Intelligent telemonitoring with decision support for insulin-treated type 2 diabetes
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial
This trial tests whether adding decision-support algorithms to home telemonitoring helps adults with type 2 diabetes who use insulin manage their blood sugar better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg, North Jutland) |
| Trial ID | NCT06185296 on ClinicalTrials.gov |
What this trial studies
This is an open-label randomized controlled trial that will randomize adults with type 2 diabetes on insulin in a 3:1:1 ratio to intelligent telemonitoring, telemonitoring alone, or usual care for three months. Participants in both telemonitoring arms will use an insulin pen, activity tracker, continuous glucose monitor (CGM), and a smartphone app while hospital staff monitor incoming data and contact patients by phone. The intelligent telemonitoring arm adds decision-support algorithms to provide clinicians and patients with risk overviews and an app-based nightly hypoglycemia risk assessment to guide insulin adjustments. The usual care group will use blinded CGM and a blinded insulin pen on scheduled periods and their data will not be monitored in real time.
Who should consider this trial
Good fit: Adults (≥18) with type 2 diabetes treated with or about to start insulin who can read Danish, travel to North Denmark for visits, have internet access and MitID, and are willing to use a smartphone and the trial devices.
Not a fit: People who are pregnant or breastfeeding, have recent cancer, plan major surgery during the trial, have limited literacy or are uncomfortable with the required technology, or live too far from the trial site will likely not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce hypoglycemia and improve overall glucose control by enabling more timely, data-driven insulin adjustments.
How similar studies have performed: Previous telemonitoring and CGM plus telehealth studies have shown improvements in glycemic control, but combining clinician- and patient-facing decision-support algorithms for insulin adjustment is less tested and remains relatively novel with only preliminary supportive data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalborg, North Jutland
- Department of Endocrinology — Aalborg, North Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Peter Vestergaard, MD, PhD — Steno Diabetes Center North Denmark
- Study coordinator: Jannie Nørlev, PhD
- Email: jadano@hst.aau.dk
- Phone: 004523676513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.