Type 2 Diabetes Clinical Trial
Official title:
Bias Source of Signal in SCOUT DS
The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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