Assessment of the system accuracy of different blood glucose monitoring systems available in Europe
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
126
Capillary blood samples will be used for the evaluation of system accuracy.
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Ulm, Germany
Analysis of system accuracy based on ISO 15197
Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197
Time frame: For each subject, the experimental phase has an expected duration of up to 6 hours
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