Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample (e.g., a whole blood sample) includes a housing, with an outer surface, and an analytical test strip ejection mechanism (“ATSEM”). The ATSEM has an actuation button disposed in the outer surface of the housing, a motion amplification and rotation assembly (“MA&RA”) operatively connected to the actuation button and a test strip slider (“TSS”) operatively connected to the MA&RA. The actuation button is configured for movement by a user's digit in a first direction and the MA&RA and TSS are configured to convert the movement in the first direction into amplified movement of the TSS in a second direction with the second direction being rotated with respect to the first direction. Moving the TSS in the second direction from the engaged state to an ejected state ejects the strip.

Abstract: An analytical test strip (“ATS”) for use with a hand-held test meter (“HHTM”) in the determination of an analyte in a bodily fluid sample (“BFS”) includes a first patterned conductive layer with a working electrode and a reference electrode, as well as a method for determining an analyte in BFS. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a patterned spacer layer disposed over the first patterned conductive layer and configured to define a sample chamber (“SC”) within the ATS, and a second patterned conductive layer disposed above the first patterned conductive layer. The second patterned conductive layer includes a first phase-shift measurement electrode and a second phase-shift measurement electrode, which electrodes are disposed in the SC and are configured to measure, along with the HHTM, a phase shift of an electrical signal forced through a BFS introduced into the SC during the ATS' use.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: An analytical test strip (“ATS”) for use with a hand-held test meter in the determination of an analyte in a bodily fluid sample includes an electrically insulting substrate, a first patterned conductor layer disposed on the electrically insulating substrate and having a working electrode and a reference electrode. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a first patterned spacer layer disposed over the first patterned conductor layer and defining both a first sample-receiving channel and an analyte determination sample chamber within the ATS, and a second patterned spacer layer disposed over the first patterned spacer layer and defining at least a second sample-receiving channel. The ATS further includes a bodily fluid phase-shift sample chamber in fluidic communication with the second sample-receiving channel.

Abstract: The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Abstract: The invention provides a method for varying the intercept of a batch of test strips by varying the height of the strip's sample-receiving chamber.

Abstract: The invention provides a method of controlling the slope, intercept and bias for a batch of test strips by increasing or decreasing the enzyme pad height of the strips. The invention provides an improved method for the production of single calibration code strip lots with good yields.

Abstract: A method for wireless transmission of data between a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18), and to a corresponding blood glucose system (1, I1). The slave device (3) is normally operated in a power saving mode in which its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) by means of a signal comprising a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Abstract: The invention relates to a method for wireless transmission of data between components of a blood glucose system including a master controller (i.e., “master”) and a slave device (i.e., “slave”). The master and slave each have a receiver and transmitter. The method comprises operating the slave normally in a power saving mode, activating the transmitter of the master for a transmission period and subsequently activating the receiver of the master for a response period. When the slave receives a preamble signal during a listening period the slave receiver is activated until a portion of a transmitted data frame from the master is received, switched into a communication mode to transmit a response to the master and switched from the communication mode to the power saving mode. In the power saving mode the activation frequency of the slave receiver and the transmission of the data frame are controlled to save power.

Abstract: An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion.

Abstract: Described herein are systems and methods to utilize factual information based on stored blood glucose data to allow greater insight into the management of diabetes of a user.

Abstract: A method and system are provided to determine fill sufficiency of a biosensor test chamber by determining capacitance of the test chamber.

Abstract: Methods and systems to provide for safeguards in the insulin dosing calculation as part of the diabetes management. The system or method provides a warning if the person with diabetes is calculating a dosing regimen outside of a preselected time period in which certain dosing parameters are customized to the preselected time period.

Abstract: A meter is provided that includes an improved user interface that enables the user to take a specific action, leading them directly to data input options. Such a user interface could be used to input first selected information, such as whether a test was premeal or postmeal, immediately after receiving a result. Optionally, the user interface may include the ability to add an additional comment after inputting the first selected information. Provision of such a user interface would facilitate simpler capture of the first selected information each time the user performs a test, leading to an enhanced understanding of a patient's level of glycemic control. Designing a user interface to enable first selected information to be entered by a user directly after receiving a result is more likely to engage a patient by making it easy and simple to enter important information. This may enable capture of the information thought to be most pertinent e.g.

Abstract: A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Abstract: Described and illustrated herein are one exemplary method and a measurement system having a meter and a test strip. The test strip has a first working electrode, reference electrode and second working electrode. In this method, acceptable fill data from known first current and known second current are used to predict an estimated second current at proximate the second time period (for a given batch of test strips) during the test sequence. The estimated second current at proximate the second time interval is then compared with a measured actual second current at proximate the second time interval during an actual test to determine if the measured actual second current is substantially equal to or within an acceptable percent deviation from the estimated second current so as to determine sufficient volume of a physiological fluid sample in the test strip.

Abstract: Various embodiments are described and illustrated to calculate an insulin bolus, recommend such bolus, and provide reminder messages for performing an additional glucose test.

Abstract: A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

Abstract: Described herein are systems and methods to utilize factual information based on stored blood glucose data to allow greater insight into the management of diabetes of a user.