Oral Glucose-Lowering Agents and Large-for-Gestational-Age Infants in Gestational Diabetes—Reply

In Reply Dr Su raises several concerns about our recent article. Regarding the noninferiority margin of 8% for the primary outcome, this margin was selected based on prior studies in the field and expert consensus on what would be deemed a clinically acceptable difference. A lower margin would not have changed the main conclusion of noninferiority. We agree that a larger sample size would have been helpful to detect smaller differences in clinically relevant secondary outcomes, including neonatal hypoglycemia and maternal adverse effects.

Jun 17, 2025 - 17:15
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In Reply Dr Su raises several concerns about our recent article. Regarding the noninferiority margin of 8% for the primary outcome, this margin was selected based on prior studies in the field and expert consensus on what would be deemed a clinically acceptable difference. A lower margin would not have changed the main conclusion of noninferiority. We agree that a larger sample size would have been helpful to detect smaller differences in clinically relevant secondary outcomes, including neonatal hypoglycemia and maternal adverse effects.