System Accuracy of 12 Bloog Glucose Monitoring Systems

Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015

The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.

Inclusion Criteria:

• Male or female, with clinical indication for blood glucose measurement
• Signed informed consent form
• Minimum age of 18 years
• Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

• Pregnancy or lactation period
• Severe acute disease (at the study physician's discretion)
• Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
• Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
• A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
• Being unable to give informed consent
• < 18 years
• Legally incompetent