System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia Diabetes Care Deutschland GmbH gemäß DIN EN ISO 15197:2015

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015

Inclusion criteria:

• Male or female patients with hypo-, eu- or hyperglycaemia
• The written informed consent had to be signed
• The volunteers must be older than 18 years
• The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

• Pregnancy or lactation
• Acute or chronic diseases with the risk of aggravation by the measure
• A current constitution that does not allow participating in the study
• Participation in another study or activity with the blood glucose measuring system evaluated in the present study
• Application of substances listed in Appendix A of DIN EN ISO 15197:2015