Continuous glucose monitoring in early gestational diabetes improves maternal and neonatal outcomes—The Steady Sugar trial

Aims: Early detection and management of gestational diabetes mellitus (GDM) benefits both mother and infants. We aimed to compare continuous glucose monitoring (CGM) to routine self-monitoring of blood glucose (SMBG) in a randomised controlled trial on glycaemic management and pregnancy outcomes in women with GDM diagnosed in gestational Weeks 8–26. Materials and Methods: From October 2021 to December 2023, 128 women with GDM were enrolled and 120 completed the trial after 2:1 randomisation to either the intervention (Dexcom G6 CGM, n = 80) or the control group (SMBG 4×/day and monthly blinded CGM [Dexcom G6 Pro], n = 40). Both groups received lifestyle and medication advice based on the CGM interpretation, clinical follow-up and glucose monitoring until delivery. CGM metrics were evaluated with the automated glucose data analysis (AGATA) toolbox (https://github.com/gcappon/agata) and maternal and neonatal outcomes were collected from medical records. Participants completed the CGM Satisfaction survey prior to delivery. Results: While no significant differences between groups in time spent in the glucose target range (TIR) 63–140 mg/dL (primary outcome) were found (p = 0.37), the intervention group experienced significantly lower unscheduled caesarean section rates (20.0% vs. 44.4%, p = 0.046, V = 0.19) and preterm deliveries (6.8% vs. 18.4%, p = 0.041, V = 0.19). Neonates experienced lower large-for-gestational-age rates (5.0% vs. 18.4%, p = 0.019, V = 0.22) and neonatal intensive care unit admissions (22.5% vs. 44.7%, p = 0.013, V = 0.23) compared to the control group. Participants in the intervention group reported high CGM satisfaction and endorsed the behavioural and psychosocial benefits. Conclusions: For women with early GDM, despite no improvement in TIR, CGM improved maternal and neonatal outcomes versus SMBG. The effect may be mediated by improved awareness of glycaemic excursions and by facilitation of treatment regimen adjustments.