Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— TCOYD  

Official title:

An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346033
• Other study ID #: VL-2714
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: December 3, 2012
• Start date: October 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	San Diego Convention Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of SCOUT DS algorithm for detecting known type 2 diabetes	Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes	1 day	No