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App and coach aim to cut diabetes risk in pregnancy

NCT ID NCT07189221

Prevention Sponsor: University College Dublin 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This European study tests a program called B2B&ME+ that uses a smartphone app and personal health coaching to help pregnant women at high risk for gestational diabetes. 3600 women will be enrolled across four countries. The goal is to see if this approach can reduce diabetes and improve health for mothers and babies.

What this could mean

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

Active substance
Lifestyle intervention (smartphone app with Bluetooth scale and health coaching)
What this could lead to
If successful, this could provide a practical way to prevent gestational diabetes and improve long-term health for mothers and babies.
What could go wrong
This is an implementation study, not a drug trial. Results depend on how well women follow the program, and benefits may vary across countries and healthcare systems.

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

About 3,600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

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: * Pregnant women attending their first/early antenatal appointments at participating sites * Gestation less than 24 weeks at enrolment * Age 18 years or older * Ability to provide informed consent Additional for the intervention group (Block B): * Identified as higher risk for GDM using the MMLGDST * Ownership of a smartphone compatible with the B2B\&Me+ app Exclusion Criteria: * 24 weeks gestation or higher * Multiple pregnancy (twins, triplets, etc.) Additional for the intervention group (Block B): * Participation in another health behaviour change intervention study during pregnancy * Inability to understand the language of the intervention (English in Ireland, Spanish in Spain, Norwegian in Norway, Polish in Poland) * Severe mental illness, drug or alcohol abuse that would impair ability to participate * Cancer (not in remission) * Myocardial infarction in the last three months * Pre-existing diabetes (Type 1 or Type 2), or early GDM. * Not owning a smartphone capable of hosting the intervention app

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Conditions

The condition(s) this trial relates to.

gestational diabetes prevention target

As listed by the trial registrant

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

Gestational diabetes mellitus (GDM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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