Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT05923827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2023-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults
Sponsor:
Insulet Corporation
Organization:
Study Overview
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)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIANT
Brief 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.
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.
Participants in Belgium and France will be given the option to continue using the Omnipod 5 System for up to an additional 9-months.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: