Screening for Early Evidence of Diabetes (SEED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT00614783
First received: January 30, 2008
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Produced SCOUT DS measurement algorithm. [ Time Frame: At completion of second visit which occurs within 1 to 14 days after the first visit. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Intra- and inter-day Scout test reproducibility. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 3478
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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. FPG also has poor sensitivity contributing to late diagnoses. A more accurate and convenient screening method, like SCOUT, will improve early detection and allow the physician to begin a treatment regimen to prevent or delay the development of the disease and its serious complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614783

Locations
United States, Alabama
Accelovance
Huntsville, Alabama, United States, 35802
United States, California
Veteran's Administration Hospital
San Diego, California, United States, 92161
Accelovance
San Diego, California, United States, 92108
United States, District of Columbia
MedStar Research Institute
Washington, DC, District of Columbia, United States, 20003
United States, Hawaii
Kaiser Permanente-Center for Health Research
Honolulu, Hawaii, United States, 96813
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
Accelovance
Peoria, Illinois, United States, 61602
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66202
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
New York Hospital Queens-Lang Research Center
Flushing, New York, United States, 11355
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
United States, Oklahoma
Oklahoma Diabetes Center, University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Diabetes and Lipid Research, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Radiant Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
VeraLight, Inc.
Investigators
Study Director: John Maynard, MS Executive Vice President, VeraLight Inc.
  More Information

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT00614783     History of Changes
Other Study ID Numbers: VL-2701
Study First Received: January 30, 2008
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:
Screening

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014