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Smart insulin pump could transform hospital diabetes care

NCT ID NCT07645079

Disease control Sponsor: Steno Diabetes Center Copenhagen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial compares an automated insulin delivery system (AID) to standard insulin injections for managing blood sugar in hospitalized adults with type 2 diabetes who have an infection. The AID system uses a continuous glucose monitor and a smart pump to automatically adjust insulin. The study aims to see if the AID system keeps blood sugar in a healthy range better than usual care. Participants are randomly assigned to either the AID system or standard insulin therapy, and their blood sugar levels are tracked throughout their hospital stay.

What this could mean

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

Active substance
automated insulin delivery system (mylife YpsoPump with FreeStyle Libre 3 sensor)
What this could lead to
If successful, this could show that automated insulin delivery is safer and more effective than standard care for managing blood sugar in hospitalized patients with type 2 diabetes.
What could go wrong
This is a relatively small trial (92 participants) and results may not apply to all hospitals or patient groups. The device may not work as well in sicker patients or could have technical issues.

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 92 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

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: * A documented history of Type 2 diabetes mellitus (T2DM) which requires subcutaneous insulin therapy * acute infectious disease of any kind * age ≥ 18 years old * willingness and ability to comply with theclinical investigation plan * ability to communicate with the trial personal * an expected length of hospital stay for at least 2 days after enrolment Exclusion Criteria: * Patients already using AID for their glycemic management * Patients in use of an insulin pump * Skin pathologies that hinder application of a FreeStyle Libre-3 CGM and mylife YpsoPump * Participation in another trial, which could influence the outcome of the trial * Any mental condition rendering the patient incapable of giving informed consent * Known or suspected allergy to adhesive material/tape of the Libre-3-sensor and/or YpsoPump * Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient * Diagnoses/treatments/clinical parameters prohibiting use of Insulin/AID such as * Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2 OR * Treated with hydroxyurea/hydroxycarbamide OR * Nutritional therapy (continuous enteral or parenteral feeding) OR * Clinically relevant pancreatic disease OR * Aystemic glucocorticoid treatment with prednisone equivalent dose \>5 mg/day OR * Expected to require admission to the intensive-care unit OR \> Patients in dialysis

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Conditions

The condition(s) this trial relates to.

congenital primary megaureter Infections infectious disease type 2 diabetes mellitus

As listed by the trial registrant

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

CGM Diabetes mellitus type 2 Infection

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Steno Diabetes Center Copenhagen

    Copenhagen, 2730, Denmark

  • University Hospital of Graz

    Graz, Styria, 8036, Austria

More trials for these conditions

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