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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, de Bock, Martin I, Sundararajan, Vijaya, Lee, Melissa H, Paldus, Barbora, Ambler, Geoff R, Bach, Leon A, Burt, Morton G, Cameron, Fergus J, Clarke, Philip M, Cohen, Neale D, Colman, Peter G, Davis, Elizabeth A, Fairchild, Jan M, Hendrieckx, Christel, Holmes-Walker, D Jane, Horsburgh, Jodie C, Jenkins, Alicia J, Kaye, Joey, Keech, Anthony C, King, Bruce R, Kumareswaran, Kavita, MacIsaac, Richard J, McCallum, Roland W, Nicholas, Jennifer A, Sims, Catriona, Speight, Jane, Stranks, Stephen N, Trawley, Steven, Ward, Glenn M, Vogrin, Sara, Jones, Timothy W and O'Neal, David N 2018, Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol, BMJ open, vol. 8, no. 6, pp. 1-10, doi: 10.1136/bmjopen-2017-020274.

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Title Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol
Author(s) McAuley, Sybil A
de Bock, Martin I
Sundararajan, Vijaya
Lee, Melissa H
Paldus, Barbora
Ambler, Geoff R
Bach, Leon A
Burt, Morton G
Cameron, Fergus J
Clarke, Philip M
Cohen, Neale D
Colman, Peter G
Davis, Elizabeth A
Fairchild, Jan M
Hendrieckx, ChristelORCID iD for Hendrieckx, Christel orcid.org/0000-0002-0075-828X
Holmes-Walker, D Jane
Horsburgh, Jodie C
Jenkins, Alicia J
Kaye, Joey
Keech, Anthony C
King, Bruce R
Kumareswaran, Kavita
MacIsaac, Richard J
McCallum, Roland W
Nicholas, Jennifer A
Sims, Catriona
Speight, JaneORCID iD for Speight, Jane orcid.org/0000-0002-1204-6896
Stranks, Stephen N
Trawley, Steven
Ward, Glenn M
Vogrin, Sara
Jones, Timothy W
O'Neal, David N
Journal name BMJ open
Volume number 8
Issue number 6
Article ID e020274
Start page 1
End page 10
Total pages 10
Publisher BMJ Publishing Group
Place of publication London, Eng.
Publication date 2018-06
ISSN 2044-6055
Keyword(s) adult
closed loop
type 1 diabetes
science & technology
life sciences & biomedicine
Summary 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.
Language eng
DOI 10.1136/bmjopen-2017-020274
Field of Research 170106 Health, Clinical and Counselling Psychology
Socio Economic Objective 920104 Diabetes
HERDC Research category C1 Refereed article in a scholarly journal
Grant ID JDRF 201302573
Copyright notice ©2018, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30109416

Document type: Journal Article
Collections: School of Psychology
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.