NCT06185296Recruiting
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 6 Dec 2023
- Start date
- 15 Nov 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06185296
What you commit to
- Study type: Interventional
- Planned participants: 51
- From 15 Nov 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery is planned during the trial period.
- Cancer diagnosis within five years prior to inclusion.
- Patient who has worn a CGM monitor less than 6 months prior to the trial.
- Patients treated with mixed insulin.
Other
- Pregnancy or breastfeeding.
- Participation in other interventional trials.
- Limited literacy affecting the use of trial devices.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.