Insulet Artificial Pancreas Early Feasibility Study

Inclusion criteria

Subjects must meet all of the following criteria to be included in the study:

• Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
• Diagnosed with type 1 diabetes for at least 1 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 for at least 6 months prior to start of study
• Willing to use the study CGM device for one week prior to study start and for the duration of the study
• Willing to use the OmniPod® Insulin Management System during the study
• Willing to perform all SMBG 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 refrain from use of acetaminophen, pseudoephedrine, 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) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from the study:

• 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 or more "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 on the abdomen
• Known history of myocardial infarction (MI) or stroke within the past 6 months
• Known history of seizure disorder
• Known history of adrenal insufficiency
• Current renal or hepatic disease
• Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
• Currently undergoing cancer treatment
• Currently undergoing systemic treatment with steroids or immunosuppressive medication
• 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
• Current illness that would interfere with participation in the study
• Untreated or inadequately treated mental illness
• Current alcohol abuse per investigator's judgment
• Electrically-powered implants that may be susceptible to RF interference
• Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
• Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.