Department of Clinical and Experimental Medicine, Endocrinology Section, University of Catania Medical School, Catania, Italy.
Department of Clinical and Experimental Medicine, Endocrinology Section, University of Catania Medical School, Catania, Italy.
Nutr Metab Cardiovasc Dis. 2021 Jun 7;31(6):1851-1859. doi: 10.1016/j.numecd.2021.03.013. Epub 2021 Mar 24.
Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes.
Forty women with inadequately controlled type 1 (T1D, n = 34) and type 2 (T2D, n = 6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n = 21) using FGM, and the control group (CG, n = 19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p < 0.01) and similarly (-0.65 ± 0.7 vs. -0.67 ± 0.8 for FG and CG, respectively; p = 0.89) in both groups during pregnancy. HbA1c reduction was positively associated with the number of daily FGM scans (p < 0.01). TBR (12.1 ± 2.0% vs. 19.6 ± 3.9%, p = 0.04) and the mean of the daily serum glucose difference (MODD) index (59.1 ± 5.4 vs. 77.7 ± 4.6, p = 0.02) were significantly lower in FG at second trimester. The rates of perinatal adverse outcomes were not different in the two studied groups.
In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor.
At ClinicalTrials.gov as NCT04666818 on December 14, 2020.
良好的血糖控制对于降低不良妊娠结局的风险至关重要。我们的目的是评估即时血糖监测（Flash Glucose Monitoring，FGM）在孕前糖尿病患者中的血糖控制效果。
在妊娠前，40 名血糖控制不理想的 1 型糖尿病（T1D，n=34）和 2 型糖尿病（T2D，n=6）患者被随机分为两组：Flash Glucose 组（FG，n=21）使用 FGM，对照组（CG，n=19）使用自我血糖监测（SMBG）。评估糖化血红蛋白（HbA1c，%）、时间在目标范围内（TIR）、低于目标范围（TBR）和高于目标范围（TAR）的时间、血糖变异性以及母婴不良结局的发生情况。
结果显示，两组患者的 HbA1c 在妊娠期间均显著下降（p<0.01），且下降幅度相似（FG 组下降-0.65±0.7%，CG 组下降-0.67±0.8%；p=0.89）。HbA1c 的降低与每日 FGM 扫描次数呈正相关（p<0.01）。在妊娠中期，FG 组的 TBR（12.1±2.0% vs. 19.6±3.9%，p=0.04）和平均每日血清血糖差（MODD）指数（59.1±5.4 vs. 77.7±4.6，p=0.02）均显著低于 CG 组。两组患者的围产期不良结局发生率无差异。
在孕前糖尿病患者中，FGM 和 SMBG 在妊娠期间的血糖控制效果相似。FGM 在 TBR 和血糖变异性方面具有额外的优势。良好的代谢结果取决于血糖传感器的充分使用。
本研究于 2020 年 12 月 14 日在 ClinicalTrials.gov 注册，编号为 NCT04666818。
