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

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: Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of wherein G is a linking group covalently bonding the redox mediator to the polymer. A mass transport limiting membrane permeable to the analyte may overcoat the active area. In some sensor configurations, the mass transport limiting membrane may comprise a membrane polymer crosslinked with a branched crosslinker comprising three or more crosslinkable groups, such as polyethylene glycol tetraglycidyl ether.

Abstract: The present disclosure provides analyte sensors comprising a sensor tail substrate having a lower portion and configured for insertion into a tissue; a first working electrode disposed on the lower portion of the sensor tail substrate; a first sensing layer disposed upon a surface of the first working electrode; and a membrane disposed over at least the sensing layer; wherein the membrane comprises 20% to 50% by weight of a silver salt. The present disclosure also provides methods of using such analyte sensors for detecting one or more analytes present in a biological sample and methods of manufacturing the analyte sensors.

Abstract: The present invention provides systems, devices and methods for in vivo monitoring of an analyte level. In particular, the present invention relates to improved sensors for use in in vivo monitoring of an analyte level.

Abstract: Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Abstract: Methods and analyte sensors including a sensor tail comprising at least a first working electrode and a second working electrode that are spaced apart from one another along a length of the sensor tail. A first active area is disposed upon a surface of the first working electrode and a second active area is disposed upon a surface of the second working electrode, the first active area and the second active area being responsive to different analytes. A mass transport limiting membrane is deposited upon the first active area and the second active area by sequential dip coating operations, and the mass transport limiting membrane comprises a bilayer membrane portion overcoating the first active area and a homogeneous membrane portion overcoating the second active area.

Abstract: An analyte sensor comprising: a sensing layer disposed on the analyte sensor; and a membrane disposed over at least a portion of the sensing layer, wherein the membrane comprises a low surface tension polymer of a modified polysiloxane in an amount of 1% or less by weight of a total formulation of the membrane.

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 an array two or more discontiguous sensing elements deposited on a substrate surface, where the sensing elements comprise one or more droplets of a sensing element formulation.

Abstract: Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of wherein G is a linking group covalently bonding the redox mediator to the polymer. A mass transport limiting membrane permeable to the analyte may overcoat the active area. In some sensor configurations, the mass transport limiting membrane may comprise a membrane polymer crosslinked with a branched crosslinker comprising three or more crosslinkable groups, such as polyethylene glycol tetraglycidyl ether.

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: The present disclosure provides a drug delivery composition and a method of controlling a drug delivery rate of an analyte sensor. The drug delivery composition includes a copolymer including a plurality of copolymer chains, where each of the plurality of copolymer chains comprises a backbone including a plurality of hydrophilic units and a plurality of hydrophobic units, a crosslinker, and a therapeutic agent, where the crosslinker crosslinks at least a portion of the hydrophilic units of respective copolymer chains to form charges, and the hydrophobic units of the copolymer interact with the therapeutic agent through the non-polar intermolecular interaction. The drug delivery composition continuously releases the therapeutic agent at a set or predetermined drug delivery rate for a set or predetermined period of time.

Abstract: Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts , on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes , on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

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: A blood glucose sensing system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes stabilization circuitry. The stabilization circuitry causes a first voltage to be applied to one of the electrodes for a first timeframe and causes a second voltage to be applied to one of the electrodes for a second timeframe. The stabilization circuitry repeats the application of the first voltage and the second voltage to continue the anodic—cathodic cycle. The sensor electronics device may include a power supply, a regulator, and a voltage application device, where the voltage application device receives a regulated voltage from the regulator, applies a first voltage to an electrode for the first timeframe, and applies a second voltage to an electrode for the second timeframe.

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: Disclosed herein are techniques related to model predictive control. The techniques may involve generating a desired glucose trajectory that approaches a desired steady state setpoint from a current glucose value over a prediction horizon. The techniques may involve generating a plurality of insulin delivery patterns. Each insulin delivery pattern may correspond to an amount of insulin to be delivered over a control horizon. The techniques may involve generating a plurality of predicted glucose trajectories over the control horizon. Each predicted glucose may be generated based on the current glucose value and a respective insulin delivery pattern. The techniques may involve comparing the desired glucose trajectory against each predicted glucose trajectory and selecting a predicted glucose trajectory that is more similar to the desired glucose trajectory than any other predicted glucose trajectory.

Abstract: Analyte sensor comprises a substrate having an upper surface including a first portion and a second exposed portion, an electrode layer disposed on the first portion and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15 mm2 to 0.25 mm2, at least one sensing spot with at least one analyte responsive enzyme disposed on the active working electrode area. Additional analyte sensors are disclosed.