Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults

Exclusion Criteria

• •1. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk.
• •2. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
• •3. History of diabetic ketoacidosis (DKA) in the past 6 months.
• •4. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c.
• •5. Using any form of pump therapy, including non-automated and automated insulin delivery (AID) systems, within 6 months prior to screening.
• •6. Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. If previously on oral steroids, last intake should be ≥14 days prior to screening visit.
• •7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement.
• •8. Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the baseline visit and during the 6-month study. Participants taking metformin should remain on a steady dose during study participation.
• •9. Pregnant or lactating (lactating women are only excluded in France), or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
• •10. Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other drug or device study during this study period.
• •11. 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.
• •12. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned.
• •13. Participants who have had a pancreas or pancreatic islet transplantation
• •14. Presence of unstable retinopathy or painful neuropathy, per Investigator's judgement.
• •15. Adult participants or parents/guardians with hearing and/or vision impairment that would interfere with recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders.