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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 our 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, we 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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jonatan I. Bagger, MD, Ph.d., Chief Physician
- Telefonní číslo: +45 28341036
- E-mail: jonatan.ising.bagger@regionh.dk
Studijní záloha kontaktů
- Jméno: Julie E. Stenvang, MD, Ph.d.-student
- Telefonní číslo: +45 51429941
- E-mail: julie.christine.egelund.stenvang.01@regionh.dk
Studijní místa
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-
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Herlev, Dánsko, 2730
- Steno Diabetes Center Copenhagen
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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)
|
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)
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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)
|
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)
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Children: Rate of diabetes related hospitalisations or prehospital contacts.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
Children are defined as age below 18 years of age.
Diagnoses are based on ICD-10 diagnoses of Hypoglycemia, Diabetic Ketoacidosis and Hyperglycemia.
|
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).
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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).
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
Adults are defined as age equal to or above 18 years of age.
Change in blood pressure from PRE to POST period.
|
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
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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. |
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
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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.
|
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.
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
Adults are defined as age equal to or above 18 years of age.
Change in blood pressure from PRE to POST period.
|
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)
Časové okno: From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
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)
|
From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Metabolické choroby
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Poruchy metabolismu glukózy
- Nutriční a metabolické nemoci
- Diabetes mellitus, typ 2
- Diabetes Mellitus
- Diabetes mellitus, typ 1
- Správa zdravotnických služeb
- Poskytování zdravotní péče
- Telemedicína
- Řízení péče o pacienty
- Vzdálené monitorování pacienta
Další identifikační čísla studie
- SDCC-Detektor2.0
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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