Abstract：
Aims: 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. Methods: 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. Results: One hundred twelve women were included (HCL n = 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, P = 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 (βadjusted = 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 (βadjusted = 279.0 g, 95% CI 39.5-518.5) and macrosomia (ORadjusted = 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. Conclusions: 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.
摘要：
目的：比较使用混合闭环（HCL）与每日多次胰岛素注射（MDI）加连续血糖监测的1型糖尿病（T1D）妇女的血糖控制和母婴结局。方法：西班牙T1D孕妇的多中心前瞻性队列研究。我们评估了HbA1c和在(TIR)内花费的时间，下面（TBR），和以上（TAR），妊娠特异性葡萄糖范围为3.5-7.8mmol/L。调整后的模型用于不良妊娠结局，包括基线产妇特征和中心。结果：112名妇女被纳入（HCLn=59）。HCL组的女性患糖尿病的时间更长，孕前护理的发生率更高。在所有三个月中，HbA1c没有组间差异。然而,在妊娠中期，MDI用户的HbA1c下降幅度更大（-6.12±9.06与-2.16±7.42mmol/mol,P=0.031)。HCL和MDI使用者之间的TIR（3.5-7.8mmol/L）和TAR没有差异，但妊娠中期总胰岛素剂量较高[+0.13IU/kg·day）]。HCL治疗与怀孕期间母亲体重增加增加相关（β调整=3.20kg，95%置信区间[CI]0.90-5.50)。关于新生儿结局，HCL使用者的新生儿更有可能有更高的出生体重(β调整=279.0克，与MDI使用者相比，95%CI39.5-518.5）和巨大儿（OR调整=3.18，95%CI1.05-9.67）。当模型中包括母体体重增加或妊娠晚期HbA1c时，这些关联消失了。结论：在现实世界中，HCL使用者在怀孕期间体重增加，新生儿比MDI使用者大，同时在HbA1c和TIR方面实现相似的血糖控制。
