NCT06185296 The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
| NCT ID | NCT06185296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Type 2 Diabetes Treated With Insulin |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-11-15 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 51 participants in total. It began in 2025-11-15 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for three months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.
Eligibility Criteria
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.
Contact & Investigator
Peter Vestergaard, MD, PhD
PRINCIPAL INVESTIGATOR
Steno Diabetes Center North Denmark
Frequently Asked Questions
Who can join the NCT06185296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Treated With Insulin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06185296 currently recruiting?
Yes, NCT06185296 is actively recruiting participants. Contact the research team at jadano@hst.aau.dk for enrollment information.
Where is the NCT06185296 trial being conducted?
This trial is being conducted at Aalborg, Denmark.
Who is sponsoring the NCT06185296 clinical trial?
NCT06185296 is sponsored by Aalborg University Hospital. The principal investigator is Peter Vestergaard, MD, PhD at Steno Diabetes Center North Denmark. The trial plans to enroll 51 participants.
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