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: 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: Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (kgly), a red blood cell generation rate constant (kgen), a red blood cell elimination constant (kage), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.

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: Methods and devices for statistical determination of medication dosage level such as bolus amount based on contextual information are provided.

Abstract: Embodiments described herein include an analyte monitoring system including an application executing on a mobile device and an analyte monitoring system server. The application is configured to detect that a communication channel between the application and the analyte monitoring system server is non-responsive and taking actions in response or recommending options to correct the non-responsive communication channel. Techniques include receiving a notification from the analyte monitoring system server via a notification service server. In response to receiving the notification, output of a first connectivity alert is canceled. Also in response to receiving the notification, output of a second connectivity alert is scheduled to be output at expiration of a timer unless the mobile device receives a second notification from the analyte monitoring system server.

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: Acupuncture needles may be used for piercing tissue with less trauma than may occur when employing larger gauge needles. However, because acupuncture needles are fabricated and packaged differently than are larger gauge needles, acupuncture needles may be less compatible with certain manufacturing processes. Needle assemblies compatible with manufacturing processes may comprise a continuous support material having a plurality of apertures defined therein, and a first injection molded coupler that surrounds a proximal portion of an acupuncture needle and connects the acupuncture needle to a first location upon the continuous support material, such that the acupuncture needle is held in a pre-determined orientation with respect to a longitudinal axis of the first injection molded coupler. The acupuncture needles in adjacent apertures may also be spaced apart substantially uniformly.

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: Methods, devices, and systems are provided for correcting lag in measurements of glucose concentration level in interstitial fluid. A method includes defining a scaling factor for lag correction, receiving glucose data from the glucose sensor, the sensor data including historical glucose sensor data over a plurality of intervals, defining a probability density function of the glucose data over at least a portion of one of the plurality of intervals, determining a value of the scaling factor based on the probability density function and a normalized analyte variability ratio, and computing lag corrected values based on the determined value of the scaling factor. Numerous additional features are disclosed.

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: Embodiments described herein include an analyte monitoring system including an application executing on a mobile device and an analyte monitoring system server. The application is configured to detect that a communication channel between the application and the analyte monitoring system server is non-responsive and taking actions in response or recommending options to correct the non-responsive communication channel. Techniques include receiving a notification from the analyte monitoring system server via a notification service server. In response to receiving the notification, output of a first connectivity alert is canceled. Also in response to receiving the notification, output of a second connectivity alert is scheduled to be output at expiration of a timer unless the mobile device receives a second notification from the analyte monitoring system server.

Abstract: Method and system for providing diabetes management and insulin therapy based on substantially real time glucose monitoring system is provided.

Abstract: A system and method provides a glucose report for determining glycemic risk based on an ambulatory glucose profile of glucose data over a time period, a glucose control assessment based on median and variability of glucose, and indicators of high glucose variability. Time of day periods are shown at which glucose levels can be seen. A median glucose goal and a low glucose line provide coupled with glucose variability provide a view into effects that raising or lowering the median goal would have. Likelihood of low glucose, median glucose compared to goal, and variability of glucose below median provide probabilities based on glucose data. Patterns can be seen and provide guidance for treatment.

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

Abstract: Systems, devices and methods for the management of glucose levels in the body of patient featuring user interface input mechanisms configured to provide haptic feedback to the user are provided.