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

Sponsor
Steno Diabetes Center Copenhagen
Study ID
NCT07617519
Status
Recruiting
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Conditions

  • Diabetes
  • Diabetes Care
  • Diabetes Type 1
  • Diabetes Type 2
  • Digital Health
  • Remote Patient Monitoring

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remote-Patient-Monitoring (RPM) — OTHER
    The RPM-system "Steno Detektor" integrated within the EHR-system

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
12,000 participants (estimated)

Primary Outcome Measure

Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) [ Time Frame: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028). ]

Central Contacts

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