Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

Overview

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Full Title of Study: “An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 2010

Detailed Description

Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Arms, Groups and Cohorts

  • Those with Type 2 diabetes
    • All subjects have been diagnosed with type 2 diabetes.

Clinical Trial Outcome Measures

Primary Measures

  • Validation of SCOUT DS algorithm for detecting known type 2 diabetes
    • Time Frame: 1 day
    • Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

Participating in This Clinical Trial

Inclusion Criteria

1. Age greater than or equal to 18 years 2. Self-reported diagnosis of type 2 diabetes Exclusion Criteria:

  • Not diagnosed with type 2 diabetes – Diagnosed with type 1 diabetes – Known to be pregnant (Self Reported) – Receiving dialysis or having known renal compromise – Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. – Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VeraLight, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martin L Kabongo, MD,PhD, Principal Investigator, Accelovance San Diego

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