Diabetes Mellitus Clinical Trial
Official title:
User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo 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® Next One (Ascensia Diabetes Care GmbH),
Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes
Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics
S.r.l. (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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