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Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes 50 Postpartum

Not yet recruiting
Clinical Trial NCT07034261 is an interventional study for Gestational Diabetes and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 50 participants. Led by University of Chicago, this study is expected to complete by 1 September 2026. The latest data from ClinicalTrials.gov was last updated on 13 February 2026.
Brief 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 glucos...Show More
Official Title

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

Conditions
Gestational Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • IRB25-0910
NCT ID Number
NCT07034261
Start Date (Actual)
2026-04
Last Update Posted
2026-02-13
Completion Date (Estimated)
2026-09
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
CGM Device
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBlinded Continuous Glucose Monitoring Device
Subjects will wear a blinded continuous glucose monitoring device.
Blinded Continuous Glucose Monitoring Device
Subjects will be asked to wear blinded continuous glucose monitoring device for 14 days.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Determine the ability of continuous glucose monitoring to predict dysglycemia
Assess the validity of the continuous glucose monitoring metrics (percentage) proposed by Cabrera et al. (percent time \>180 of \>4%)
baseline to Day 70
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  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

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Study Central Contact
Contact: Laura Dickens, MD, 773-795-0460, [email protected]
No location data.