Bias Source of Signal in SCOUT DS (BSOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01550328|
Recruitment Status : Terminated (Protocol no longer meets sponsor objectives)
First Posted : March 9, 2012
Last Update Posted : January 15, 2013
|Condition or disease|
|Type 2 Diabetes|
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 Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Bias Source of Signal in SCOUT DS|
|Study Start Date :||April 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||January 2013|
- Determine Device Bias [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550328
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Jon Aase, MD||VeraLight, Inc.|