Bias Source of Signal in SCOUT DS (BSOS)
The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.
Type 2 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Bias Source of Signal in SCOUT DS|
- Determine Device Bias [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
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
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550328
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Jon Aase, MD||VeraLight, Inc.|