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NCT Number: NCT07034261

Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes

The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).

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Key information

About this study

Gestational diabetes (GDM) is glucose intolerance that develops during pregnancy. In the US, GDM affected 8.3% of pregnancies in 2021. Persistent glucose intolerance is present in up to 20% of women at post-partum follow up and subsequent risk for type 2 diabetes is significantly increased. All patients with GDM should undergo post-partum oral glucose tolerance test (OGTT) at 4-12 weeks to identify persistence glucose intolerance or overt diabetes. Detecting postpartum dysglycemia in people with GDM is a critical step for reducing long-term risk of type 2 diabetes and its associated complications. However, <50% of people complete the postpartum OGTT due to barriers in transportation, finances, and childcare. Recent studies have examined the use of postpartum continuous glucose monitoring (CGM) and proposed CGM metrics to predict dysglycemia on postpartum OGTT in people with GDM. These findings should be validated in other cohorts to confirm broad applicability.

This pilot study aims to enroll subjects with GDM at the University of Chicago to wear a blinded CGM for 14 days postpartum (study intervention) and then complete a OGTT at 4-12 weeks postpartum (standard of care).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18
  • Completed pregnancy with delivery of a live born infant(s). Pregnancies with multiple gestations will be included
  • No prior history of type 1 or type 2 diabetes
  • Patients with a history of gestational diabetes (GDM) in a prior pregnancy will be eligible for inclusion.
  • GDM diagnosis by standard screening at 24-28 weeks
  • 2 hour 75g oral glucose tolerance test (OGTT); one abnormal value required for diagnosis
  • Fasting glucose 92
  • 1 hour 180
  • 2 hour 153
  • 3 hour 100g OGTT - two abnormal values required for diagnosis
  • Fasting glucose - 95
  • 1 hour 180
  • 2 hour 155
  • 3 hour 140

There are no exclusion criteria for this study. Eligibility will be based on inclusion criteria.

Treatment and study plan

Blinded Continuous Glucose Monitoring Device

Device

Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.

Primary outcomes

  1. Determine the ability of continuous glucose monitoring to predict dysglycemia

    Time frame: baseline to Day 70

    Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time >180 of >4%)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Dickens, MD

CONTACT

[email protected]

773-795-0460

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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