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


ABSTRACT:

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.

Trial registration number

ACTRN12617000520336; Pre-results.

SUBMITTER: McAuley SA 

PROVIDER: S-EPMC6009467 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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

McAuley Sybil A SA   de Bock Martin I MI   Sundararajan Vijaya V   Lee Melissa H MH   Paldus Barbora B   Ambler Geoff R GR   Bach Leon A LA   Burt Morton G MG   Cameron Fergus J FJ   Clarke Philip M PM   Cohen Neale D ND   Colman Peter G PG   Davis Elizabeth A EA   Fairchild Jan M JM   Hendrieckx Christel C   Holmes-Walker D Jane DJ   Horsburgh Jodie C JC   Jenkins Alicia J AJ   Kaye Joey J   Keech Anthony C AC   King Bruce R BR   Kumareswaran Kavita K   MacIsaac Richard J RJ   McCallum Roland W RW   Nicholas Jennifer A JA   Sims Catriona C   Speight Jane J   Stranks Stephen N SN   Trawley Steven S   Ward Glenn M GM   Vogrin Sara S   Jones Timothy W TW   O'Neal David N DN  

BMJ open 20180609 6


<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This open-label, seven-centre, randomise  ...[more]

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