Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 Diabetes

Inclusion Criteria:

1. Age at time of consent 2-70 years (inclusive)

2. Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - < 7years and at least 1 year for participants aged 7 - 70 years. Diagnosis is based oninvestigator's clinical judgment

3. Living with a parent or guardian if < 18 years old

4. Current Omnipod 5 user for at least 3 months prior to screening

5. Must have used the target of 110mg/dL for at least 30% of the time for 2-13 yearolds and for at least 50% of the time for 14-70 year olds for the 2 weeks precedingthe screening visit

6. Willing to use only the following types of U-100 insulin during the study: HumalogU-100, Novolog, or Admelog or their generic equivalents

7. Participant agrees to provide their own insulin for the duration of the study

8. Investigator has confidence that the participant and/or caregiver can safely operateall study devices and can adhere to the protocol

9. Willing to wear the system continuously throughout the study

10. Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardianwilling and able to sign the ICF. Assent will be obtained from pediatric andadolescent participants aged < 18 years per state requirements

11. Able to read and understand English

12. If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

1. Any medical condition, which in the opinion of the investigator, would put theparticipant at an unacceptable safety risk

2. Any planned surgery during the study which could be considered major

3. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is definedas an event that requires the assistance of another person due to altered mentaland/or physical status, and requires another person to actively administercarbohydrate, glucagon, or other resuscitative actions.

4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to anintercurrent illness or infusion failure

5. Unable to tolerate adhesive tape or has any unresolved skin condition in the area ofsensor or pump placement

6. Blood disorder or dyscrasia within 3 months prior to screening, which in theInvestigator's opinion could interfere with determination of HbA1c

7. Use of hydroxyurea

8. Use of non-insulin anti-hyperglycemic medication other than metformin and GLP1, inthe 4 weeks prior to screening. Participants taking metformin and/or GLP1 shouldremain on a steady dose during study participation

9. Pregnant or lactating, or of childbearing potential and not on acceptable form ofbirth control (acceptable forms of contraception include abstinence, barrier methodssuch as condoms, hormonal contraceptives, intrauterine device, surgicalsterilization such as tubal ligation or hysterectomy, or vasectomized partner)

10. In the past 30-days, has participated in a clinical study using any investigationaldrug or any investigational device. Additionally, may not intend to participate inany other clinical study during this study period.

11. Planned international travel during the study

12. Unable to follow clinical protocol for the duration of the study or is otherwisedeemed unacceptable to participate in the study per the Investigator's clinicaljudgment

13. Participant is an employee of Insulet, an Investigator or Investigator's study team,or immediate family member of any of the aforementioned