The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University Hospital

About this trial

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

Qualifiers

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

Disqualifiers

Pregnancy or breastfeeding.

Major surgery is planned during the trial period.

Cancer diagnosis within five years prior to inclusion.

Participation in other interventional trials.

Trial design

Treatments tested in this trial

  • Intelligent telemonitoring
  • Telemonitoring

Treatment groups

51 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Aalborg University Hospital

Lead sponsor

Novo Nordisk A/S

Collaborator

DexCom, Inc.

Collaborator