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Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS

NCT01375686 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 486

Last updated 2012-12-04

No results posted yet for this study

Summary

The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The study will involve up to two unique Scout devices at each clinical site. Each site will initially contain only a CS-1 (Commercial SCOUT 1) "A" for collection of data. As they become available, CS-1 "B"s operating with latest version of SCOUT software will be shipped to each site.

The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately 9 clinical sites distributed across the United States. Eligible subjects must be at least 18 years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.

The data will be collected and a partial area under the receiver operator curve (pAUC) will be computed via the method of moments between the 20% and 50% false positive rates based on the first valid Scout "A" measurement for each patient. The impaired glucose tolerance status will be determined by the average of the two hour, post challenge plasma glucose samples measured at the central laboratory. This will be compared to 1000 bootstrap re-samplings of the calibration data pulling a cohort that matches that collected during this study. A test will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence interval based on the bootstrap re-sampling.

Conditions

Sponsors & Collaborators

  • VeraLight, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kyle, MD · Radiant Chicago

  • Tami Helmer, MD · Radiant Minneapolis

  • Michael Noss, MD · Radiant Cincinnati

  • William Jennings, MD · Radiant San Antonio

  • Daniel Brune, MD · Accelovance Peoria

  • Martin L Kabongo, MD · Accelovance San Diego

  • Earl Martin, MD · DM Clinical

  • Audrey Lacour, MD · JUNO Research

  • David Bolshoun, MD · Radiant Denver

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375686 on ClinicalTrials.gov