System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System

Status Completed

Clinical Trial Summary

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

Diabetes

Clinical Trial Details

NCT number	NCT02710617
Study type	Interventional
Source	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Contact
Status	Completed
Phase	N/A
Start date	March 2016
Completion date	May 2016

View Details

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