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Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China (COOPERATIONS)

31 de mayo de 2022 actualizado por: Peking University Third Hospital
For last decade, the innovation of mobile health platform has brought new opportunities for disease management. Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients. Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Tipo de estudio

De observación

Inscripción (Anticipado)

500

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kun Yang, MD
  • Número de teléfono: 86-13651315864
  • Correo electrónico: yangkun@bjmu.edu.cn

Copia de seguridad de contactos de estudio

  • Nombre: Jin Yang, PhD
  • Número de teléfono: 86-15810298367
  • Correo electrónico: yangjin@bjmu.edu.cn

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana, 100191
        • Peking University Third Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with type 1 diabetes from in-patient and out-patient.

Descripción

Inclusion Criteria:

  • At least 12 years old;
  • Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999;
  • Be able to use smart mobile phones;
  • Informed consent and voluntary participation.

Exclusion Criteria:

  • Secondary diabetes;
  • Complicated with malignant diseases, such as cancer, hepatic and renal failure;
  • Complicated with cognitive impairment or mental illness;
  • Be pregnant or lactating at the time of enrollment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c
Periodo de tiempo: Outcome evaluation at 10 years.
HbA1c is one of the indicators that reflects the level of blood glucose control overall. Blood sample will be required and tested.
Outcome evaluation at 10 years.
Time in range (TIR)
Periodo de tiempo: Outcome evaluation at 10 years.
TIR is one of the indicators that reflects the level of blood glucose control from the point of view of target time. Continuous glucose monitoring (CGM) devices will be used.
Outcome evaluation at 10 years.
Incidence of hypoglycemia
Periodo de tiempo: Outcome evaluation at 10 years.
Incidence of hypoglycemia is one of the indicators that reflects the level of blood glucose control. Hypoglycemia is defined as blood glucose lower than 3.9mmol/L with or without symptoms. Incidence of hypoglycemia is occurence times per month according to patients self-reported.
Outcome evaluation at 10 years.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Comprehensive metabolic control
Periodo de tiempo: Outcome evaluation at 10 years.
Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Outcome evaluation at 10 years.
Comprehensive metabolic control
Periodo de tiempo: Outcome evaluation at 10 years.
Blood lipid is one of the control level of comprehensive metabolic indicators, including total cholesterol (TC), total triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C).
Outcome evaluation at 10 years.
Occurrence of Diabetes-related complications.
Periodo de tiempo: Outcome evaluation at 10 years.
To observe and analyze occurrence of diabetes-related acute and chronic complications. Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS). Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA). Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death.
Outcome evaluation at 10 years.
Progression of Diabetes-related complications.
Periodo de tiempo: Outcome evaluation at 10 years.
To observe and analyze progression of diabetes-related acute and chronic complications. Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS). Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA). Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death.
Outcome evaluation at 10 years.
Anxiety condition.
Periodo de tiempo: Outcome evaluation at 10 years.
Anxiety condition is one of the psychosocial status indicators, and Self-Rating Anxiety Scale (SAS) will be used to assess anxiety level. The score ranges from 20 to 100, and higher score indicates more prone to anxiety.
Outcome evaluation at 10 years.
Anxiety condition.
Periodo de tiempo: Outcome evaluation at 10 years.
Anxiety condition is one of the psychosocial status indicators. Generalized Anxiety Disorder 7-Item Scale (GAD-7 scale) will be used to assess anxiety symptoms. The score ranges from 0 to 7, and higher score indicates more anxiety symptoms.
Outcome evaluation at 10 years.
Depression condition.
Periodo de tiempo: Outcome evaluation at 10 years.
Depression condition is one of the psychosocial status indicators, and Self-Rating Depression Scale (SDS) will be used to assess depression level. The level of depression is measured by depression severity index. The index ranges from 0.25 to 1.0, with higher scores associated with greater depression.
Outcome evaluation at 10 years.
Depression condition.
Periodo de tiempo: Outcome evaluation at 10 years.
Depression condition is one of the psychosocial status indicators, and Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression level. The score ranges from 0 to 27. A higher score indicates a higher degree of depression.
Outcome evaluation at 10 years.
Depression condition.
Periodo de tiempo: Outcome evaluation at 10 years.
Depression condition is one of the psychosocial status indicators, and Problem Areas in Diabetes-Short form (PAID-5) will be used to evaluate the diabetes related emotional distress, which is strongly association with depression. A score ≥40 indicates high diabetes-related distress.
Outcome evaluation at 10 years.
Life quality.
Periodo de tiempo: Outcome evaluation at 10 years.
Life quality is one of the psychosocial status indicators, and specific scales as World Health Organization-5 well-being index (WHO-5) will be used to assess this factor. A score <50 indicates poor psychological well-being.
Outcome evaluation at 10 years.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Peking University Third Hospital

Investigadores

  • Director de estudio: Jin Yang, PhD, Peking University Third Hospital
  • Investigador principal: Kun Yang, MD, Peking University Third Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de junio de 2022

Finalización primaria (Anticipado)

1 de enero de 2032

Finalización del estudio (Anticipado)

1 de enero de 2032

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

6 de diciembre de 2021

Publicado por primera vez (Actual)

20 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2022

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M2021380

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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