Table 1.

Inclusion and Exclusion Criteria

Inclusion criteria, run-in phase
	Age 16–70 years (subjects aged 16–21 years must have appropriate support system to be determined by the investigator)
	Psychological soundness
	Age <40 years at disease onset
	Diagnosed with type 1 diabetes ≥2 years prior to screening
	Negative stimulated C-peptide test
	Willingness to perform ≥4 finger stick blood glucose measurements daily
	Willingness to perform required sensor calibrations
	Willingness to wear the system continuously throughout the study
	Willingness to keep a log to record—at minimum—sick days, days with exercise, and days with symptoms of low glucose
	A1C from 5.8% to 10.0%
	Pump therapy for >6 months
	Under the care of diabetes health care provider(s) for 6 months or more
	Ability and willingness to upload data on a weekly basis
	Adequate treatment for celiac disease, if it exists
	Use of insulin lispro or insulin aspart and ability to pay for them
Inclusion criteria, study phase
	During the run-in phase, demonstrated sensor wear for ≥80% of the time
	During the run-in phase, at least two episodes of nocturnal hypoglycemia, defined as consecutive sensor glucose values ≤65 mg/dl for >20 min, starting between 10:00 pm and 8:00 am, with no evidence of user–pump interaction
Exclusion criteria
	History of >1 episode of severe hypoglycemia resulting in any of the following during the 6 months prior to screening: medical assistance, coma, or seizures
	Inability to tolerate tape adhesive in the area of sensor placement
	Unresolved adverse skin condition in the area of sensor placement
	Pregnancy or plans to become pregnant during the study
	Subject has a new diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease
	Current treatment for hyperthyroidism
	Abnormal creatinine or thyroid-stimulating hormone value
	Oral, injectable, or intravenous steroids within 8 weeks from time of screening visit
	Participation in an investigational study (drug or device) in the past 2 weeks
	Hospitalization or emergency room visit in the 6 months prior to screening, resulting in a primary diagnosis of uncontrolled diabetes
	Currently abusing illicit drugs
	Currently abusing prescription drugs
	Currently abusing alcohol
	Use of pramlintide at time of screening
	History of visual impairment, which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
	Elective surgery planned that requires general anesthesia during the course of the study
	Is a shift worker with working hours between 10:00 pm and 8:00 am
	Has a sickle cell disease or hemoglobinopathy or has received red blood cell transfusion