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.
Study Type
OBSERVATIONAL
Enrollment
12,000
The RPM-system "Steno Detektor" integrated within the EHR-system
Steno Diabetes Center Copenhagen
Herlev, Denmark
RECRUITINGChildren: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Children are defined as age below 18 years of age. Change from PRE to POST period in a CGM endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) TAR is defined as percentage of time spent with a blood glucose \>10 mmol/L, and TBR is defined as level 2 TBR (percentage of time spent with a blood glucose \<3.0 mmol/L)
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).
Adults with Type 1 diabetes: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Adults are defined as age equal to or above 18 years of age. Change from PRE to POST period in a CGM endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR). TAR is defined as percentage of time spent with a blood glucose \>10 mmol/L, and TBR is defined as level 2 TBR (percentage of time spent with a blood glucose \<3.0 mmol/L)
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).
Adults with Type 2-diabetes: HbA1c (mmol/L)
Adults are defined as age equal to or above 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Children: Rate of diabetes related hospitalisations or prehospital contacts.
Children are defined as age below 18 years of age. Diagnoses are based on ICD-10 diagnoses of Hypoglycemia, Diabetic Ketoacidosis and Hyperglycemia.
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).
Children: HbA1c (mmol/L).
Children are defined as age below 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 1 diabetes: Rate of diabetes related hospitalisations or prehospital contacts.
Adults are defined as age equal to or above 18 years of age. Diagnoses are based on ICD-10 diagnoses of Hypoglycemia, Diabetic Ketoacidosis, Hyperglycemia and Hyperosmolar hyperglycaemic state.
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).
Adults with Type 1 diabetes: HbA1c (mmol/L).
Adults are defined as age equal to or above 18 years of age. Change in HbA1c (mmol/L) from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 1 diabetes: eGFR.
Adults are defined as age equal to or above 18 years of age. Change in eGFR from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 1 diabetes: UACR.
Adults are defined as age equal to or above 18 years of age. Change in UACR from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 1 diabetes: Blood pressure.
Adults are defined as age equal to or above 18 years of age. Change in blood pressure from PRE to POST period.
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).
Adults with Type 1 diabetes: Incident diagnoses of stroke, ischemic heart disease, and chronic kidney disease
Adults are defined as age equal to or above 18 years of age. The outcome measure is the incidence of newly diagnosed stroke, ischemic heart disease, and chronic kidney disease, comparing the PRE- and POST-period. The incident diagnoses are defined as ICD-10 diagnoses.
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).
Adults with Type 2 diabetes: Incident diagnoses of stroke, ischemic heart disease, and chronic kidney disease
Adults are defines as equal to or above 18 years of age. The outcome measure is the incidence of newly diagnosed stroke, ischemic heart disease, and chronic kidney disease, comparing the PRE- and POST-period. The incident diagnoses are defined as ICD-10 diagnoses.
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).
Adults with Type 2-diabetes: eGFR
Adults are defined as age equal to or above 18 years of age. Change in eGFR from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 2-diabetes: UACR
Adults are defined as age equal to or above 18 years of age. Change in UACR from PRE to POST period. If more than one measurement within the time period exists the last measured value will be used.
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).
Adults with Type 2 diabetes: Blood pressure.
Adults are defined as age equal to or above 18 years of age. Change in blood pressure from PRE to POST period.
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).
Adults with Type 2 diabetes: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Adults are defined as age equal to or above 18 years of age. Change from PRE to POST period in a CGM endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR). TAR is defined as percentage of time spent with a blood glucose \>10 mmol/L, and TBR is defined as level 2 TBR (percentage of time spent with a blood glucose \<3.0 mmol/L)
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).
Julie E. Stenvang, MD, Ph.d.-student
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