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Evaluation of SCOUT DS in Subjects With Type 2 Diabetes (TCOYD)

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ClinicalTrials.gov Identifier: NCT01346033
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
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.

Condition or disease
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 Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes
Study Start Date : October 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Those with Type 2 diabetes
All subjects have been diagnosed with type 2 diabetes.

Primary Outcome Measures :
  1. Validation of SCOUT DS algorithm for detecting known type 2 diabetes [ Time Frame: 1 day ]
    Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346033

United States, California
San Diego Convention Center
San Diego, California, United States, 92111
Sponsors and Collaborators
VeraLight, Inc.
Principal Investigator: Martin L Kabongo, MD,PhD Accelovance San Diego

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01346033     History of Changes
Other Study ID Numbers: VL-2714
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012

Keywords provided by VeraLight, Inc.:
Type 2 Diabetes
Adults 18 years and older
Taking Control of Your Diabetes Health Fair

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases