Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment

Type 2 Diabetes Clinical Trial

Official title: Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening and Treatment

Status Not yet recruiting

Clinical Trial Summary

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM.

Clinical Trial Description

Gestational diabetes mellitus (GDM) affects 6 to 8% of U.S. pregnancies annually and upwards of 1 in every 8 pregnancies worldwide. Pregnant individuals with GDM have higher rates of hypertensive disorders of pregnancy, cesarean delivery, and maternal mortality as compared to those without GDM. While GDM frequently resolves after delivery, up to 70% of patients will develop type 2 diabetes mellitus (T2DM) later in life10 and one third will develop subsequent diabetes or impaired glucose metabolism at the time of postpartum screening.

While postpartum screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) between 4-12 weeks postpartum for all patients with GDM in pregnancy, nearly 40% of patients do not attend a postpartum visit. Attendance is even lower among populations with limited resources, contributing to health disparities.

To address this issue, immediate in-hospital postpartum glucose tolerance testing has been evaluated and found to yield diagnostic values comparable to postpartum screening with the advantage of ~100% adherence. However, 2 challenges remain: currently there is a lack of widespread clinical implementation of 1) in-hospital immediate postpartum diabetes screening, and 2) treatment with metformin for those patients who screen positive.

To implement early in-hospital screening and treatment, providers require clear guidelines on the optimal management of patients with impaired glucose tolerance. Therefore, the overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment for postpartum patients with pregnancies affected by GDM. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Type 2 Diabetes

• NCT number: NCT06457139
• Study type: Interventional
• Source: University of Massachusetts, Worcester
• Contact: Gianna Wilkie, MD
• Phone: 508-3444982
• Email: Gianna.Wilkie@umassmemorial.org
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2025
• Completion date: December 1, 2028