Screening for Early Evidence of Diabetes

NCT00614783 | Completed

• 1 other identifier: VL-2701
• Study Type: observational
• Target: 3,478
• Locations: 1 country
• Sites: 15

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 Glucose), using the Oral Glucose Tolerance Test as the reference standard. SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood sugar. Persons will be eligible for the study if they are 'at risk' for diabetes based on their age and other risk factors as defined by the American Diabetes Association.

Conditions

Diabetes Mellitus, Type 2

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

• Produced SCOUT DS measurement algorithm.

  Relative true positive and false positive fractions between Scout (Visit 2, nonfasting) and FPG (Visit 1, fasting) for detecting abnormal glucose tolerance, using the 2 hr OGTT ≥ 140 mg/dL as the threshold for a positive result.

  At completion of second visit which occurs within 1 to 14 days after the first visit.

Secondary Outcomes (2)

• Secondary endpoints include the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Scout (Visit 2, nonfasting), FPG, and A1c tests for detection of abnormal glucose tolerance.

  End of study

• Intra- and inter-day Scout test reproducibility.

  End of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population who are 'at risk' for pre-diabetes or diabetes.

You may qualify if:

• Age greater than or equal to 45 years
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VeraLight, Inc.: lead

Study Sites (15)

Accelovance

Huntsville, Alabama, 35802, United States

Location

Accelovance

San Diego, California, 92108, United States

Location

Veteran's Administration Hospital

San Diego, California, 92161, United States

Location

MedStar Research Institute

Washington D.C., District of Columbia, 20003, United States

Location

Kaiser Permanente-Center for Health Research

Honolulu, Hawaii, 96813, United States

Location

Radiant Research

Chicago, Illinois, 60610, United States

Location

Accelovance

Peoria, Illinois, 61602, United States

Location

Radiant Research

Overland Park, Kansas, 66202, United States

Location

Radiant Research

Edina, Minnesota, 55435, United States

Location

Lovelace Scientific Resources

Albuquerque, New Mexico, 87108, United States

Location

New York Hospital Queens-Lang Research Center

Flushing, New York, 11355, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Oklahoma Diabetes Center, University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Diabetes and Lipid Research, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Radiant Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John Maynard, MS

  Executive Vice President, VeraLight Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

US (15)