Insulet Artificial Pancreas Free-Living IDE3

This is an interventional device feasibility trial for Type1 Diabetes Mellitus focused on measuring T1D, Omnipod Read More

Inclusion Criteria:

1. Age at time of consent 2.0-85 years
2. Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
3. A1C <10% at screening
4. Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 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 or per investigator discretion
8. Willing to participate in setpoint and meal challenges
9. Willing to use carbohydrate counting for determination of meal boluses
10. Willing to participate in moderate intensity exercise for at least 30 minutes per day
11. Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
12. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects per State requirements.

Exclusion Criteria:

1. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
2. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
3. Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days.
4. Using a basal insulin with a usual duration of insulin action > 36 hours
5. 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)
6. Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
7. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. Abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QT interval (> 440 ms). Electrocardiogram is only required for subjects >50 years old or with diabetes duration >20 years.
8. Stroke
9. Known history of seizure disorder
10. Known history of adrenal insufficiency
11. Current renal or hepatic disease
12. Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
13. Currently undergoing cancer treatment
14. Currently undergoing systemic treatment with steroids or immunosuppressive medication
15. Known history of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
16. Current illness that would interfere with participation in the study
17. Untreated or inadequately treated mental illness
18. Current alcohol abuse per investigator's judgment
19. Electrically-powered implants that may be susceptible to RF interference
20. Currently participating in another clinical study using an investigational drug or device
21. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug
22. Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.