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

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1.

This is a prospective, randomized, parallel-group multicenter trial followed by an extension phase during which both groups use the Omnipod 5 system.

Participants will undergo a two-week standard therapy period utilizing the FreeStyle Libre 2 continuous glucose monitor (CGM) to collect baseline glycemic information.

Participants will then be randomized to the intervention or control groups (2:1).

Both groups will then participate in Period 1 for a total of 26-weeks after the completion of standard therapy period. During the first 13-weeks, participants randomized to the Control group will continue using MDI therapy with their Libre 2 CGM. Participants randomized to the Intervention group will onboard onto the Omnipod 5 System. At the conclusion of the 13-weeks, the Control group will onboard and use the Omnipod 5 System for an additional 13 weeks. Both groups will continue using the Omnipod 5 System for the remainder of the 26-weeks.

Participants in Belgium and France will be given the option to continue using the Omnipod 5 System for up to an additional 9-months.

Eligibility Criteria:
Inclusion Criteria:

1. Age at time of consent 4-70 years.
2. Clinical diagnosis of type 1 diabetes for at least 1 year prior to screening. Diagnosis is based on investigator's clinical judgement.
3. On MDI therapy (≥ 3 insulin injections per day and/or a basal/bolus regimen) for ≥ 3 months prior to screening. Have used insulin for at least 1 year prior to screening.
4. Have used the FreeStyle Libre 2 Sensor for ≥ 3 months with a daily average number of scans ≥ 4 and with sensor readings \> 70% of time over the previous month prior to screening. Sensor usage is determined from the download summary report for 30 days preceding screening visit.
5. Must be willing to use the FreeStyle Libre 2 Sensor for the duration of the study.
6. HbA1c 7.5-11% (58-97mmol/mol) by point-of-care taken at screening visit
7. Deemed appropriate for pump therapy per investigator's assessment with respect to previous history of severe hypoglycemic and hyperglycemic events, other comorbidities, and capability of operating study devices and adhering to the protocol.
8. Willing to use and obtain U-100 insulin: either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)) as the primary insulin treatment while using the Omnipod 5 System.
9. Participants or parent/guardian able to read and understand Dutch, English or French.
10. Willing to wear the system continuously throughout the study
11. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged \< 18 years per Country requirements.
12. Willing to limit vitamin C supplementation to 2000 mg or less per day.
13. Must be familiar with carbohydrate counting.

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.