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.
Allen, Janet M
Buckingham, Bruce A
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Musolino, G., Allen, J. M., Hartnell, S., Wilinska, M., Tauschmann, M., Boughton, C., Campbell, F., et al. (2019). 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.. BMJ open, 9 (6), e027856. https://doi.org/10.1136/bmjopen-2018-027856
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 to 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, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (age ≥ 6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with sub-optimal glycaemic control [glycated haemoglobin ≥58mmol/mol (7.5%) and ≤86mmol/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 to 10mmol/l, 70 to 180mg/dl), mean sensor glucose, and time spent above and below target. Secondary outcomes include standard deviation and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5mmol/l (63mg/dl) and <3.0mmol/l (54mg/dl), area under the curve of glucose <3.5mmol/l (63mg/dl), time with glucose levels >16.7mmol/l (300mg/dl), area under the curve of glucose >10.0mmol/l (180mg/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 (ICER) 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.
Humans, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Treatment Outcome, Insulin Infusion Systems, Pancreas, Artificial, Adolescent, Child, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Insulins, Patient Safety
Wellcome Trust (100574/Z/12/Z)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (UC4DK108520)
Cambridge University Hospitals NHS Foundation Trust (CUH) (146281)
Embargo Lift Date
External DOI: https://doi.org/10.1136/bmjopen-2018-027856
This record's URL: https://www.repository.cam.ac.uk/handle/1810/292053
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