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BMJ Open. 2019 Jun 3;9(6):e027856. doi: 10.1136/bmjopen-2018-027856.

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.

Author information

1
Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
2
Department of Paediatrics, University of Cambridge, Cambridge, UK.
3
Department of Diabetes and Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
4
Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.
5
Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.
6
Department of Paediatric Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
7
Department of Paediatric Endocrinology and Diabetes, Southampton Children's Hospital, Southampton General Hospital, Southampton, UK.
8
Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, Colorado, USA.
9
Department of Pediatrics, Division of Pediatric Endocrinology and Diabetology, Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, Indiana, USA.
10
Division of Pediatric Endocrinology, Stanford University, Stanford, California, USA.
11
Department of Pediatrics, Yale University, New Haven, Connecticut, USA.
12
Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, California, USA.
13
Jaeb Center for Health Research, Tampa, Florida, USA.

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.

KEYWORDS:

artificial pancreas; closed-loop; type 1 diabetes

PMID:
31164368
DOI:
10.1136/bmjopen-2018-027856
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Conflict of interest statement

Competing interests: RH reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panel for Eli Lilly and Novo Nordisk, receiving licence fees from BBraun and Medtronic. RH and MEW report patent patents and patent applications. MT has received speaker honoraria from Medtronic and NovoNordisk. PW reports receiving speaker honoraria from Dexcom and serving on advisory panels for Eli Lilly and Novo Nordisk and research support from Bigfoot Biomedical, Dexcom, Lexicon, Mannkind and Novo Nordisk. BAB is on Advisory Boards for Novo Nordisk and Convatec, has received research support from Medtronic Diabetes, Tandem Diabetes, Insulet, Convatec and Dexcom. SW has received speaker honoraria from Medtronic, Insulet and Tandem, and has received consultant honoraria from Sanofi and Zealand Pharmaceuticals. KH has received research support from Dexcom for an investigator-initiated project; he has received consultant fees from Lilly Innovation Center, Bigfoot Biomedical and Insulet. LDM reports grants from Medtronic.

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