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

An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: SCOUT DS measurement

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.

• Study Type: Observational
• Enrollment (Actual): 509

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Accelovance - Huntsville
  • California
    • San Diego, California, United States, 92108
      • Accelovance - San Diego, CA
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc. - Chicago
    • Peoria, Illinois, United States, 61602
      • Accelovance - Peoria, IL
  • Kansas
    • Kansas City, Kansas, United States, 66202
      • Radiant Research, Inc. - Kansas City
  • Maryland
    • Rockville, Maryland, United States
      • Accelovance - Rockville, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55345
      • Radiant Research, Inc. - Minneapolis
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc. - Cincinnati
  • Texas
    • Houston, Texas, United States, 77036
      • Juno Research, LLC
    • Houston, Texas, United States, 77375
      • Dynamed Clinical Research, LP
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc. - San Antonio

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: 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Volunteers 18+, at risk for diabetes	Device: SCOUT DS measurement; Non-invasive 3-5 volar forearm scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance.	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)	Outcome measure is determined 2-3 months after completion of Visit 3

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Outcome measure is determined 2-3 months after completion of Visit 3

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes; Diabetes Screening; Experimental Medical Device
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: VL-2712