Method of Calibrating an Analyte-Measurement Device, and Associated Methods, Devices and Systems

• US 20120197576A1
• Filed: 04/04/2012
• Published: 08/02/2012
• Est. Priority Date: 10/31/2003
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin J., McGarraugh, Geoffrey V.
• Application Number:
  US13/439,793
• Publication Number:
  US 20120197576A1
• Time in Patent Office: Days
• US Class Current: 702/104
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.

Claims

1. (canceled)

2. A method for processing data from an analyte sensor, the method comprising:

receiving, with an electronic system, sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;

receiving, with the electronic system, reference data, wherein the reference data comprises at least one reference data point;

matching, with the electronic system, a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;

forming, with the electronic system, a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity;

adjusting, with the electronic system, the conversion function using a second baseline determined at least in part by prior information; and

determining, with the electronic system, an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point.

3. The method of claim 2, wherein adjusting the conversion function comprises modifying the first analyte sensitivity.

4. The method of claim 2, further comprising:

adjusting, with the electronic system, the adjusted conversion function using a third baseline determined at least in part by prior information; and

determining, with the electronic system, an analyte output value in substantially real-time by applying the twice-adjusted conversion function to a sensor data point.

5. The method of claim 4, wherein adjusting the adjusted conversion function comprises modifying a second analyte sensitivity.

6. The method of claim 2, wherein the first non-zero baseline is predetermined.

7. The method of claim 2, further comprising:

determining, with the electronic system, whether at least one attribute of the conversion function is outside at least one predetermined range, wherein the at least one attribute of the conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof; and

determining, with the electronic system, whether at least one attribute of the adjusted conversion function is outside the at least one predetermined range, wherein the at least one attribute of the adjusted conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof;

wherein adjusting the conversion function is performed in response to a determination that the at least one attribute of the conversion function is outside the at least one predetermined range; and

wherein determining an analyte output value is performed in response to a determination that the at least one attribute of the adjusted conversion function is within the at least one predetermined range.

8. The method of claim 7, wherein the at least one predetermined range is based on at least one of a baseline, an analyte sensitivity, or combinations thereof.

9. The method of claim 7, wherein the at least one predetermined range is associated with a clinical acceptability, wherein the clinical acceptability is determined by an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a consensus grid, and combinations thereof.

10. The method of claim 2, wherein receiving sensor data comprises receiving sensor data from a continuous analyte sensor.

11. The method of claim 2, wherein the analyte sensor is a continuous glucose sensor.

12. The method of claim 2, wherein prior information is obtained from in vivo tests or in vitro tests.

13. A system for processing data from an analyte sensor, the system comprising:

a first receiver module configured to receive sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;

a second receiver module configured to receive reference data, wherein the reference data comprises at least one reference data point; and

a processor module configured to;

match a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;

form a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity;

adjust the conversion function using a second baseline determined at least in part by prior information; and

determine an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point.

14. The system of claim 13, wherein the processor module is further configured to adjust the conversion function by modifying the first analyte sensitivity.

15. The system of claim 13, wherein the processor module is further configured to:

adjust the adjusted conversion function by using a third baseline determined at least in part by prior information; and

determine an analyte output value in substantially real-time by applying the twice-adjusted conversion function to a sensor data point.

16. The system of claim 15, wherein the processor module is further configured to adjust the adjusted conversion function by modifying a second analyte sensitivity.

17. The system of claim 13, wherein the first non-zero baseline is predetermined.

18. The system of claim 13, wherein the processor module is further configured to:

determine whether at least one attribute of the conversion function is outside at least one predetermined range, wherein the at least one attribute of the conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof; and

determine whether at least one attribute of the adjusted conversion function is outside the at least one predetermined range, wherein the at least one attribute of the adjusted conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof;

wherein adjustment of the conversion function is performed in response to a determination that the at least one attribute of the conversion function is outside the at least one predetermined range; and

wherein determination of an analyte output value is performed in response to a determination that the at least one attribute of the adjusted conversion function is within the at least one predetermined range.

19. The system of claim 18, wherein the at least one predetermined range is based on at least one of a baseline, an analyte sensitivity, or combinations thereof.

20. The system of claim 13, wherein the analyte sensor is a continuous glucose sensor.

21. A system for processing data from an analyte sensor, the system comprising:

means for receiving sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;

means for receiving reference data, wherein the reference data comprises at least one reference data point;

means for matching a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;

means for forming a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity;

means for adjusting the conversion function using a second baseline determined at least in part by prior information; and

means for determining an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point.