Method for optical measurements of tissue to determine disease state or concentration of an analyte
First Claim
1. A method for the determination of a disease state in a human subject, said method comprising the steps of:
- (a) measuring at least one optical property at a first area on a body part of said human subject to obtain a first set of data, said first area being subjected to a first temperature program;
(b) measuring at least one optical property at a second area on said body part to obtain a second set of data, said second area being subjected to a second temperature program, said second temperature program being different from the first temperature program, said second area of said body part being morphologically similar to, adjacent to, but not substantially overlapping with said first area of said body part;
(c) inserting said first set of data and said second set of data into a mathematical relationship to calculate a mathematical output; and
(d) using said mathematical output with a decision rule to determine said disease state of said human subject, wherein said disease state is selected from the group consisting of diabetic state, dermal disease state, neoplasmic disease state, and vascular disease state.
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Abstract
A method for collecting optical data at two morphologically similar, substantially non-overlapping, and preferably adjacent, areas on the surface of a tissue, while the temperature in each area is being maintained or modulated according to a temperature program. The optical data obtained are inserted into a mathematical relationship, e.g., an algorithm, that can be used to predict a disease state (such as the diabetes mellitus disease state) or the concentration of an analyte for indicating a physical condition (such as blood glucose level). This invention can be used to differentiate between disease status, such as, for example, diabetic and non-diabetic. The method involves the generation of a calibration (or training) set that utilizes the relationship between optical signals emanating from the skin under different thermal stimuli and disease status, e.g., diabetic status, established clinically. This calibration set can be used to predict the disease state of other subjects. Structural changes, as well as circulatory changes, due to a disease state are determined at two morphologically similar, but substantially non-overlapping areas on the surface of human tissue, e.g., the skin of a forearm, with each area being subjected to different temperature modulation programs. In addition to determination of a disease state, this invention can also be used to determine the concentration of an analyte in the tissues. This invention also provides an apparatus for the determination of a disease state, such as diabetes, or concentration of an analyte, such as blood glucose level, by the method of this invention.
251 Citations
7 Claims
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1. A method for the determination of a disease state in a human subject, said method comprising the steps of:
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(a) measuring at least one optical property at a first area on a body part of said human subject to obtain a first set of data, said first area being subjected to a first temperature program; (b) measuring at least one optical property at a second area on said body part to obtain a second set of data, said second area being subjected to a second temperature program, said second temperature program being different from the first temperature program, said second area of said body part being morphologically similar to, adjacent to, but not substantially overlapping with said first area of said body part; (c) inserting said first set of data and said second set of data into a mathematical relationship to calculate a mathematical output; and (d) using said mathematical output with a decision rule to determine said disease state of said human subject, wherein said disease state is selected from the group consisting of diabetic state, dermal disease state, neoplasmic disease state, and vascular disease state. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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Specification