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Recruiting NCT07449039

Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial

No phase Interventional Gestational Diabetes Mellitus in Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Glucose Monistor.
Who it may be relevant to
Registry conditions: Gestational Diabetes Mellitus in Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a pilot study designed to evaluate the effectiveness of continuous glucose monitoring (CGM) within hours of delivery to predict long-term risk of Type 2 Diabetes Mellitus in patients diagnosed with gestational diabetes. Participants will be provided a CGM within 2 hours after delivery and wear the device for 24 hours. Participants will be instructed to peel off the device after 24 hours. Participants will also be asked to complete two surveys regarding their experience at 1-3 months postpartum and 12-14 months postpartum.

Interventions

  • Device Continuous Glucose Monistor
    Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.

Primary outcome measures

  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test [Time frame: 24 hours postpartum and 1-3 months postpartum]
  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum [Time frame: 24 hours postpartum and 1-3 months postpartum]
Secondary outcome measures (1)
  • Patient satisfaction with CGM use immediately postpartum to evaluate long term risk [Time frame: 1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test]

Eligibility criteria

Inclusion criteria

  • Prenatal care at UCLA Health
  • Planning to deliver at UCLA Ronald Reagan or UCLA Santa Monica
  • Confirmed gestational diabetes diagnosis based on 2-step approach
  • Maternal age >= 18 years

Exclusion criteria

  • Pre-gestational diabetes (T1DM or T2DM)
  • Multifetal gestation
  • Intra-amniotic infection by clinical criteria
  • Postpartum hemorrhage
  • Maternal ICU admission
  • Known allergy to medical-grade adhesive
  • Presence of skin lesions at anticipated CGM application site
  • Scheduled postpartum non-sonographic imaging study (radiograph, magnetic resonance imaging (MRI), or computed tomography (CT) scan) during trial
  • Metformin use
  • Steroid use
  • Terbutaline use within 4 hours of delivery
  • Cystic fibrosis
  • MODY (mature onset of diabetes in the young)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Identifiers

NCT: NCT07449039 · 25-0020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗