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AI coach joins fight against diabetes in new online lifestyle trial

NCT ID NCT07661381

Disease control Sponsor: University of Twente 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a personalized online lifestyle program, with or without a virtual AI coach, can help people with type 2 diabetes improve their blood sugar control. 160 adults will use continuous glucose monitors and attend online group sessions over 12 months, with follow-ups up to 24 months. The main goal is to see if HbA1c levels drop, along with other health measures like weight and blood pressure.

What this could mean

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

Active substance
Lifestyle program with virtual AI lifestyle coach and continuous glucose monitoring
What this could lead to
If successful, this could offer an effective, remote way to help people with type 2 diabetes better manage their blood sugar and overall health without needing extra medication.
What could go wrong
This is a feasibility study, not a large late-stage trial. The AI coach is new, and results may not apply to everyone. Lifestyle changes can be hard to maintain long-term.

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 160 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

Anyone

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: * Age: ≥18 years * HbA1c: ≥53 mmol/mol (7 - 12%) * Signed informed consent form and willing to comply with the study procedures * Persons who are naïve for participation in a lifestyle program for the past two years * Being digitally competent * Mastering the Dutch language * Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years) Exclusion Criteria: * Medication use: any other glucose-lowering medication than metformin * Comorbidities or medical conditions requiring a special diet that conflicts with the study * Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight) * Circumstances that lead to unreliable HbA1c values, such as blood donation * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes type 2

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • University of Twente

    Enschede, Overijssel, 7500 AE, Netherlands

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