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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05923827
Study type Interventional
Source Insulet Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date September 11, 2023
Completion date August 8, 2024
View Details
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