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 - Funding Information:
This study is funded by the Australian Research Council (with the funding administered by JDRF Australia), and by the National Health and Medical Research Council of Australia. Material support is being provided via a grant from the Medtronic External Research Program. SAM is supported by a JDRF Early-Career Patient-Orientated Diabetes Research Award. MIdB was supported by a Raine Clinical Research Fellowship. AJJ is supported by an NHMRC Practitioner Fellowship. JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by Diabetes Victoria and Deakin University.
Funding Information:
Competing interests MIdB and NDC report receiving speaker honoraria from Medtronic. DJHW reports receiving speaker and advisory board honoraria from Medtronic. RWM reports receiving conference travel and accommodation support from Medtronic. JS reports that the ACBRD has received honoraria from Medtronic in relation to her speaking engagements and role in advisory boards. DNON reports receiving speaker honoraria and research grants from Medtronic.
Funding Information:
Funding This study is funded by the Australian Research Council (with the funding administered by JDRF Australia), and by the National Health and Medical Research Council of Australia. Material support is being provided via a grant from the Medtronic External Research Program. SAM is supported by a JDRF Early-Career Patient-Orientated Diabetes Research Award. MIdB was supported by a Raine Clinical Research Fellowship. AJJ is supported by an NHMRC Practitioner Fellowship. JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by Diabetes Victoria and Deakin University. disclaimer The study funders and sponsor did not have any role in study design or contribution to the manuscript, and they will not be involved in collection, management, analysis or interpretation of the data. The study funders will not have any role in writing the study report or the decision to submit the report for publication.
Publisher Copyright:
© 2018 Article author(s).
PY - 2018/6/1
Y1 - 2018/6/1
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 -
