Individual calibration of blood glucose for supporting noninvasive self-monitoring blood glucose

• US 6,309,884 B1
• Filed: 12/07/1999
• Issued: 10/30/2001
• Est. Priority Date: 02/26/1997
• Status: Expired due to Fees

• Current Assignee: Dominion Assets LLC
• Original Assignee: Diasense Inc.
• Inventors: Barker, Todd Q., Cooper, Patrick J.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/367,625
• Time in Patent Office: 693 Days
• Field of Search: 436/8, 436/14, 436/164, 436/171, 435/14, 600/365, 600/310, 600/316, 600/322, 702/19, 702/22, 702/23, 702/27, 702/28, 356/39
• US Class Current: 436/14
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

A method is provided for calibrating a noninvasive glucose monitor for prospective noninvasive glucose determination. Spectroscopic transflectance readings are measured on the patient'"'"'s skin using a noninvasive glucose monitor. The patient'"'"'s blood glucose level is measured with an invasive glucose monitor. The noninvasive and invasive measurements are correlated to form an individual algorithm for each patient. Preferably, the position of the patient'"'"'s skin with respect to the probe of the noninvasive monitor is spatially adjusted while collecting the transflectance measurements such that multiple readings are taken on the patient'"'"'s skin. The measurements are preferably taken over a period of time and over a plurality of glucose levels in the patient.

Claims

1. A method of calibrating a noninvasive glucose monitor for prospective noninvasive glucose determination, comprising the steps of:

measuring spectroscopic transflectance readings of a patient'"'"'s skin using a noninvasive glucose monitor;

measuring the patient'"'"'s blood glucose level with an invasive glucose monitor;

correlating the noninvasive and invasive measurements to form an individual algorithm for the patient; and

spatially adjusting a position of the patient'"'"'s skin with respect to a probe of the noninvasive glucose monitor while collecting transflectance measurements such that multiple readings are taken over a relatively large area of the patient'"'"'s skin.

2. The method as claimed in claim 1, including taking noninvasive and invasive measurements over at least a two-epoch period.

3. The method as claimed in claim 2, including using the noninvasive and invasive measurements from the first epoch to calibrate the noninvasive monitor.

4. The method as claimed in claim 2, including using the measurements from the second epoch to determine the patient'"'"'s glucose level.

5. The method as claimed in claim 2, wherein the number of transflectance readings is determined by the formula N≧

Zσ

/L, where N is the number of readings during calibration, Z is approximated by the standard normal statistic, σ

represents the patient'"'"'s skin variation and L relates to a desired clinical accuracy of the patient'"'"'s skin variation.

6. The method as claimed in claim 2, including adjusting the number of transflectance measurements over time after determining a between-epoch variation between transflectance measurements.

7. The method as claimed in claim 6, including determining the between-epoch variation between transflectance measurements by calculating the mean and standard deviation of spectra over about two to seven days.

8. The method as claimed in claim 2, wherein the first epoch lasts for a period of about 2-60 days.

9. The method as claimed in claim 1, including taking noninvasive and invasive measurements over a plurality of glucose levels in the patient.

10. The method as claimed in claim 1, including converting the spectroscopic transflectance readings to glucose levels using the individual algorithm.

11. The method as claimed in claim 1, including replicating the transflectance measurements until there is no improvement in sampling variance.

12. The method as claimed in claim 1, including spatially adjusting the position of the patient'"'"'s skin or the probe by a plurality of dithering movements.

13. The method as claimed in claim 1, including taking multiple transflectance measurements in a pattern on the patient'"'"'s skin.

14. The method as claimed in claim 1, wherein the transflectance readings of the patient'"'"'s skin are taken by illuminating an area of the patient'"'"'s skin and taking multiple transflectance readings over this area.

15. A method of calibrating a noninvasive glucose monitor for prospective noninvasive glucose determination, comprising the steps of:

measuring spectroscopic transflectance readings of a patient'"'"'s skin using a noninvasive glucose monitor;

measuring the patient'"'"'s blood glucose level with an invasive glucose monitor;

correlating the noninvasive and invasive measurements to form an individual algorithm for the patient;

spatially adjusting a position of the patient'"'"'s skin with respect to a probe of the noninvasive glucose monitor while collecting transflectance measurements such that multiple readings are taken over a relatively large area of the patient'"'"'s skin;

taking noninvasive and invasive measurements over at least a two-epoch period;

taking noninvasive and invasive measurements over a plurality of glucose levels in the patient; and

converting the spectroscopic transflectance readings to glucose levels using the individual algorithm.

16. The method as claimed in claim 15, including spatially adjusting the position of the patient'"'"'s skin or the probe by a plurality of dithering movements.

17. The method as claimed in claim 15, including taking multiple transflectance measurements in a pattern on the patient'"'"'s skin.

18. The method as claimed in claim 15, including using the noninvasive and invasive measurements from the first epoch to calibrate the noninvasive monitor.

19. The method as claimed in claim 15, including using the measurements from the second epoch to determine the patient'"'"'s glucose level.

20. A method of calibrating a noninvasive glucose monitor for prospective noninvasive glucose determination, comprising the steps of:

measuring spectroscopic transflectance readings of a patient'"'"'s skin using a noninvasive glucose monitor;

measuring the patient'"'"'s blood glucose level with an invasive glucose monitor;

correlating the noninvasive and invasive measurements to form an individual algorithm for the patient;

spatially adjusting a position of the patient'"'"'s skin with respect to a probe of the noninvasive glucose monitor while collecting transflectance measurements such that multiple readings are taken over relatively large area of the patient'"'"'s skin;

taking noninvasive and invasive measurements over at least a two-epoch period;

taking noninvasive and invasive measurements over a plurality of glucose levels in the patient;

converting the spectroscopic transflectance readings to glucose levels using the individual algorithm;

spatially adjusting the position of the patient'"'"'s skin or the probe by a plurality of dithering movements;

taking multiple transflectance measurements in a pattern on the patient'"'"'s skin;

using the noninvasive and invasive measurements from the first epoch to calibrate the noninvasive monitor; and

using the measurements from the second epoch to determine the patient'"'"'s glucose level.