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Glucose monitors may outshine standard test for pregnancy diabetes

NCT ID NCT05981547

Knowledge-focused Sponsor: Portsmouth Hospitals NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looks at whether a continuous glucose monitor (CGM) can provide better insight into blood sugar patterns in pregnant women at risk for gestational diabetes than the usual oral glucose tolerance test (OGTT). Researchers will give 400 high-risk pregnant women a CGM sensor and compare their glucose data with their OGTT results and pregnancy outcomes. The goal is to see if the OGTT misses important high blood sugar episodes, which could lead to better diagnosis in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Libre 3 continuous glucose monitoring sensor
What this could lead to
If successful, this study could point toward using continuous glucose monitors as a more reliable way to diagnose gestational diabetes than the current oral glucose tolerance test.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change care yet. The results may show no clear difference between groups, limiting the case for changing diagnostic methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

180 people

The number who actually took part.

Started

Nov 2023

Finished

May 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The investigators will recruit 400 patients, with the expectation that approximately 120 of these will have confirmed GDM following an OGTT. Of these patients, we expect 50% will require glucose lowering therapy (metformin and/or insulin) and 50% willo manage their GDM with dietary measures. The sample sizes are derived from the fact that CGM (AGP) comparisons across groups require n=18-20 in each group to give 80% power to detect clinically significant differences and so our sample size calculations are driven by making sure no sub-group has less than 20 subjects in it. The total of 120 positive OGTTs can be further sub-divided by how they achieved the positive OGTT (fasting, post glucose load, or both).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female aged 18 years of above * Between 12-26 weeks gestation * Identified by NICE as having one or more independent risk factor for GDM * Suitable for the standard care pathway under the joint antenatal clinic for GDM * Willing and able to give informed consent. Exclusion Criteria: * Pre-existing diabetes * Previous GDM * Unsuitable for standard joint antenatal clinic pathway * Known allergy to freestyle libre adhesive pad * Planning to move geographical area during the study timeframe * Participating in a different study that could interfere with glucose levels or affect ability to participate.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes

Contacts and locations

Locations

  • Portsmouth Hospitals University NHS Trust

    Portsmouth, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.