Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol
Year: 2019
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes. METHODS AND ANALYSIS: The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2-3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9-10 mmol/L, 70-180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated. ETHICS AND DISSEMINATION: Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02925299; Pre-results.
Source: BMJ Open
Authors: Gianluca Musolino, Janet M Allen, Sara Hartnell, Malgorzata E Wilinska, Martin Tauschmann, Charlotte Boughton, Fiona Campbell, Louise Denvir, Nicola Trevelyan, Paul Wadwa, Linda DiMeglio, Bruce A Buckingham, Stuart Weinzimer, Carlo L Acerini, Korey Hood, Steven Fox, Craig Kollman, Judy Sibayan, Sarah Borgman, Peiyao Cheng, Roman Hovorka
Institutions: University of Cambridge, Wellcome/MRC Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, Medical University of Vienna, Leeds Teaching Hospitals NHS Trust, Nottingham University Hospitals NHS Trust, Southampton General Hospital, Southampton Children's Hospital, University of Colorado Anschutz, Indiana University Indianapolis, Indiana University School of Medicine, Indiana University – Purdue University Indianapolis, Stanford Medicine, Stanford University, Yale University, University of Southern California, Jaeb Center for Health Research
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Funders: Wellcome Trust, National Institute for Health and Care Research, Cambridge University Hospitals, National Institutes of Health, Abbott Diabetes Care, NIHR Cambridge Biomedical Research Centre, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Advancing Translational Sciences
OpenAlex ID: W2948187632