Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07332416
Status
Enrolling By Invitation

Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott — OTHER
    Postpartum CGM

Study Details

The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Postpartum CGM
    Postpartum continuous glucose monitoring
  • No Intervention: Postpartum OGTT
    Postpartum oral glucose tolerance test
  • No Intervention: No screening
    No postpartum glucose screening

Primary Outcome Measure

Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients [ Time Frame: 20 weeks postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

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By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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