Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015

Leistungsbewertung Durch Den Anwender. Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia gemäß DIN EN ISO 15197:2015

Performance Evaluation by the User of the Blood Glucose Monitoring SystemContour Care in accordance with DIN EN ISO 15197:2015

Inclusion Criteria:

• Male or female patients with clinical indication for blood glucose measurements (i.e. Diabetes mellitus)
• Male or female patients with hypo-, eu- or hyperglycemia
• 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 that

  • pose a risk of aggravation by the measure
  • pose a health hazard to the personnel

• 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