Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)

The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.

Inclusion criteria

• Age at time of consent 18.0 to 65.0 years
• Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
• Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening
• Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
• Willing to use the study CGM device for the duration of the study
• Willing to use the Omnipod® Insulin Management System during the study
• Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
• Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
• Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
• Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
• Willing and able to sign the Informed Consent Form (ICF)

Exclusion criteria

• A1C >10% at the screening visit
• One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
• Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
• One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
• Used non-insulin anti-diabetic medication within last 30 days
• Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
• Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
• Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
• Currently undergoing systemic treatment with steroids or immunosuppressive medication
• Current illness that would interfere with participation in the study
• Currently participating in another clinical study using an investigational drug or device
• Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.