Non-invasive diabetes detector unveiled

2 July 2007

Chicago, USA. VeraLight Inc. has introduced an experimental device that uses light-induced fluorescence to detect diabetes-related biomarkers found in skin.

Called the Scout DS, the device weighs about 10 pounds and does not require the patient to fast or provide a blood sample. Using light directed onto a small area of an individual's forearm the device is able to detect abnormal concentrations of advanced glycation endproducts (AGEs), which correlate well with diabetes and pre-diabetes and are associated with the disease's serious complications.

The SCOUT DS diabetes screening systemAfter the subject places the palm-side of the forearm onto the cradle of the Scout DS, the device shines multiple wavelengths of light into the skin causing AGEs to emit fluorescent light that is measured by the machine. The instrument compensates for skin pigmentation so that performance is not diminished by skin coloration. The system's software uses multivariate statistical techniques that are applied to the spectra to obtain a diabetes risk score. As with all diabetes screening methods, an additional test is required to confirm diagnosis — the recommended confirmation for Scout DS is an OGTT.

The company reports that previous studies of a prototype of the portable desktop system have shown that it outperforms both the fasting plasma glucose (FPG) test and the A1C test as a rapid and non-invasive screen for pre-diabetes and type 2 diabetes.

The device, which is not yet approved for use in the United States, is being designed for use at the point of care under physician supervision. The company aims to introduce it to the US market in the second half of 2008. It is currently undergoing a large-scale trial in the United States.

"Considering its excellent speed, convenience and sensitivity, the Scout DS may be ideally suited to detect the more than 70 million individuals worldwide who have undiagnosed type 2 diabetes," said Timothy J. Lyons, M.D., a clinical investigator for VeraLight who heads the endocrinology section at the Oklahoma University Health Science Center. "VeraLight's diabetes screening technology represents a critical response to the worldwide diabetes epidemic, making screening more accurate and accessible to everyone at risk for this devastating disease."

Usefulness of AGEs for detecting diabetes

AGEs are a sensitive metric for the cumulative damage the body endures due to the effects of abnormally high blood sugar and oxidative stress. AGEs harm the proteins that make up the blood vessels and connective tissue, 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 FPG test for screening people suspected of having diabetes.

Problems of conventional screening tests

Conventional diabetes screening methods such as the FPG and the OGTT are inconvenient and often perform poorly. Diagnosis of diabetes typically doesn't occur until 7-9 years post onset when 50% of patients have one or more irreversible complications.

The FPG requires a fasting blood sample; and the OGTT test requires fasting, ingestion of a glucose load, and multiple blood samples.

Due to poor sensitivity the FPG misses up to 60% of the people, and the OGTT suffers from poor reproducibility with a Coefficient of Variation of up to 18%. These deficiencies can lead to false-negative or inconsistent results and add to the undiagnosed problem.

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