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

Prior treatment

• Using any form of pump therapy, including non-automated and automated insulin delivery (AID) systems, within 6 months prior to screening.
• 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.
• 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.
• 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).
• 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.
• Participants who have had a pancreas or pancreatic islet transplantation

Other illness

• 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.
• 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.
• History of diabetic ketoacidosis (DKA) in the past 6 months.
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement.
• 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.

Lab values

• 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.

Other

• 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.
• Presence of unstable retinopathy or painful neuropathy, per Investigator's judgement.

• Age at time of consent 4-70 years.
• Clinical diagnosis of type 1 diabetes for at least 1 year prior to screening. Diagnosis is based on investigator's clinical judgement.
• 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.
• 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.
• Must be willing to use the FreeStyle Libre 2 Sensor for the duration of the study.
• HbA1c 7.5-11% (58-97mmol/mol) by point-of-care taken at screening visit
• 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.
• 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.
• Participants or parent/guardian able to read and understand Dutch, English or French.
• Willing to wear the system continuously throughout the study
• 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.
• Willing to limit vitamin C supplementation to 2000 mg or less per day.
• Must be familiar with carbohydrate counting.