Lee Tara T M, Collett Corinne, Bergford Simon, Hartnell Sara, Scott Eleanor M, Lindsay Robert S, Hunt Katharine F, McCance David R, Reynolds Rebecca M, Wilinska Malgorzata E, Sibayan Judy, Kollman Craig, Hovorka Roman, Murphy Helen R
Norwich Medical School, University of East Anglia, Norwich, UK; Diabetes and Antenatal Care, Norfolk and Norwich NHS Foundation Trust, Norwich, UK.
Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Lancet Diabetes Endocrinol. 2025 Mar;13(3):210-220. doi: 10.1016/S2213-8587(24)00340-1. Epub 2025 Jan 27.
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: Of the 124 AiDAPT trial participants, 66 (53%) were ineligible for inclusion in the postpartum extension, and 57 participants consented to continue their treatment per original random allocation. The mean age was 31 years (SD 4), and all participants had early pregnancy HbA 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 was higher in the HCL group compared with the standard care group (72% [SD 12%] vs 54% [17%]), with an adjusted treatment difference of 15% (95% CI 7 to 22). Results for hyperglycaemia (>10·0 mmol/L) and mean CGM glucose also favoured HCL (-14% [95% CI -23% to -6%] and -1·3 mmol/L [-2·3 to -0·3], respectively). Hypoglycaemia rates were low, with no between-group differences (2·4% vs 2·6%). There were no treatment effect changes depending on postpartum period (0 up to 3 months vs 3 to 6 months) and no unanticipated safety problems. INTERPRETATION: Participants in the HCL group maintained 70% TIR during the first 6 months postpartum, supporting continued use of HCL rather than standard insulin therapy for people with diabetes once they have given birth. FUNDING: National Institute for Health Research, Juvenile Diabetes Research Foundation, and Diabetes Research & Wellness Foundation. CGM devices were provided by Dexcom at a discounted price.
背景:在英国及其他地区,临床指南并未专门涉及产后这一需要全身心照顾新生儿的时期使用混合闭环(HCL)的情况。我们的目的是评估产后前6个月使用HCL相较于标准护理的安全性和有效性。 方法:在这项对一项多中心随机对照试验的预先设定的扩展研究中,英国9个地点的1型糖尿病孕妇在产后接受了6个月的随访。符合条件的参与者(在产后方案修正案批准实施后招募的AiDAPT参与者,即在修正案实施时仍怀孕或在分娩后6个月内且仍在使用HCL或持续葡萄糖监测[CGM]治疗的参与者)继续接受其随机分配的治疗,即标准胰岛素联合CGM治疗或HCL治疗(CamAPS FX系统版本0.3.1,英国剑桥的CamDiab公司)。参与者按1:1的比例随机分组,根据临床地点分层,使用随机排列的2或4的区组大小。主要结局是产后0至3个月、3至6个月以及产后6个月期间测量的血糖在目标范围内的时间百分比([TIR] 3.9 - 10.0 mmol/L [70 - 180mg/dL])的组间差异。该研究已在ClinicalTrials.gov注册(ISRCTN56898625)且已完成。 结果:在124名AiDAPT试验参与者中,66名(53%)不符合纳入产后扩展研究的条件,57名参与者同意按照最初的随机分配继续治疗。平均年龄为31岁(标准差4),所有参与者孕早期糖化血红蛋白为59.4 mmol/mol(标准差10.5 [7.6% 标准差1.0%])。在产后6个月,HCL组血糖水平在目标范围内的平均时间高于标准护理组(72% [标准差12%] 对54% [17%]),调整后的治疗差异为15%(95%置信区间7至22)。高血糖(>10.0 mmol/L)和平均CGM血糖结果也有利于HCL组(分别为 - 14% [95%置信区间 - 23%至 - 6%] 和 - 1.3 mmol/L [- 2.3至 - 0.3])。低血糖发生率较低,组间无差异(2.4%对2.6%)。根据产后时期(0至3个月对3至6个月)没有治疗效果变化,也没有出现意外的安全问题。 解读:HCL组参与者在产后前6个月维持了70%的血糖在目标范围内的时间,这支持糖尿病患者产后继续使用HCL而非标准胰岛素治疗。 资助:英国国家卫生研究院、青少年糖尿病研究基金会和糖尿病研究与健康基金会。CGM设备由德康公司以折扣价提供。
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