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

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.

This study is a prospective observational pre-post cohort study evaluating the RPM-system Steno Detektor within the Steno Care outpatient structure using real world EHR data on approximately 12.000 people with diabetes.

Growing populations, increasing life expectancy and the rising prevalence of diabetes expand the demand for high-quality, personalized treatment for both current and future healthcare systems. Advancements in medical treatments and health technologies have generated new possibilities for managing chronic conditions. Modern health technology generates vast amounts of data, creating new opportunities for precision care, however the potential has yet to be fully realized. This highlights a critical opportunity: rethinking how outpatient care is organized, and how technology can support more efficient and meaningful clinical workflows.

Steno Diabetes Center Copenhagen (SDCC) provides care for more than 12.000 individuals - adults and children - with type 1, complicated type 2, rare hereditary forms and other types of diabetes. Previously, individuals were seen in fixed 3-4-month intervals for routine consultations regardless of individual health status and need. With the rapid evolving health technology and increasing availability of data, this one-size-fits-all is no longer optimal nor necessary. Therefore, SDCC developed a new patient-centred and needs-based structure for outpatient care named Steno Care including remote-patient-monitoring (RPM) within the structure. With the Steno Care structure up to two years may pass between in-patient visits depending on the patient.

All patients under active care at SDCC (children, adolescents and adults) are included in the study as inclusion in the RPM-system is part of their regular medical care for diabetes. The study population is a dynamic cohort; some will be referred to other care facilities, while others will begin their care at SDCC within the study period. Participants will contribute data until termination of their care at SDCC.

To the investigators knowledge, no RPM system has been applied to a population at this scale, across all ages and including both type 1 and type 2 diabetes, whilst also incorporating parameters beyond glycaemic data.

Steno Detektor was implemented in the daily clinical practice outside the EHR system in October 2024, followed by an iterative improvement process, and is planned for integration within the EHR system "Sundhedsplatformen" (EPIC) in 2026.

The RPM-system will be evaluated by comparing parameters prior to the implementation of Steno Care, and up to two years after the integration of the RPM-system within the EHR system. The primary endpoint will be to evaluate non-inferiority in glyceamic endpoints, and secondary to evaluate non-inferiority in cardiometabolic complications, renal markers, diabetes related admissions and diabetes related prehospital contacts.

By integrating the RPM within the EHR-system and developing this system iteratively in real-world practice, the investigators aim to demonstrate how a RPM-system can enable personalized diabetes care, supporting both HCPs and patients, and establishing a foundation for a scalable system for future chronic disease management.

Inclusion Criteria:

• All people with active clinical care at SDCC during each period and thereby included in the RPM.

Exclusion Criteria:

• All people without active clinical care at SDCC during each period.