DipGluMo
Trial question
What is the effect of real-time continuous glucose monitoring in pregnant women with gestational diabetes?
Study design
Single center
Open label
RCT
Population
299 female patients.
Inclusion criteria: pregnant women, aged 18-45 years, with gestational diabetes.
Key exclusion criteria: glucose monitoring and lifestyle intervention before 24 weeks of gestation; maternal age < 18 years, multifetal gestations; known fetal structural or chromosomal anomalies; chronic use of medications associated with hyperglycemia; planned preterm delivery; overt T1DM or T2DM.
Interventions
N=156 real-time continuous glucose monitoring (Dexcom G6® combined with a smartphone application or with a receiver).
N=143 self-monitoring of blood glucose (test of capillary glucose concentrations 6 times daily as advised before enrolment).
Primary outcome
Adverse pregnancy and neonatal outcomes
36%
35%
36.0 %
27.0 %
18.0 %
9.0 %
0.0 %
Real-time continuous glucose
monitoring
Self-monitoring of blood
glucose
No significant
difference ↔
No significant difference in adverse pregnancy and neonatal outcomes (36% vs. 35%; OR 1.06, 95% CI 0.66 to 1.71).
Secondary outcomes
No significant difference in fetal growth restriction (7% vs. 7%; OR 1.02, 95% CI 0.45 to 2.49).
No significant difference in pre-eclampsia (5% vs. 3%; OR 1.31, 95% CI 0.45 to 3.72).
No significant difference in spontaneous premature birth (3% vs. 1%; OR 1.82, 95% CI 0.43 to 9.99).
Safety outcomes
No significant difference in skin reactions and discomfort.
Conclusion
In pregnant women, aged 18-45 years, with gestational diabetes, real-time continuous glucose monitoring was not superior to self-monitoring of blood glucose with respect to adverse pregnancy and neonatal outcomes.
Reference
Sofia Amylidi-Mohr, Giulia Zennaro, Sophie Schneider et al. Continuous glucose monitoring in the management of gestational diabetes in Switzerland (DipGluMo): an open-label, single-centre, randomised, controlled trial. Lancet Diabetes Endocrinol. 2025 May 26:S2213-8587(25)00063-4. Online ahead of print.
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