Abstract: A method for determining an analyte in a bodily fluid sample includes inserting the analyte test strip into a test meter. The insertion is such that an electrical connector pin of the test meter travels along an electrical contact pad of the analyte test strip, and across a meter identification feature disposed on the electrical contact pad, during the insertion. Moreover, during the insertion, a signal processing module of the test meter measures an electrical characteristic via the electrical connector pin as the electrical connector pin travels along the electrical contact pad and across the meter identification feature. The method also includes identifying the analyte test strip, using the signal processing module, based on the electrical characteristic measured as the analyte test strip is inserted into the test meter and, thereafter, applying the bodily fluid sample to the analyte test strip upon notification by the test meter that the identification indicates that such applying is appropriate.

Abstract: A system and method of detecting a flagged glucose concentration pattern with the use of medians having a common type of flag collected over discrete time periods so that whenever significant differences between the medians arise, the user or a caretaker of a diabetic user is notified.

Abstract: Described herein are various methods to ensure safety and the compliance of therapeutic diabetes protocols. The method can be achieved by performing safeguards against hypoglycemia of the user prior to any change in basal insulin dosage based on the plurality of data.

Abstract: The present invention relates to electrochemical cells including a connector which mates with a connection device to provide electrical connection to meter circuitry.

Abstract: A flexible indwelling electrochemical-based biosensor includes an elongated framework and an integrated electrochemical-based biosensor. The elongated framework is formed of an electrically conductive flexible material (e.g., a Nitinol) with a body portion, a sharp head, a distal end and a proximal end. The integrated electrochemical-based biosensor (such as an electrochemical-based glucose sensor) is integrated with the elongated framework in that the biosensor has a sensing element that is disposed over the body portion or sharp head of the elongated framework and a portion of the elongated framework is configured as an electrode component that electrically cooperates with the sensing element. The electrode component can, for example, be configured to electrically cooperate as a working electrode, counter electrode, reference electrode or combined reference/counter electrode of the sensing element.

Abstract: The present invention relates to methods and systems for monitoring the effectiveness of diabetes treatment. Methods and systems in accordance with the present invention provide information relating to variability of glucose levels and hypoglycemia and hyperglycemia. Such information is based on time-stamped blood glucose data obtained from a meter or the like and actual measurements of HbA1c levels are not required.

Abstract: Methods and apparatus for electrochemically determining an analyte concentration value in a physiological sample are disclosed. The methods include using a test strip in which two time-current transients are measured by a meter electrically connected to an electrochemical test strip. Integrative current values are derived from the time-current transients and used in the calculation of analyte concentration.

Abstract: A method for measuring and managing an analyte (e.g., blood glucose) in a bodily fluid includes storing a therapeutic administration protocol in a memory module of an analyte measurement and management device and measuring the analyte in the bodily fluid sample using an analyte measurement module of the device. The method also includes calculating, with a processor module of the device, a recommended therapeutic agent dosage (for example, an insulin dosage) and a recommended administration time for user-activated delivery of the dosage by employing the therapeutic administration protocol. The method further includes displaying the recommended therapeutic agent dosage and administration time to a user on a visual display of the device, delivering a therapeutic agent dosage to the user via a user-activated therapeutic agent delivery device, and detecting the user-activated administration of the therapeutic agent using a delivery device communication module of the device.

Abstract: System, circuits, and methods to reduce or eliminate uncompensated voltage drop between an electrode of an electrochemical cell usable for analyte measurement. In one example, a system is provided that includes a test strip, a reference voltage circuit, an operational amplifier connected to the reference voltage circuit to provide a pre-determined fraction of a reference voltage substantially equal to the test voltage applied to the first line, the operational amplifier having an output configured for one of a connected or disconnected state to the first line, and a processing circuit connected to the output of the operational amplifier and the first line such that, during a disconnected state between the output and the first line, the processing circuit remains in connection with the first line.

Abstract: A method of manufacture of an electrochemical cell is provided. In one exemplary embodiment, at least one non-metal working electrode is provided, at least one counter electrode or counter/reference electrode is provided such that it is not co-planer with respect to the working electrode, and a spacer is provided interposed between the working and counter or counter/referenced electrode. In one embodiment the counter or counter/reference electrode can be separated from the working electrode by a distance of from about 20 microns to about 200 microns. Alternatively, the cell can have an effective volume of less than 1.5 microliters. A method of manufacture of an electrochemical apparatus is also provided. The method can include providing both a hollow electrochemical cell for measuring a concentration of glucose in a blood sample and a mechanism configured to determine a concentration of a redox mediator from, at least in part, a measured current of the cell.

Abstract: In one example, the present invention is directed to a wound-healing patch including a flexible substrate, at least one wound electrode, at least one guard electrode and at least one return electrode. The guard electrode is positioned between the wound and return electrodes in the electrical path of current traveling between the return and wound electrodes on the surface of the skin, sinking the surface current and force the wound current to travel deeper into the tissue. In the invention, the wound electrode(s) is positioned on a portion of the flexible substrate designed to be placed over wounded tissue and the return electrode is positioned on a portion of the substrate substantially surrounding the wound and guard electrodes and is designed to be placed over healthy tissue.

Abstract: Methods and apparatus for electrochemically determining an analyte concentration value in a physiological sample are disclosed. The methods include using a test strip in which two time-current transients are measured by a meter electrically connected to an electrochemical test strip. Integrative current values are derived from the time-current transients and used in the calculation of analyte concentration.

Abstract: Devices, systems and methods are provided for drug delivery and the monitoring thereof.

Abstract: A method for the integrated facilitization of blood flow and monitoring of blood analyte concentration (for example, blood glucose concentration) includes implanting a stent configured to facilitate blood flow into a cardiovascular system of a user's body with the stent having attached thereto a continuous blood analyte determination module of a blood analyte monitoring system.

Abstract: Devices, systems and methods are provided for drug delivery and the monitoring thereof. The systems include a drug delivery device, a holder for the drug delivery device when the device is not in use, a detector for detecting the presence of the drug delivery device within or close to the holder, and at least one algorithm for querying and prompting a user of the drug delivery device, wherein the at least one algorithm is activated upon removal of the drug delivery device from the holder.

Abstract: A method for determining the concentration of a reduced or oxidized form of a redox species is provided. In one exemplary embodiment, an electrochemical apparatus is provided in which the apparatus includes a hollow electrochemical cell for measuring a concentration of glucose in a blood sample, a current of the cell is measured, and a concentration of a redox mediator is determined, at least in part from, a measured current of the cell. The hollow electrochemical cell can include at least one non-metal working electrode, at least one counter electrode or counter/reference electrode, and a spacer interposed between the working electrode and the counter or counter/reference electrode. In one embodiment the working electrode and the counter or counter/reference electrode are not co-planer and are separated by a distance of from about 20 microns to about 200 microns.

Abstract: A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 ?m. In one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 ?m apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 ?m. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.

Abstract: A method for preparing an electrokinetic element is provided and generally includes providing a porous membrane adapted for use in an electrokinetic pump and encapsulating the porous membrane within a polymer substrate to yield an electrokinetic element base member having the porous membrane encapsulated by the polymer. In one embodiment, the method can include laminating the porous membrane between opposed sheets of a polymer before the step of encapsulating. The method can also include cutting the electrokinetic element base member into a plurality of slices and assembling an electrokinetic infusion pump by inserting a slice into a chamber of the pump.

Abstract: The present application is directed to systems and methods associated with infusion pumps, which can optionally utilize an electrokinetic driving mechanism. Infusion pumps, including electrokinetically-driven pumps, are discussed, along with schemes for controlling their operation. As well, systems and methods of detecting malfunctions in infusion pumps are discussed. Any number of malfunctions can be detected including the presence of occlusions and/or leaks. In some instances, a measurement associated with some aspect of electrokinetic phenomena (e.g., an electrode measurement such as voltage or current) is compared with one or more sample values, the comparison allowing an indication of pump malfunction to be determined. A variety of such measurements and comparison techniques are discussed in the present disclosure.