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

Abstract: The present invention is directed to, inter alia, systems and methods for calculating a temperature associated with an analyte measurement component of a biosensing instrument (such as a blood glucose monitor), with a test strip that is inserted in a biosensing instrument, or both. The present systems and methods may employ at least two temperature sensors, and the acquired temperature information may be used to modulate data regarding an analyte in a biological sample, thereby providing a more accurate measurement of the analyte.

Abstract: An adhesive composition for use in devices and methods for measuring a presence or a concentration of a particular component, such as an antigen, in a sample, such as blood, are provided. In one exemplary embodiment of an adhesive composition, the composition includes an adhesive, water, a poloxamer, and an anticoagulant. The adhesive can include particular properties, such as being hydrophilic, pressure-sensitive, heat-activated, and/or water soluble. The adhesive is particularly useful because it can help improve the flow of sample a device. For example, when the device is an immunosensor, the adhesive can help prevent the blood from clotting in chambers of the immunosensor. This results in a more efficient and accurate determination of the concentration of the sample. Methods of making the composition and device in which the composition can be used are provided, as are methods of using the same.

Abstract: An adhesive composition for use in devices and methods for measuring a presence or a concentration of a particular component, such as an antigen, in a sample, such as blood, are provided. In one exemplary embodiment of an adhesive composition, the composition includes an adhesive, water, a poloxamer, and an anticoagulant. The adhesive can include particular properties, such as being hydrophilic, pressure-sensitive, heat-activated, and/or water soluble. The adhesive is particularly useful because it can help improve the flow of sample a device. For example, when the device is an immunosensor, the adhesive can help prevent the blood from clotting in chambers of the immunosensor. This results in a more efficient and accurate determination of the concentration of the sample. Methods of making the composition and device in which the composition can be used are provided, as are methods of using the same.

Abstract: An electrochemical sensing apparatus and methods are provided. In one embodiment, an apparatus is provided having a carrier that supports an electrochemical module and that communicates between electrodes on the electrochemical module and an analyte measurement device.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing, a buttons electrical circuit block, at least one user operable button in operable communication with the buttons electrical circuit block, a microcontroller block, and a first-time-on (FTO) electrical circuit block. The FTO electrical circuit block is disposed within the housing and includes an activation node and a signal reception contact. In addition, the FTO electrical circuit block is configured to place the hand-held test meter into a deep power conservation mode upon either the direct application of an electrical signal to the activation node by an external device (e.g., a manufacturing tester) or a deactivation signal received at the signal reception contact.

Abstract: An electronics device (“ED”) includes a housing, a buttons electrical circuit block, at least one user operable button in operable communication with the buttons electrical circuit block, a microcontroller block, and a first-time-on (FTO) electrical circuit block, disposed within the housing. The FTO electrical circuit block includes an activation node and a signal reception contact, and is configured: (i) to place the ED into a deep power conservation mode (“DPCM”) upon either the direct application of an electrical signal to the activation node by an ED or a deactivation signal received at the signal reception contact; (ii) to terminate the DPCM and place the ED into a normal operating mode upon receiving a predetermined user triggered signal from the at least one user operable button; and (ii) to generate the deactivation signal received at the signal reception contact in response to an external command signal received by the microcontroller block.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: A method of manufacturing an analyte test strip includes positioning a patterned spacer layer between a first insulating layer and a second insulating layer such that the second insulating is disposed above the first insulating layer and a channel is defined between the first and second insulating layers. Moreover, the channel thus defined has a sample-receiving chamber therein, a first port, and a second port. The method also includes coupling a third insulating layer to the first insulating layer such that the third insulating layer is disposed at least partially below the first insulating layer. In the coupling step, the third insulating layer includes a platform portion that extends beyond the first insulating layer and the second insulating layer and the platform portion has an upper surface.

Abstract: Described herein are systems and methods to utilize factual information based on stored analyte data to allow greater insight into a chronic disease of a user, such as, for example a diabetic patient.

Abstract: A method for determining (e.g., detecting and/or measuring the concentration of) an analyte in a bodily fluid sample includes obtaining a bodily fluid sample, applying the bodily fluid sample to an analyte test strip, transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip, and determining an analyte in the bodily fluid sample. The analyte test strip employed in the method includes a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip. Moreover, the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port.

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: Disclosed herein are methods and apparatus for determining analyte concentration in a rapid and accurate manner. The methods include depositing a physiological sample in an electrochemical cell and finding a first and second current transient. Peak current values are obtained from the first and second peak current values and used to reduce the influence of interferents in a current value. Based on this “corrected” current value, an accurate analyte concentration can be determined.

Abstract: Methods and devices for improving measurements of test meter, and in particular for detecting a presence of an electrochemical sensor or strip in the test meter and a start time of an electrochemical reaction, are provided. In one exemplary embodiment of an electrochemical system includes an electrochemical sensor , a test meter, and a circuit. The circuit is configured to form an electrical connection with the electrochemical sensor such that the circuit can detect three distinct voltage ranges. The voltage ranges can be indicative of an absence of the electrochemical sensor, a presence of the sensor that is devoid of a sample, and a presence of the sensor with a sample. Test meters, methods for detecting when a sample starts to fill an electrochemical sensor for establishing when a reaction starts, and circuits for use with electrochemical strips, are also provided.

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 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: Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a fill time of the sample into the device is calculated. A concentration of the analyte in view of fill time can then be determined. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.

Abstract: A system and method of processing a test current for an analyte measurement in a fluid using a test strip and a test meter are disclosed. The method comprises sampling the test current at a pre-determined sampling rate to acquire a plurality of A/D conversions. The method also comprises filtering out at least a highest magnitude A/D conversion and a lowest magnitude A/D conversion leaving a plurality of accepted A/D conversions. Further, the method comprises calculating an average or a summation of the plurality of accepted A/D conversions and converting the average or the summation into a glucose concentration.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.

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.