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Search / Trial NCT06185296

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

Launched by AALBORG UNIVERSITY HOSPITAL · Dec 14, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Diabetes Insulin Telemedicine Telehealth Telemonitoring Cgm Wearable Devices Adherence Decision Support Algorithms

ClinConnect Summary

This clinical trial is exploring new ways to help people with Type 2 Diabetes (T2D) who are on insulin therapy manage their condition more effectively. It will involve three groups of patients: one group will use advanced telemonitoring tools with support from hospital staff and decision-making algorithms, another group will use basic telemonitoring tools, and the last group will receive standard care without extra monitoring. The goal is to see if the intelligent telemonitoring leads to better management of diabetes over a six-month period.

To participate, you must be at least 18 years old, have been diagnosed with T2D for at least a year, and be currently using or about to start using insulin. You should be comfortable using a smartphone and have internet access at home. Participants will need to attend in-person visits in North Denmark and must be able to read and understand Danish. This trial will not accept individuals who are pregnant, have certain medical conditions, or have participated in other trials recently. If you join, you can expect to use various devices at home to help monitor your diabetes, with support from healthcare professionals throughout the study.

Gender

ALL

Eligibility 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.

About Aalborg University Hospital

Aalborg University Hospital is a leading healthcare institution in Denmark, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, the hospital actively engages in innovative studies aimed at improving health outcomes across various medical disciplines. With a focus on collaboration and interdisciplinary approaches, Aalborg University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous clinical trials, ensuring adherence to the highest ethical standards and regulatory requirements. The institution is dedicated to fostering a culture of research excellence, contributing valuable insights to the medical community and enhancing treatment options for patients.

Locations

Aalborg, North Jutland, Denmark

Patients applied

0 patients applied

Trial Officials

Peter Vestergaard, MD, PhD

Principal Investigator

Steno Diabetes Center North Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported