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

Last updated: January 28, 2025
Sponsor: Aalborg University Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Intelligent telemonitoring

Telemonitoring

Clinical Study ID

NCT06185296
DiaTRUST
  • Ages > 18
  • All Genders

Study 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 six 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

Inclusion

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-personvisits.

  • Have internet at home, have MitID, and willingness to use a smartphone and the otherdevices used in the trial

  • Signed informed consent.

  • Ability to understand and read Danish.

Exclusion

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 theparticipant unfit to conduct the trial, including lack of understanding of the trialor lack of physical or cognitive ability to participate.

  • Patients treated with mixed insulin.

Study Design

Total Participants: 51
Treatment Group(s): 2
Primary Treatment: Intelligent telemonitoring
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
June 30, 2026

Study Description

The DiaTRUST trial is an open-label randomized controlled trial with a six-month trial period. The trial will be conducted at Steno Diabetes Center North Jutland. Patients with T2D on insulin therapy will be randomized (3:1:1) to an intelligent telemonitoring group (intervention), telemonitoring alone (control), or a usual care group (control). Both telemonitoring groups will use an insulin pen, an activity tracker, a CGM, and a smartphone application throughout the trial period. Hospital staff (lab technicians and nurses) will monitor the telemonitoring groups' data and contact the subjects by telephone repeatedly throughout the trial period. For patients assigned to the intelligent telemonitoring group, decision support algorithms will provide hospital staff with insight and data overviews to support treatment evaluation and adjustment throughout the trial. Furthermore, patients in the intelligent telemonitoring group will have access to algorithms through a smartphone application that can provide a risk assessment before bed of nocturnal hypoglycemia. The usual care group will use a blinded CGM for the first 20 days after inclusion, 20 days before the second visit to the trial site, and 20 days before the end of trial and will use a blinded insulin pen for the entire period. The usual care groups' data will not be monitored during the trial.

Connect with a study center

  • Department of Endocrinology

    Aalborg, North jutland 9000
    Denmark

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.