Assessing 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
Introduction 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 fo...
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BMJ Publishing Group
2020-03-01
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| Online Access: | https://bmjopen.bmj.com/content/10/3/e033500.full |
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| author | 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 Nate Cohen |
| author_facet | 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 Nate Cohen |
| author_sort | Fiona Campbell |
| collection | DOAJ |
| description | Introduction 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. |
| format | Article |
| id | doaj-art-b051c1ecba6d43e7bf3e8c14aeefc55a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-b051c1ecba6d43e7bf3e8c14aeefc55a2024-12-07T01:00:09ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-033500Assessing 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 protocolFiona Campbell0John Todd1Tabitha Randell2Daniela Elleri3Gianluca Musolino4Janet M Allen5Sara Hartnell6Malgorzata E Wilinska7Martin Tauschmann8Charlotte Boughton9Nicola Trevelyan10Carlo L Acerini11Korey Hood12Craig Kollman13Judy Sibayan14Roman Hovorka15Professor David Dunger16Atrayee Ghatak17Rachel Besser18Elizabeth Northam19Eleanor Scott20Julia Lawton21Stephane Roze22Nate Cohen23AstraZeneca, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG2Singulex, Inc., Alameda, United States of AmericaNottingham Children`s Hospital, Nottingham, UKDepartment of Diabetes, Royal Hospital for Sick Children, Edinburgh, UKWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UKWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UKWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UKWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UKDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Wien, AustriaWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK5 Southampton Children’s Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UKDepartment of Paediatrics, University of Cambridge, Cambridge, UKEndocrinology, Stanford University School of Medicine, Stanford, California, USAJaeb Center for Health Research, Tampa, Florida, USAJaeb Centre for Health Research, Tampa, Florida, USAWellcome Trust, MRC Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, UKDepartment of Paediatrics, University of Cambridge, Cambridge, UKDepartment of Diabetes, Alder Hey Children`s NHS Foundation Trust, Liverpool, UK15 Department of Paediatrics, University of Oxford, Oxford, UKMurdoch Children’s Research Institute, Parkville, Victoria, Australia9University of Leeds, Leeds Institute of Cardiovascular and Metabolic MedicineCentre for Population Health Sciences, University of Edinburgh, Edinburgh, UKVyoo Agency Sarl, Lyon, FranceJaeb Center for Health Research, Tampa, Florida, USAIntroduction 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.https://bmjopen.bmj.com/content/10/3/e033500.full |
| spellingShingle | 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 Nate Cohen Assessing 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 BMJ Open |
| title | Assessing 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 |
| title_full | Assessing 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 |
| title_fullStr | Assessing 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 |
| title_full_unstemmed | Assessing 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 |
| title_short | Assessing 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 |
| title_sort | assessing 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 |
| url | https://bmjopen.bmj.com/content/10/3/e033500.full |
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