Navigator 1.5 Accuracy Study

Exclusion Criteria

• •Pregnancy;
• •Type 2, gestational, or secondary diabetes;
• •Known allergy to medical grade adhesives or skin disinfectant;
• •Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
• •Blood donation within 6 weeks prior to beginning study activities;
• •Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
• •Active myocardial ischemia;
• •Previous history of stroke;
• •Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
• •Current participation in another clinical trial.