1st Department of Obstetrics and Gynaecology, Medical University of Warsaw, Starynkiewicza Square 1/3, 02-015, Warsaw, Poland.
Polish Society of Gynecologists and Obstetricians, Club 35, 02-677, Warsaw, Poland.
Acta Diabetol. 2023 Sep;60(9):1171-1177. doi: 10.1007/s00592-023-02091-2. Epub 2023 May 10.
Gestational diabetes mellitus (GDM) is the most common type of hyperglycaemia in pregnancy. GDM is a risk factor of adverse perinatal outcomes, with the incidence rate increasing proportionally to the level of maternal dysglycaemia. Therefore, glycaemic control plays an important role in management of GDM. The aim of this study was to assess the efficacy of flash glucose monitoring (FGM) in GDM.
This was a non-blinded, randomised controlled trial, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. After meeting the inclusion criteria patients were randomly allocated to the study group (FGM, n = 50) or control group (self-monitoring of blood glucose-SMBG, n = 50). Clinical and laboratory results were assessed at four follow-up visits. The primary outcome was mean fasting and postprandial glycaemia. The secondary outcomes were perinatal outcomes.
There was no significant difference in mean glycaemia between the groups (p = 0.437) Compared to the control group, the study group significantly reduced their fasting (p = 0.027) and postprandial glycaemia (p = 0.034) during the first 4 weeks following GDM diagnosis, with no significant difference in progression to insulin therapy (OR 1.09, 95% CI 0.47-2.57). Incidence of fetal macrosomia was significantly higher in SMBG as compared to FGM group (OR 5.63, 95% CI 1.16-27.22).
Study results indicate that FGM has an impact on glycaemic control, dietary habits and incidence of fetal macrosomia in patients with GDM. Trial registration clinicaltrials.gov ID: NCT04422821.
妊娠期糖尿病（GDM）是妊娠期间最常见的高血糖类型。GDM 是不良围产期结局的危险因素，其发生率与母体糖代谢异常的程度成正比。因此，血糖控制在 GDM 的管理中起着重要作用。本研究旨在评估瞬态血糖监测（FGM）在 GDM 中的疗效。
这是一项非盲、随机对照试验，在华沙医科大学第一妇产科招募了 100 名 24-28 周妊娠诊断为 GDM 的孕妇。符合纳入标准的患者被随机分配到研究组（FGM，n=50）或对照组（自我监测血糖-SMBG，n=50）。在四次随访中评估临床和实验室结果。主要结局是平均空腹和餐后血糖。次要结局是围产期结局。
两组平均血糖无显著差异（p=0.437）。与对照组相比，研究组在 GDM 诊断后 4 周内显著降低了空腹（p=0.027）和餐后血糖（p=0.034），但胰岛素治疗的进展无显著差异（OR 1.09，95%CI 0.47-2.57）。与 FGM 组相比，SMBG 组胎儿巨大儿的发生率显著更高（OR 5.63，95%CI 1.16-27.22）。
研究结果表明，FGM 对 GDM 患者的血糖控制、饮食习惯和胎儿巨大儿的发生率有影响。试验注册临床Trials.gov ID：NCT04422821。
