Abstract: Systems, devices and methods are provided for the monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor. Generally, a sensor control device is provided for wear on the body. The sensor control device can include an in vivo analyte sensor for measuring an analyte level in a bodily fluid, an accelerometer for measuring the physical activity level of the subject, as well as communications circuitry for wirelessly transmitting data to a reader device. Furthermore, disclosed herein are embodiments of various graphical user interfaces for displaying analyte metrics on a reader device, comparing the analyte response of various foods and/or meals, modifying daily nutrient recommendations based on analyte metrics and physical activity level measurements, and other features described herein. Additionally, the embodiments disclosed herein can be used to monitor various types of analytes.

Abstract: Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

Abstract: Methods of compensating for ambient temperature using temperature sensors, the method comprising: sampling at a first sampling rate, with a processor, first temperature measurements from a first temperature sensor on an on-body sensor. Then determining, with a processor, first ambient-compensated temperatures from the first temperature measurements; and determining, with a processor, final ambient-compensated temperatures by applying a correction gain or factor to the first ambient-compensated temperatures. Wherein the correction gain or factor changes value at a slower rate than the sampling rate.

Abstract: Systems, devices, kits, and methods are provided herein in the form of example embodiments that relate to calibration of medical devices. The medical devices can be sensors adapted to sense a biochemical attribute. The embodiments can be used to determine calibration information specific to an individual medical device. The embodiments can determine the calibration information by reference to one or more parameters obtained during manufacturing of the medical device. The embodiments can also determine the calibration information by reference to in vitro testing of the medical devices. The embodiments also apply to systems incorporating those medical devices in their use in the field. Also described are embodiments of modifications to surfaces of sensor substrates, such as through applied radiation and/or the creation of a well, to aid in the placement and/or sizing of a sensor element on the substrate.

Abstract: Glucose monitoring devices and related systems and methods, the glucose monitoring devices including a sensor electronics unit having a housing and a printed circuit board disposed within the housing, a transcutaneous glucose sensor assembly, and a conductive sensor connector. The printed circuit board includes a first electrical contact, the transcutaneous glucose sensor assembly includes a distal portion having a working electrode and proximal portion having a working-electrode contact in electrical communication with the working electrode, and the conductive sensor connector electrically connects the working-electrode contact with the first electrical contact. Further, the conductive sensor connector extends through a hole in the proximal portion of the transcutaneous glucose sensor assembly and through a hole in the printed circuit board.

Abstract: Systems, devices, kits, and methods are provided herein in the form of example embodiments that relate to calibration of medical devices. The medical devices can be sensors adapted to sense a biochemical attribute. The embodiments can be used to determine calibration information specific to an individual medical device. The embodiments can determine the calibration information by reference to one or more parameters obtained during manufacturing of the medical device. The embodiments can also determine the calibration information by reference to in vitro testing of the medical devices. The embodiments also apply to systems incorporating those medical devices in their use in the field. Also described are embodiments of modifications to surfaces of sensor substrates, such as through applied radiation and/or the creation of a well, to aid in the placement and/or sizing of a sensor element on the substrate.

Abstract: An analyte sensor and methods and systems related thereto, where at least one or more of a lower portion of a sensor tail substrate, at least one electrode, a sensing element, a membrane, and an optional non-electrochemical functional layer comprise an antimicrobial quality. Asymmetric, double-sided adhesive binders suitable for adhering the analyte sensor to a skin surface comprising a non-woven scrim, a first pressure-sensitive adhesive layer, a second pressure-sensitive adhesive layer. Overbandages comprising a vapor-permeable backing, an aperture to circumferentially surround a sensor housing, a contact adhesive layer, first and second peelable release liners, and a third peelable release liner disposed upon an anchoring adhesive strip of the contact adhesive layer.

Abstract: Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user. The in vivo analyte sensor is coupled to an electronics unit holding a memory with instruction to cause processing circuitry to initiate a predetermined time period that is longer than a predetermined life of the sensor, during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device, and at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature.

Abstract: Methods and devices for providing application specific integrated circuit architecture for a two electrode analyte sensor or a three electrode analyte sensor are provided. Systems and kits employing the same are also provided.

Abstract: Analyte sensors and methods of use thereof, the analyte sensors comprising a base substrate, a first conductive layer positioned on a first side of the base substrate and a fiducial mark positioned on a portion of the analyte sensor. The fiducial mark is indicative of a location of at least the first conductive layer on the base substrate.

Abstract: Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: An analyte sensor comprising: a non-conductive material; a conductive material disposed on the non-conductive material; and at least two sensing structures defined by a removed portion of the conductive material, the at least two sensing structures comprising a reagent composition.

Abstract: Glucose monitoring devices and related systems and methods, the glucose monitoring devices including a sensor electronics unit having a housing and a printed circuit board disposed within the housing, a transcutaneous glucose sensor assembly, and a conductive sensor connector. The printed circuit board includes a first electrical contact, the transcutaneous glucose sensor assembly includes a distal portion having a working electrode and proximal portion having a working-electrode contact in electrical communication with the working electrode, and the conductive sensor connector electrically connects the working-electrode contact with the first electrical contact. Further, the conductive sensor connector extends through a hole in the proximal portion of the transcutaneous glucose sensor assembly and through a hole in the printed circuit board.

Abstract: The present disclosure provides therapeutic compositions and methods for delivering a therapeutic agent in close proximity to an analyte sensor. In certain embodiments, the present disclosure provides analyte sensors including one or more therapeutic agents, e.g., covalently-bound therapeutic agents. In certain embodiments, the present disclosure further provides therapeutic releasing compositions and methods of delivering such therapeutic releasing compositions.

Abstract: The present disclosure provides redox mediators having two tridentate ligands and analyte sensors comprising such redox mediators. The present disclosure further provides methods of using such analyte sensors for detecting one or more analytes present in a biological sample of a subject.

Abstract: Analyte sensor comprises an electrode layer having an elongate body comprising a proximal end and a distal end. The electrode layer includes a first active working electrode area, a second electrode portion, and at least one gap electrically separating the first active working electrode portion and the second electrode portion. The first active working electrode area comprises at least one sensing spot with at least one analyte responsive enzyme disposed thereupon. Additional analyte sensors disclosed.

Abstract: Low profile continuous analyte measurement systems and systems and methods for implantation within the skin of a patient are provided.