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Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

NCT05430204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1628

Last updated 2025-12-04

Study results available
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Summary

The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care

Conditions

  • Gestational Diabetes

Interventions

DEVICE

Group 1: one-hour GCT

Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.

DEVICE

Group 2: CGM placement

CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group: * Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or * Average glucose≥130 mg/dL or * Any glucose value ≥200 mg/dL

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Michal Fishel Bartal, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2024-08-02
Completion
2024-09-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430204 on ClinicalTrials.gov