Gestational Diabetes Treatment: Should Metformin Be Continued When Starting Insulin? A Randomized Trial

What this Trial Is About

Researchers are evaluating treatment options for pregnant women diagnosed with gestational diabetes who need medication to control their blood sugar. This study focuses on whether continuing metformin when insulin is added is better than stopping metformin once insulin is required. The goal is to find out if keeping metformin reduces the amount of insulin needed and improves health outcomes for both mother and baby. This is a Phase 4 randomized trial addressing a question that has not been studied before in this specific way. Participants will be randomly assigned to one of two groups. One group will continue taking metformin while adding insulin to control blood sugar, and the other group will stop metformin and start insulin alone. Both treatments are standard for gestational diabetes, but this study compares their combined use to clarify the best approach. The study will last from enrollment until delivery, with a maximum of 20 weeks. During the study, participants will be monitored regularly and asked to check their blood sugar levels four times daily. Researchers will measure how much insulin is needed and track maternal and neonatal health outcomes. The study also involves adherence to medication and blood sugar monitoring schedules. Safety and effectiveness will be evaluated throughout the pregnancy until delivery.

GDM: Insulin with or Without Metformin?