Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall objective of this study is to increase the number of dark skin tone individuals in the data set and evaluate if this increase in dark skin tone data has an impact on the accuracy of the SCOUT DS Diabetes Risk Score (DRS).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes risk factors | Very dark skin subjects with with diabetes risk factors |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals | The primary study endpoint is the relative true positive and relative true negative fractions between the SCOUT DS and FPG test for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare SCOUT DS and FPG to HbA1c | Secondary endpoint is to evaluate the receiver operator characteristic area under the curve, sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of SCOUT DS, FPG, and A1C test for detection of abnormal glucose tolerance. | 6 months |
Not provided
Inclusion Criteria:
Dark Skin Tone (Von Luschan chromatic skin color > 35)
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 diabetes risk factors:
Exclusion Criteria:
Not provided
Not provided
Not provided
Community sample
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Maynard, MS | VeraLight, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | United States | |||
| Radiant Research |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Atlanta |
| Georgia |
| United States |
| Radiant Research | Chicago | Illinois | United States |
| Accelovance | Rockville | Maryland | United States |
| Radiant Research | Kansas City | Missouri | United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |