Quirós Carmen, Herrera Arranz María Teresa, Amigó Judit, Wägner Ana M, Beato-Vibora Pilar I, Azriel-Mira Sharona, Climent Elisenda, Soldevila Berta, Barquiel Beatriz, Colomo Natalia, Durán-Martínez María, Corcoy Rosa, Codina Mercedes, Díaz-Soto Gonzalo, Márquez Pardo Rosa, Martínez-Brocca Maria A, Rebollo Román Ángel, López-Gallardo Gema, Cuesta Martín, García Fernández Javier, Goya Maria, Vega Guedes Begoña, Mendoza Mathison Lillian C, Perea Verónica
Endocrinology Department, Hospital Universitari Mútua de Terrassa, Terrassa, Spain.
Endourology Department, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain.
Diabetes Technol Ther. 2024 Aug;26(8):596-606. doi: 10.1089/dia.2023.0594. Epub 2024 May 24.
To compare glycemic control and maternal-fetal outcomes of women with type 1 diabetes (T1D) using hybrid closed loop (HCL) versus multiple daily insulin injections (MDI) plus continuous glucose monitoring. Multicenter prospective cohort study of pregnant women with T1D in Spain. We evaluated HbA1c and time spent within (TIR), below (TBR), and above (TAR) the pregnancy-specific glucose range of 3.5-7.8 mmol/L. Adjusted models were performed for adverse pregnancy outcomes, including baseline maternal characteristics and center. One hundred twelve women were included (HCL = 59). Women in the HCL group had a longer duration of diabetes and higher rates of prepregnancy care. There was no between-group difference in HbA1c in any trimester. However, in the second trimester, MDI users had a greater decrease in HbA1c (-6.12 ± 9.06 vs. -2.16 ± 7.42 mmol/mol, = 0.031). No difference in TIR (3.5-7.8 mmol/L) and TAR was observed between HCL and MDI users, but with a higher total insulin dose in the second trimester [+0.13 IU/kg·day)]. HCL therapy was associated with increased maternal weight gain during pregnancy (β = 3.20 kg, 95% confidence interval [CI] 0.90-5.50). Regarding neonatal outcomes, newborns of HCL users were more likely to have higher birthweight (β = 279.0 g, 95% CI 39.5-518.5) and macrosomia (OR = 3.18, 95% CI 1.05-9.67) compared to MDI users. These associations disappeared when maternal weight gain or third trimester HbA1c was included in the models. In a real-world setting, HCL users gained more weight during pregnancy and had larger newborns than MDI users, while achieving similar glycemic control in terms of HbA1c and TIR.
比较使用混合闭环（HCL）与多次每日胰岛素注射（MDI）加持续葡萄糖监测的1型糖尿病（T1D）女性的血糖控制情况及母婴结局。对西班牙患有T1D的孕妇进行多中心前瞻性队列研究。我们评估了糖化血红蛋白（HbA1c）以及在妊娠特异性血糖范围3.5 - 7.8 mmol/L内（TIR）、低于（TBR）和高于（TAR）该范围的时间。针对不良妊娠结局进行了校正模型分析，包括基线产妇特征和中心因素。共纳入112名女性（HCL组 = 59名）。HCL组女性糖尿病病程更长，孕前保健率更高。在任何孕周，两组间HbA1c均无差异。然而，在孕中期，MDI使用者的HbA1c下降幅度更大（-6.12 ± 9.06 vs. -2.16 ± 7.42 mmol/mol，P = 0.031）。HCL组和MDI使用者之间在TIR（3.5 - 7.8 mmol/L）和TAR方面未观察到差异，但孕中期总胰岛素剂量更高[+0.13 IU/kg·天]。HCL治疗与孕期产妇体重增加有关（β = 3.20 kg，95%置信区间[CI] 0.90 - 5.50）。关于新生儿结局，与MDI使用者相比，HCL使用者的新生儿更有可能出生体重更高（β = 279.0 g，95% CI 39.5 - 518.5）和发生巨大儿（OR = 3.18，95% CI 1.05 - 9.67）。当模型中纳入产妇体重增加或孕晚期HbA1c时，这些关联消失。在实际临床环境中，HCL使用者在孕期体重增加更多，新生儿更大，而在HbA1c和TIR方面实现了相似的血糖控制。
