Department of Internal Diseases and Diabetology, Medical University of Lodz, Pomorska Str. 251, 92-213, Lodz, Poland.
Department of Reproduction, Poznan University of Medical Sciences, Poznań, Poland.
Acta Diabetol. 2023 Apr;60(4):553-561. doi: 10.1007/s00592-022-02020-9. Epub 2023 Jan 19.
The effects of continuous subcutaneous insulin infusion (CSII) therapy with or without continuous glucose monitoring (CGM) on neonatal outcomes and glycemic outcomes of pregnant women with type 1 diabetes (T1D), living in Poland, were assessed.
This prospective observational study enrolled women with T1D (N = 481, aged 18-45 years) who were pregnant or planned pregnancy. All used CSII therapy and a subset used CGM with CSII (CSII + CGM). Neonatal outcomes (e.g., rate of large for gestational age [LGA] delivery [birth weight > 90th percentile]) and maternal glycemia (e.g., HbA1c and percentage of time at sensor glucose ranges) were evaluated.
Overall HbA1c at trimesters 1, 2, and 3 was 6.8 ± 1.1% (50.9 ± 12.3 mmol/mol, N = 354), 5.8 ± 0.7% (40.1 ± 8.0 mmol/mol, N = 318), and 5.9 ± 0.7% (41.4 ± 8.0 mmol/mol, N = 255), respectively. A HbA1c target of < 6.0% (42 mmol/mol) at each trimester was achieved by 20.9% (74/354), 65.1% (207/318), and 58.0% (148/255), respectively. For women using CSII + CGM versus CSII only, HbA1c levels at trimesters 1, 2, and 3 were 6.5 ± 0.9% versus 7.1 ± 1.3% (47.8 ± 9.7 mmol/mol versus 54.3 ± 14.0 mmol/mol, p < 0.0001), 5.7 ± 0.6% versus 6.0 ± 0.9% (38.9 ± 6.5 mmol/mol versus 41.6 ± 9.3 mmol/mol, p = 0.0122), and 5.8 ± 0.6% versus 6.1 ± 0.8% (40.3 ± 6.9 mmol/mol versus 42.9 ± 9.1 mmol/mol, p = 0.0117), respectively. For the overall, CSII only, and CSII + CGM groups, rates of LGA delivery were 22.7% (74/326), 24.6% (34/138), and 21.3% (40/188), respectively.
Observational assessment of women with T1D using CSII therapy demonstrated low HbA1c throughout pregnancy and low rates of LGA. The addition of CGM to CSII therapy compared to CSII therapy alone was associated with some improved maternal glycemic and neonatal outcomes.
NCT01779141 (January 2013).
评估波兰 1 型糖尿病（T1D）孕妇在接受持续皮下胰岛素输注（CSII）治疗联合或不联合连续血糖监测（CGM）的情况下，对新生儿结局和血糖控制的影响。
这项前瞻性观察性研究纳入了 481 名年龄在 18-45 岁之间的 T1D 孕妇或计划妊娠的孕妇，她们均使用 CSII 治疗，其中一部分使用 CSII 联合 CGM（CSII+CGM）。评估新生儿结局（如巨大儿发生率[出生体重超过第 90 百分位数]）和产妇血糖（如 HbA1c 和传感器葡萄糖范围内的时间百分比）。
妊娠第 1、2 和 3 期的平均 HbA1c 分别为 6.8±1.1%（50.9±12.3mmol/mol，N=354）、5.8±0.7%（40.1±8.0mmol/mol，N=318）和 5.9±0.7%（41.4±8.0mmol/mol，N=255）。分别有 20.9%（74/354）、65.1%（207/318）和 58.0%（148/255）的孕妇在各期实现了 HbA1c<6.0%（42mmol/mol）的目标。与仅使用 CSII 相比，使用 CSII+CGM 的孕妇在妊娠第 1、2 和 3 期的 HbA1c 水平分别为 6.5±0.9%（47.8±9.7mmol/mol）和 7.1±1.3%（54.3±14.0mmol/mol，p<0.0001）、5.7±0.6%（38.9±6.5mmol/mol）和 6.0±0.9%（41.6±9.3mmol/mol，p=0.0122）以及 5.8±0.6%（40.3±6.9mmol/mol）和 6.1±0.8%（42.9±9.1mmol/mol，p=0.0117）。在总体、仅使用 CSII 和使用 CSII+CGM 的组中，巨大儿的发生率分别为 22.7%（74/326）、24.6%（34/138）和 21.3%（40/188）。
对使用 CSII 治疗的 T1D 孕妇进行观察性评估发现，整个孕期的 HbA1c 水平较低，巨大儿的发生率较低。与仅使用 CSII 相比，CSII 联合 CGM 治疗与一些改善的产妇血糖和新生儿结局相关。
NCT01779141（2013 年 1 月）。
