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Clinical Trial Summary

Assessment of the system accuracy of different blood glucose monitoring systems available in Europe


Clinical Trial Description

A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03737188
Study type Interventional
Source Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Contact
Status Completed
Phase N/A
Start date November 14, 2018
Completion date December 5, 2018

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