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Smart diabetes monitoring trial aims to improve insulin management

NCT ID NCT06185296

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This trial tests whether a smart telemonitoring system can help people with type 2 diabetes who use insulin. Participants will use a continuous glucose monitor, insulin pen, and Fitbit at home. One group will also get decision-support algorithms to guide insulin adjustments. The study will compare blood sugar control among three groups over three months.

What this could mean

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

Active substance
intelligent telemonitoring system (continuous glucose monitor, insulin pen, Fitbit, and decision-support algorithms)
What this could lead to
If it works, this could give doctors and patients a smarter way to manage insulin dosing at home, leading to better blood sugar control.
What could go wrong
This is a small, early-stage trial with only 51 participants, so results may not apply to everyone. The technology may be too complex for some users.

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 51 people

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

Started

Nov 2025

Expected to finish

Sep 2026

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: * Adults ≥ 18 years. * Diagnosis of T2D for at least 12 months prior to the day of screening. * Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits. * Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial * Signed informed consent. * Ability to understand and read Danish. Exclusion Criteria: * Pregnancy or breastfeeding. * Major surgery is planned during the trial period. * Cancer diagnosis within five years prior to inclusion. * Participation in other interventional trials. * Limited literacy affecting the use of trial devices. * Patient who has worn a CGM monitor less than 6 months prior to the trial. * Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate. * Patients treated with mixed insulin.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes treated with insulin

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

  • Department of Endocrinology

    RECRUITING

    Aalborg, North Jutland, 9000, Denmark

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