NCT00614783

Screening for Early Evidence of Diabetes

A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,478 (actual)
• Sponsor: VeraLight, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard. SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood sugar. Persons will be eligible for the study if they are 'at risk' for diabetes based on their age and other risk factors as defined by the American Diabetes Association.

Detailed description

Current methods for detecting pre-diabetes and diabetes are inconvenient and inaccurate. The most widely used screening test, Fasting Plasma Glucose (FPG), requires an overnight fast and a blood draw. FPG also has poor sensitivity contributing to late diagnoses. A more accurate and convenient screening method, like SCOUT, will improve early detection and allow the physician to begin a treatment regimen to prevent or delay the development of the disease and its serious complications.

Conditions

• Diabetes Mellitus, Type 2

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-02-13
• Last updated: 2012-12-04

Locations

15 sites across 1 country: United States