- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346033
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
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California
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San Diego, California, United States, 92111
- San Diego Convention Center
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-
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:
- Age greater than or equal to 18 years
- 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 |
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VL-2714
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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