Complex redundancy in continuous glucose monitoring

Patent metadata

Field	Value
Publication number	US-11471082-B2
Application number	US-201715840673-A
Country	US
Kind code	B2
Filing date	Dec 13, 2017
Priority date	Dec 13, 2017
Publication date	Oct 18, 2022
Grant date	Oct 18, 2022

Abstract

A continuous glucose monitoring system may employ complex redundancy to take operational advantage of disparate characteristics of two or more dissimilar, or non-identical, sensors, including, e.g., characteristics relating to hydration, stabilization, and durability of such sensors. Fusion algorithms, Electrochemical Impedance Spectroscopy (EIS), and advanced Application Specific Integrated Circuits (ASICs) may be used to implement use of such redundant glucose sensors, devices, and sensor systems in such a way as to bridge the gaps between fast start-up, sensor longevity, and accuracy of calibration-free algorithms. Systems, devices, and algorithms are described for achieving a long-wear and reliable sensor which also minimizes, or eliminates, the need for BG calibration, thereby providing a calibration-free, or near calibration-free, sensor.

First claim

What is claimed is:

1. A glucose monitoring system comprising:
a glucose sensor device for determining a concentration of glucose in a body of a user during a total sensor-device wear time without requiring an external reference blood glucose value from the user, the total sensor-device wear time including a first time window, a subsequent second time window, and a transition period between the first time window and the second time window, the glucose sensor device comprising:
a first glucose sensor that self-calibrates in real time and has first characteristics;
a second glucose sensor that is to be calibrated and has second characteristics, which is different from the first characteristics in at least one of hydration, stabilization, or durability; and
sensor electronics including at least one physical microprocessor that is configured to:
receive, from the first glucose sensor, a first output signal indicative of a glucose concentration level in the user's body;
receive, from the second glucose sensor, a second output signal indicative of a glucose concentration level in the user's body, wherein the second glucose sensor is calibrated based on the first output signal; and
determine the transition period for transitioning from the first glucose sensor to the second glucose sensor based on the first characteristics and the second characteristics, such that transition from the glucose concentration level from the first glucose sensor to the glucose concentration level from the second glucose sensor is smooth during the total sensor-device wear time; and
to calculate the glucose concentration level in the user's body, executing a calibration-free algorithm based entirely on the first output signal during the first time window, a fusion algorithm based on the first and second output signals during the transition period, and a calibration-free algorithm based entirely on the second output signal during the second time window.

2. The system of claim 1 , wherein the glucose sensor device is configured to be either implanted or subcutaneously disposed in the user's body.

3. The system of claim 1 , wherein, based on the hydration, stabilization, and durability characteristics of the first and second glucose sensors, the microprocessor determines a beginning time and an end time for the transition period.

4. The system of claim 3 , wherein the microprocessor periodically fuses the first and second output signals to calculate a single, fused glucose value during the transition period.

5. The system of claim 1 , wherein, during the transition period, the microprocessor compares the first and second output signals to diagnose whether each respective glucose sensor is functioning properly.

6. The system of claim 5 , wherein, based on the comparison and diagnosis, the microprocessor assigns respective weights to the first and second output signals to generate respective weighted first and second signals.

7. The system of claim 6 , wherein the microprocessor periodically calculates a single, fused glucose value based on the weighted first and second output signals.

8. The system of claim 1 , wherein the glucose monitoring system further comprises a transmitter, wherein the transmitter is configured to be worn on the user's body.

9. The system of claim 8 , wherein the glucose monitoring system further comprises a handheld monitor.

10. The system of claim 9 , wherein the glucose monitoring system further comprises an insulin pump.

11. The system of claim 10 , wherein the glucose monitoring system is a closed-loop system.

12. A method for monitoring glucose using a calibration-free glucose sensor device that determines a concentration of glucose in a body of a user during a total sensor-device wear time without requiring an external reference blood glucose value from the user, the total sensor-device wear time including a first time window, a second time window subsequent to the first time window, and a transition period between the first time window and the second time window, wherein the glucose sensor device comprises a first glucose sensor that self-calibrates in real time and has first characteristics and a second glucose sensor that is to be calibrated and has second characteristics, which is different from the first characteristics in at least one of hydration, stabilization, or durability, the method comprising:
receiving, at sensor electronics, from the first glucose sensor, a first output signal indicative of a glucose concentration level in the user's body;
receiving, at the sensor electronics, from the second glucose sensor, a second output signal indicative of a glucose concentration level in the user's body, wherein the second glucose sensor is calibrated based on the first output-signal;
determining the transition period for transitioning from the first glucose sensor to the second glucose sensor based on the first characteristics and the second characteristics, such that transition from the glucose concentration level from the first glucose sensor to the glucose concentration level from the second glucose sensor is smooth during the total sensor-device wear time; and
to calculate the glucose concentration level in the user's body, executing, at the sensor electronics, a calibration-free algorithm based entirely on the first output signal during the first time window, a fusion algorithm based on the first and second output signals during the transition period, and a calibration-free algorithm based entirely on the second output signal during the second time window.

Assignees

• Medtronic Minimed Inc

Inventors

• Varsavsky Andrea
• Nishida Jeffrey
• Engel Taly G
• Nogueira Keith
• Tsai Andy Y
• Ajemba Peter

Classifications

• A61M2230/201

  Glucose concentration · CPC title

• A61B5/6849

  in combination with a needle set · CPC title

• A61B5/14865

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• A61B5/0002

  Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07) · CPC title

• A61B5/1473

  invasive, e.g. introduced into the body by a catheter · CPC title