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: Multiple enzymes may be present in the active area(s) of an electrochemical sensor to facilitate analysis of one or more analytes. The multiple enzymes may function independently to detect several analytes or in concert to detect a single analyte. One sensor configuration includes a first active area and a second active area, where the first active area has an oxidation-reduction potential that is sufficiently separated from the oxidation-reduction potential of the second active area to allow independent signal production. Some sensor configurations may have an active area overcoated with a multi-component membrane containing two or more different membrane polymers. Sensor configurations having multiple enzymes capable of interacting in concert include those in which a first enzyme converts an analyte into a first product and a second enzyme converts the first product into a second product, thereby generating a signal at a working electrode that is proportional to the analyte concentration.

Abstract: The present disclosure provides an analyte sensor comprising a working electrode, a sensing layer disposed on at least a portion of the working electrode, and a hydrophilic polyurethane membrane overcoating at least the sensing layer, wherein the hydrophilic polyurethane is aliphatic, aromatic, or both aliphatic and aromatic. The hydrophilic polyurethane membrane limits the transport of mass to the sensing layer without the need to be crosslinked. With such membrane, the analyte sensor can provide consistent analyte measurements over a temperature range of about 22-42° C. The present disclosure is further related to a method of forming an analyte sensor comprising providing a working electrode, disposing a sensing layer on at least a portion of the working electrode, and coating at least the sensing layer with a hydrophilic polyurethane membrane, wherein the hydrophilic polyurethane is aliphatic, aromatic, or both aliphatic and aromatic.

Abstract: The present disclosure relates to sensing composition comprising a pyruvate-responsive enzyme and thiamine pyrophosphate (TPP). In particular, the sensing composition can comprise a pyruvate-responsive enzyme (e.g., pyruvate oxidase), TPP, optionally flavin adenine dinucleotide (FAD), a stabilizing agent (e.g., an albumin), and a redox mediator. The sensing composition forms a sensing layer on a working electrode to form a sensing electrode. The sensing electrode, along with a circuit, can form part of a system for sensing pyruvate. The present disclosure is further related to a method for sensing pyruvate, which includes accumulating charge derived from pyruvate reacting with the sensing composition for a set period of time and then measuring a signal from the accumulated charge.

Abstract: The present disclosure provides analyte sensors including one or more NAD(P)-dependent enzymes and an internal supply of NAD(P) for the detection of an analyte. 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, and methods of manufacturing said analyte sensors.

Abstract: The present disclosure provides membrane structures that exhibit low temperature sensitivity. Analyte sensors including said membranes are also provided herein. The present disclosure further provides methods of detecting analytes using said sensors.

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: Multiple enzymes may be present in the active area(s) of an electrochemical sensor to facilitate analysis of one or more analytes. The multiple enzymes may function independently to detect several analytes or in concert to detect a single analyte. One sensor configuration includes a first active area and a second active area, where the first active area has an oxidation-reduction potential that is sufficiently separated from the oxidation-reduction potential of the second active area to allow independent signal production. Some sensor configurations may have an active area overcoated with a multi-component membrane containing two or more different membrane polymers. Sensor configurations having multiple enzymes capable of interacting in concert include those in which a first enzyme converts an analyte into a first product and a second enzyme converts the first product into a second product, thereby generating a signal at a working electrode that is proportional to the analyte concentration.

Abstract: NADP-dependent oxidoreductase compositions, and electrodes, sensors and systems that include the same. Analyte sensors include an electrode having a sensing layer disposed thereon, the sensing layer comprising a polymer and an enzyme composition distributed therein. The enzyme composition includes nicotinamide adenine dinucleotide phosphate (NAD(P)+) or derivative thereof; an NAD(P)+-dependent dehydrogenase; an NAD(P)H oxidoreductase; and an electron transfer agent comprising a transition metal complex.

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: Apparatus, methods, and systems for detecting alcohol concentrations of an individual, and in particular in vivo alcohol concentrations of an individual. Alcohol sensing compositions include at least one alcohol-responsive active area comprising a concerted enzyme system having at least a first enzyme and second enzyme capable of acting in concert to facilitate the detection of alcohol. At least one of the enzymes in the concerted enzyme system is a ketoreductase.

Abstract: Methods and analyte sensors including at least a first working electrode having a first active area thereon, and performing a dip coating operation to deposit a bilayer membrane upon the first working electrode and the first active area. The bilayer may include an inner layer having a first membrane polymer and an outer layer having a second membrane polymer, the first membrane polymer and the second membrane polymer differing from one another. The dip coating operation may comprise one or more first dips in a first membrane formulation to form the inner layer of the bilayer membrane and one or more second dips in a second membrane formulation to form the outer layer of the bilayer membrane upon the inner layer.

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: Medical devices configured for in vivo assays of one or more analytes can sometimes be problematic if left inserted in a tissue, such as skin, for an extended time. Certain medical device surface profiles may aid in alleviating this issue. Accordingly, medical devices may comprise a base surface having a tissue-facing surface profile defined thereon, and a sensor extending through the base surface and at least a portion of the tissue-facing surface profile. The tissue-facing surface profile deviates from the base surface, and the tissue-facing surface profile is also configured to undergo a change in shape, hardness, or a combination thereof after contacting a tissue for a length of time. A dynamic material may be present in at least a portion of the tissue-facing surface profile.

Abstract: Apparatus, methods, and systems for detecting alcohol concentrations of an individual, and in particular in vivo alcohol concentrations of an individual. Alcohol sensing compositions include at least one alcohol-responsive active area comprising a concerted enzyme system having at least a first enzyme and second enzyme capable of acting in concert to facilitate the detection of alcohol. At least one of the enzymes in the concerted enzyme system is a ketoreductase.

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.

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: Analyte sensors are being increasingly employed for monitoring various analytes in vivo. Analyte sensors configured to monitor multiple analytes are also in development. Sufficient sensitivity for low-abundance analytes and multiple analytes having differing membrane permeability values may complicate analyte detection in some cases. Analyte sensors may feature enhancements to address one or both of these issues. Some analyte sensors may comprise a carbon working electrode comprising a dielectric substrate, one or more apertures extending through the dielectric substrate and filled with a carbon conductor pillar, a carbon conductor coating on a first face of the dielectric substrate in direct contact with each carbon conductor pillar, and one or more active areas on a second face of the dielectric substrate in electrical communication with the carbon conductor pillars.

Abstract: The present disclosure provides an analyte sensor for use in detecting glutamate. In certain embodiments, a glutamate-responsive active site of a presently disclosed analyte sensor includes a glutamate oxidase and a redox mediator disposed upon a surface of a working electrode. The present disclosure further provides methods for detecting glutamate using the disclosed analyte sensors.