Efficacy and safety of a tubeless AID system compared with MDI in children and adolescents with T1D in the RADIANT study

Nikolaos Daskas; Frohock Anne Marie; Kevin Perge; Jacques Beltrand; Aurelie Berot; Elise Bismuth; Marie-Beatrice Saade; Randa Salet; Rachel Reynaud; Emeline Renard; Cecile Gouillard-Darnaud; Ng Sze May; Philippe Lysy; Pete Jennings; Trang Ly; Marc Nicolino

doi:10.1530/endoabs.111.OC7.5

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Endocrine Abstracts (2025) 111 OC7.5 | DOI: 10.1530/endoabs.111.OC7.5

BSPED2025 Oral Communications Diabetes Oral Communications 1 (5 abstracts)

Efficacy and safety of a tubeless AID system compared with MDI in children and adolescents with T1D in the RADIANT study

Nikolaos Daskas ¹ , Anne Marie Frohock ¹ , Kevin Perge ^2,3 , Jacques Beltrand ⁴ , Aurelie Berot ⁵ , Elise Bismuth ⁶ , Marie-Beatrice Saade ⁷ , Randa Salet ⁸ , Rachel Reynaud ⁹ , Emeline Renard ¹⁰ , Cecile Gouillard-Darnaud ¹¹ , Sze May Ng ^12,13 , Philippe Lysy ¹⁴ , Pete Jennings ¹⁵ , Trang Ly ¹⁵ & Marc Nicolino ^2,3

Author affiliations

¹Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Department of Paediatric Endocrinology and Diabetes, Oxford, United Kingdom; ²Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Service d’Endocrinologie et Diabétologie Pédiatrique, Bron, France; ³Université Claude Bernard, Lyon 1, Lyon, France; ⁴Pediatric Endocrinology, Gynecology and Diabetology Department, Hôpital Necker enfants malades, APHP Centre, Université de Paris, Paris, France; ⁵Departement of Pediatrics, American Memorial Hospital, CHU Reims, Reims, France; ⁶Departement of Pediatric Endocrinology and Diabetology, Robert Debré Hospital, Assistance Publique Hopitaux de Paris, Paris, France; ⁷Pediatric Endocrinology and Diabetology Unit, Department of Pediatrics, Rennes University Hospital, Rennes, France; ⁸Department of Pediatrics, Nîmes University Hospital, Nîmes, France; ⁹Multidisciplinary Pediatrics Department, Timone Hospital, Aix-Marseille University, Marseille, France; ¹⁰Pediatric Medicine Department, Children’s Hospital, CHRU of Nancy and Lorraine University, Nancy, France; ¹¹Lenval University Pediatric Hospital, Nice, France; ¹²Paediatric Department, Mersey and West Lancashire Teaching Hospitals, Ormskirk, United Kingdom; ¹³Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom; ¹⁴Division of Pediatric Endocrinology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; ¹⁵Insulet Corporation, Acton, MA, USA

Background and Aims: Despite advances in technology, many children and adolescents with type 1 diabetes (T1D) continue to use multiple daily injections (MDI), with glycaemic outcomes remaining at suboptimal levels. This analysis evaluated outcomes in paediatric participants with T1D from the RADIANT study, a randomized controlled trial comparing the Omnipod® 5 Automated Insulin Delivery (AID) System with MDI and CGM therapy.

Methods: Children and adults aged 4-70y with T1D ≥1y and screening HbA1c 58-97 mmol/mol currently using MDI with a FreeStyle Libre 2 CGM (study CGM) for ≥3 months were enrolled. Participants completed 14 days of data collection with MDI+CGM, then were randomly assigned 2:1 to intervention (Omnipod 5 + CGM) or continued with MDI+CGM for 13 weeks (control). Secondary and exploratory endpoints included glycaemic and clinical outcomes in paediatric participants.

Results: A total of 109 paediatric participants (median age: 12y; 43% female) were randomly assigned to intervention (n = 73) or control (n = 36). After 13 weeks, HbA1c improvements were observed with AID compared with control (adjusted mean difference: -9 mmol/mol, P < 0.0001), with a higher proportion of participants achieving HbA1c <53 mmol/mol at study end with AID, P <0.01. Similarly, time in range (3.9-10.0 mmol/l) was greater with AID, with an adjusted mean difference (95% CI) of 20.5% (17.5, 23.4; P < 0.0001), corresponding to +4.9 hours per day in range. There were no significant differences in time <3.0 mmol/l and <3.9 mmol/l with AID compared with control (median 0.44% compared with 0.18% and 2.92% compared with 3.31%, respectively, both P>0.05). No episodes of severe hypoglycaemia or diabetic ketoacidosis occurred in either treatment group.

Conclusions: These results demonstrate the efficacy and safety of direct transition from MDI+CGM therapy to the Omnipod 5 System in children and adolescents with T1D not meeting glycaemic targets.