Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol
Sybil A McAuley, Martin de Bock, Vijaya Sundararajan, Melissa H Lee, Barbora Paldus, Geoff R Ambler, Leon A Bach, Morton G Burt, Fergus J Cameron, Philip M Clarke, Neale D Cohen, Peter G Colman, Elizabeth A Davis, Jan M Fairchild, Christel Hendrieckx, D Jane Holmes-Walker, Jodie C Horsburgh, Alicia J Jenkins, Joey Kaye, Anthony C Keech Show all
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2018
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 ..View full abstract
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.