Method, system and computer program product for real-time detection of sensitivity decline in analyte sensors

• US 9,882,660 B2
• Filed: 04/30/2014
• Issued: 01/30/2018
• Est. Priority Date: 10/26/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated), University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated), University of Virginia Patent Foundation (University of Virginia)
• Inventors: Breton, Marc D., Kovatchev, Boris P., Budiman, Erwin Satrya, Doniger, Kenneth J.
• Primary Examiner(s): Lau, Tung
• Application Number:
  US14/266,612
• Publication Number:
  US 20140244216A1
• Time in Patent Office: 1,371 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04B 17/00 Monitoring; Testing of line transmission systems H04B3/46; arrangements for monitoring or testing transmission systems employing electromagnetic waves other than radio waves H04B10/07

Abstract

Method, system and computer program product for providing real time detection of analyte sensor sensitivity decline is continuous glucose monitoring systems are provided.

Claims

1. A system for detecting signal attenuation comprising:

an analyte sensor for positioning under a skin surface in fluid contact with bodily fluid; and

a data processing device comprising a memory, wherein the data processing device is operatively coupled to the analyte sensor, the data processing device configured to receive a first plurality of analyte sensor related signals from the analyte sensor within a first predetermined time period determined within the first 24 hours of analyte sensor positioning under the skin surface,

wherein a computer program is stored on the memory such that, when executed, the computer program causes the data processing device;

to determine a probability of signal attenuation associated with the analyte sensor based at least in part on the first plurality of analyte sensor related signals,

to determine a sensitivity of the analyte sensor based on a second plurality of analyte sensor related signals from the analyte sensor and a reference analyte measurement, the reference analyte measurement comprising a finger stick measurement of a blood analyte level,

to determine a sensitivity ratio based on the determined sensitivity of the analyte sensor divided by a nominal sensitivity determined prior to analyte sensor positioning, the nominal sensitivity comprising a sensitivity value of the analyte sensor at the time of manufacture, and

to verify a presence of signal attenuation associated with a decline in analyte sensor sensitivity when the determined sensitivity ratio is less than a first predetermined signal attenuation threshold level.

2. The system of claim 1, wherein the computer program, when executed, causes the data processing device to determine one or more characteristics associated with the first plurality of analyte sensor related signals, and to apply a predetermined coefficient to the first plurality of analyte sensor related signals.

3. The system of claim 1, wherein the computer program, when executed, causes the data processing device to generate a second output signal associated with absence of signal attenuation when the determined probability of signal attenuation does not exceed the first predetermined signal attenuation threshold level.

4. The system of claim 1, wherein the computer program, when executed, causes the data processing device to select a signal attenuation threshold level and confirm the presence of signal attenuation based at least in part on a comparison of the determined sensitivity ratio and the selected signal attenuation threshold level.

5. The system of claim 1, wherein the computer program, when executed, causes the data processing device to determine the sensitivity of the analyte sensor as a ratio of the average of the second plurality of analyte sensor related signals and the reference analyte measurement.

6. The system of claim 1, including a user output unit operatively coupled to the data processing device to display an output signal associated with the presence of signal attenuation.

7. The system of claim 1, wherein the second plurality of analyte sensor related signals from the analyte sensor are approximately contemporaneous with the reference analyte measurement.

8. The system of claim 2, wherein the determined one or more characteristics includes one or more of a mean value associated with the first plurality of analyte sensor related signals, a least square slope associated with the first plurality of analyte sensor related signals, a standard deviation associated with the first plurality of analyte sensor related signals, an average elapsed time from positioning the analyte sensor, or a variance about a least squares slope associated with the first plurality of analyte sensor related signals.

9. The system of claim 4, wherein the selected signal attenuation threshold level is associated with the reference analyte measurement.

10. The system of claim 4, wherein the computer program, when executed, causes the data processing device to determine that the sensitivity ratio of the analyte sensor is less than the selected signal attenuation threshold level.