Abstract: A method for factory calibration of a sensor of a CGM system is disclosed. A processor receives an enzyme membrane thickness after each dip of a working wire according to first parameters. The processor receives a glucose limiting membrane thickness after each dip of the working wire according to second parameters. The processor determines a working wire diameter, and includes the membrane thicknesses. The processor in communication with the CGM system, automatically generates a correlation between the first and the second parameters to at least one of a factory sensitivity and a drift profile. The drift profile predicts a sensitivity of the sensor over time. The processor associates the at least one of the factory sensitivity or the drift profile with the sensor. The sensor outputs a glucose reading during in-vivo use based on the at least one of the factory sensitivity or the drift profile.

Abstract: A method for factory calibration of a sensor of a CGM system is disclosed. A processor receives an enzyme membrane thickness after each dip of a working wire according to first parameters. The processor receives a glucose limiting membrane thickness after each dip of the working wire according to second parameters. The processor determines a working wire diameter, and includes the membrane thicknesses. The processor in communication with the CGM system, automatically generates a correlation between the first and the second parameters to at least one of a factory sensitivity and a drift profile. The drift profile predicts a sensitivity of the sensor over time. The processor associates the at least one of the factory sensitivity or the drift profile with the sensor. The sensor outputs a glucose reading during in-vivo use based on the at least one of the factory sensitivity or the drift profile.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a working electrode and a reference electrode. The reference electrode comprises a reference substrate, an ion limiting layer over the reference substrate and a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode comprising a composition for releasing nitric oxide (NO). The composition has a NO release compound, a hydrophilic material and a hydrophobic material. The reference electrode is positioned separate from a working electrode.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode, a working electrode, and a composition for releasing nitric oxide (NO). The reference electrode includes a reference substrate and an ion limiting layer over the reference substrate. The working electrode includes a conductive substrate, an interference layer over the conductive substrate, an enzyme layer over the interference layer, and a glucose limiting layer. The enzyme layer has an enzyme for reacting with in-vivo glucose in body fluid of a patient. The glucose limiting layer is over the enzyme layer and limits an amount of the in-vivo glucose from the body fluid of the patient that passes to the enzyme layer. The composition for releasing nitric oxide (NO) includes a NO release compound, a hydrophilic material and a hydrophobic material. The composition is on the reference electrode.

Abstract: A subcutaneous sensor for use with a continuous glucose monitor includes a reference electrode, a working electrode, and a composition for releasing nitric oxide (NO). The reference electrode includes a reference substrate and an ion limiting layer over the reference substrate. The working electrode includes a conductive substrate, an interference layer over the conductive substrate, an enzyme layer over the interference layer, and a glucose limiting layer. The enzyme layer has an enzyme for reacting with in-vivo glucose in body fluid of a patient. The glucose limiting layer is over the enzyme layer and limits an amount of the in-vivo glucose from the body fluid of the patient that passes to the enzyme layer. The composition for releasing nitric oxide (NO) includes a NO release compound, a hydrophilic material and a hydrophobic material. The composition is on the reference electrode.

Abstract: A working wire for a continuous biological sensor is disclosed and includes a substrate having a conductive surface and an enzyme layer formed on the conductive surface. The enzyme layer includes enzymes, an immobilization matrix and a polymeric crosslinking agent that crosslinks the enzymes and the immobilization matrix creating an enzyme immobilization network. A protective layer is included over the enzyme layer. A method for making the working wire for a continuous biological sensor is disclosed and includes combining an enzyme with a solvent creating an enzyme mixture. An immobilization matrix is mixed with the enzyme mixture. After the mixing, a polymeric crosslinking agent is combined with the enzyme mixture and the immobilization matrix creating a crosslinked mixture. The crosslinked mixture is allowed to stabilize. The stabilized crosslinked mixture is applied to the working wire, and the applied mixture is cured on the working wire.

Abstract: A glucose-specific sensor has a glucose limiting layer (GLL), an enzyme layer and an interference layer. The GLL comprises polyurethane with a molecular weight greater than 100,000 Daltons that is physically crosslinked with a water-soluble polymer having a molecular weight greater than 100,000 Daltons. The interference layer has a polymer formed from pyrrole, phenylenediamine (PDA), aminophenol, aniline, or combinations thereof. Methods for making a glucose-specific sensor include mixing a monomer with a solvent to form a monomer solution, applying the monomer solution to a substrate and electropolymerizing the monomer to form a polymer on the substrate. The polymer is an interference layer for the glucose-specific sensor. An enzyme layer is formed on the interference layer, and a glucose limiting layer is formed on the enzyme layer.

Abstract: A metabolic analyte sensor includes a substrate having an electrically conductive surface, an interference layer on the conductive surface, an enzyme layer on the interference layer, and a glucose limiting layer on the enzyme layer. The interference layer or the enzyme layer is configured such that the metabolic analyte sensor has an improved performance characteristic after sterilization compared to before sterilization. A packaged continuous metabolic monitor includes a sealed container; a metabolic sensor in the sealed container for insertion into a patient after the metabolic sensor is removed from the sealed container, the metabolic sensor comprising a conductive surface and an enzyme layer; electronic operating circuitry in the sealed container and coupled to the metabolic sensor; and a residue of a sterilizing gas in the metabolic sensor. The sealed container, the metabolic sensor and the electronic operating circuitry are sterilized together in the sealed container using the sterilizing gas.

Abstract: A sensor system for determining glucose concentration in a tear fluid sample includes a working electrode including an immobilized glucose oxidase enzyme portion for reacting with glucose in the tear fluid sample, and a selectivity portion for enhancing the selectivity for glucose over electroactive interferent species in the tear fluid sample. Alternatively, a vessel for receiving the tear fluid sample may include the enzyme portion on an inner wall thereof. A reference electrode is disposed adjacent the working electrode, wherein the electrochemical reaction of the enzyme portion with glucose in the tear fluid sample generates a current related to the glucose concentration in the tear fluid sample.

Abstract: A sensor system for determining glucose concentration in a tear fluid sample includes a working electrode including an immobilized glucose oxidase enzyme portion for reacting with glucose in the tear fluid sample, and a selectivity portion for enhancing the selectivity for glucose over electroactive interferent species in the tear fluid sample. Alternatively, a vessel for receiving the tear fluid sample may include the enzyme portion on an inner wall thereof. A reference electrode is disposed adjacent the working electrode, wherein the electrochemical reaction of the enzyme portion with glucose in the tear fluid sample generates a current related to the glucose concentration in the tear fluid sample.