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.
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
509
Non-invasive 3-5 volar forearm scan
Accelovance - Huntsville
Huntsville, Alabama, United States
Accelovance - San Diego, CA
San Diego, California, United States
Radiant Research, Inc. - Chicago
Chicago, Illinois, United States
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)
Time frame: Outcome measure is determined 2-3 months after completion of Visit 3
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
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Accelovance - Peoria, IL
Peoria, Illinois, United States
Radiant Research, Inc. - Kansas City
Kansas City, Kansas, United States
Accelovance - Rockville, MD
Rockville, Maryland, United States
Radiant Research, Inc. - Minneapolis
Minneapolis, Minnesota, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Radiant Research, Inc. - Cincinnati
Cincinnati, Ohio, United States
Juno Research, LLC
Houston, Texas, United States
...and 2 more locations