Project Frazier 3 Regulatory Clinical Evaluation

Project Frazier 3 Regulatory Clinical Evaluation

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Summary of Inclusion Criteria

• Age - Subject is at least 12 years old.
• Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
• Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
• Language - Subject reads and understands local language
• SMBG status confirmed
• Subject agrees to complete all aspects of the study

Summary of exclusion criteria

• Conflict of Interest
• Pregnancy - Subject is pregnant (as confirmed by Subject)
• User Performance Accuracy Testing - Technical Expertise