Gestational diabetes & diabetes in pregnancy
Glycaemic control and pregnancy outcomes with real-time continuous glucose monitoring in gestational diabetes (GRACE): an open-label, multicentre, multinational, randomised controlled trial
Primary result · LGA newbornsResult — go to the resultOdds ratio 0.32 95% CI 0.10–0.87Authors' conclusion
rt-CGM use in women with gestational diabetes reduced LGA births, without differences in serious adverse events. The higher-than-expected overall prevalence of SGA infants, possibly related to the tight glycaemic control in our cohort, requires further research.
Study context
- Population
- Women aged 18–55 years with singleton pregnancy and GDM (IADPSG criteria), 4 university hospitals in Austria, Germany and Switzerland; randomised at mean 28.6 weeks of gestationrandomised 1:1
- Participants
- 375 women
- Comparison
- rtCGM vs self-monitoring of blood glucose (SMBG)
- Real-time continuous glucose monitoring (rt-CGM)n = 190
- SMBGn = 185reference
- Primary endpoint
- Proportion of large-for-gestational-age (LGA) newborns (GROW customised birthweight percentiles)
Methodological detailsopen-label, parallel-group, multicentre, multinational, minimisation
- Open-label
- Parallel-group
- Multicentre
- Multinational
- Minimisation
Primary result
LGA newborns
Odds ratio
0.32
95% CI 0.10–0.87
P = 0.014
Events by treatment group
rt-CGMvs SMBG
OR 0.32 (95% CI 0.10–0.87); P = 0.014
As reported in the abstract
Secondary outcomes
| Outcome | rt-CGM | SMBG | OR (CI) | P value | |
|---|---|---|---|---|---|
| SGA neonates | 19% | 13% | 1.59 (0.86–2.99) | P = 0.11 | |
| 0.20.5125Odds ratio (log scale) |
Safety
- No differences in serious adverse events between rt-CGM and SMBG
- P = 0.39
Original publication
Glycaemic control and pregnancy outcomes with real-time continuous glucose monitoring in gestational diabetes (GRACE): an open-label, multicentre, multinational, randomised controlled trial. Lancet Diabetes Endocrinol. Published 24 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →