Abstract: An analyte sensor configured to utilize oxygen as an oxidant and method for manufacturing and using the same are provided. The analyte sensor includes a catalyst to facilitate use of oxygen as oxidant. The catalyst may be provided on an electrode of the analyte sensor.

Abstract: The disclosure provides method and materials for preparing biosensors (e.g., in vitro test strips and in vivo sensors) with improved mechanical properties. In some aspects, for example, the electrochemical sensors have improved durability and are better able to withstand mechanical and electrochemical stresses such as those encountered during manufacturing, transportation, storage, and use (e.g., in vivo positioning, in vivo operation, or in vitro operation). Also for example, in some aspects the electrochemical sensors are less susceptible to pinholes and other manufacturing defects that degrade performance in traditional sensors.

Abstract: In some aspects, methods of lag compensation of analyte measurements are provided. Methods of lag-compensation are provided for analyte point measurements and/or for analyte rate-of-change measurements. The methods include receiving a series of uncompensated analyte measurements and determining parameter values for analyte point and/or rate-of-change estimates based on reference analyte measurements. The analyte rate-of-change estimate is based on a sum of a plurality of scaled rates-of-changes. The analyte point estimate is based on a sum of an analyte point and a sum of a plurality of scaled rates-of-changes. Devices related to the methods are also provided.

Abstract: Methods, devices and systems for receiving an instruction to determine a glycemic variation level, retrieving a stored metric for determining the glycemic variation level, retrieving one or more parameters associated with the retrieved metric analysis, determining the glycemic variation level based on the retrieved one or more parameters for the retrieved metric analysis, and outputting the determined glycemic variation level when it is determined that the retrieved one or more parameters associated with the retrieved metric analysis meets a predetermined condition are disclosed.

Abstract: Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiating a non-zero pre-programmed medication delivery rate are provided.

Abstract: A glucose monitor having only a test strip reader and wireless transmission to a remote hand held calculation processor. All glucose data processing occurs in a remote hand held calculator processor with the glucose monitor providing only sensing and wireless transfer of data. In an embodiment, the glucose monitor includes a button for use in wirelessly pairing the monitor to a smart phone for data communication with a non-proprietary communication protocol, and a light source to communicate the progress of the pairing. In a further embodiment, the glucose monitor includes a switch coupled to the strip reader such that power is applied to the monitor when a test strip is inserted and power is removed with the withdrawal of the test strip. In another embodiment, inserting the test strip and activating the switch also places the glucose monitor into the pairing search mode to communication with a host remote processor.

Abstract: Method and apparatus for providing a data stream generator that generates a data stream associated with a monitored analyte level, and a radio frequency logic portion operatively coupled to the data stream generator, the radio frequency logic portion configured to generate a radio frequency data stream based on the data stream generated from the data stream generator, the radio frequency logic portion further including one or more finite state machines and a plurality of discrete digital logic circuits, the one or more finite state machines configured to control the plurality of digital logic circuits to generate the radio frequency data stream for wireless communication are provided. Systems and kits incorporating the same are also provided.

Abstract: A polymer matrix that may coated on an electrode is created by co-crosslinking (1) an adduct of a polyaniline formed by templated oxidative polymerization on a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme. The polymer matrix may be hydrated, and the absorbed water may make it permeable to, for example, glucose. The polyaniline may be polyaniline itself or a substituted polyaniline; the water-soluble crosslinker may be poly(ethylene glycol) diglycidyl ether, and the redox enzyme may be glucose oxidase. The polymer matrix may be produced by co-crosslinking (1) an adduct of an electrically conductive polymer and a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme in a single step at an about neutral pH, curing by drying. After hydration, the crosslinked polymer matrix may form a 3-dimensional glucose-permeable bioelectrocatalyst, catalyzing the electrooxidation of glucose.

Abstract: Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of the sensing layer by inclusion of a high-boiling point solvent, where the sensing layer is disposed proximate to 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: Methods, devices, and kits are provided for determining a recommended insulin dose to be administered to user based upon analyte data determined by an analyte sensor.

Abstract: Generally, embodiments of the invention relate to analyte determining devices (e.g., electrochemical analyte monitoring systems) that include an indicator element that provides information relating to service history of the analyte determining devices, including, for example, previous use of the analyte determining devices. Also provided are systems and methods of using the, for example electrochemical, analyte determining devices in analyte monitoring.

Abstract: Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

Abstract: Method and apparatus for providing a fault tolerant display unit for an electronic device such as a glucose meter, including display unit, and a controller unit operatively coupled to the display unit, the controller unit configured to control the display unit to display an information, where when a failure mode of the display unit occurs, the display unit is configured to display a modified information, where the modified information is different from the information for display under the control of the controller unit, is provided.

Abstract: In particular embodiments, methods, devices and systems including calibrating analyte data associated with a monitored analyte level received from an analyte sensor based on a reference measurement, determining a lag time constant associated with the calibrated analyte data, and performing lag correction of the calibrated analyte data based on the determined time lag constant are disclosed.

Abstract: Generally, packages for an analyte monitoring device are provided. The packages include a container for containing an analyte monitoring device. The container includes a bottom wall, a front wall, a rear wall, and two sidewalls extending from sides of the bottom wall to an open top end of the container. The front wall is shorter in height than the rear wall, and is on an opposite side of the bottom wall than the rear wall. The two sidewalls are on opposite sides of the bottom wall, and extend from the front wall to the rear wall. The package also includes an inner panel disposed between the front wall and the rear wall. A front compartment is formed between the inner panel and the front wall, and a rear compartment is formed between the inner panel and the rear wall. The opening of the rear compartment is at the top end of the container, and an opening of the front compartment is at the top end of the container. Analyte monitoring kits and methods relating thereto are also provided.

Abstract: The present disclosure provides small volume analyte sensors having large sample fill ports, supported analyte sensors, analyte sensors having supported tip protrusions and methods of making and using same.

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: Aspects of the present disclosure include methods for making an electrode for an electrochemical sensor. In practicing methods according to certain embodiments, a conductive layer is deposited on a substrate by high voltage electron beam thermal evaporation followed by depositing a reactive layer on a surface of the conductive layer by low-voltage resistive thermal evaporation using a sequential step, single production chamber. Also provided are methods for a producing a multi-layered reference electrode having silver or ITO and silver chloride thereon in the absence of a separate curing stage. Systems for practicing the subject methods are also described.

Abstract: The present disclosure provides methods of processing data provided by a transcutaneous or subcutaneous analyte sensor utilizing different algorithms to strike a balance between signal responsiveness accompanied by signal noise and the introduction of error associated with that noise. The methods utilize the strengths of a lag correction algorithm and a smoothing algorithm to optimize the quality and value of the resulting data (glucose concentrations and the rates of change in glucose concentrations) to a continuous glucose monitoring system. Also provided are systems and kits.

Abstract: A glucose monitoring system, includes a glucose sensor strip or package of strips. The strip includes a substrate and a glucose monitoring circuit that has electrodes and a bodily fluid application portion of selected chemical composition. An antenna is integrated with the glucose sensor strip. An RFID sensor chip is coupled with the glucose sensor strip and the antenna. The chip has a memory containing digitally-encoded data representing calibration and/or expiration date information for the strip.