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

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).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Impaired Glucose Tolerance; Gestational Diabetes

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Radiant Research
  • Georgia
    • Atlanta, Georgia, United States
      • Radiant Research
  • Illinois
    • Chicago, Illinois, United States
      • Radiant Research
  • Maryland
    • Rockville, Maryland, United States
      • Accelovance
  • Missouri
    • Kansas City, Missouri, United States
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

1. Dark Skin Tone (Von Luschan chromatic skin color > 35)

2. Age greater than or equal to 45 years;

   OR

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diabetes risk factors; Very dark skin subjects with with diabetes risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Impaired Glucose Tolerance; Diabetes Risk Factors; Dark Skin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Pregnancy Complications; Hyperglycemia; Metabolic Syndrome; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: VL-2718