Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

Exclusion Criteria

• •Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
• •Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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 12 months prior to screening
• •Any planned surgery during the study which could be considered major in the judgment of the investigator
• •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 mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
• •History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
• •Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• •Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
• •Use of hydroxyurea
• •Plans to receive blood transfusion over the course of the study
• •Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
• •Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
• •Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
• •Pregnant or lactating, or 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).
• •Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
• •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
• •Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned