Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study
Thomas Crabtree, Tomás P. Griffin, Yew W. Yap, Parth Narendran, Geraldine Gallen, Niall Furlong, Iain Cranston, Ali Chakera, Chris Philbey, Muhammad Ali Karamat, Sanjay Saraf, Shafie Kamaruddin, Eleanor Gurnell, Alyson Chapman, Sufyan Hussain, Jackie Elliott, Lalantha Leelarathna, Robert E. J. Ryder, Peter Hammond, Alistair Lumb, Pratik Choudhary, Emma G. Wilmot, The ABCD Closed-Loop Audit Contributors, Mark Evans, Eleanor Gurnell, Sara Hartnell, Katy Davenport, Iona O’Reilly, Helen Brown, Shafie Kamaruddin, Sharon Pickering, Kamal Abouglia, Claire Wadham, Gerry Rayman, Sufyan Hussain, Anna Brackenridge, Siobhan Pender, Rosarie Atkinson, Melanie Bahadur, Hatem Eid, Janet Carling, Linzi Oldfield, Christopher Philbey, Peter Hammond, Sean Haywood, Geraldine Gallen, Helen Rodgers, Kaylee Lovie, Emma Whight, Georgia Nobel-Bell, Sophie Harris, Anne Cartwright, Ian Garnett, Jennifer Harvey, Frances McCulloch, Yew Wen Yap, Philip J. Weston, Alyson Chapman, Lynne Ann Findlow, Lalantha Leelarathna, Sheetal Ohol, Hood Thabit, Andrea Urwin, Darron Cowlam, Sonia Thomas, Emma Hyland, Zoey Yearsley, Johnathan Schofield, Clare Soar, Laura Fenn, Budd Mendis, Zin Zin Htike, Elizabeth Cheyne, Julie Emsley, Elisabeth Jones, Vernon Parfitt, Lynn Sawyer, Santo Colosimo, Shani Apsara, Dilrukshi Mathara Diddhenipothage, Alistar Lumb, Katie Hards, Florence Edohen, Sue Beaden, Iain Cranston, Julie Taylor, Lisa A. Skinner, Zosanglura Bawlchhim, B. Tuthill, MELISSA L. CULL, Robert E. J. Ryder, Sarah Mitchell, Jill Rimell, Clare Foley, Carla Gianfrancesco, Daisy Elliott, Sally Butter, Giorgio Carrieri, Isy Douek, Rhodri King
Abstract
OBJECTIVE: We explored longitudinal changes associated with switching to hybrid closed-loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. RESEARCH DESIGN AND METHODS: We undertook a pragmatic, preplanned observational study of participants included in the National Health Service England closed-loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with an HbA1c ≥8.5% who were willing to commence HCL therapy were included. Outcomes included change in HbA1c, sensor glucometrics, diabetes distress score, Gold score (hypoglycemia awareness), acute event rates, and user opinion of HCL. RESULTS: In total, 570 HCL users were included (median age 40 [IQR 29-50] years, 67% female, and 85% White). Mean baseline HbA1c was 9.4 ± 0.9% (78.9 ± 9.1 mmol/mol) with a median follow-up of 5.1 (IQR 3.9-6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8; P < 0.0001) (18.1 mmol/mol [95% CI 16.6, 19.6]; P < 0.0001). Time in range (70-180 mg/dL) increased from 34.2 to 61.9% (P < 0.001). Individuals with HbA1c of ≤58 mmol/mol rose from 0 to 39.4% (P < 0.0001), and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8 to 28.2% (P < 0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7% [540 of 570]). CONCLUSIONS: Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia, and diabetes-related distress and quality of life in people with type 1 diabetes in the real world.