Diabetes Clinical Trial
Official title:
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
The user performance evaluation shows whether people with diabetes are able to obtain
accurate measurement results with a blood glucose monitoring system. In this study, user
performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care),
Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch
Select Simple (LifeScan) following ISO 15197:2013, clause 8.
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
For each BGMS, measurement procedures for user performance evaluation will be performed with
1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed
by study personnel (with the same reagent system lot used by subjects).
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