6/30/23, 2:17 AM TOBOGM Pathway Feedback Search Clinical Topics Home Studies TOBOGM TOBOGM Disease Diabetes during pregnancy Trial question What is the role of immediate treatment of gestational diabetes before 20 weeks gestation? Study design Multi-center Open label RCT Population 802 female patients Inclusion criteria: women between 4 weeks and 19 weeks 6 days gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes Key exclusion criteria: pre-existing diabetes; fasting glucose level 110 mg/dL; or a 2-hour glucose level 200 mg/dL Interventions N=406 immediate treatment (education, dietary advice and instructions on how to monitor capillary blood glucose levels) N=396 no treatment (no treatment or deferred treatment) Primary outcome Adverse neonatal outcome 30.5 % 30.5 24.9 22.9 % 15.3 % Significant decrease 7.6 % NNT = 18 0 0 % https://web.pathway.md/studies/reciu1rTeQnpQ2Zhk 1/2 6/30/23, 2:17 AM 0.0 % TOBOGM Pathway Immediate treatment No treatment Significant decrease in adverse neonatal outcome (24.9% vs. 30.5%; RR 0.82, 95% CI 0.68 to 0.98) Secondary outcomes No significant difference in pregnancy-related hypertension (10.6% vs. 9.9%; RR 1.08, 95% CI 0.85 to 1.38) No significant difference in mean neonatal lean body mass (2.86 kg vs. 2.91 kg; AD -0.04 kg, 95% CI -0.09 to 0.02) Borderline significant decrease in perineal injury (0.8% vs. 3.6%; RR 0.23, 95% CI 0.1 to 0.51) Safety outcomes No significant difference in serious adverse events. Conclusion In women between 4 weeks and 19 weeks 6 days gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes, immediate treatment was superior to no treatment with respect to adverse neonatal outcome. Reference David Simmons, Jincy Immanuel, William M Hague et al. Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. 2023 Jun 8;388(23):2132-2144. Open reference URL https://web.pathway.md/studies/reciu1rTeQnpQ2Zhk 2/2