TY - JOUR
T1 - Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes
T2 - A randomised controlled trial protocol
AU - McAuley, Sybil A.
AU - De Bock, Martin I.
AU - Sundararajan, Vijaya
AU - Lee, Melissa H.
AU - Paldus, Barbora
AU - Ambler, Geoff R.
AU - Bach, Leon A.
AU - Burt, Morton G.
AU - Cameron, Fergus J.
AU - Clarke, Philip M.
AU - Cohen, Neale D.
AU - Colman, Peter G.
AU - Davis, Elizabeth A.
AU - Fairchild, Jan M.
AU - Hendrieckx, Christel
AU - Holmes-Walker, D. Jane
AU - Horsburgh, Jodie C.
AU - Jenkins, Alicia J.
AU - Kaye, Joey
AU - Keech, Anthony C.
AU - King, Bruce R.
AU - Kumareswaran, Kavita
AU - MacIsaac, Richard J.
AU - McCallum, Roland W.
AU - Nicholas, Jennifer A.
AU - Sims, Catriona
AU - Speight, Jane
AU - Stranks, Stephen N.
AU - Trawley, Steven
AU - Ward, Glenn M.
AU - Vogrin, Sara
AU - Jones, Timothy W.
AU - O'Neal, David N.
N1 - Open access This is an Open Access article distributed in accordance with the
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and license their derivative works on different terms, provided the original work is
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licenses/by-nc/4.0/
© Article author(s) (or their employer(s) unless otherwise stated in the text of the
article) 2018. All rights reserved. No commercial use is permitted unless otherwise
expressly granted
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
KW - adult
KW - closed loop
KW - type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85053114554&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-020274
DO - 10.1136/bmjopen-2017-020274
M3 - Article
C2 - 29886443
AN - SCOPUS:85053114554
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e020274
ER -
