Status:
NOT_YET_RECRUITING
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Novo Nordisk A/S
DexCom, Inc.
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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)...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06185296
Start Date
May 1 2025
End Date
June 1 2026
Last Update
January 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Endocrinology
Aalborg, North Jutland, Denmark, 9000