1. Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol
- Author
-
Elizabeth A. Davis, Sybil A McAuley, Fergus J. Cameron, Jennifer Nicholas, David N O'Neal, Geoff Ambler, Elizabeth Geelhoed, Martin de Bock, Jan Fairchild, Timothy W. Jones, Mary B Abraham, Bruce R. King, and Grant J. Smith
- Subjects
Blood Glucose ,Male ,Insulin pump ,medicine.medical_specialty ,Adolescent ,medicine.medical_treatment ,030209 endocrinology & metabolism ,Artificial pancreas ,law.invention ,paediatrics ,Young Adult ,03 medical and health sciences ,Insulin Infusion Systems ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Diabetes mellitus ,Protocol ,medicine ,Humans ,Insulin ,030212 general & internal medicine ,Child ,clinical trials ,Type 1 diabetes ,business.industry ,General Medicine ,medicine.disease ,Clinical trial ,Diabetes and Endocrinology ,Diabetes Mellitus, Type 1 ,Physical therapy ,Female ,business - Abstract
IntroductionAutomated 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 –Methods and analysisThis 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 –Ethics and disseminationEthics 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.
- Published
- 2018
- Full Text
- View/download PDF