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Status:

RECRUITING

CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Lead Sponsor:

Jaeb Center for Health Research

Collaborating Sponsors:

The Leona M. and Harry B. Helmsley Charitable Trust

DexCom, Inc.

Conditions:

Gestational Diabetes Mellitus in Pregnancy

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer ...

Detailed Description

Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks. * Pre...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Maternal age of 18 years and older
  • Singleton pregnancy
  • Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
  • • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available
  • HbA1c \<6.5% (48 mmol/mol) since onset of pregnancy
  • • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.
  • No prior history of gestational diabetes mellitus (GDM)
  • Able to read English or Spanish
  • Exclusion Criteria
  • Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
  • Planned termination of pregnancy or any indications of miscarriage
  • Prior gastric bypass surgery
  • Pregravid diabetes (type 1 or type 2)
  • Unwillingness/inability to wear CGM sensor
  • Unwillingness to attend routine antenatal obstetric appointments
  • Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening
  • • Topical and inhaled corticosteroids are acceptable
  • Use of insulin during the pregnancy prior to enrollment
  • Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
  • Deemed unable to participate for medical reasons identified by their physician
  • Additional Criteria for RCT Eligibility
  • Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL
  • Randomization by 16 week 6 days of pregnancy
  • No participation in a separate intervention trial.

Exclusion

    Key Trial Info

    Start Date :

    May 27 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 27 2027

    Estimated Enrollment :

    6000 Patients enrolled

    Trial Details

    Trial ID

    NCT06957028

    Start Date

    May 27 2025

    End Date

    November 27 2027

    Last Update

    December 23 2025

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35173

    2

    University of Miami

    Miami, Florida, United States, 33016

    3

    Emory University

    Decatur, Georgia, United States, 30033

    4

    IDC at Park Nicollet

    Saint Louis Park, Minnesota, United States, 55416