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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.
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| 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. |
| Measure | Description | 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. |
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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:
Exclusion Criteria:
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General population who are 'at risk' for pre-diabetes or diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| John Maynard, MS | Executive Vice President, VeraLight Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accelovance | Huntsville | Alabama | 35802 | United States | ||
| Accelovance |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| End of study |
| San Diego |
| California |
| 92108 |
| United States |
| Veteran's Administration Hospital | San Diego | California | 92161 | United States |
| MedStar Research Institute | Washington D.C. | District of Columbia | 20003 | United States |
| Kaiser Permanente-Center for Health Research | Honolulu | Hawaii | 96813 | United States |
| Radiant Research | Chicago | Illinois | 60610 | United States |
| Accelovance | Peoria | Illinois | 61602 | United States |
| Radiant Research | Overland Park | Kansas | 66202 | United States |
| Radiant Research | Edina | Minnesota | 55435 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| New York Hospital Queens-Lang Research Center | Flushing | New York | 11355 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| Oklahoma Diabetes Center, University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Diabetes and Lipid Research, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Radiant Research | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |