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

15 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

12000

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Jonatan I. Bagger, MD, Ph.d., Chief Physician
  • Номер телефона: +45 28341036
  • Электронная почта: jonatan.ising.bagger@regionh.dk

Учебное резервное копирование контактов

Места учебы

  • Дания
      • Herlev, Дания, 2730
        • Рекрутинг
        • Steno Diabetes Center Copenhagen
        • Контакт:
          • Jonatan I. Bagger, MD, Ph.d., Chief Physician
          • Номер телефона: +45 28341036
          • Электронная почта: jonatan.ising.bagger@regionh.dk
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Children: Rate of diabetes related hospitalisations or prehospital contacts.
Временное ограничение: 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).
Временное ограничение: 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.
Временное ограничение: 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).
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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)
Временное ограничение: 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).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Steno Diabetes Center Copenhagen

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

10 июня 2026 г.

Первичное завершение (Оцененный)

1 июля 2028 г.

Завершение исследования (Оцененный)

1 июля 2028 г.

Даты регистрации исследования

Первый отправленный

22 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

22 мая 2026 г.

Первый опубликованный (Действительный)

1 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

17 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 июля 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SDCC-Detektor2.0

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Data will be shared upon request for it.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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