Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
Completed
Conditions studied: Diabetes
In brief
The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.
Key facts
- Study ID
- NCT01080157
- Run by
- VeraLight, Inc.
- People needed
- 509
- Starts
- 2010-03-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2012-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age greater than or equal to 45 years; OR
- 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
You may not qualify if…
- Prior participation in VL-2701
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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