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)

L Leelarathna; E Wilmot; J Beltrand; B Guerci; A Berot; H Hanaire; E Bismuth; P Gillard; M B Saade; M Joubert; R Salet; P Choudhary; R Reynaud; E Renard; S Lablanche; C Gouillard-Darnaud; S M Ng; P Lysy; N Daskas; K Perge; T Crabtree; T Ly; M Nicolino

doi:10.1055/s-0045-1807545

Diabetologie und Stoffwechsel, Inhaltsverzeichnis

Diabetologie und Stoffwechsel 2025; 20(S 01): S93-S94
DOI: 10.1055/s-0045-1807545

Abstracts | DDG 2025

Poster

Posterwalk 14: Neue Technologien

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)

Authors

L Leelarathna

¹Imperial College, Department of Metabolism, Digestion and Reproduction, London, United Kingdom
E Wilmot

²University of Nottingham, School of Medicine, Nottingham, United Kingdom
J Beltrand

³Hôpital Necker enfants malades, APHP Centre, Université de Paris, Pediatric Endocrinology, Gynecology and Diabetology Department, Paris, France
B Guerci

⁴Brabois Adults Hospital, CHRU of Nancy and Lorraine University, Endocrinology, Diabetology and Nutrition, Nancy, France
A Berot

⁵American Memorial Hospital, CHU Reims, Department of Pediatrics, Reims, France
H Hanaire

⁶University Hospital of Toulouse, Department of Diabetology, Toulouse, France
E Bismuth

⁷Robert Debré Hospital, Assistance Publique Hopitaux de Paris, Department of Pediatric Endocrinology and Diabetology, Paris, France
P Gillard

⁸University Hospitals Leuven, KU Leuven, Department of Endocrinology, Leuven, Belgium
M B Saade

⁹Rennes University Hospital, Pediatric Endocrinology and Diabetology Unit, Department of Pediatrics, Rennes, France
M Joubert

¹⁰Caen University Hospital, UNICAEN, Diabetes Care Unit, Caen, France
R Salet

¹¹Nîmes University Hospital, Department of Pediatrics, Nîmes, France
P Choudhary

¹²University of Leicester, Diabetes Research Centre, Leicester, United Kingdom
R Reynaud

¹³Timone Hospital, Aix-Marseille University, Multidisciplinary Pediatrics Department, Marseille, France
E Renard

¹⁴Children’s Hospital, CHRU of Nancy and Lorraine University, Pediatric Medicine Department, Nancy, France
S Lablanche

¹⁵Grenoble Alpes University Hospital, Grenoble Alpes University, Diabetology Department, Grenoble, France
C Gouillard-Darnaud

¹⁶Lenval University Pediatric Hospital, Pediatrics, Nice, France
S M Ng

¹⁷Mersey and West Lancashire Teaching Hospitals, Edge Hill University, Faculty of Health, Social Care and Medicine, Ormskirk, United Kingdom
P Lysy

¹⁸Cliniques Universitaires Saint-Luc, Division of Pediatric Endocrinology, Brussels, Belgium
N Daskas

¹⁹Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Department of Paediatric Endocrinology and Diabetes, Oxford, United Kingdom
K Perge

²⁰Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Claude Bernard University Lyon 1, Department of Pediatric Endocrinology and Diabetology, Lyon, France
T Crabtree

²University of Nottingham, School of Medicine, Nottingham, United Kingdom
T Ly

²¹Insulet Coroporation, Clinical Affairs, Acton, MA, United States
M Nicolino

²⁰Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Claude Bernard University Lyon 1, Department of Pediatric Endocrinology and Diabetology, Lyon, France

Abstract

Volltext

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.

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)

Authors

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)