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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

2016-09-27 22:53:21 | BioPortfolio

Summary

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).

Study Design

N/A

Conditions

Diabetes

Intervention

Blood-Glucose Monitoring Systems for self-testing

Location

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm
Germany
89081

Status

Enrolling by invitation

Source

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-27T22:53:21-0400

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