Trials / Not Yet Recruiting
Not Yet RecruitingNCT07034261
Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Blinded Continuous Glucose Monitoring Device | Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-06-01
- Completion
- 2026-09-01
- First posted
- 2025-06-24
- Last updated
- 2026-02-13
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07034261. Inclusion in this directory is not an endorsement.