Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes (ENGINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01080157
First received: March 1, 2010
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.


Condition Intervention
Diabetes
Device: SCOUT DS measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance. [ Time Frame: Outcome measure is determined 2-3 months after completion of Visit 3 ] [ Designated as safety issue: No ]
    The relative true positive and relative true negative fractions between the SCOUT DS and FPG tests for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL)


Secondary Outcome Measures:
  • Receiver operator characteristic area under the curve, sensitivity, specificity, and postive & negative predictive values of the SCOUT DS, FPG, and A1C tests for detection of abnormal glucose tolerance, and the intra- & inter-day SCOUT DS test [ Time Frame: Outcome measure is determined 2-3 months after completion of Visit 3 ] [ Designated as safety issue: No ]

Enrollment: 509
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Volunteers 18+, at risk for diabetes Device: SCOUT DS measurement
Non-invasive 3-5 volar forearm scan

Detailed Description:

The trial will be a prospective, multi-center, paired data, cohort screening trial. Up to 960 subjects will complete the study to determine the relative accuracy of SCOUT DS compared to the FPG and HbA1c tests in screening for abnormal glucose tolerance. All methods will be compared to the 2 hour value of the OGTT. An algorithm utilizes skin optical modeling as well as the spectral and blood assay data accumulated from the initial phase of the study to produce a risk score for abnormal glucose tolerance. This algorithm and the calculation of the score will be integrated into the SCOUT DS for prospective testing. The design requires three patient visits to the clinical site and up to a total of seven measurements on the SCOUT device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 12 clinical sites. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Those in the 18-44 age group will have an additional risk factor, and the addition of the waist circumference and hypertension thresholds from the National Cholesterol Education Program Adult Treatment Panel III Guidelines for metablolic syndrome

Criteria

Inclusion Criteria:

  1. Age greater than or equal to 45 years; OR
  2. Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following risk factors:

    • Elevated waist circumference, > 35 inches for women and >40 inches for men
    • Habitually physically inactive (does not exercise regularly)
    • Has a first-degree relative with diabetes
    • African American, Latino, Native American, Asian American, Pacific Islander
    • Has delivered a baby weighing > 9 lb or diagnosed with gestational diabetes
    • Hypertension (≥130/≥ 85 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 yrs
    • Conditions associated with insulin resistance such as 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 in VL-2701
  • 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)
  • 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: NCT01080157

Locations
United States, Alabama
Accelovance - Huntsville
Huntsville, Alabama, United States, 35802
United States, California
Accelovance - San Diego, CA
San Diego, California, United States, 92108
United States, Illinois
Radiant Research, Inc. - Chicago
Chicago, Illinois, United States, 60654
Accelovance - Peoria, IL
Peoria, Illinois, United States, 61602
United States, Kansas
Radiant Research, Inc. - Kansas City
Kansas City, Kansas, United States, 66202
United States, Maryland
Accelovance - Rockville, MD
Rockville, Maryland, United States
United States, Minnesota
Radiant Research, Inc. - Minneapolis
Minneapolis, Minnesota, United States, 55345
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
United States, Ohio
Radiant Research, Inc. - Cincinnati
Cincinnati, Ohio, United States, 45249
United States, Texas
Juno Research, LLC
Houston, Texas, United States, 77036
Dynamed Clinical Research, LP
Houston, Texas, United States, 77375
Radiant Research, Inc. - San Antonio
San Antonio, Texas, United States, 78229
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: NCT01080157     History of Changes
Other Study ID Numbers: VL-2712
Study First Received: March 1, 2010
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:
Diabetes
Diabetes Screening
Experimental Medical Device

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 28, 2014