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dc.contributor.authorBoughton, Charlotte
dc.contributor.authorAllen, Janet M
dc.contributor.authorTauschmann, Martin
dc.contributor.authorHartnell, Sara
dc.contributor.authorWilinska, Malgorzata E
dc.contributor.authorMusolino, Gianluca
dc.contributor.authorAcerini, Carlo L
dc.contributor.authorDunger, Professor David
dc.contributor.authorCampbell, Fiona
dc.contributor.authorGhatak, Atrayee
dc.contributor.authorRandell, Tabitha
dc.contributor.authorBesser, Rachel
dc.contributor.authorTrevelyan, Nicola
dc.contributor.authorElleri, Daniela
dc.contributor.authorNortham, Elizabeth
dc.contributor.authorHood, Korey
dc.contributor.authorScott, Eleanor
dc.contributor.authorLawton, Julia
dc.contributor.authorRoze, Stephane
dc.contributor.authorSibayan, Judy
dc.contributor.authorKollman, Craig
dc.contributor.authorCohen, Nate
dc.contributor.authorTodd, John
dc.contributor.authorHovorka, Roman
dc.description.abstractINTRODUCTION:Management 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 ANALYSIS:The 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 (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost-utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D. ETHICS AND DISSEMINATION:Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT02871089; Pre-results.
dc.rightsAttribution 4.0 International
dc.sourceessn: 2044-6055
dc.sourcenlmid: 101552874
dc.subjecttype 1 diabetes
dc.subjectArtificial Pancreas
dc.titleAssessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol.
prism.publicationNameBMJ open
dc.contributor.orcidBoughton, Charlotte [0000-0003-3272-9544]
dc.contributor.orcidDunger, Professor David [0000-0002-2566-9304]
pubs.funder-project-idWellcome Trust (107212/A/15/Z)

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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International