Bias Source of Signal in SCOUT DS

Terminated

• Conditions: Type 2 Diabetes

• Registration Number: NCT01550328
• Lead Sponsor: VeraLight, Inc.

Brief Summary

The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.

Detailed Description

In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation.

The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting.

The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Study Start: 2012-04
• Primary Completion: 2012-09
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Males and/ or females greater than or equal to 18 years of age

Exclusion Criteria

• Have received investigational treatments in the past 14 days
• Have psychosocial issues that interfere with an ability to follow study procedures
• Are known to be pregnant
• Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
• Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
• Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
• Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine Device Bias	Up to 1 year	The primary objective of this study is to identify device characteristics, components, or subsystems that manifest as screening score bias in SCOUT DS.; The study will switch subsystems between devices and if the bias differs by more than 3.5 Diabetes Risk Score units compared to the baseline score, we would conclude that the bias was contained within that particular subsystem

Trial Locations

Locations (1)

VeraLight; 🇺🇸 Albuquerque, New Mexico, United States