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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
  1. Martin de Bock1,2,3,
  2. Sybil A McAuley4,5,
  3. Mary Binsu Abraham1,2,3,
  4. Grant Smith2,
  5. Jennifer Nicholas1,2,
  6. Geoff R Ambler6,
  7. Fergus J Cameron7,8,
  8. Jan M Fairchild9,
  9. Bruce R King10,11,
  10. Elizabeth A Geelhoed9,
  11. Elizabeth A Davis1,2,3,
  12. David Norman O’Neal4,5,
  13. Timothy W Jones1,2,3
  14. on behalf of the Australian JDRF Closed-Loop Research Group
    1. 1 Department of Endocrinology and Diabetes, Perth Children’s Hospital, Perth, Western Australia, Australia
    2. 2 Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia
    3. 3 School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia
    4. 4 Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
    5. 5 Department of Endocrinology and Diabetes, St Vincent’s Hospital Melbourne, Melbourne, Victoria, Australia
    6. 6 Institute of Endocrinology and Diabetes, The Children’s Hospital at Westmead, Sydney, New South Wales, Australia
    7. 7 Department of Endocrinology and Diabets Centre for Hormone Research, Royal Children’s Hospital and Murdoch Children’s Research Institute, Parkville, Victoria, Australia
    8. 8 Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia
    9. 9 Endocrinology and Diabetes Centre, Women’s and Children’s Hospital, Adelaide, South Australia, Australia
    10. 10 Department of Endocrinology and Diabetes, John Hunter Children’s Hospital, Newcastle, New South Wales, Australia
    11. 11 School of Allied Health, The University of Western Australia, Perth, Western Australia, Australia
    1. Correspondence to Professor Timothy W Jones; Tim.Jones{at}health.wa.gov.au

    Abstract

    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.

    • clinical trials
    • paediatrics

    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/.

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    Footnotes

    • Contributors MB, SAM, MBA and JN contributed to the study design and were responsible for writing the detailed protocol. TWJ, EAD and DNO were responsible for study concept and design and provided expert opinion and oversight during protocol development. GS provided statistical analyses input. EAG provided input to the protocol that will inform health economic data. GRA, FJC, JMF and BRK reviewed and refined the study protocol to ensure feasibility at the non-lead sites.

    • Funding The study is supported by Juvenile Diabetes Research Foundation (JDRF) Australia, the recipient of the Australia Research Council Special Research Initiative in Type 1 Juvenile Diabetes. MDB was funded by Western Australia Department of Health and the Raine Medical Research Foundation, and the Australian Type 1 Diabetes Clinical Research Network initiative undertaken by the JDRF Australia supported by funding from the Australian Government Department of Health and Ageing. SAM is supported by a JDRF Early-Career Patient-Orientated Diabetes Research Award. Insulin pumps, transmitter and glucose sensors were provided by Medtronic via an unrestricted grant. MA was supported by JDRF Australia, the recipient of the Australian Research Council Special Research Initiative in Type 1 Juvenile Diabetes.

    • Disclaimer Medtronic has no role in the design and conduct of the study; data collection, analysis and interpretation of the data; the preparation, review or approval of the manuscript; and decision to submit the manuscript.

    • Competing interests MB reports receiving speaker honoraria from Medtronic. DNO reports receiving speaker honoraria and research grants from Medtronic.

    • Patient consent Not required.

    • Ethics approval Princess Margaret Hospital Ethics Committee Perth(HREC/2016087EP).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators Leon A Bach; Morton G Burt; Philip M Clarke; Neale D Cohen; Peter G Colman; Christel Hendrieckx; D Jane Holmes-Walker; Jodie C Horsburgh; Alicia J Jenkins; Joey Kaye; Anthony C Keech; Kavita Kumareswaran; Melissa H Lee; Richard J MacIsaac; Roland W McCallum; Barbora Paldus; Catriona Sims; Jane Speight; Stephen N Stranks; Vijaya Sundararajan; Steven Trawley; Sara Vogrin; Glenn M Ward.

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