Method for building an algorithm for converting spectral information

• US 8,452,359 B2
• Filed: 10/10/2007
• Issued: 05/28/2013
• Est. Priority Date: 02/11/2002
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Rebec, Mihailo V., Smous, James E., Brown, Steven D., Tan, Hu-Wei
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US11/973,790
• Publication Number:
  US 20080045820A1
• Time in Patent Office: 2,057 Days
• Field of Search: 600/310, 600/316, 600/322, 600/331, 600/341, 600/343, 600/473
• US Class Current: 600/316
• 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: A61B 5/726 using Wavelet transforms
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 2201/067 Electro-optic, magneto-optic, acousto-optic elements

Abstract

A system for determining the concentration of an analyte in at least one body fluid in body tissue comprises an infrared light source, a body tissue interface, a detector, and a central processing unit. The body tissue interface is adapted to contact body tissue and to deliver light from the infrared light source to the contacted body tissue. The detector is adapted to receive spectral information corresponding to infrared light transmitted through the portion of body tissue being analyzed and to convert the received spectral information into an electrical signal indicative of the received spectral information. The central processing unit is adapted to compare the electrical signal to an algorithm built upon correlation with the analyte in body fluid, the algorithm adapted to convert the received spectral information into the concentration of the analyte in at least one body fluid.

Claims

1. A method for building an algorithm for converting spectral information obtained from body tissue into the concentration of an analyte in at least one body fluid in the body tissue, the method comprising the acts of:

modulating the concentration of the analyte in at least one body fluid in the body tissue to a plurality of predetermined levels within a range of predetermined analyte concentration levels;

directing infrared light onto the body tissue of at least one test subject being analyzed during an analyte clamping test;

collecting spectral information from the body tissue;

collecting data other than spectral information from the body tissue of the at least one test subject during the modulating of the concentration of the analyte in at least one body fluid in the body tissue;

modeling spectral information corresponding to analyte concentration levels outside the range of analyte concentration levels; and

filtering the collected and modeled spectral information to remove non-analyte spectral information using one or more chemometric techniques selected from the group consisting of wavelets analysis, orthogonal signal correction, partial least squares regression, principal components analysis, and genetic algorithms.

2. The method of claim 1 further comprising recording invasively determined analyte concentration levels of the body tissue of the at least one test subject in a invasively determined analyte data set.

3. The method of claim 2 further comprising recording the collected spectral information and the modeled spectral information in a spectral data set.

4. The method of claim 3 further comprising normalizing the data of the spectral data set.

5. The method of claim 4 further comprising applying an orthogonal signal correction analysis to the normalized data set to create a corrected spectral data set.

6. The method of claim 5 further comprising filtering the corrected spectral data set by applying a wavelet analysis to form a filtered spectral data set.

7. The method of claim 6 further comprising applying a partial least squares regression analysis to the filtered spectral data set and the invasively determined analyte data set to build an analyte calibration algorithm.

8. The method of claim 1 wherein modulating further comprises conducting an analyte clamping experiment.

9. The method of claim 1 wherein the data are selected from the group consisting of invasively determined analyte concentration levels of the body tissue, temperature of the body tissue, pressure applied to the body tissue, frequency of the infrared light directed onto the body tissue, and time of data collection.

10. The method of claim 1 wherein the analyte is glucose.