Amylidi-Mohr Sofia, Zennaro Giulia, Schneider Sophie, Raio Luigi, Mosimann Beatrice, Surbek Daniel
Department of Obstetrics & Gynecology, Inselspital University Hospital of Bern, University of Bern, Bern, Switzerland.
Department of Obstetrics & Gynecology, Inselspital University Hospital of Bern, University of Bern, Bern, Switzerland.
Lancet Diabetes Endocrinol. 2025 Jul;13(7):591-599. doi: 10.1016/S2213-8587(25)00063-4. Epub 2025 May 26.
In gestational diabetes, one of the key factors affecting perinatal outcomes is glycaemic control. We aimed to investigate the effect of real-time continuous glucose monitoring (rtCGM) on perinatal outcomes versus self-monitoring of blood glucose (SMBG).
In this open-label, randomised, controlled trial, we recruited pregnant individuals aged 18-45 years with gestational diabetes, according to the International Association of Diabetes and Pregnancy Study Groups criteria, from a university hospital in Bern, Switzerland. Participants were randomly assigned (1:1) to the rtCGM intervention group or the SMBG control group. Randomisation was done centrally on the basis of pre-pregnancy BMI, previous gestational diabetes, family history of type 2 diabetes, and ethnicity. The primary endpoint was a composite of perinatal outcomes: large for gestational age, macrosomia, polyhydramnios, neonatal hypoglycaemia, and stillbirth. Key secondary outcomes were patient preference and maternal glycaemic control. Analyses were conducted on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT05037526.
Between Sept 29, 2021, and June 11, 2024, 302 pregnant women with gestational diabetes were included in the study and randomly assigned to one of the groups. 156 participants were assigned to the rtCGM intervention group and 143 were assigned to the SMBG control group completed the study. Primary outcome data were available for 297 (99%) of 299 participants. The composite outcome did not differ significantly between the two groups (odds ratio 1·02 [95% CI 0·63-1·66]). The only adverse events were skin changes, occurring in six (4%) participants in the rtCGM intervention group and in one (<1%) participant in the SMBG control group (blinded device).
Our results show that the outcome in individuals with gestational diabetes is not improved by the use of rtCGM. However, individuals expressed a higher preference for the rtCGM device. This finding suggests that rtCGM could be offered to simplify the management of gestational diabetes. A cost-effectiveness study could address what method requires fewer resources. To our knowledge, this is the first randomised trial powered to evaluate the efficacy of rtCGM regarding pregnancy outcomes.
The University of Bern and the Swiss Diabetes Foundation.
For the German translation of the abstract see Supplementary Materials section.
在妊娠期糖尿病中，影响围产期结局的关键因素之一是血糖控制。我们旨在研究实时连续血糖监测（rtCGM）与自我血糖监测（SMBG）相比对围产期结局的影响。
在这项开放标签、随机、对照试验中，我们根据国际糖尿病与妊娠研究组协会的标准，从瑞士伯尔尼的一家大学医院招募了18-45岁患有妊娠期糖尿病的孕妇。参与者被随机分配（1:1）至rtCGM干预组或SMBG对照组。随机分组在中心进行，依据孕前体重指数、既往妊娠期糖尿病史、2型糖尿病家族史和种族。主要终点是围产期结局的复合指标：大于胎龄儿、巨大儿、羊水过多、新生儿低血糖和死产。关键次要结局是患者偏好和母体血糖控制。分析基于意向性治疗原则进行。本试验已在ClinicalTrials.gov注册，注册号为NCT05037526。
在2021年9月29日至2024年6月11日期间，302名患有妊娠期糖尿病的孕妇被纳入研究并随机分配至其中一组。156名参与者被分配至rtCGM干预组，143名被分配至SMBG对照组并完成研究。299名参与者中的297名（99%）可获得主要结局数据。两组之间的复合结局无显著差异（比值比1.02 [95%置信区间0.63-1.66]）。仅有的不良事件是皮肤改变，rtCGM干预组有6名（4%）参与者出现，SMBG对照组有1名（<1%）参与者出现（使用盲法设备）。
我们的结果表明，使用rtCGM并不能改善妊娠期糖尿病患者的结局。然而，患者对rtCGM设备表现出更高的偏好。这一发现提示，可以提供rtCGM以简化妊娠期糖尿病的管理。一项成本效益研究可以确定哪种方法需要的资源更少。据我们所知，这是第一项有足够效力评估rtCGM对妊娠结局疗效的随机试验。
伯尔尼大学和瑞士糖尿病基金会。
摘要的德文翻译见补充材料部分。
