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:

1. Age at time of consent 18.0 to 65.0 years

2. Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on
investigator's clinical judgment.

3. Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C >6% at screening

4. 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

5. Willing to use the study CGM device for the duration of the study

6. Willing to use the Omnipod® Insulin Management System during the study

7. Willing to perform all fingerstick BG testing with the study-approved glucose meter at
the frequency specified in the study protocol

8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the
study

9. Willing to participate in moderate intensity exercise for up to 45 minutes if taking
part in Option B

10. Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000
mg/daily) for the entire duration of participation in the study

11. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. A1C >10% at the screening visit

2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or
hospitalization within the past 6 months

3. Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke
Questionnaire

4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization
within the past 6 months

5. Used non-insulin anti-diabetic medication within last 30 days

6. 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)

7. 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

8. Current or known history of cardiovascular disease, arrhythmia, myocardial infarction
(MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.

9. Currently undergoing systemic treatment with steroids or immunosuppressive medication

10. Current illness that would interfere with participation in the study

11. Currently participating in another clinical study using an investigational drug or
device

12. Recent (within the preceding 30 days) participation in a clinical study using an
investigational drug.