NCT07449039

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
49mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Jun 2030

Study Start

First participant enrolled

September 28, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

December 18, 2025

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test

    Regression analysis to assess strength and direction of the relationship between postpartum CGM data and 2 hr GTT

    24 hours postpartum and 1-3 months postpartum

  • Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum

    Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c

    24 hours postpartum and 1-3 months postpartum

Secondary Outcomes (1)

  • Patient satisfaction with CGM use immediately postpartum to evaluate long term risk

    1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test

Study Arms (1)

Continuous Glucose Monitor

OTHER

Administration of a Continuous Glucose Monitor within 2 hours after delivery for 24-hour collection of glycemic data.

Device: Continuous Glucose Monistor

Interventions

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

Also known as: Dexcom G7
Continuous Glucose Monitor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

  • Christina Han, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will follow a within-subjects design where participants will serve as their own control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Director, Maternal-Fetal Medicine

Study Record Dates

First Submitted

December 18, 2025

First Posted

March 4, 2026

Study Start

September 28, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations