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Smart insulin pumps put to the test in thousands of diabetes patients

NCT ID NCT04414280

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 1,600 people with type 1 diabetes, including young children aged 2-6, who use hybrid closed-loop insulin pumps (Medtronic, Tandem, or Omnipod). These devices automatically adjust insulin based on blood sugar readings but still require users to enter meal information. The goal is to see how well these pumps improve blood sugar control and quality of life over 24 months in real-world conditions.

What this could mean

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

Active substance
Hybrid closed-loop insulin pumps (Medtronic MiniMed 670G/780G, Tandem t:Slim X2 Control-IQ, Omnipod 5)
What this could lead to
If successful, this could show that automated insulin pumps help people with type 1 diabetes maintain better blood sugar levels with less effort, improving daily life and reducing complications.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. The devices still require user input for meals, and long-term benefits or risks are not yet fully known.

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

About 1,600 people

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

Started

Mar 2020

Expected to finish

Apr 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.

Who is studied

Participants will be recruited at 26 diabetes convention hospitals in Belgium

Ages

2 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.

People with type 1 diabetes, aged 7 years and older who start with the Medtronic MiniMed 670G or 780G system, aged 6 years and older who start with the Tandem t:slim X2 Control-IQ or those aged 2 years and older who start with the Omnipod 5 in the participating centers and who signed informed consent or gave informed assent (pediatrics) are eligible to participate. For the safety study, children with type 1 diabetes aged 2-6 years old who start(ed) with the Medtronic MiniMed 780G system in Manual Mode, whose parents agree to enable Auto Mode (after at least 4 weeks of Manual Mode) and whose parents signed informed consent can be included. Auto Mode enablement is only possible if time since type 1 diabetes diagnosis is at least 6 months. The decision about which person with type 1 diabetes to start, is left to the clinical judgement of the treating health care professional.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1

Contacts and locations

Locations

  • AZ Delta

    Roeselare, 8800, Belgium

  • AZ Delta - pediatrics

    Roeselare, 8800, Belgium

  • AZ Groeninge - campus kennedylaan

    Kortrijk, 8500, Belgium

  • AZ Oostende

    Ostend, 8400, Belgium

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • AZ Sint-Jan - pediatrics

    Bruges, 8000, Belgium

  • AZ Turnhout - pediatrics

    Turnhout, 2300, Belgium

  • AZORG

    Aalst, 9300, Belgium

  • CHR Citadelle

    Liège, 4000, Belgium

  • CHR Citadelle - pediatrics

    Liège, 4030, Belgium

  • CHU Helora

    Mons, 7000, Belgium

  • CHU UCL Namur - pediatrics

    Yvoir, 5530, Belgium

  • CHU de Liège - site du Sart Tilman

    Liège, 4000, Belgium

  • Clinique CHC Montlégia

    Liège, 4000, Belgium

  • Clinique CHC Montlégia - pediatrics

    Liège, 4000, Belgium

  • Cliniques Universitaires St. Luc

    Brussels, 1200, Belgium

  • Cliniques Universitaires St. Luc - pediatrics

    Brussels, 1200, Belgium

  • GZA Ziekenhuizen - campus Sint-Augustinus

    Wilrijk, 2610, Belgium

  • GZA Ziekenhuizen - campus Sint-Vincentius

    Antwerp, 2018, Belgium

  • Grand Hôpital de Charleroi - pediatrics

    Charleroi, 6000, Belgium

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Hôpital Universitaire des Enfants Reine Fabiola - pediatrics

    Brussels, 1020, Belgium

  • Hôpital d'Arlon

    Arlon, 6700, Belgium

  • Imeldaziekenhuis

    Bonheiden, 2820, Belgium

  • Jessa

    Hasselt, 3500, Belgium

  • Jessa - pediatrics

    Hasselt, 3500, Belgium

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UZ Antwerpen - pediatrics

    Edegem, 2650, Belgium

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Brussel - pediatrics

    Jette, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Gent - pediatrics

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

  • VITAZ

    Sint-Niklaas, 9100, Belgium

  • Vitaz - pediatrics

    Sint-Niklaas, 9100, Belgium

  • ZAS - pediatrics

    Antwerp, 2020, Belgium

  • ZOL Maas en Kempen - pediatrics

    Maaseik, 3680, Belgium

  • ZOL Sint-Jan

    Genk, 3600, Belgium

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