Efficacy of the Omnipod®​ 5 Automated Insulin Delivery (AID) System Compared with Multiple Daily Injections in Type 1 Diabetes: A Multinational Randomized Controlled Trial (RADIANT)

Background and aims: Despite advances in technology, the prevailing therapy for most people living with type 1 diabetes continues to be multiple daily injections (MDI), with metabolic and clinical outcomes remaining at suboptimal levels. This randomized controlled study aimed to demonstrate superior efficacy of the Omnipod®​ 5 AID System compared with MDI and continuous glucose monitor (CGM) use in children and adults with type 1 diabetes.

Methods: Children and adults aged 4-70 years with type 1 diabetes duration≥1 year and screening HbA1c 7.5-11% (58-97 mmol/mol) currently using MDI with a FreeStyle Libre 2 CGM (study CGM) for≥3 months were enrolled across 19 institutions in France, the United Kingdom (UK), and Belgium. Participants completed 14 days of data collection with MDI+CGM and then were randomized 2:1 to intervention (Omnipod 5 System+CGM) or continued with MDI+CGM for 13 weeks (control). The primary endpoint is the change in HbA1c at 13 weeks. Secondary endpoints, tested in a pre-specified hierarchical order include CGM metrics and person-reported outcomes.

Results: A total of 188 participants (58.0% aged<18 years; 45.7% female; 74.5% in France; 19.7% in the UK; 5.9% in Belgium; baseline HbA1c mean±SD 8.1±0.7% [65±7.7 mmol/mol]) were randomized (2:1), 125 to the intervention arm and 63 to the control arm, with the distribution of adult and pediatric participants predefined in the study protocol. The final study visit was completed on August 16, 2024. Full results will be available at the time of the presentation.

Conclusions: This large, multinational randomized controlled trial will provide a direct comparison of outcomes with the Omnipod 5 System compared with MDI+CGM therapy.

Publication History

Article published online:
28 May 2025