Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study

作者：Tara Lee, Corinne Collett, Simon Bergford, Sara Hartnell, Eleanor Scott, Robert S. Lindsay, Katharine F. Hunt, David R. McCance, Rebecca M. Reynolds, Malgorzata E. Wilinska, Judy Sibayan, Craig Kollman, Roman Hovorka, Helen R. Murphy, Helen R Murphy, Katharine F Hunt, Helen Rogers, Damian Morris, Duncan Fowler, Josephine Rosier, Zeenat Banu, Sarah Barker, Gerry Rayman, Eleanor Gurnell, Caroline Byrne, Andrea Lake, Katy Davenport, Jeannie Grisoni, Shannon Savine, Helen R Murphy, Helen R Murphy, Tara T M Lee, Tara Wallace, Alastair McKelvey, Nina Willer, Corinne Collett, Mei-See Man, Emma Flanagan, Matt Hammond, Lee Shepstone, Anna Brackenridge, Sara White, Anna Reid, Olanike Okolo, Eleanor Scott, Del Endersby, Anna Dover, Frances Dougherty, Susan Johnstone, Rebecca M Reynolsd, Robert S Lindsay, David Carty, Sharon Mackin, Isobel Crawford, Ross Buchan, David McCance, Louisa Jones, Joanne Quinn, Sarah Cains, Goher Ayman · 发表于：The Lancet Diabetes & Endocrinology · 年份：2025 · DOI：10.1016/s2213-8587(24)00340-1 · 被引用次数：22 · 研究领域：Gestational Diabetes Research and Management、Diabetes Management and Research、Hyperglycemia and glycemic control in critically ill and hospitalized patients

BACKGROUND: Clinical guidelines in the UK and elsewhere do not specifically address hybrid closed loop (HCL) use in the postpartum period when the demands of caring for a newborn are paramount. Our aim was to evaluate the safety and efficacy of HCL use during the first 6 months postpartum compared with standard care. METHODS: In this prespecified extension to a multicentre, randomised controlled trial, pregnant women with type 1 diabetes at nine UK sites were followed up for 6 months postpartum. Eligible participants (AiDAPT participants recruited after the implementation of the postpartum protocol amendment approval, those still pregnant or within six months of delivery at the time of amendment implementation and still using HCL or continuous glucose monitoring [CGM] therapy) continued their randomly assigned treatment, either standard insulin therapy with CGM or HCL therapy (CamAPS FX system version 0.3.1, CamDiab, Cambridge, UK). Participants were randomised in a 1:1 ratio with stratification by clinical site using randomly permuted block sizes of 2 or 4. The primary outcome was the between-group difference in percentage time in range ([TIR] 3·9-10·0 mmol/L [70-180mg/dL]), measured during the periods of month 0 up to 3, months 3 to 6, and over 6 months postpartum. The study is registered at ClinicalTrials.gov (ISRCTN56898625) and is complete. FINDINGS: 59·4 mmol/mol (SD 10·5 [7·6% SD 1·0%]). In the 6 months postpartum, mean time with glucose levels within the target range ...