RecruitingNot ApplicableNCT06185296

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

The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial


Sponsor

Aalborg University Hospital

Enrollment

51 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a digital diabetes management system — including remote monitoring and decision-support tools — helps adults with type 2 diabetes manage their insulin therapy better, compared to standard care. The trial is based in North Denmark. **You may be eligible if...** - You are 18 or older - You have had type 2 diabetes for at least 12 months - You are currently on insulin or are about to start insulin treatment - You have internet access at home, a Danish digital ID (MitID), and are willing to use a smartphone and monitoring devices - You are able to travel to the trial site in North Denmark for some in-person visits **You may NOT be eligible if...** - You have type 1 diabetes - You are unable to use digital tools or smartphones - You have severe complications or other conditions making participation difficult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntelligent telemonitoring

Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.

DEVICETelemonitoring

Telemonitoring using CGM, insulin pen data, and Fitbit data


Locations(1)

Department of Endocrinology

Aalborg, North Jutland, Denmark

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NCT06185296


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