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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Blinded Continuous Glucose Monitoring Device

Subjects will wear a blinded continuous glucose monitoring device.

Group Type EXPERIMENTAL

Blinded Continuous Glucose Monitoring Device

Intervention Type DEVICE

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

Interventions

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Blinded Continuous Glucose Monitoring Device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No