NCT01572415

Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 409 (actual)
• Sponsor: VeraLight, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.

Detailed description

The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%). The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2012-04-06
• Last updated: 2012-12-05

Locations

1 site across 1 country: Greece