units. The enzyme layer protects the enzyme and prevents it from leaching from the sensing membrane into a host or deactivating.