New treatment option for Type 2 Diabetes Treated With Insulin
Official title The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
ClinicalTrials.gov ID: NCT06185296
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial
- Signed informed consent.
You likely can't join if
- Pregnancy or breastfeeding.
- Major surgery is planned during the trial period.
- Cancer diagnosis within five years prior to inclusion.
- Participation in other treatment trials.
- Limited literacy affecting the use of trial devices.
- Patient who has worn a CGM monitor less than 6 months prior to the trial.
See the full eligibility 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.
- Pregnancy or breastfeeding.
- Major surgery is planned during the trial period.
- Cancer diagnosis within five years prior to inclusion.
- Participation in other treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, North Jutland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, North Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.