Evaluation of Low Source of Signal in SCOUT DS (LSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01339637
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
VeraLight, Inc.

Brief Summary:
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).

Condition or disease
Metabolic Syndrome Impaired Glucose Tolerance Gestational Diabetes

Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Low Source of Signal in SCOUT DS
Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Diabetes risk factors
Very dark skin subjects with with diabetes risk factors

Primary Outcome Measures :
  1. Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals [ Time Frame: 6 months ]
    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).

Secondary Outcome Measures :
  1. Compare SCOUT DS and FPG to HbA1c [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

Inclusion Criteria:

  1. Dark Skin Tone (Von Luschan chromatic skin color > 35)
  2. Age greater than or equal to 45 years;


  3. Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following diabetes risk factors:

    • Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week)
    • Has a first-degree relative with type 2 diabetes
    • African American, Latino, Native American, Asian American, Pacific Islander
    • Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes
    • Hypertension (≥140/≥ 90 mmHg) or being treated for hypertension
    • HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
    • Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
    • Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years
    • Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans
    • History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

  • Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712
  • Under 18 years of age
  • Receiving investigational treatments in the past 14 days
  • Psychosocial issues that interfere with an ability to follow study procedures
  • Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
  • Diagnosed with any type of diabetes, including type 1 or 2
  • Taking glucose lowering medications
  • Known to be pregnant
  • Receiving dialysis or having known renal compromise
  • Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  • Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
  • Current chemotherapy, or chemotherapy within the past 12 months
  • Receiving medications that fluoresce*
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
  • Known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream)
  • Prior bariatric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01339637

United States, Alabama
Radiant Research
Birmingham, Alabama, United States
United States, Georgia
Radiant Research
Atlanta, Georgia, United States
United States, Illinois
Radiant Research
Chicago, Illinois, United States
United States, Maryland
Rockville, Maryland, United States
United States, Missouri
Radiant Research
Kansas City, Missouri, United States
Sponsors and Collaborators
VeraLight, Inc.
Study Director: John Maynard, MS VeraLight, Inc.

Responsible Party: VeraLight, Inc. Identifier: NCT01339637     History of Changes
Other Study ID Numbers: VL-2718
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by VeraLight, Inc.:
Impaired Glucose Tolerance
Diabetes Risk Factors
Dark Skin

Additional relevant MeSH terms:
Metabolic Syndrome X
Diabetes, Gestational
Glucose Intolerance
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases