Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

Inclusion Criteria

• Subject is age 7-75 years at time of Screening
• Subjects 14-75 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Subjects 7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Study-specific inclusion criteria
• Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
• Subject is willing to perform required sensor calibrations
• Subject is willing to wear the system continuously throughout the study
• Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
• Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of Screening visit Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
• Subject has TSH in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
• Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
• Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
• Subject willing to upload data from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
• If subject has celiac disease, it has been adequately treated as determined by the investigator
• Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
• Humalog™* (insulin lispro injection)
• NovoLog™* (insulin aspart)
• Subjects with history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
• Subjects with the 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist

a. Cardiovascular risk factors include:

• Age >35 years
• Type 1 diabetes of >15 years' duration
• Presence of any additional risk factor for coronary artery disease
• Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
• Presence of peripheral vascular disease
• Presence of autonomic neuropathy
• Subjects with history of cardiovascular event 1 year or more from the time of screening must have a stress test within 6 months prior to screening or during run in period. If subject fails stress test, participation is allowed if there is clearance from a cardiologist

Exclusion Criteria

• Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
• Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
• Coma
• Seizures
• Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
• Subject has had Diabetic Ketoacidosis (DKA) in the 6 month