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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01346033
First received: April 28, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Validation of SCOUT DS algorithm for detecting known type 2 diabetes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes


Enrollment: 270
Study Start Date: October 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Those with Type 2 diabetes
All subjects 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346033

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

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01346033     History of Changes
Other Study ID Numbers: VL-2714
Study First Received: April 28, 2011
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014