NCT01080157

Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 509 (actual)
• Sponsor: VeraLight, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.

Detailed description

The trial will be a prospective, multi-center, paired data, cohort screening trial. Up to 960 subjects will complete the study to determine the relative accuracy of SCOUT DS compared to the FPG and HbA1c tests in screening for abnormal glucose tolerance. All methods will be compared to the 2 hour value of the OGTT. An algorithm utilizes skin optical modeling as well as the spectral and blood assay data accumulated from the initial phase of the study to produce a risk score for abnormal glucose tolerance. This algorithm and the calculation of the score will be integrated into the SCOUT DS for prospective testing. The design requires three patient visits to the clinical site and up to a total of seven measurements on the SCOUT device.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	SCOUT DS measurement	Non-invasive 3-5 volar forearm scan

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-03-03
• Last updated: 2012-12-04

Locations

12 sites across 1 country: United States