Abstract: The present embodiments provide systems and methods for, among others, tracking sensor insertion locations in a continuous analyte monitoring system. Data gathered from sensor sessions can be used in different ways, such as providing a user with a suggested rotation of insertion locations, correlating data from a given sensor session with sensor accuracy and/or sensor session length, and providing a user with a suggested next insertion location based upon past sensor accuracy and/or sensor session length at that location.

Abstract: Diabetes prediction using glucose measurements and machine learning is described. In one or more implementations, the observation analysis platform includes a machine learning model trained using historical glucose measurements and historical outcome data of a user population to predict a diabetes classification for an individual user. The historical glucose measurements of the user population may be provided by glucose monitoring devices worn by users of the user population, while the historical outcome data includes one or more diagnostic measurements obtained from sources independent of the glucose monitoring devices. Once trained, the machine learning model predicts a diabetes classification for a user based on glucose measurements collected by a wearable glucose monitoring device during an observation period spanning multiple days. The predicted diabetes classification may then be output, such as by generating one or more notifications or user interfaces based on the classification.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice.

Abstract: This document discusses, among other things, systems and methods to compensate for the effects of temperature on sensors, such as analyte sensor. An example method may include determining a temperature-compensated glucose concentration level by receiving a temperature signal indicative of a temperature parameter of an external component, receiving a glucose signal indicative of an in vivo glucose concentration level, and determining a compensated glucose concentration level based on the glucose signal, the temperature signal, and a delay parameter.

Abstract: Various analyte sensing apparatuses and associated housings are provided. Some apparatuses comprise one or more caps. Some apparatuses comprise a two-part adhesive patch. Some apparatuses comprise one or more sensor bends configured to locate and/or hold a sensor in place during mounting. Some apparatuses utilize one or more dams and/or wells to retain epoxy for securing a sensor. Some apparatuses utilize a pocket and one or more adjacent areas and various transitions for preventing epoxy from wicking to undesired areas of the apparatus. Some apparatuses include heat-sealable thermoplastic elastomers for welding a cap to the apparatus. Related methods of fabricating such apparatuses and/or housings are also provided.

Abstract: This document discusses, among other things, systems and methods to compensate for the effects of temperature on sensors, such as analyte sensor. An example method may include determining a temperature-compensated glucose concentration level by receiving a temperature signal indicative of a temperature parameter of an external component, receiving a glucose signal indicative of an in vivo glucose concentration level, and determining a compensated glucose concentration level based on the glucose signal, the temperature signal, and a delay parameter.

Abstract: Systems, methods, apparatuses, and devices, for the wireless communication of analyte data are provided. In some embodiments, a method and calibration station for calibrating a continuous analyte sensor system is provided. Methods and testing systems for testing a continuous analyte sensor system is provided. Continuous analyte sensor systems, display devices and peripheral devices configured for wireless communication of analyte, connection, alarm and/or alert data and associated methods are provided.

Abstract: In accordance with a system and/or method for monitoring an analyte concentration, a sensor signal indicative of an analyte concentration in a host may be received from an analyte sensor. The sensor signal may be filtered using a Kalman filter having process noise with a process covariance and measurement noise with a measurement covariance. The filtering may include updating a value associated with at least one of the process covariance and the measurement covariance using a value associated with one or more parameters employed in a model of the Kalman filter. A filtered sensor signal representative of the analyte concentration in the host may be output from the Kalman filter.

Abstract: Systems, methods, apparatuses, and devices, for the wireless communication of analyte data are provided. In some embodiments, a method and calibration station for calibrating a continuous analyte sensor system is provided. Methods and testing systems for testing a continuous analyte sensor system is provided. Continuous analyte sensor systems, display devices and peripheral devices configured for wireless communication of analyte, connection, alarm and/or alert data and associated methods are provided.

Abstract: Systems and methods for wireless communication of analyte information are disclosed. Example embodiments include an analyte sensor system. The analyte sensor system may include an analyte sensor to gather information related to a level of an analyte in a host. The analyte sensor system may include circuitry to transmit and receive wireless signals using a first antenna. The analyte sensor may be coupled to the circuitry before the analyte sensor system is transitioned into an operational state. The analyte sensor system may include a second antenna to receive an input signal from a source external to the analyte sensor system and to transmit a modified signal. The circuitry may use the first antenna to receive the modified signal. The analyte sensor system may transition into the operational state in response to the modified signal received using the first antenna.

Abstract: Various analyte sensing apparatuses and associated housings are provided. Some apparatuses comprise one or more caps. Some apparatuses comprise a two-part adhesive patch. Some apparatuses comprise one or more sensor bends configured to locate and/or hold a sensor in place during mounting. Some apparatuses utilize one or more dams and/or wells to retain epoxy for securing a sensor. Some apparatuses utilize a pocket and one or more adjacent areas and various transitions for preventing epoxy from wicking to undesired areas of the apparatus. Some apparatuses include heat-sealable thermoplastic elastomers for welding a cap to the apparatus. Related methods of fabricating such apparatuses and/or housings are also provided.

Abstract: Sensor devices including dissolvable tissue-piercing tips are provided. Methods of using and fabricating sensor devices are also provided.

Abstract: Disclosed are systems and methods for providing automated or semi-automated technical support for patients using medical devices, such as continuous glucose monitoring systems. Disclosed embodiments of automated tech support system include collection and storage of copies of streams of medical device data on multiple servers, analysis and comparison of data streams, remote tech support initiation and usage of the automated tech support system for providing improved products and services by storing and analyzing historical tech support data.

Abstract: Disclosed are systems and methods for secure and seamless set up and modification of bolus calculator parameters for a bolus calculator tool by a health care provider (HCP). In one aspect, a method for enabling HCP set up of a bolus calculator includes providing a server accessible by both an HCP and a patient; upon login by the HCP, displaying, or transmitting for display, a fillable form, the fillable form including one or more fields for entry of one or more bolus calculator parameters; receiving data from the fillable form, the data corresponding to one or more bolus calculator parameters; and upon login by the patient, transmitting data to a device associated with the patient, the transmitted data based on the received data, where the transmitted data corresponds to one or more of the bolus calculator parameters in a format suitable for entry to a bolus calculator.

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: The present disclosure relates generally to drug releasing membranes utilized with implantable devices, such as devices for the detection of analyte concentrations in a biological sample. More particularly, the disclosure relates to novel drug releasing membranes, to devices and implantable devices including these membranes, methods for forming the drug releasing membranes on or around the implantable devices, and to methods for monitoring analyte levels in a biological fluid sample using an implantable analyte detection device.

Abstract: Systems and methods are disclosed that provide smart alerts to users, e.g., alerts to users about diabetic states that are only provided when it makes sense to do so, e.g., when the system can predict or estimate that the user is not already cognitively aware of their current condition, e.g., particularly where the current condition is a diabetic state warranting attention. In this way, the alert or alarm is personalized and made particularly effective for that user. Such systems and methods still alert the user when action is necessary, e.g., a bolus or temporary basal rate change, or provide a response to a missed bolus or a need for correction, but do not alert when action is unnecessary, e.g., if the user is already estimated or predicted to be cognitively aware of the diabetic state warranting attention, or if corrective action was already taken.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: A method of providing performance reports to persons associated with the monitoring of an analyte level, such as blood glucose concentrations in a host, is provided. The performance reports can indicate a measure of an analyte variability of the host over a first analysis time period compared to a measure of analyte variability of the host over one or more other analysis time periods. The analyte level of the host can be received in each of a plurality of sensor readings from a continuous analyte sensor, such as multiple sensor readings per hour, so that the analyte variability that is used in determining the performance report of the host can be based on not just a few metered readings taken by the host, but a plurality of intermittent readings that are taken by a continuous analyte sensor, for example.