Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial

作者：Martin Tauschmann, Hood Thabit, Lia Bally, Janet M. Allen, Sara Hartnell, Malgorzata E. Wilinska, Yue Ruan, Judy Sibayan, Craig Kollman, Peiyao Cheng, Roy W. Beck, Carlo L. Acerini, Mark L. Evans, David B. Dunger, Daniela Elleri, Fiona Campbell, Richard M. Bergenstal, Amy Criego, Viral N. Shah, Lalantha Leelarathna, Roman Hovorka, Barvan Alvarado, Charlotte Ashanti, Julie Baggott, Karthirani Balakrishnan, Nicole Barber, Louise Bath, Shannon Beasley, Christie Beatson, Sarah Borgman, Shenan Bradshaw, Brian Bugielski, A Carlson, Emily Collett, Jane Curtis, Jamie K. Demmitt, Denise Donahue, Jane Exall, Rachel Forshaw, Josephine Hayes, S. K. Heath, Andrzej Hellmann, Viki Huegel, Jamie Hyatt, Linda James, H Joseph, Prakriti Joshee, Wanda Konerza, John W. Lum, M. Madden, Thomas W. Martens, Chris McCarthy, Morag McDonald, Vera Mikityuk, Harriet Miles, Debbie Miller, Womba Mubita, Cairo Murphy, Beth A. Olson, Rebecca Pad, Naga Lokesh Chowdari Patibandla, Key Riding, Angel Shaju, Ludivine Thomas, Jane Thomson, Dawn White, Stefanie Yau, James Yong · 发表于：The Lancet · 年份：2018 · DOI：10.1016/s0140-6736(18)31947-0 · 被引用次数：441 · 研究领域：Diabetes Management and Research、Pancreatic function and diabetes、Diabetes and associated disorders

Background The achievement of glycaemic control remains challenging for patients with type 1 diabetes. We assessed the effectiveness of day-and-night hybrid closed-loop insulin delivery compared with sensor-augmented pump therapy in people with suboptimally controlled type 1 diabetes aged 6 years and older. Methods In this open-label, multicentre, multinational, single-period, parallel randomised controlled trial, participants were recruited from diabetes outpatient clinics at four hospitals in the UK and two centres in the USA. We randomly assigned participants with type 1 diabetes aged 6 years and older treated with insulin pump and with suboptimal glycaemic control (glycated haemoglobin [HbA 1c ] 7·5–10·0%) to receive either hybrid closed-loop therapy or sensor-augmented pump therapy over 12 weeks of free living. Training on study insulin pump and continuous glucose monitoring took place over a 4-week run-in period. Eligible subjects were randomly assigned using central randomisation software. Allocation to the two study groups was unblinded, and randomisation was stratified within centre by low (<8·5%) or high (≥8·5%) HbA 1c . The primary endpoint was the proportion of time that glucose concentration was within the target range of 3·9–10·0 mmol/L at 12 weeks post randomisation. Analyses of primary outcome and safety measures were done in all randomised patients. The trial is registered with ClinicalTrials.gov, number NCT02523131, and is closed to accrual. Findings From Ma...