Abstract: A continuous glucose monitoring system may include a hand-held monitor, a transmitter, an insulin pump, and an orthogonally redundant glucose sensor, which may comprise an optical glucose sensor and a non-optical glucose sensor. The former may be a fiber optical sensor, including a competitive glucose binding affinity assay with a glucose analog and a fluorophore-labeled glucose receptor, which is interrogated by an optical interrogating system, e.g., a stacked planar integrated optical system. The non-optical sensor may be an electrochemical sensor having a plurality of electrodes distributed along the length thereof. Proximal portions of the optical and electrochemical sensors may be housed inside the transmitter and operationally coupled with instrumentation for, e.g., receiving signals from the sensors, converting to respective glucose values, and communicating the glucose values.

Abstract: A sensor assembly is disclosed. The sensor assembly includes a piercing member with an interior and exterior. Also included within the sensor assembly is a sensor that is formed on a flexible substrate. The sensor includes a proximal end and a distal end where the distal end includes a flex that is terminated at a terminal end. The terminal end of the sensor being located within the interior of the piercing member.

Abstract: A system to automatically detect at least one physiological state is disclosed. The system includes a single probe for insertion within a subject that has an analyte sensor array for continuous monitoring of at least glucose and a second analyte. The system further includes an electronics module that includes a power supply, a processor, memory and a bi-directional communications module. When the electronics module is coupled with the analyte sensor array the power supply delivers power to the analyte sensor array and the processor. The processor analyzing glucose and the second analyte data to detect a first physiological state from a plurality of physiological states.

Abstract: In one embodiment, a sensor is disclosed that includes a first conductive substrate coupled to, and electrically isolated from, a second conductive substrate. The sensor includes a first electrode trace within the first conductive substrate with a plurality of first working electrode openings. The sensor also includes a second electrode trace within the first conductive substrate with a plurality of second working electrode openings. Additionally a first transport material is included that covers the plurality of first working electrode openings and a second transport material that covers the plurality of second working electrode openings. A third transport material covers, and forms a barrier between the first and the second transport material. The sensor additionally includes a counter-reference electrode that is formed on the second conductive substrate.

Abstract: An on-body insertion system is described. The on-body system includes a sensor in a first position being substantially parallel to an insertion surface. Activation of an actuator transitions the sensor to a second position. Wherein the transition imparts movement to the sensor that is substantially parallel to the insertion surface and the second position results in the sensing area being beneath the insertion surface.

Abstract: Sensing and infusion devices are described. In one embodiment, a sensing and infusion device may include an implantable segment having a sensor. The sensing and infusion device may also include a catheter, and a sensor channel may be formed in the catheter. The sensor channel may be configured to retain at least a portion of the implantable segment.

Abstract: In one embodiment, a sensor to measure the presence of an analyte is disclosed. The sensor includes a working conductor with an electrode reactive surface. The sensor further includes a first reactive chemistry that is responsive to a first analyte and is in direct contact with the electrode reactive surface. The first reactive chemistry includes an enzyme, a first transport material, and an entrappable cofactor that includes a cofactor for the enzyme coupled to an anchor molecule. The sensor further includes a second transport material that enables diffusion of the first analyte to the first reactive chemistry.

Abstract: A method for retrospective calibration of a glucose sensor uses stored values of measured working electrode current (Isig) to calculate a final sensor glucose (SG) value retrospectively. The Isig values may be preprocessed, discrete wavelet decomposition applied. At least one machine learning model, such as, e.g., Genetic Programing (GP) and Regression Decision Tree (DT), may be used to calculate SG values based on the Isig values and the discrete wavelet decomposition. Other inputs may include, e.g., counter electrode voltage (Vcntr) and Electrochemical Impedance Spectroscopy (EIS) data. A plurality of machine learning models may be used to generate respective SG values, which are then fused to generate a fused SG. Fused SG values may be filtered to smooth the data, and blanked if necessary.

Abstract: An on-body insertion system is described. The on-body system includes a sensor in a first position being substantially parallel to an insertion surface. Activation of an actuator transitions the sensor to a second position. Wherein the transition imparts movement to the sensor that is substantially parallel to the insertion surface and the second position results in the sensing area being beneath the insertion surface.

Abstract: Sensing and infusion devices are described. In one embodiment, a sensing and infusion device may include an implantable segment having a sensor. The sensing and infusion device may also include a catheter, and a sensor channel may be formed in the catheter. The sensor channel may be configured to retain at least a portion of the implantable segment.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: An electrode measuring the presence of an analyte is described as one embodiment. The electrode includes a working conductor with an electrode reactive surface and a first reactive chemistry that is responsive to the analyte. The electrode further includes a first transport material that enables flux of the first analyte to the first reactive chemistry and a second transport material that supplies a reactant to the first reactive chemistry. Wherein the first reactive chemistry does not contact the electrode reactive surface while at least partially shadowing a portion of the electrode reactive surface.

Abstract: In one embodiment, an infusion set and sensor assembly delivered within a subject is disclosed. The assembly includes a cannula that is terminated at a cannula opening. The assembly further includes a sharp that is at least partially within the hollow of the cannula. A sensor having a proximal end and a distal end is also included in the assembly. The proximal end of the sensor is held in a fixed location while the distal end is retained with a portion of the cannula. The sensor further includes sensor slack, wherein transitioning the sharp from a first position to a second position simultaneously inserts the cannula and sensor to a desired insertion depth within a subject via a single point of insertion.

Abstract: A biosensor assembly that measures multiple physical parameters is disclosed. The biosensor assembly includes a first implantable probe and a first skin contacting electrode. Wherein a first physiological parameter is measured between the first implantable probe and the first skin contactable electrode.

Abstract: Electrochemical impedance spectroscopy (EIS) may be used in conjunction with continuous glucose monitoring (CGM) to enable identification of valid and reliable sensor data, as well implementation of Smart Calibration algorithms.

Abstract: An electrode measuring the presence of an analyte is described as one embodiment. The electrode includes a working conductor with an electrode reactive surface and a first reactive chemistry that is responsive to the analyte. The electrode further includes a first transport material that enables flux of the first analyte to the first reactive chemistry and a second transport material that supplies a reactant to the first reactive chemistry. Wherein the first reactive chemistry does not contact the electrode reactive surface while at least partially shadowing a portion of the electrode reactive surface.

Abstract: In one embodiment, an infusion set and sensor assembly delivered within a subject is disclosed. The assembly includes a cannula that is terminated at a cannula opening. The assembly further includes a sharp that is at least partially within the hollow of the cannula. A sensor having a proximal end and a distal end is also included in the assembly. The proximal end of the sensor is held in a fixed location while the distal end is retained with a portion of the cannula. The sensor further includes sensor slack, wherein transitioning the sharp from a first position to a second position simultaneously inserts the cannula and sensor to a desired insertion depth within a subject via a single point of insertion.

Abstract: A biosensor assembly that measures multiple physical parameters is disclosed. The biosensor assembly includes a first implantable probe and a first skin contacting electrode. Wherein a first physiological parameter is measured between the first implantable probe and the first skin contactable electrode.

Abstract: In one embodiment, a working electrode measuring the presence of a first analyte is disclosed. The working electrode includes a working conductor that has a first electrode reactive surface. The working electrode further includes a first transport material that enables flux of the first analyte to the first reactive chemistry. Additionally, a first reactive chemistry that is responsive to the first analyte is included in the working electrode. The first reactive chemistry includes a mediator, an enzyme and a cofactor. Wherein the first reactive chemistry is located between the working conductor and the first transport material.

Abstract: A product allows gaseous manufacturing by-products to be vented from the inside a sealed package tray. An exemplary method for packaging a device includes sealing the device inside a package tray with a gas-permeable sealing material, resulting in a sealed package tray. The sealing material allows volatile substances to vent from inside the sealed package tray to outside the sealed package tray.