GAP (gestational diabetes and pharmacotherapy) - study protocol for a randomized controlled, two-arm, single-site...

Area of Science:

• Obstetrics and Gynecology
• Endocrinology
• Neonatal Medicine

Background:

• Gestational diabetes (GDM) affects 10% of US pregnancies, with medical nutrition therapy (MNT) and exercise as first-line treatments.
• The threshold for initiating pharmacotherapy after MNT and exercise failure in GDM is not clearly defined.
• While tight glycemic control reduces GDM complications, it may increase small-for-gestational age infants and negatively impact patient-reported outcomes like anxiety.

Purpose of the Study:

• To investigate the effect of earlier and stricter pharmacotherapy in GDM on clinical and patient-reported outcomes.
• To determine the optimal glycemic threshold for adding pharmacotherapy to MNT and exercise in GDM management.
• To promote standardization in GDM clinical management.

Main Methods:

• A pragmatic randomized controlled trial (GAP study) involving 416 participants with GDM.
• Participants were randomized to an intervention group (insulin initiation at 20% elevated glucose) or an active control group (insulin initiation at 40% elevated glucose).
• Primary outcome: composite neonatal complications. Secondary outcomes: maternal complications and patient-reported outcomes (anxiety, depression, stress, self-efficacy).

Main Results:

• Data collection and analysis are ongoing for the GAP study.
• The study aims to provide evidence-based recommendations for GDM pharmacotherapy initiation.
• Results will inform clinical practice guidelines for managing GDM.

Conclusions:

• The GAP study will elucidate the optimal glycemic threshold for pharmacotherapy in GDM.
• Findings are expected to standardize GDM management protocols.
• The study has direct clinical relevance for improving maternal and neonatal outcomes in GDM pregnancies.