Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.
Conditions:
🦠 Gestational Diabetes
🗓️ Study Start (Actual) 17 September 2021
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria for early GDM women:
  • * Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • * Gestational diabetes mellitus identified at \< 20 weeks' gestation requiring pharmacologic treatment (class A2)
  • Exclusion Criteria for early GDM women:
  • * History of prediabetes or polycystic ovarian syndrome
  • * History of pregestational type 2 diabetes mellitus
  • * Skin conditions which prevent wearing a continuous glucose monitor
  • Inclusion Criteria for 3rd trimester GDM women:
  • * Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • * Gestational diabetes mellitus identified at \>= 24 weeks' gestation requiring pharmacologic treatment (class A2)
  • Exclusion Criteria for 3rd trimester GDM women:
  • * History of prediabetes or polycystic ovarian syndrome
  • * History of pregestational type 2 diabetes mellitus
  • * Skin conditions which prevent wearing a continuous glucose monitor
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 August 2020
  • First Submitted that Met QC Criteria 18 August 2020
  • First Posted 20 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 December 2023
  • Last Update Posted 19 December 2023
  • Last Verified December 2023