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Could a wearable sensor replace the glucose drink test for diabetes in pregnancy?

NCT ID NCT05430204

Diagnosis Sponsor: The University of Texas Health Science Center, Houston 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compared continuous glucose monitoring (CGM) to the standard glucose challenge test for screening gestational diabetes in over 1,600 pregnant women. The goal was to see if CGM leads to better health outcomes for mothers and babies, such as fewer large babies or birth injuries. Participants wore a CGM device for several days instead of or alongside the usual blood sugar test.

What this could mean

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

Active substance
continuous glucose monitor (CGM)
What this could lead to
If successful, CGM could become a better way to screen for gestational diabetes, leading to fewer birth complications and lower healthcare costs.
What could go wrong
This is a completed trial, but results may not apply to all populations or settings. CGM is more complex and costly than standard screening, which could limit widespread use.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,628 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * 24-30 weeks gestation undergoing GDM screening Exclusion Criteria: * Known diagnosis of Type I and II DM * History of bariatric surgery * Major fetal anomalies * Unwilling to use CGM for GDM screening * Incarcerated subjects * History of allergic reaction to any of CGM metals or adhesives in contact with the skin

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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

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

More trials for these conditions

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