Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT01346033
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2011-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes
Sponsor:
VeraLight, Inc.
Organization:
Study Overview
Official Title:
An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 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:
TCOYD
Brief Summary:
The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.
Detailed Description:
Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.
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?: