A Performance Evaluation of the Enlite 3 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 Enlite 3 Sensors or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• •3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from 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 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