Assessment of an Automatic Closed-loop Insulin Delivery System

Exclusion Criteria

• •1. Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol
• •2. Diabetic ketoacidosis in the past month
• •3. Hypoglycemic seizure or loss of consciousness or an event requiring glucagon or IV glucose in the past 3 months
• •4. Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis
• •5. Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
• •6. Subject has a history of liver or kidney disease (other than microalbuminuria)
• •7. Subject has active Graves' disease
• •8. Subjects with inadequately treated thyroid disease or celiac disease
• •9. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
• •10. Subject has a history of diagnosed medical eating disorder
• •11. Subject has a history of known illicit drug abuse
• •12. Subject has a history of known prescription drug abuse
• •13. Subject has a history of current alcohol abuse
• •14. Subject has a history of visual impairment which would not allow subject to participate
• •15. Subject has an active skin condition that would affect sensor placement
• •16. Subject has adhesive allergies
• •17. Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
• •18. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
• •19. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• •20. Subject is currently on beta blocker medication
• •21. Subject is currently participating in another investigational study (drug or device)
• •22. Subject is deemed by the investigator to be unwilling or unable to follow the protocol
• •23. Presence of a febrile illness within 24 hours of enrollment