Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Inclusion Criteria:

• History consistent with type 1 diabetes
• At least 18 years of age
• Available and capable of following the protocol instructions provided by the healthcare professional
• Signed and dated informed consent form

Exclusion Criteria:

• Pregnancy
• Type 2, gestational, or secondary diabetes
• Known allergy to medical grade adhesives
• Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
• Seizure disorder
• Myocardial ischemia
• History of stroke
• Severe hypoglycemia unawareness
• Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety