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Patterns and Glycaemic Endpoints for Diagnosing Gestational Diabetes

NCT05981547 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-23

No results posted yet for this study

Summary

Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes.

If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated.

The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.

Conditions

  • Gestational Diabetes

Interventions

DEVICE

Libre 3 continuous glucose monitoring sensor

Libre 3 CGM sensor applied to women prior to their Oral Glucose Tolerance test.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Portsmouth Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Laura Marshall, Bsc · Portsmouth Hospitals University NHS Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2026-06-21
Completion
2026-06-21

Countries

  • United Kingdom

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 NCT05981547 on ClinicalTrials.gov