NCT05923827

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

Randomized Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 System When Compared to Multiple Daily Injections for Treatment of Type 1 Diabetes (RADIANT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 diabetes.

Detailed description

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. Following Period 1, participants in Belgium and France will be given the option to continue using the Omnipod 5 System with the Libre 2 CGM through commercialization.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Omnipod 5 System	The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.

Timeline

• Start date: 2023-09-11
• Primary completion: 2024-08-16
• Completion: 2026-02-12
• First posted: 2023-06-28
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

19 sites across 3 countries: Belgium, France, United Kingdom

Regulatory

• FDA-regulated device study