Screening for Early Evidence of Diabetes (SEED)

A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

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.

• Study Type: Observational
• Enrollment (Actual): 3478

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Accelovance
  • California
    • San Diego, California, United States, 92108
      • Accelovance
    • San Diego, California, United States, 92161
      • Veteran's Administration Hospital
  • District of Columbia
    • Washington, DC, District of Columbia, United States, 20003
      • Medstar Research Institute
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Kaiser Permanente-Center for Health Research
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Radiant Research
    • Peoria, Illinois, United States, 61602
      • Accelovance
  • Kansas
    • Overland Park, Kansas, United States, 66202
      • Radiant Research
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources
  • New York
    • Flushing, New York, United States, 11355
      • New York Hospital Queens-Lang Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Diabetes Center, University of Oklahoma
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Diabetes and Lipid Research, University of Pittsburgh
  • Texas
    • San Antonio, Texas, United States, 78229
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: VeraLight, Inc.
• Investigators: Study Director: John Maynard, MS, Executive Vice President, VeraLight Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 30, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Screening
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: VL-2701