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.
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
3,478
Accelovance
Huntsville, Alabama, United States
Accelovance
San Diego, California, United States
Veteran's Administration Hospital
San Diego, California, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Kaiser Permanente-Center for Health Research
Honolulu, Hawaii, United States
Radiant Research
Chicago, Illinois, United States
Accelovance
Peoria, Illinois, United States
Radiant Research
Overland Park, Kansas, United States
Radiant Research
Edina, Minnesota, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, United States
...and 5 more locations
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.
Time frame: At completion of second visit which occurs within 1 to 14 days after the first visit.
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
Intra- and inter-day Scout test reproducibility.
Time frame: End of study
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