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
Aalborg University Hospital
51 participants
Nov 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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.
Interventions
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
Telemonitoring using CGM, insulin pen data, and Fitbit data
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06185296