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

Conditions studied

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

About this study

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.

Interventions

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

Primary outcomes

• Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)
• Adults with Type 1 diabetes: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)
• Adults with Type 2-diabetes: HbA1c (mmol/L) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)

Eligibility information

Study locations

• Steno Diabetes Center Copenhagen, Herlev, 2730 Denmark