System Accuracy and Performance Evaluation by the User of BGM LS-9

Evaluation of the Blood Glucose Monitoring System LS-9 of Leison Biotech Co., Ltd. in Accordance With DIN EN ISO 15197:2015

This study assesses the system accuracy and performance evaluation by the user of a blood glucose monitoring system pursuant to ISO 15197

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