Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Endocrinology
RECRUITING
Aalborg
Contact Information
Primary
Jannie Nørlev, PhD
jadano@hst.aau.dk
004523676513
Backup
Stine Hangaard, PhD
svh@hst.aau.dk
Time Frame
Start Date: 2025-11-15
Estimated Completion Date: 2026-09
Participants
Target number of participants: 51
Treatments
Experimental: Intelligent telemonitoring
The subjects will be telemonitored using the intelligent telemonitoring system. All subjects will use a CGM, a Fitbit, and a smart pen during the trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject) using the intelligent telemonitoring system with embedded decision support to facilitate treatment evaluation and adjustments. The subjects will have access to a smartphone app that is able to provide a risk for nocturnal hypoglycemia before bed.
Active_comparator: Telemonitoring
The subjects will be telemonitored. All subjects will use a CGM, a Fitbit, and a smart pen during the entire trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)
No_intervention: Usual care
The subjects will wear a blinded CGM the first 20 days after inclusion, 20 days before the second visit to the trial site, and the final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects cannot see their measured data during the trial and will not be monitored.
Related Therapeutic Areas
Sponsors
Collaborators: DexCom, Inc., Novo Nordisk A/S
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov