Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Exclusion Criteria

• •1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
• •2. History of severe hypoglycemia in the past 6 months
• •3. History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
• •4. Diagnosed with sickle cell disease
• •5. Diagnosed with hemophilia or any other bleeding disorders
• •6. Plans to receive blood transfusion over the course of the study
• •7. Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR \< 45) or currently on hemodialysis
• •8. History of adrenal insufficiency
• •9. Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study
• •10. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• •11. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
• •12. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
• •13. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
• •14. Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period
• •15. 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