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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01339637
First received: April 18, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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
Metabolic Syndrome
Impaired Glucose Tolerance
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Low Source of Signal in SCOUT DS

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Validation of the SCOUT DS algorithm comparing it to Oral Glucose Tolerance Test in dark skinned individuals [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Compare SCOUT DS and FPG to HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 196
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes risk factors
Very dark skin subjects with with diabetes risk factors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339637

Locations
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
Accelovance
Rockville, Maryland, United States
United States, Missouri
Radiant Research
Kansas City, Missouri, United States
Sponsors and Collaborators
VeraLight, Inc.
Investigators
Study Director: John Maynard, MS VeraLight, Inc.
  More Information

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01339637     History of Changes
Other Study ID Numbers: VL-2718
Study First Received: April 18, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014