Adult Accuracy Study of the Enlite 3 Glucose Sensor

Exclusion Criteria

• •1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
• •2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
• •3. Subject is actively participating in an investigational study (drug or device) in the last 2 weeks
• •4. Subject is female and has a positive pregnancy screening test
• •5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by the investigator
• •6. Subject is female and plans to become pregnant during the course of the study
• •7. Subject has had a hypoglycemic seizure within the past 6 months
• •8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
• •9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
• •10. Subject has a history of a seizure disorder
• •11. Subject has central nervous system or cardiac disorder resulting in syncope
• •12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• •13. Subject has a hematocrit (Hct) lower than the normal reference range
• •14. Subject has a history of adrenal insufficiency