Abstract: The efficacy of tissue piercing elements in the area of transdermal drug delivery is well-documented. Multiple studies have shown that enhancement of skin permeation via creation of microscopic pores in the stratum corneum can greatly improve the delivery rates of drugs. However, skin perforation with tissue piercing elements is not the only factor affecting the rate of drug transport. Other factors including such as the formulation of the drug and rate of closure of the micropores closure also need to be considered. Similarly micro tissue piercing elements have been used with less success by several workers for continuous glucose monitoring.

Abstract: A method of monitoring an analyte (such as, e.g., glucose) including the following steps: diffusing the analyte from a sampling location into a sensing fluid within a sensing chamber; detecting a concentration of the analyte in the sensing fluid; moving flushing fluid into the sensing chamber and simultaneously removing sensing fluid from the sensing chamber; permitting the flushing fluid to remain in the sensing chamber without flowing for a dwell time; removing the flushing fluid from the sensing chamber after the dwell time expires; and, after removing the flushing fluid from the sensing chamber, moving sensing fluid into the sensing chamber. The invention also includes an analyte monitoring device performing this method.

Abstract: An analyte monitor having a plurality of fluid paths, each fluid path having a distal opening adapted to be disposed on one side of a stratum corneum layer of a user's skin, a proximal opening adapted to be disposed on another side of the stratum corneum layer and an interior space extending between the distal and proximal openings; a sensing zone in fluid communication with the proximal openings of the fluid paths; sensing fluid extending from the sensing zone into substantially the entire interior space of the fluid paths; and an analyte sensor adapted to detect a concentration of analyte in the sensing fluid within the sensing zone, wherein at least one of the sensing fluid and the analyte sensor comprises a catalyst for mutarotation of glucose. The invention also includes a method of using the monitor.

Abstract: One aspect of the invention is a method of in vivo monitoring of an individual's interstitial fluid glucose concentration comprising inserting a plurality of tissue piercing elements through a stratum corneum layer of an area of the individual's skin. The tissue piercing elements each comprise a distal end in fluid communication with interstitial fluid of the individual, and a proximal end in fluid communication with a sensing zone located outside of the patient's body. An interior space extends between the distal and proximal ends of the tissue piercing elements. A sensing fluid fills substantially the entire interior space and the sensing fluid concentration comprises a concentration of citrate in a buffer solution. The concentration of citrate may range from 100 mM to 200 mM, preferably 135-165 mM.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: Methods and devices are provided for measuring the concentration of target chemical analytes present in a biological system. Device configuration and/or measurement techniques are employed in order to reduce the effect of interfering species on sensor sensitivity. One important application of the invention involves a method and device for monitoring blood glucose values.

Abstract: The present invention comprises one or more microprocessors programmed to execute methods for improving the performance of an analyte monitoring device including prediction of glucose levels in a subject by utilizing a predicted slower-time constant (1/k2). In another aspect of the invention, pre-exponential terms (1/c2) can be used to provide a correction for signal decay (e.g., a Gain Factor). In other aspects, the present invention relates to one or more microprocessors comprising programming to control execution of (i) methods for conditional screening of data points to reduce skipped measurements, (ii) methods for qualifying interpolated/extrapolated analyte measurement values, (iii) various integration methods to obtain maximum integrals of analyte-related signals, as well as analyte monitoring devices comprising such microprocessors.

Abstract: The present invention relates to methods to increase the number of analyte-related signals used to provide analyte measurement values, e.g., when two or more analyte-related signals are used to obtain a single analyte measurement value a “rolling” value based on the two or more signals can be employed. In another aspect, interpolation and/or extrapolation methods are used to estimate unusable, missing or error-associated analyte-related signals. Further, interpolation and extrapolation of values are employed in another aspect of the invention that reduces the incident of failed calibrations. Further, the invention relates to methods, which employ gradients and/or predictive algorithms, to provide an alert related to analyte values exceeding predetermined thresholds.

Abstract: One aspect of the invention provides an analyte monitor including a sensing volume, an analyte extraction area in contact with the sensing volume adapted to extract an analyte into the sensing volume, and an analyte sensor adapted to detect a concentration of analyte in the sensing volume. The sensing volume is defined by a first face, a second face opposite to the first face, and a thickness equal to the distance between the two faces. The surface area of the first face is about equal to the surface area of the second face and the extraction area is about equal to the surface area of the first and second face of the sensing volume. The analyte sensor includes a working electrode in contact with the sensing volume, the working electrode having a surface area at least as large as the analyte extraction area, and a second electrode in fluid communication with the sensing volume.

Abstract: A transdermal electrotransport fentanyl delivery system having relatively stable fentanyl flux. The system has a controller that controls a current through a donor reservoir wherein the current is generally changed nonlinearly with time with conductance or resistance as a factor to result in a relatively stable fentanyl flux.

Abstract: One aspect of the invention provides a glucose monitor having a plurality of tissue piercing elements, each tissue piercing element having a distal opening, a proximal opening and interior space extending between the distal and proximal openings; a sensing volume in fluid communication with the proximal openings of the tissue piercing elements; sensing fluid extending into the sensing volume; and a glucose sensor adapted to detect a concentration of glucose in the sensing fluid within the sensing volume.

Abstract: The present invention comprises one or more microprocessors programmed to execute methods for improving the performance of an analyte monitoring device including prediction of glucose levels in a subject by utilizing a predicted slower-time constant (1/k2). In another aspect of the invention, pre-exponential terms (1/c2) can be used to provide a correction for signal decay (e.g., a Gain Factor). In other aspects, the present invention relates to one or more microprocessors comprising programming to control execution of (i) methods for conditional screening of data points to reduce skipped measurements, (ii) methods for qualifying interpolated/extrapolated analyte measurement values, (iii) various integration methods to obtain maximum integrals of analyte-related signals, as well as analyte monitoring devices comprising such microprocessors.

Abstract: The present invention comprises one or more microprocessors programmed to execute methods for improving the performance of an analyte monitoring device including prediction of glucose levels in a subject by utilizing a predicted slower-time constant (1/k2). In another aspect of the invention, pre-exponential terms (1/c2) can be used to provide a correction for signal decay (e.g., a Gain Factor). In other aspects, the present invention relates to one or more microprocessors comprising programming to control execution of (i) methods for conditional screening of data points to reduce skipped measurements, (ii) methods for qualifying interpolated/extrapolated analyte measurement values, (iii) various integration methods to obtain maximum integrals of analyte-related signals, as well as analyte monitoring devices comprising such microprocessors.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: A method is provided for continually or continuously measuring the concentration of target chemical analytes present in a biological system, and processing analyte-specific signals to obtain a measurement value that is closely correlated with the concentration of the target chemical analyte in the biological system. One important application of the invention involves a method for signal processing in a system for monitoring blood glucose values.

Abstract: Methods and devices are provided for measuring the concentration of target chemical analytes present in a biological system. Device configuration and/or measurement techniques are employed in order to reduce the effect of interfering species on sensor sensitivity. One important application of the invention involves a method and device for monitoring blood glucose values.