Multi-analyte continuous glucose monitoring

Inventors

Shah, Rajiv • LIANG, Bradley C • BOWMAN, ELLEN • Wolfe, Katherine

Assignees

Percusense LLC

Abstract

A system to automatically detect at least one physiological state is disclosed. The system includes a single probe for insertion within a subject that has an analyte sensor array for continuous monitoring of at least glucose and a second analyte. The system further includes an electronics module that includes a power supply, a processor, memory and a bi-directional communications module. When the electronics module is coupled with the analyte sensor array the power supply delivers power to the analyte sensor array and the processor. The processor analyzing glucose and the second analyte data to detect a first physiological state from a plurality of physiological states.

Core Innovation

The disclosure provides a system to automatically detect at least one physiological state using a single probe having an A-side and a B-side for insertion within a subject. The single probe includes an analyte sensor array for continuous monitoring of at least glucose and a second analyte, with working electrodes on the A-side and a pseudo-reference electrode on the B-side opposite the A-side. The working electrodes and the pseudo-reference electrode are patterned on different substrates, enabling electrochemical sensing for the analyte sensor array.

An electronics module couples with the analyte sensor array and includes a power supply, a processor, memory, and a bi-directional communications module. The processor analyzes glucose and the second analyte to detect a first physiological state from a plurality of physiological states. The physiological-state detection is based on relationships among analyte measurements, including trends and relationships using threshold values and absolute change and rate of change relationships across glucose and the second analyte, with probabilistic confirmation of detected states.

The disclosure also describes optional physiological-state confirmation using trends and threshold or change relationships involving optional physical sensors such as an accelerometer, temperature sensor, hydration-related sensing, and ECG skin-contact electrodes, and links detected physiological states including sleep, exercise, meal intake, stress, and illness to probabilistic confirmation. When used with an artificial pancreas, the detected states can be used for automated adjustments of basal and bolus insulin or glucagon based on a confidence probability exceeding a threshold. The probe-electrode concepts include A-side/B-side electrode arrangements such as working electrodes and pseudo-reference (combined counter-reference) electrodes, including discussion of two- versus three-electrode arrangements.

Claims Coverage

The independent claim covers a physiological-state detection system with a single probe having an A-side/B-side electrode arrangement and an electronics module that analyzes continuous glucose and a second analyte to detect one physiological state from a plurality of physiological states. Dependent claims further define the detection basis using specific glucose/change logic, specify which second analytes are measured, and specify example physiological-state categories; additional dependents refine analysis relationships involving other named analytes such as reactive oxygen species and third analytes including lactate, tissue oxygen, reactive oxygen species, and ketones.

Overall, the claim set is centered on a single probe with A-side/B-side electrode patterning and continuous monitoring of glucose and a second analyte, followed by processor-based detection of a physiological state from a plurality of states. The dependents narrow detection logic using absolute change and rate of change, define specific analytes such as tissue oxygen and third analytes such as lactate, reactive oxygen species, and ketones, and refine physiological-state categories and analysis relationships involving glucose and reactive oxygen species.

Stated Advantages

Documented Applications

No documented applications found