Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2

Inclusion criteria

• Diabetes duration > 1 year since diagnosis
• Pump therapy for at least 6 months and experience with sensor use
• Age10-40 years: Age 10-30 for segments 1-3, Age 14-40 for segment 4.
• 7>HbA1c <10.0 at time of screening visit for segments 1 and 2, <10.0 at segments 3 and 4.
• Willing to follow study instructions
• Willing to perform ≥ 3 finger stick blood glucose measurements daily
• Willing to perform required sensor calibrations
• Patient capable of reading and understand instructions in English
• Willing to have an adult experienced in the management of diabetes to live with during the outpatient phase of the protocol.

Exclusion criteria

• Subject is unable to tolerate tape adhesive in the area of sensor placement
• Subject has any unresolved adverse skin condition in the area of sensor or device placement
• 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
• Subject has a positive pregnancy screening test
• Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception
• Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit
• Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
• Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
• Subject has a history of a seizure disorder
• Subject has central nervous system or cardiac disorder resulting in syncope
• 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
• Subjects with hematocrit lower than the normal reference range per local lab testing
• Subjects with a history or findings on screening electrocardiogram of any cardiac arrhythmia
• Subjects with a history of adrenal insufficiency
• Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
• Any disease or condition that may influence the HbA1c testing
• Subject needs to travel by air during the study duration.