Status:
COMPLETED
Screening for Early Evidence of Diabetes
Lead Sponsor:
VeraLight, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Gluco...
Detailed Description
Current methods for detecting pre-diabetes and diabetes are inconvenient and inaccurate. The most widely used screening test, Fasting Plasma Glucose (FPG), requires an overnight fast and a blood draw....
Eligibility Criteria
Inclusion
- Age greater than or equal to 45 years
- OR
- Age 18 to 44 years, with two or more of the following risk factors:
- Overweight (BMI ≥ 25 kg/m2)
- Elevated waist circumference, \>35 inches for women and \>40 inches for men
- Habitually physically inactive
- Has a first-degree relative with diabetes
- African American, Latino, Native American, Asian American, Pacific Islander
- Delivered a baby weighing \>9 lb or diagnosed with gestational diabetes
- Hypertension (\>130/\>85 mm Hg) or being treated for hypertension
- HDL cholesterol \<35 mg/dL and/or triglycerides \>250 mg/dL or being treated for dyslipidemia with medication
- Previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- Abnormal Glucose Tolerance on previous testing within the last 3 years
- Has a condition associated with insulin resistance (e.g., acanthosis nigricans)
- History of vascular disease (e.g., heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure, or peripheral arterial disease)
Exclusion
- Prior bariatric surgery
- Diagnosed with type 1 or 2 diabetes
- Taking glucose lowering medications
- Receiving dialysis or having known renal compromise
- Receiving investigational treatments
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm
- Recent or current oral steroid therapy or topical steroids applied to the left forearm
- Current chemotherapy, or chemotherapy within the past 12 months
- Conditions that cause secondary diabetes (e.g., Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis)
- Receiving other investigational treatments
- Receiving drugs that fluoresce (e.g., Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline, Hydroxychloroquine or Quinidine)
- Known to be pregnant
- Psychosocial issues that interfere with an ability to follow study procedures
- Known to have, or at risk for, photosensitivity reactions (e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
3478 Patients enrolled
Trial Details
Trial ID
NCT00614783
Start Date
May 1 2007
End Date
December 1 2010
Last Update
December 4 2012
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Accelovance
Huntsville, Alabama, United States, 35802
2
Accelovance
San Diego, California, United States, 92108
3
Veteran's Administration Hospital
San Diego, California, United States, 92161
4
MedStar Research Institute
Washington D.C., District of Columbia, United States, 20003