Method and System for Evaluating Analyte Sensor Response Characteristics

• US 20140136145A1
• Filed: 01/17/2014
• Published: 05/15/2014
• Est. Priority Date: 06/23/2010
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Budiman, Erwin Satrya
• Application Number:
  US14/158,662
• Publication Number:
  US 20140136145A1
• Time in Patent Office: Days
• US Class Current: 702/179
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G06F 17/18 for evaluating statistical data , e.g. average values, frequency distributions, probability functions, regression analysis forecasting specially adapted for a specific administrative, business or logistic context G06Q10/04

Abstract

Apparatus, method, system and kit for receiving a plurality of continuous analyte sensor values for corresponding reference analyte values, calculating a rate of change value for the continuous analyte sensor values, defining a plurality of data range windows of the reference analyte values, evaluating the corresponding continuous analyte sensor values, the rate of change values, the reference analyte values, and/or a plurality of corresponding difference values for the plurality of data range windows, and determining a best fit based on the evaluation of the plurality of data range windows are provided.

Claims

1. A method, comprising:

evaluating, using one or more processors, a plurality of data range windows corresponding to a plurality of reference analyte values by evaluating one or more of a plurality of analyte sensor values from an analyte sensor, a rate of change value for each of the plurality of the analyte sensor values, the plurality of reference analyte values, or a plurality of corresponding difference values;

determining, using the one or more processors, a least-squares line based on a graphical representation of the rate of change value for each of the plurality of the analyte sensor values and the corresponding difference values for each of the plurality of data range windows; and

determining, using the one or more processors, a linearity characteristic of the analyte sensor based on a graphical representation of one or more of intercepts of the least-squares lines of each of the plurality of data range windows and the reference analyte values at centers of the plurality of data range windows.

2. The method of claim 1, wherein each of the plurality of corresponding difference values includes a difference between an analyte sensor value and a corresponding reference analyte value.

3. The method of claim 1, wherein determining the linearity characteristic includes evaluating a weighted graphical representation of the intercepts of the least-squares lines of each of the plurality of data range windows and the reference analyte values at the centers of the plurality of data range windows.

4. The method of claim 3, wherein the weighted graphical representation includes scaling by a number of points in each of the plurality of data range windows, scaling by an inverse of a square of a standard error of a slope in each of the plurality of data range windows, or scaling by the inverse of the square of a standard deviation of a slope in each of the plurality of data range windows.

5. The method of claim 1, wherein the analyte sensor values are obtained using the analyte sensor that comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

6. A method, comprising:

evaluating, using one or more processors, a plurality of data range windows by evaluating one or more of a plurality of analyte sensor values, a rate of change value for each of the plurality of the analyte sensor values, a plurality of reference analyte values, or a plurality of corresponding difference values;

determining, using the one or more processors, a least-squares line based on a graphical representation of the rate of change value for each of the plurality of the analyte sensor values and the corresponding difference values for each of the plurality of data range windows; and

determining, using the one or more processors, a lag characteristic of an analyte sensor based on a graphical representation of slopes of the least-squares lines of each of the plurality of data range windows and the reference analyte values at centers of the plurality of data range windows.

7. The method of claim 6, wherein determining the lag characteristic of the analyte sensor is based on a weighted graphical representation of the slopes of the least-squares lines of each of the plurality of data range windows and the reference analyte values at the centers of the plurality of data range windows.

8. The method of claim 7, wherein the weighted graphical representation includes scaling by a number of points in each of the plurality of data range windows, scaling by an inverse of a square of a standard error of a slope in each of the plurality of data range windows, or scaling by the inverse of the square of a standard deviation of a slope in each of the plurality of data range windows.

9. The method of claim 7, wherein a corrected slope is determined based on weighted slopes of the least-squares lines of each of the plurality of data range windows.

10. The method of claim 6, wherein the analyte sensor values are obtained using the analyte sensor that comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

11. A method, comprising:

evaluating, using one or more processors, a plurality of data range windows by evaluating one or more plurality of analyte sensor values, a rate of change value for each of the plurality of the analyte sensor values, a plurality of reference analyte values, or a plurality of corresponding difference values;

determining, using the one or more processors, a least-squares line based on a graphical representation of the rate of change value for each of the plurality of the analyte sensor values and the corresponding difference values for each of the plurality of data range windows;

determining, using the one or more processors, a slope and an intercept of the least-squares line for each of the plurality of data range windows; and

determining, using the one or more processors, a corrected slope for each of the slopes of the least-squares lines of each of the plurality of data range windows and determining a lag characteristic of an analyte sensor based on a graphical representation of the corrected slopes of the least-squares lines of each of the plurality of data range windows and the reference analyte values at centers of the plurality of data range windows.

12. The method of claim 11, wherein the analyte sensor values are obtained using the analyte sensor that comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.