Diagnosis of Gestational Diabetes Based on a 50-gram Glucose Challenge

June 8, 2026 updated by: Methodist Health System
The aim of this study is to determine a 1-hour glucose tolerance test (GTT) value at which the diagnosis of gestational diabetes can be made without undergoing a 3-hour test.

Study Overview

Status

Completed

Conditions

Detailed Description

Retrospective chart review to ascertain the 50-gram glucose screen values in pregnant women at Methodist Dallas Medical Center from April 2020 to April 2023 who failed the 100-gram glucose load.

Study Type

Observational

Enrollment (Actual)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Clinical Research Institute at Methodist Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.

Description

Inclusion Criteria:

  • Singleton pregnancies in which a 3-hour, 100-gram glucose test was completed and failed after 24-weeks' gestation.

Exclusion Criteria:

  • Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if there is glucose value after the 50-gram oral GTT that can be used to diagnose gestational diabetes
Time Frame: through study completion, up to 18 months
The primary outcome will be the 50-gram glucose results for patients that were diagnosed with gestational diabetes by a 100-gram glucose challenge.
through study completion, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Margaret Warren, DO, MFM, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Actual)

March 29, 2024

Study Completion (Actual)

March 29, 2024

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 017.MFM.2023.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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