Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

NCT01080157 | Completed

• 1 other identifier: VL-2712
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes; Diabetes Screening; Experimental Medical Device

Outcome Measures

Primary Outcomes (1)

• Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance.

  The relative true positive and relative true negative fractions between the SCOUT DS and FPG tests for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL)

  Outcome measure is determined 2-3 months after completion of Visit 3

Secondary Outcomes (1)

• Receiver operator characteristic area under the curve, sensitivity, specificity, and postive & negative predictive values of the SCOUT DS, FPG, and A1C tests for detection of abnormal glucose tolerance, and the intra- & inter-day SCOUT DS test

  Outcome measure is determined 2-3 months after completion of Visit 3

Study Arms (1)

Volunteers 18+, at risk for diabetes

Device: SCOUT DS measurement

Interventions

SCOUT DS measurement DEVICE

Non-invasive 3-5 volar forearm scan

Volunteers 18+, at risk for diabetes

Eligibility Criteria

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

Study Population

Volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 12 clinical sites. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Those in the 18-44 age group will have an additional risk factor, and the addition of the waist circumference and hypertension thresholds from the National Cholesterol Education Program Adult Treatment Panel III Guidelines for metablolic syndrome

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

Sponsors & Collaborators

• VeraLight, Inc.: lead

Study Sites (12)

Accelovance - Huntsville

Huntsville, Alabama, 35802, United States

Location

Accelovance - San Diego, CA

San Diego, California, 92108, United States

Location

Radiant Research, Inc. - Chicago

Chicago, Illinois, 60654, United States

Location

Accelovance - Peoria, IL

Peoria, Illinois, 61602, United States

Location

Radiant Research, Inc. - Kansas City

Kansas City, Kansas, 66202, United States

Location

Accelovance - Rockville, MD

Rockville, Maryland, United States

Location

Radiant Research, Inc. - Minneapolis

Minneapolis, Minnesota, 55345, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Radiant Research, Inc. - Cincinnati

Cincinnati, Ohio, 45249, United States

Location

Juno Research, LLC

Houston, Texas, 77036, United States

Location

Dynamed Clinical Research, LP

Houston, Texas, 77375, United States

Location

Radiant Research, Inc. - San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• John Maynard, MS

  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: March 1, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

US (12)