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

December 3, 2012 updated by: VeraLight, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92111
        • San Diego Convention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Martin L Kabongo, MD,PhD, Accelovance San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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