Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol.
McAuley SA1,2, de Bock MI3,4,5, Sundararajan V1, Lee MH1,2, Paldus B1, Ambler GR6, Bach LA7,8, Burt MG9,10, Cameron FJ11,12,13, Clarke PM14, Cohen ND15, Colman PG16, Davis EA3,4,5, Fairchild JM17, Hendrieckx C18,19, Holmes-Walker DJ20,21, Horsburgh JC2, Jenkins AJ1,2,22, Kaye J23, Keech AC22, King BR24, Kumareswaran K7,15, MacIsaac RJ1,2, McCallum RW25, Nicholas JA3,4, Sims C1, Speight J18,19, Stranks SN9,10, Trawley S19,26, Ward GM2,27, Vogrin S1, Jones TW3,4, O'Neal DN1,2.
INTRODUCTION:
Manual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months' closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes.
METHODS AND ANALYSIS:
This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users.
ETHICS AND DISSEMINATION:
The study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications.
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