Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01346033
• Lead Sponsor: VeraLight, Inc.

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Age greater than or equal to 18 years
2. Self-reported diagnosis of type 2 diabetes

Exclusion Criteria

• Not diagnosed with type 2 diabetes

  • Diagnosed with type 1 diabetes
  • Known to be pregnant (Self Reported)
  • Receiving dialysis or having known renal compromise
  • Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of SCOUT DS algorithm for detecting known type 2 diabetes	1 day	Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

Trial Locations

Locations (1)

San Diego Convention Center; 🇺🇸 San Diego, California, United States