Intelligent telemonitoring with decision support for insulin-treated type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using continuous glucose monitors during pregnancy for women with type 2 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.