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一项比较1型糖尿病女性孕期先进混合闭环系统的真实世界研究。

A Real-World Study Comparing Advanced Hybrid Closed-Loop Systems During Pregnancy in Women with Type 1 Diabetes.

作者信息

Quirós Carmen, Wägner Ana M, Azriel Sharona, Soldevila Berta, Beato-Vibora Pilar I, Herrera Arranz Mayte, Nattero Lía, Picón-César María José, Climent Elisenda, Amigó Judit, Colomo Natalia, Durán-Martínez María, Alpañes Buesa Macarena, Megía Ana, Vinagre Irene, Vega Guedes Begoña, Díaz-Soto Gonzalo, Bandrés Orosia, Barquiel Beatriz, López Tinoco Cristina, Márquez-Pardo Rosa, Martínez-Brocca Maria A, Corcoy Rosa, Codina Mercè, Piedra María, Rebollo Román Ángel, Cuesta Martín, López-Gallardo Gema, Goya Canino Maria M, Bugatto Fernando, Mendoza Lilian C, Olvera Márquez María Del Pilar, Perea Verónica

机构信息

Hospital Universitari Mútua de Terrassa, Terrassa, Spain.

Complejo Hospitalario Universitario Insular Materno-Infantil de Canarias, Instituto Universitario de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain.

出版信息

Diabetes Technol Ther. 2025 Sep 26. doi: 10.1177/15209156251379488.

Abstract

To compare maternal glucose metrics and pregnancy outcomes of three advanced hybrid closed-loop (aHCL) systems (MiniMed 780G®, CamAPS® FX, and Tandem Control-IQ) in a real-world, multicenter cohort of pregnant women with type 1 diabetes. Cohort study including 137 pregnant women with type 1 diabetes using aHCL from 27 hospitals in Spain. Participants were grouped according to the aHCL system used: 85 MiniMed 780G (62%), 38 CamAPS FX (27.7%), and 14 Control-IQ (10.2%). Maternal glucose metrics (HbA1c and time spent within [TIRp], below [TBRp], and above [TARp] the pregnancy-specific glucose range 3.5-7.8 mmol/L), as well as pregnancy outcomes, were analyzed. Adjusted models were applied to account for potential confounding factors. No between-group differences in HbA1c levels were observed at baseline. By the third trimester, CamAPS FX and Control-IQ users had significantly lower HbA1c levels compared with the MiniMed 780G group (β -4.77 mmol/mol, 95% confidence interval [CI] -7.40 to -2.13; and β -4.79, 95% CI -8.53 to -1.06; respectively). In the second trimester, CamAPS FX was associated with a higher percentage of time in range (β +5.88%, 95% CI 1.09 to 10.67) and a lower percentage of time above range (β -6.36%, 95% CI -11.46 to -1.26) compared with MiniMed 780G, with no other significant differences observed in other trimesters. Both CamAPS FX and Control-IQ were associated with lower odds of large-for-gestational-age (LGA) infants (CamAPS FX: OR 0.25, 95% CI 0.08 to 0.77; Control-IQ: OR 0.10, 95% CI 0.01 to 0.99) compared with MiniMed 780G. In this multicenter observational study, CamAPS FX and Control-IQ users achieved better glycemic metrics and lower odds of delivering LGA infants compared with those using MiniMed 780G. These findings warrant investigation to confirm associations and inform individualized clinical decision-making in pregnant women with type 1 diabetes.

摘要

为比较三种先进的混合闭环(aHCL)系统(美敦力780G®、CamAPS® FX和串联Control-IQ)在患有1型糖尿病的孕妇这一真实世界多中心队列中的母体血糖指标和妊娠结局。队列研究纳入了西班牙27家医院使用aHCL的137名患有1型糖尿病的孕妇。参与者根据所使用的aHCL系统分组:85名使用美敦力780G(62%),38名使用CamAPS FX(27.7%),14名使用Control-IQ(10.2%)。分析了母体血糖指标(糖化血红蛋白[HbA1c]以及在妊娠特异性血糖范围3.5 - 7.8毫摩尔/升内的时间[TIRp]、低于该范围的时间[TBRp]和高于该范围的时间[TARp])以及妊娠结局。应用校正模型以考虑潜在的混杂因素。在基线时未观察到组间HbA1c水平的差异。到孕晚期,与美敦力780G组相比,使用CamAPS FX和Control-IQ的患者HbA1c水平显著更低(β -4.77毫摩尔/摩尔,95%置信区间[CI] -7.40至 -2.13;以及β -4.79,95% CI -8.53至 -1.06)。在孕中期,与美敦力780G相比,CamAPS FX与更高的血糖达标时间百分比(β +5.88%,95% CI 1.09至10.67)和更低的高于目标范围时间百分比(β -6.36%,95% CI -11.46至 -1.26)相关,在其他孕期未观察到其他显著差异。与美敦力780G相比,CamAPS FX和Control-IQ均与巨大儿(LGA)的几率更低相关(CamAPS FX:优势比[OR] 0.25,95% CI 0.08至0.77;Control-IQ:OR 0.10,95% CI 0.01至0.99)。在这项多中心观察性研究中,与使用美敦力780G的患者相比,使用CamAPS FX和Control-IQ的患者实现了更好的血糖指标以及更低的分娩LGA婴儿的几率。这些发现值得进一步研究以确认相关性,并为患有1型糖尿病的孕妇的个体化临床决策提供参考。

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