Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
NCT ID: NCT01080157
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
509 participants
OBSERVATIONAL
2010-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Volunteers 18+, at risk for diabetes
SCOUT DS measurement
Non-invasive 3-5 volar forearm scan
Interventions
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SCOUT DS measurement
Non-invasive 3-5 volar forearm scan
Eligibility Criteria
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Inclusion Criteria
2. Age 18 to 44 years and a BMI \> 25 kg/m² with one or more of the following risk factors:
* Elevated waist circumference, \> 35 inches for women and \>40 inches for men
* Habitually physically inactive (does not exercise regularly)
* Has a first-degree relative with diabetes
* African American, Latino, Native American, Asian American, Pacific Islander
* Has delivered a baby weighing \> 9 lb or diagnosed with gestational diabetes
* Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
* HDL cholesterol level \< 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
* Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
* Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
* Conditions associated with insulin resistance such as acanthosis nigricans
* History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
Exclusion Criteria
* Receiving investigational treatments in the past 14 days
* Psychosocial issues that interfere with an ability to follow study procedures
* Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
* Diagnosed with any type of diabetes, including type 1 or 2
* Taking glucose lowering medications
* Known to be pregnant
* Receiving dialysis or having known renal compromise
* Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded Current chemotherapy, or chemotherapy within the past 12 months
* Receiving medications that fluoresce
* Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
* Prior bariatric surgery
18 Years
ALL
Yes
Sponsors
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VeraLight, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Maynard, MS
Role: STUDY_DIRECTOR
VeraLight, Inc.
Locations
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Accelovance - Huntsville
Huntsville, Alabama, United States
Accelovance - San Diego, CA
San Diego, California, United States
Radiant Research, Inc. - Chicago
Chicago, Illinois, United States
Accelovance - Peoria, IL
Peoria, Illinois, United States
Radiant Research, Inc. - Kansas City
Kansas City, Kansas, United States
Accelovance - Rockville, MD
Rockville, Maryland, United States
Radiant Research, Inc. - Minneapolis
Minneapolis, Minnesota, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Radiant Research, Inc. - Cincinnati
Cincinnati, Ohio, United States
Juno Research, LLC
Houston, Texas, United States
Dynamed Clinical Research, LP
Houston, Texas, United States
Radiant Research, Inc. - San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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VL-2712
Identifier Type: -
Identifier Source: org_study_id