Real-Time Continuous Glucose Monitoring Lowers Risk of Large for Gestational Age Infants in Gestational Diabetes

Use of real-time continuous glucose monitoring (rt-CGM) in women with gestational diabetes mellitus (GDM) was associated with improved glycemic control and a reduced risk of large for gestational age (LGA) newborns compared with self-monitored blood glucose (SMBG), according to findings from the GRACE randomized controlled trial (NCT03981328) presented at the 61st annual meeting of the European Association for the Study of Diabetes.¹

The open-label, international trial was designed to address the lack of sufficiently powered randomized controlled trials evaluating rt-CGM in GDM. Conducted across multiple European centers, the study was designed to determine whether continuous glucose feedback could improve both maternal glycemic management and neonatal outcomes. Prior evidence for rt-CGM in pregnancy had been limited, making the study a key contribution to clinical decision-making for this population.²

Investigators enrolled 375 women with GDM, who were randomly assigned to either SMBG (n=185) or rt-CGM (n=190). The primary outcome was the proportion of LGA infants. Secondary endpoints included requirement for glucose-lowering medication and glucose metrics derived from CGM. Women in the SMBG group used a blinded CGM device for 10 days after randomization and again between 36–38 weeks of gestation, while the rt-CGM group used the devices continuously until delivery.¹

After accounting for dropouts, 170 women in the rt-CGM group and 175 in the SMBG group were included in the primary endpoint analysis. The proportion of LGA newborns was significantly lower among women using rt-CGM compared with SMBG (3.5% vs 10.3%; P=.014). Newborn weight percentiles were also lower in the rt-CGM group.¹

Women using rt-CGM demonstrated improved time in tight range (65–140 mg/dL) between 36 and 38 weeks of gestation, particularly among those prescribed glucose-lowering medications. Although the total amount of glucose-lowering medication did not differ between groups, rapid-acting insulin was prescribed more frequently in the rt-CGM group than in the SMBG group (41.2% vs 30.3%; P=.035).¹

"Rt-CGM outperforms SMBG in reducing the risk of LGA offspring. Glycemic control improves modestly in rt-CGM users, who also require more rapid acting insulin. Consequently, rt-CGM should be offered as standard care for women with GDM," investigators concluded.¹

“Each year, EASD provides a high-profile opportunity to highlight our latest product innovations and new clinical data that demonstrates how Dexcom glucose biosensing technology can empower people with all types of diabetes across the globe to take control of their health, while reinforcing Dexcom CGM as a cost-effective solution for diabetes management,” Jake Leach, president and chief operating officer of Dexcom, said in a press release.³ “With one of our most exciting new features, Dexcom Smart Basal, now under FDA and CE mark review, we are aiming to deliver a simpler and easier basal titration process that helps patients and providers alike.”

References:

1. Linder T, et al. Glycaemic control and pregnancy outcomes with real-time continuous glucose monitoring in gestational diabetes (GRACE): an open-label, international, randomised controlled trial. Presented at EASD 2025.
2. Real-time Continuous Glucose Monitoring for Reduced Adverse Complications and Events in Women With Gestational Diabetes (GRACE): a Multicentre International Randomized Controlled Trial (GRACE). ClinicalTrials.gov identifier NCT03981328. https://clinicaltrials.gov/study/NCT03981328#publications. Accessed September 16, 2025.
3. Dexcom Spotlights Upcoming Feature Launches, Improved Health Outcomes and Cost-Effectiveness With Dexcom Glucose Biosensing at EASD 2025. News release. Dexcom. September 15, 2025. Accessed September 16, 2025. https://investors.dexcom.com/news/news-details/2025/Dexcom-Spotlights-Upcoming-Feature-Launches-Improved-Health-Outcomes-and-Cost-Effectiveness-With-Dexcom-Glucose-Biosensing-at-EASD-2025/default.aspx