System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Inclusion Criteria:

• Male or female patients with clinical indication for blood glucose testing
• Signed form of consent
• 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
• Severe acute disease (at study physician's discretion)
• Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
• Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
• Being unable to give informed consent
• Age younger than 18 years
• Legally incompetent