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Study Shows New Non-Invasive Device Screens Diabetes Better Than Fasting Plasma Glucose Test

Posted: Friday, June 30, 2006

Researchers reported a new non-invasive technology that uses fluorescent light to detect the presence of abnormal concentrations of diabetes-related biological markers found in skin was able to significantly outperform fasting plasma glucose (FPG) as a screening test for pre-diabetes and type 2 diabetes.

Diabetes Biomarkers Found in Skin Shown to Correlate Well With Diabetes Risk. At the lower, impaired fasting glucose threshold of 100 milligrams per deciliter (mg/dl), the FPG sensitivity was 57.5% with a specificity (a measure of true normals) of 78%. At that specificity, the Scout sensitivity was 68.9%, showing the ability to detect 20% more individuals with diabetes or its precursor.

Results from a clinical study showed a prototype medical device using the technology was able to identify 20% more patients with type 2 diabetes or its precursor.

Previous studies have shown that the presence of so-called "advanced glycation endproducts," or AGEs, found in skin correlate well with diabetes and are a predictor of the disease's serious complications. Analogous to a "diabetes odometer," AGEs are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar. They affect the proteins that make up blood vessels, connective tissue and skin, and are thought to be major factors in aging and age-related chronic diseases.

According to medical experts, non-invasive skin detection of AGEs could replace the fasting plasma glucose test as the medical workhorse for screening people suspected of having diabetes.

"AGEs have been well-recognized as a diabetes biomarker and as a predictor of complications that may lead to blindness and kidney disease," said Robert E. Ratner, MD, vice president of scientific affairs at Medstar Research Institute. "Until the advent of VeraLight's technology and the Scout system, a skin biopsy was the only way to detect AGEs which made them impractical for clinical use. With a simple, non-invasive technology, skin AGEs will be a valuable tool for identifying people with sub-clinical disease. Lack of a fasting requirement, overall convenience and superior accuracy may make this the technology of choice for diabetes and pre-diabetes screening."

The study was undertaken in 328 subjects at risk for diabetes or pre-diabetes to evaluate VeraLight's non-invasive Scout technology against the FPG test, which measures a patient's blood sugar after a 12-hour fast. The oral glucose tolerance test, which measures blood glucose two hours after oral administration of a 75-gram glucose load, was used as a confirmatory test. The subjects in the study ranged in age from 21 to 88 years old.

The results were analyzed to compare each test's "receiver-operator characteristics" -- a statistical measure that graphically illustrates a test's false-positive relationship to sensitivity (a measure of true positives). At the lower, impaired fasting glucose threshold of 100 milligrams per deciliter (mg/dl), the FPG sensitivity was 57.5% with a specificity (a measure of true normals) of 78%. At that specificity, the Scout sensitivity was 68.9%, showing the ability to detect 20% more individuals with diabetes or its precursor.

Weighting about 10 pounds, the VeraLight Scout utilizes proprietary fluorescence spectroscopic technology that does not require patient fasting. The subject inserts the palm-side of the forearm into the system, which resembles a drug-store blood-pressure monitor. In about a minute the Scout shines various wavelengths of light on the skin to stimulate fluorescence that is measured by the machine to provide an indication of diabetes risk based on the presence of AGEs. The instrument optically calibrates for skin pigmentation so that performance is not diminished by skin coloration. A specially designed fiber-optic probe couples the excitation light to the subject and relays resulting skin fluorescence to a detection module. The system's software utilizes multivariate statistical techniques that are applied to the spectra to obtain a diabetes risk score.

Due to their inaccuracy and inconvenience, current screening methods for diabetes are grossly inadequate. The result is that 50% of diabetics are not identified until they present 5-to-9 years into the disease with one or more (often irreversible) complications. A more accurate and convenient screening method could dramatically reduce the costs and morbidity associated with such complications, allowing patients to halt or reverse disease progression.

Source: Diabetes In Control: Presented at the 66th annual Scientific Sessions of the American Diabetes Association