Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: A randomised controlled trial protocol

Sybil A. McAuley, Martin I. De Bock, Vijaya Sundararajan, Melissa H. Lee, Barbora Paldus, Geoff R. Ambler, Leon A. Bach, Morton G. Burt, Fergus J. Cameron, Philip M. Clarke, Neale D. Cohen, Peter G. Colman, Elizabeth A. Davis, Jan M. Fairchild, Christel Hendrieckx, D. Jane Holmes-Walker, Jodie C. Horsburgh, Alicia J. Jenkins, Joey Kaye, Anthony C. KeechBruce R. King, Kavita Kumareswaran, Richard J. MacIsaac, Roland W. McCallum, Jennifer A. Nicholas, Catriona Sims, Jane Speight, Stephen N. Stranks, Steven Trawley, Glenn M. Ward, Sara Vogrin, Timothy W. Jones, David N. O'Neal

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    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.

    Original languageEnglish
    Article numbere020274
    Number of pages10
    JournalBMJ Open
    Issue number6
    Publication statusPublished - Jun 2018

    Bibliographical note

    Open access This is an Open Access article distributed in accordance with the
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    • adult
    • closed loop
    • type 1 diabetes


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