The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
NCT06185296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2026-02-09
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.
Conditions
- Type 2 Diabetes Treated With Insulin
Interventions
- DEVICE
-
Intelligent telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
- DEVICE
-
Telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data
Sponsors & Collaborators
- collaborator INDUSTRY
-
DexCom, Inc.
collaborator INDUSTRY -
Aalborg University Hospital
lead OTHER
Principal Investigators
-
Peter Vestergaard, MD, PhD · Steno Diabetes Center North Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-15
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- Denmark
Study Locations
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