NCT01550328

Bias Source of Signal in SCOUT DS

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: VeraLight, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2013-01-01
• First posted: 2012-03-09
• Last updated: 2013-01-15

Locations

1 site across 1 country: United States