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

22 maggio 2026 aggiornato da: Steno Diabetes Center Copenhagen

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

12000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Danimarca
      • Herlev, Danimarca, 2730
        • Steno Diabetes Center Copenhagen

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population is a dynamic cohort: Participants contribute data until termination of their care at SDCC (e.g., transfer to GP/other hospital). This marks the end of the observation window for that specific participant within the population.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Children: Rate of diabetes related hospitalisations or prehospital contacts.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Steno Diabetes Center Copenhagen

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 luglio 2028

Completamento dello studio (Stimato)

1 luglio 2028

Date di iscrizione allo studio

Primo inviato

22 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SDCC-Detektor2.0

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data will be shared upon request for it.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sedi

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