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Can a simple monitor predict type 1 diabetes before symptoms start?

NCT ID NCT05777330

Knowledge-focused Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 2 times

Summary

This study is testing whether a continuous glucose monitor (CGM) can predict blood sugar problems in people who are at risk for type 1 diabetes but have no symptoms. Researchers will follow 75 people aged 5 to 39 who have diabetes-related autoantibodies. They will compare CGM data with standard tests like oral glucose tolerance tests and hyperglycemic clamps over 2-3 years to see if the monitor can catch early signs of diabetes.

What this could mean

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

What this could lead to
If successful, this could lead to a simpler way to detect early signs of type 1 diabetes using a continuous glucose monitor instead of frequent lab tests.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear link between CGM readings and disease progression, and results may not apply to all risk groups.

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 75 people

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

Started

Aug 2023

Expected to finish

Nov 2027

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

5 to 39 years

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: 1. aged 5-39 years at inclusion; 2. absence of diabetes meeting the clinical diagnostic American Diabetes Association (ADA) criteria; 3. persistently positive for one or multiple types of autoantibodies among IAA, GADA, IA-2A and ZnT8A. Exclusion Criteria: 1. Pregnancy or lactation in women; \<6 months postpartum 2. Diabetes meeting the clinical diagnostic ADA criteria; 3. Use of illicit drugs, or overconsumption of alcohol, or history of drug or alcohol abuse; 4. Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders; 5. Treatment with immune modulating or diabetogenic medication (e.g. corticosteroids) or medication that act to lower glycemia (oral antidiabetics) or agents that may influence insulin sensitivity or secretion; 6. Gastric bypass or banding; 7. History of acute or chronic pancreatitis, or (partial) pancreatectomy 8. History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

TYPE1 diabetes mellitus

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.Z. Sint-Jan Brugge

    RECRUITING

    Bruges, West-Vlaanderen, 8000, Belgium

  • Clinique CHC MontLégia

    RECRUITING

    Liège, Liège, 4000, Belgium

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Antwerp, 2650, Belgium

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Jette, 1090, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

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