Ascensia Diabetes Care Holdings Ag

Bayer Healthcare LLC

Huan-Ping Wu

Christine D Nelson

Greg P Beer

Eric Anthony Maurer

Sung-Kwon Jung

Dijia Huang

Amy H Chu

Christina Blaschke

Hope Spradlin

Nicole D Ellis

Steven C Charlton

Andrew J Edelbrock

Joseph E Perry

Henry C Arndt

Jing Lin

Fu Hsiung Tsai

Allen J Brenneman

Bern Everett Harrison

Mark D Cerutti

Scott E Carpenter

Kin-Fai Yip

Christine G Trippel

Weiping Zhong

Boru Zhu

Mary Ellen Warchal-Windham

Theresa A Rey

A biosensor system is configured to establish a steady-state condition and alternate between the steady-state condition and a non-steady-state condition to determine an analyte concentration. The biosensor system includes an electrode system having at least one working electrode and one counter electrode. The working electrode is covered with an analyte catalyzing layer for converting an analyte into measurable species. A membrane system encompasses the electrode system and comprises an analyte permeable membrane. The membrane has an analyte permeability with lower analyte solubility than an analyte solubility outside the membrane. The membrane is configured to trap a measureable species within the membrane such that a steady-state of the measurable species resulting from the analyte is established near the electrode surface. A bias circuit is configured to apply a potential modulation sequence to the working electrode to cause alternating of steady-state and non-steady-state conditions within the electrode system for analyte concentration determination.

Biosensor with membrane structure for steady-state and non-steady-state conditions for determining analyte concentrations

A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a ratio of measured probing potential modulation current signals; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.

Extracting parameters for analyte concentration determination

A biosensor system determines analyte concentration from an output signal generated from a light-identifiable species or a redox reaction of the analyte. The biosensor system compensates at least 50% of the total error in the output signal with a primary function and compensates a portion of the remaining error with a residual function. The amount of error compensation provided by the primary and residual functions may be adjusted with a weighing coefficient. The compensation method including a primary function and a residual function may be used to determine analyte concentrations having improved accuracy from output signals including components attributable to error.

Residual compensation including underfill error

A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.

Methods and apparatus information gathering, error detection and analyte concentration determination during continuous analyte sensing

A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a measured probing potential modulation current signal; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are disclosed.

Non-steady-state determination of analyte concentration for continuous glucose monitoring by potential modulation

During analyte analysis, errors may be introduced into an analysis by both the biosensor system used to perform the analysis and by errors in the output signal measured by the measurement device of the biosensor. For a reference sample, system error may be determined through the determination of relative error. However, during an analysis of a test sample with the measurement device of the biosensor system, true relative error cannot be known. A pseudo-reference concentration determined during the analysis may be used as a substitute for true relative error. The present invention introduces the determination of a pseudo-reference concentration determined during the analysis as a substitute for the true relative error and uses an anchor parameter to compensate for the system error in the analysis-determined pseudo-reference concentration.

System error compensation of analyte concentration determinations based on pseudo-reference concentration and signal-based anchor parameters

A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function value and the primary current signal; determining a connection function based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value. Other aspects are provided.

Continuous analyte monitoring sensor calibration and measurements by a connection function

Apparatus and methods are operative to probe the condition of a sensor either initially, at any point thereafter or continuously during a continuous sensor operation for measuring an analyte in a bodily fluid (such as performed by, e.g., a continuous glucose monitoring (CGM) sensor). Results of the probe may include calibration indices determined from electrical signals obtained during the probe. The calibration indices may indicate whether in-situ adjustment of the sensor's calibration should be performed either initially and/or at random check points. Probing potential modulation parameters also may be used during analyte calculations to reduce the effects of lot-to-lot sensitivity variations, sensitivity drift during monitoring, temperature, interferents, and/or the like. Other aspects are disclosed.

Apparatus and methods of probing sensor operation and/or determining analyte values during continuous analyte sensing

Methods and apparatus for information gathering, error detection and analyte concentration determination during continuous analyte sensing

Methods and biosensor systems for compensating an analyte measurement are provided. The methods and systems determine a secondary output signal based on the measured primary output signal in order to better approximate the effects of an extraneous stimulus on the primary output signal under actual measurement conditions. The methods and systems according to the present disclosure may provide a more accurate analyte measurement, and may be particularly useful in detecting and compensating an analyte measurement during an off-condition.

Biosensor system analyte measurement

Apparatus and methods for probing sensor operation of continuous analyte sensing and auto-calibration

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated voltammetric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, a single set of calibration constants, under-fill, and changes in the active ionizing agent content of the sensor strip.

Devices using gated voltammetry methods

Methods, devices, and systems are disclosed for the determination and logging of risk factor parameters associated with a sample, in association with the measurement of a concentration of an analyte in the sample. The methods, devices, and systems provide for applying an input signal to a sample via an electrode. The input signal has at least one excitation. The methods, devices, and systems further provide for measuring an output signal responsive to the input signal. The methods, devices, and systems further provide for determining a concentration of an analyte within the sample based on the output signal, and determining at least one risk factor parameter associated with at least one species in the sample other than the analyte.

Risk factor monitoring

Devices and methods for determining one or more analyte concentrations in a sample, determining a sample type, and/or accounting for interference species in a sample are disclosed that include intertwining a first input signal, via a first electrode having a reagent, with a second input signal, via a second electrode lacking a reagent, by applying to the sample the first input signal having at least two excitations and a relaxation, and applying to the sample the second input signal having at least two excitations and a relaxation, such that the excitations of the first input signal are nonconcurrent with the excitations of the second input signal. The method further includes measuring a first output signal responsive to the first input signal and a second output signal responsive to the second input signal.

Intertwined electrical input signals

A biosensor system determines an analyte concentration of a biological sample using an electrochemical process without Cottrell decay. The biosensor system generates an output signal having a transient decay, where the output signal is not inversely proportional to the square root of the time. The transient decay is greater or less than the &#x2212;0.5 decay constant of a Cottrell decay. The transient decay may result from a relatively short incubation period, relatively small sample reservoir volumes, relatively small distances between electrode surfaces and the lid of the sensor strip, and/or relatively short excitations in relation to the average initial thickness of the reagent layer. The biosensor system determines the analyte concentration from the output signal having a transient decay.

Growing community of inventors

Granger, IN, United States of America

Huan-Ping Wu