Abstract: Embodiments of the present disclosure include a method for receiving sensor data indicative of a glucose level from a glucose sensor configured to be positioned in contact with a bodily fluid under a skin surface of a subject, receiving, from a temperature sensor, temperature data indicative of a temperature of the skin surface, determining a rate of change of the glucose level, wherein the rate of change indicates a presence of a hypoglycemic condition, determining that a variation of the temperature of the skin surface is within a predetermined range of temperature values, and determining, in response to the variation of the temperature data, that the rate of change of the glucose level corresponds to a sensor signal attenuation.

Abstract: Presented herein is a handheld analyte measurement device. The analyte measurement device includes one or more software applications to help the user manager their diabetes. Embodiments and descriptions of the various applications are provided below in conjunction with the handheld analyte measurement device.

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: A system and method to provide guidance for diabetes therapy includes determining glycemic risks based on an analysis of glucose data. The analysis includes visualization of a glucose median, the variability of glucose in a patient, and the risk of hypoglycemia. An Advanced Daily Patterns report includes a visualization of an ambulatory glucose profile and a glucose control measure. The glucose control measure provides a highly visible and understandable display of the glucose condition of a patient visually expressed in the categories of low glucose, median glucose, and glucose variability.

Abstract: Methods of analyte monitoring management are provided. The methods include indicating on a user interface a plurality of analyte management procedures available for user-selection, where the plurality of analyte management procedures relate to analyte management parameters. Embodiments include receiving an indication to initiate a first procedure of the plurality of analyte management procedures, where the first procedure is for determining a first analyte management parameter. The methods may further include outputting user-instructions associated with the first procedure; receiving analyte measurement data for the first procedure; estimating the first analyte management parameter based on the analyte measurement data; calculating a degree of certainty for the estimation of the first analyte management parameter; and, initiating an action in response to an event associated with a status of the estimation of the first analyte management parameter or the degree of certainty.

Abstract: The subject matter disclosed herein relates to methods for analyzing and determining the kinetics of glucose internalization in single red blood cells, e.g., obtained from a patient. The present disclosure further provides kits and systems for performing the methods disclosed herein.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Methods and Devices to monitor the level of at least one analyte are provided.

Abstract: Method, device and system for providing consistent and reliable glucose response information to physiological changes and/or activities is provided to improve glycemic control and health management.

Abstract: A lactate-responsive enzyme may form the basis for lactate detection and quantification using an electrochemical analyte sensor. Various features may be incorporated within an analyte sensor containing a lactate-responsive enzyme, particularly lactate oxidase, to improve sensitivity and response stability of the analyte sensor. Such analyte sensors may comprise: a working electrode having an active area disposed thereon, and a mass transport limiting membrane overcoating at least the active area upon the working electrode. The active area comprises at least a polymer, an albumin, and a lactate-responsive enzyme that is covalently bonded to the polymer. The mass transport limiting membrane may comprise at least a crosslinked polyvinylpyridine homopolymer or copolymer. The analyte sensors may determine a lactate concentration in a biological fluid, particularly in vivo, which may be correlated to various physiological conditions.

Abstract: A glucose monitoring system includes a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level, and a reader device comprising a wireless communication circuitry configured to receive the data indicative of the analyte level, and one or more processors coupled with a memory.

Abstract: Medical devices, systems, and methods related thereto a glucose monitoring system having a first display unit in data communication with a skin-mounted assembly, the skin-mounted assembly including an in vivo sensor and a transmitter. The first display unit and a second display unit are in data communication with a data management system. The first display unit comprises memory that grants a first user first access level rights and the second display unit comprises memory that grants a second individual second access level rights.

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: Methods, devices, systems, and computer program products are provided to improve sensitivity calibration of an in vivo analyte sensor and usability of an associated analyte monitoring system. In certain embodiments, methods are provided that improve the user experience of using an analyte monitoring system. Certain embodiments of the present disclosure include features that reduce the amount of calibration or re-calibration performed by the analyte monitoring system. More specifically methods of using a suspect calibration attempt to avoid having to recalibrate by adjusting the calibration or mitigating effects of sensor signal attenuation that caused the calibration attempt to be suspect are provided. Additional features are disclosed.

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: A method, apparatus, and a kit are capable of improving accuracy of CGS devices using dynamic outputs of continuous glucose sensors.