TY - JOUR
T1 - Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes
T2 - a randomised controlled trial protocol
AU - Australian JDRF Closed-Loop Research Group
AU - De Bock, Martin
AU - McAuley, Sybil A.
AU - Abraham, Mary Binsu
AU - Smith, Grant
AU - Nicholas, Jennifer
AU - Ambler, Geoff R.
AU - Cameron, Fergus J.
AU - Fairchild, Jan M.
AU - King, Bruce R.
AU - Geelhoed, Elizabeth A.
AU - Davis, Elizabeth A.
AU - O'Neal, David Norman
AU - Jones, Timothy W.
AU - Bach, Leon A.
AU - Burt, Morton G.
AU - Clarke, Philip M.
AU - Cohen, Neale D.
AU - Colman, Peter G.
AU - Hendrieckx, Christel
AU - Holmes-Walker, D. Jane
AU - Horsburgh, Jodie C.
AU - Jenkins, Alicia J.
AU - Kaye, Joey
AU - Keech, Anthony C.
AU - Kumareswaran, Kavita
AU - Lee, Melissa H.
AU - MacIsaac, Richard J.
AU - McCallum, Roland W.
AU - Paldus, Barbora
AU - Sims, Catriona
AU - Speight, Jane
AU - Stranks, Stephen N.
AU - Sundararajan, Vijaya
AU - Trawley, Steven
AU - Vogrin, Sara
AU - Ward, Glenn M.
N1 - Copyright information: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
PY - 2018/8
Y1 - 2018/8
N2 - 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.
AB - 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.
KW - clinical trials
KW - paediatrics
KW - randomised controlled trial
KW - type 1 diabetes
KW - closed-loop insulin delivery
KW - hybrid closed-loop insulin delivery
UR - http://www.scopus.com/inward/record.url?scp=85051772588&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-020275
DO - 10.1136/bmjopen-2017-020275
M3 - Article
C2 - 30104309
AN - SCOPUS:85051772588
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e020275
ER -
