Diabetes Clinical Trial
Official title:
User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197:2013; EN ISO 15197:2015
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 One (Ascensia Diabetes Care GmbH),
Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes
Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO
15197:2015, clause 8.
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).
n/a
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