Fluid component analysis systems and methods for glucose monitoring and control

Inventors

Braig, James R. • Keenan, Richard • Rule, Peter • Rivas, Gil • Seetharaman, Mahesh

Assignees

Insulet Corp

Abstract

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Core Innovation

A system is provided for monitoring at least one analyte in a bodily fluid of a patient. The monitoring device measures a characteristic of the analyte, and a control system is coupled to the monitoring device to automatically determine a dose of insulin based on the measured characteristic. The system further includes a treatment dosing system coupled to the control system, with a pump having a variable pump rate adjustable to deliver a basal rate and adjustable to deliver a bolus injection.

The control system is configured to adjust the variable pump rate based on the measured characteristic to deliver the determined dose of insulin as a basal rate or as a bolus injection. A display device presents an indication of the measured characteristic in a graphical user interface. In a glucose-specific implementation, the control system determines glucose concentration relative to a lower threshold and provides insulin scaling based on whether glucose is below the lower threshold.

The system includes treatment dosing logic in which the dose determination is based on a treatment dosing protocol stored in computer memory. The control system further extrapolates an analyte concentration based on insulin sensitivity and an amount of administered insulin. Insulin flow is automatically stopped when the analyte concentration drops below a threshold or when a concentration trend indicates it will soon fall below the threshold, and the graphical user interface can include user interaction elements and display of determined dose, actual dose, and the measured characteristic.

Claims Coverage

The claims include one independent claim, with dependent claims refining dose determination, pump control logic, safety stopping, user interaction, and glucose-threshold behavior. Across the claims, there are eight inventive features centered on automated insulin dosing from monitored analyte characteristics and variable pump basal/bolus delivery with graphical display and threshold/trend-based control.

Overall, the claims cover an insulin dosing system that measures an analyte characteristic, automatically determines an insulin dose, and controls a variable-rate pump to deliver the dose as either a basal rate or a bolus injection. The claims further cover GUI-based presentation and interaction, dosing logic based on a stored treatment dosing protocol and extrapolation, and insulin safety stopping using threshold and trend logic, including glucose-specific lower-threshold scaling.

Stated Advantages

Documented Applications