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

De Bock, M., McAuley, S. A., Abraham, M. B., Smith, G., Nicholas, J., Ambler, G. R., Cameron, F. J., Fairchild, J. M., King, B. R., Geelhoed, E. A., Davis, E. A., O'Neal, D. N., Jones, T.W ., Bach, L. A., Burt, M. G., Clarke, P. M., Cohen, N. D., Colman, P. G., Hendrieckx, C., Holmes-Walker, D. J., Horsburgh, J. C., Jenkins, A. J., Kaye, J., Keech, A.C ., Kumareswaran, K., Lee, M. H., MacIsaac, R. J., McCallum, R. W., Paldus, B., Sims, C., Speight, J., Stranks, S. N., Sundararajan, V., Trawley, S., Vogrin, S. and Ward, G. M. 2018, Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol, BMJ Open, vol. 8, no. 8, doi: 10.1136/bmjopen-2017-020275.

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Title Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol
Author(s) De Bock, M.
McAuley, S. A.
Abraham, M. B.
Smith, G.
Nicholas, J.
Ambler, G. R.
Cameron, F. J.
Fairchild, J. M.
King, B. R.
Geelhoed, E. A.
Davis, E. A.
O'Neal, D. N.
Jones, T.W .
Bach, L. A.
Burt, M. G.
Clarke, P. M.
Cohen, N. D.
Colman, P. G.
Hendrieckx, C.ORCID iD for Hendrieckx, C. orcid.org/0000-0002-0075-828X
Holmes-Walker, D. J.
Horsburgh, J. C.
Jenkins, A. J.
Kaye, J.
Keech, A.C .
Kumareswaran, K.
Lee, M. H.
MacIsaac, R. J.
McCallum, R. W.
Paldus, B.
Sims, C.
Speight, J.ORCID iD for Speight, J. orcid.org/0000-0002-1204-6896
Stranks, S. N.
Sundararajan, V.
Trawley, S.ORCID iD for Trawley, S. orcid.org/0000-0002-0917-730X
Vogrin, S.
Ward, G. M.
Journal name BMJ Open
Volume number 8
Issue number 8
Total pages 8
Publisher BMJ Open
Place of publication London, Eng.
Publication date 2018-08-13
ISSN 2044-6055
Summary  Introduction Automated insulin delivery (also known as closed loop, or artificial pancreas) has shown potential to improve glycaemic control and quality of life in people with type 1 diabetes (T1D). Automated insulin delivery devices incorporate an insulin pump with continuous glucose monitoring(CGM) and an algorithm, and adjust insulin in real time. This study aims to establish the safety and efficacy of a hybrid closed-loop (HCL) system in a long-term outpatient trial in people with T1D aged 12 -<25 years of age, and compare outcomes with standard therapy for T1D as used in the contemporary community.

Methods and analysis
This is an open-label, multicentre, 6-month, randomised controlled home trial to test the MiniMed Medtronic 670G system (HCL) in people with T1D aged 12 -<25 years, and compare it to standard care (multiple daily injections or continuous subcutaneous insulin infusion (CSII), with or without CGM). Following a run-in period including diabetes and carbohydrate counting education, dosage optimisation and baseline glucose control data collection, participants are randomised to either HCL or to continue on their current treatment regimen. The primary aim of the study is to compare the proportion of time spent in target sensor glucose range (3.9-10.0 mmol/L) on HCL versus standard therapy. Secondary aims include a range of glucose control parameters, psychosocial measures, health economic measures, biomarker status, user/technology interactions and healthcare professional expectations. Analysis will be intention to treat. A study in adults with an aligned design is being conducted in parallel to this trial.

Ethics and dissemination Ethics committee permissions were gained from respective institutional review boards. The findings of the study will provide high-quality evidence on the role of HCL in clinical practice.
Language eng
DOI 10.1136/bmjopen-2017-020275
HERDC Research category C1 Refereed article in a scholarly journal
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:30114024

Document type: Journal Article
Collections: School of Psychology
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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.