Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-27 @ 8:15 PM
Study NCT ID:
NCT01080157
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2010-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
Sponsor:
VeraLight, Inc.
Organization:
Study Overview
Official Title:
An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENGINE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: