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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jun 10, 2026
    • Site details revised
    v3
  2. Minor Study description expanded, about 2 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07617519
Lead Sponsor Steno Diabetes Center Copenhagen
Conditions
(from sponsor)
Diabetes, Diabetes Care, Diabetes Type 1, Diabetes Type 2, Remote Patient Monitoring, Digital Health
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Enrollment 12,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov