Fiona Campbell, John Todd, Tabitha Randell, Daniela Elleri, Gianluca Musolino, Janet M Allen, Sara Hartnell, Malgorzata E Wilinska, Martin Tauschmann, Charlotte Boughton, Nicola Trevelyan, Carlo L Acerini, Korey Hood, Craig Kollman, Judy Sibayan, Roman Hovorka, Professor David Dunger, Atrayee Ghatak, Rachel Besser, Elizabeth Northam, Eleanor Scott, Julia Lawton, Stephane Roze, and Nate Cohen
IntroductionManagement of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy.Methods and analysisThe study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10–16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9–10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (