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

The University of Chicago

Status: Not yet enrolling

Conditions: Gestational Diabetes

Treatments: Device: Blinded Continuous Glucose Monitoring Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07034261

IRB25-0910

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age greater than or equal to 18

2. Completed pregnancy with delivery of a live born infant(s). Pregnancies with multiple gestations will be included

3. 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.

4. 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Blinded Continuous Glucose Monitoring Device

Experimental group

Description:

Subjects will wear a blinded continuous glucose monitoring device.

Treatment:

Device: Blinded Continuous Glucose Monitoring Device