Medical Device Dailyer
VeraLight (Albuquerque, New Mexico) is bypassing the traditional methods of screening for diabetes with its new Scout DS, a device which uses light to detect diabetes-related biomarkers found in the skin — all in one minute.
The device, which weighs about 10 pounds and doesn’t require the patient to give blood, was unveiled during the 67th annual meeting of the American Diabetes Association (Alexandria, Virginia) that closes tomorrow at Chicago’s McCormick Place.
“We have prototypes that we’ll show to doctors and get their input and feedback,” John Maynard, VP of product development for VeraLight, told Medical Device Daily. Scout “opens up the possibility of people being tested for diabetes,” who might otherwise fear a blood draw, Maynard said.
Previously reported studies of a prototype of the portable desktop system have shown it to perform faster than the fasting plasma glucose test (FPC) and the A1C test as a rapid and non-invasive screen for pre-diabetes and Type 2 diabetes.
VeraLight is touting the device to perform testing in one minute.
The investigational device, which has not yet been approved for use in the U.S., is being designed for physician-supervised point-of-care locations. It is currently undergoing a large-scale pivotal trial.
“The goal is by the end of November and beginning of December, have [Scout] ready for FDA approval,” Maynard told MDD.
Scout is able to detect abnormal concentrations of advanced glycation end products (AGEs), which correlate well with diabetes and pre-diabetes and are associated with the disease’s serious complications. The device is slated for U.S. market introduction in the second half of 2008.
A calibration trial of 1,700 subjects at risk or Type 2 diabetes has completed data collection at eight sites. This phase of the trial is designed to assess its ability to predict abnormal glucose tolerance in a wide range of individuals. In August 2007, the system will be undergoing further testing at 20 U.S. sites in 5,400 subjects at risk for Type 2 diabetes.
In all cases, Scout DS is being compared to the gold standard Oral Glucose Tolerance Test (OGTT) as the reference method.
“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 Lyons, MD, a clinical investigator for VeraLight who heads the Endocrinology section at the Oklahoma University Health Science Center (Oklahoma City).
“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.”
A study published in the May 2007 issue of Diabetes Care of the Scout DS prototype involving 351 subjects showed it significantly outperformed both FPG and A1C by detecting 29% more patients with Type 2 diabetes and impaired glucose tolerance (IGT) than FPG and 17% more cases than A1C.
Further evaluation of a sub-cohort of the clinical data showed the Scout DS prototype was able to identify 78% more individuals with IGT than the FPG test and 47% more than the A1C test. Although this was a limited early clinical trial of a prototype in a small number of patients, VeraLight is saying it can match this result in its large-scale trials with the commercially designed device.
After 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 utilizes 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.
Analogous to a “diabetes odometer,” 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, 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 as the medical workhorse for screening people suspected of having diabetes.
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 nearly nine 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.