Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison

The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is: Whether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024. Participants are included in the RPM-system as part of their regular medical care for diabetes.

NCT Number	NCT07617519
Lead Sponsor	Steno Diabetes Center Copenhagen
Conditions	Diabetes, Diabetes Care, Diabetes Type 1, Diabetes Type 2, Remote Patient Monitoring, Digital Health
Enrollment	12,000 participants
Start Date	2026-06-10
Primary Completion	2028-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-17