Point of Service Diabetes Screening Evaluation

Completed

• Conditions: Diabetes Mellitus, Non-Insulin Dependent

• Registration Number: NCT01669616
• Lead Sponsor: VeraLight, Inc.

Brief Summary

The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.

Detailed Description

The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.

Study Timeline

• Study First Submitted: 2012-07-23
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-13
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

Inclusion Criteria

• 18 years of age or older

Exclusion Criteria

• Known to be pregnant (self-reported)
• Receiving dialysis or known renal compromise
• Known to have photosensitivity
• Taking medications that fluoresce
• Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.	one week

Trial Locations

Locations (1)

Blue Cross Blue Shield of Louisiana; 🇺🇸 Baton Rouge, Louisiana, United States