1. Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol
- Author
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Stephen N Stranks, Joey Kaye, Jan Fairchild, D Jane Holmes-Walker, Christel Hendrieckx, Vijaya Sundararajan, Morton G. Burt, Martin de Bock, Leon A. Bach, Jane Speight, Richard J MacIsaac, David N O'Neal, Glenn M. Ward, Steven Trawley, Jennifer A. Nicholas, Fergus J. Cameron, Elizabeth A. Davis, Roland W. McCallum, Neale Cohen, Catriona M. Sims, Kavita Kumareswaran, Philip Clarke, Jodie C. Horsburgh, Alicia J. Jenkins, Timothy W. Jones, Sybil A McAuley, Sara Vogrin, Geoff Ambler, Bruce R. King, Melissa H Lee, Peter G. Colman, Barbora Paldus, and Anthony C Keech
- Subjects
Insulin pump ,Adult ,Blood Glucose ,medicine.medical_specialty ,Time Factors ,type 1 diabetes ,medicine.medical_treatment ,030209 endocrinology & metabolism ,closed loop ,Artificial pancreas ,Diabetes Therapy ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Insulin Infusion Systems ,Randomized controlled trial ,law ,Diabetes mellitus ,medicine ,Protocol ,Humans ,Hypoglycemic Agents ,Insulin ,Multicenter Studies as Topic ,030212 general & internal medicine ,Prospective Studies ,Randomized Controlled Trials as Topic ,Glycated Hemoglobin ,Type 1 diabetes ,business.industry ,Blood Glucose Self-Monitoring ,Australia ,General Medicine ,medicine.disease ,Home Care Services ,Hypoglycemia ,Clinical trial ,Diabetes and Endocrinology ,Diabetes Mellitus, Type 1 ,Treatment Outcome ,Emergency medicine ,Quality of Life ,Regression Analysis ,business - Abstract
IntroductionManual 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 analysisThis 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 disseminationThe 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.Trial registration numberNCT12617000520336.
- Published
- 2018