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Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis (GLANCE-PD)

24 de agosto de 2026 actualizado por: Elaine Chow

Glycemic Assessment Based on Continuous Glucose Monitoring and Clinical Outcomes in People With Diabetes on Peritoneal Dialysis: a Multi-centered Prospective Study

This prospective, multicenter observational study will evaluate glucose profiles using continuous glucose monitoring (CGM) in 100 adults with diabetes receiving peritoneal dialysis (PD) or planning to start PD within 3 months. The study will examine associations between CGM metrics and PD regimen, glucose-lowering treatment, conventional glycemic markers, dialysis-related measures, and clinical outcomes including glycemic emergencies, hospitalizations, cardiovascular events, and mortality over 12 months.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

100

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: Elaine Chow
  • Número de teléfono: +85235051549
  • Correo electrónico: e.chow@cuhk.edu.hk

Ubicaciones de estudio

      • Hong Kong, Hong Kong
        • Department of Medicine and Therapeutics, The Chinese University of Hong Kong
        • Contacto:
        • Sub-Investigador:
          • Jack Kit Chung Ng

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adults with diabetes and stage 5 chronic kidney disease who are receiving peritoneal dialysis or are planned to initiate peritoneal dialysis within 3 months.

Descripción

Inclusion criteria:

  1. Stage 5 CKD patients

    1. who have received PD for at least 3 months, OR
    2. who are planned for PD within the next 3 months.
  2. Age 18-80 years old
  3. Known history of type 1 or type 2 diabetes for at least 3 months
  4. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  5. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
  6. Willingness to abstain from swimming during their participation in the measurement phase.
  7. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
  8. Written informed consent to participate in the study provided by the patient.

Exclusion criteria:

  1. Patients who are planning to switch to hemodialysis or renal transplant in the coming 3 months
  2. Life expectancy <6 months
  3. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites
  4. HbA1c > 11% at enrolment
  5. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential.
  6. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  7. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  8. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  9. Have a known allergy to medical-grade adhesives or known hypersensitivity to any of the products used in the study.
  10. Have MRI scan, CT scan, or diathermy scheduled during the proposed period of sensor wearing during the study

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who have been receiving peritoneal dialysis for at least 3 months at enrollment.
Sibionics GS3 CGM
pre-peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who are planned to initiate peritoneal dialysis within 3 months after enrollment.
Sibionics GS3 CGM

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Continuous glucose monitoring-derived metrics
Periodo de tiempo: During period of 14 day CGM wear
CGM derived time in ranges
During period of 14 day CGM wear

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c
Periodo de tiempo: Baseline to end of study period month 12
HbA1c by venous blood
Baseline to end of study period month 12
24-hour dialysate and ultrafiltration volume
Periodo de tiempo: Baseline through to month 12
24-hour dialysate and ultrafiltration volume,
Baseline through to month 12
Residual renal function
Periodo de tiempo: From baseline through 12 months
Defined by 24-hour urine volume
From baseline through 12 months
Hospitalization for hyperglycemic or hypoglycemic emergencies
Periodo de tiempo: From baseline through 12 months
Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up
From baseline through 12 months
Hospitalizations, cardiovascular events, and all-cause mortality
Periodo de tiempo: From baseline through 12 months
Incidence of all-cause hospitalization, major cardiovascular events, and all-cause mortality during follow-up
From baseline through 12 months
Dietary intake during CGM wear
Periodo de tiempo: During the 14-day CGM wear period
Dietary intake assessed using a 3-day food diary
During the 14-day CGM wear period
Health-related quality of life
Periodo de tiempo: Baseline
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score
Baseline
Quality of life specific to kidney disease
Periodo de tiempo: Baseline
Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score
Baseline
CGM user satisfaction
Periodo de tiempo: Baseline and month 3
Total score from 10-item CGM user satisfaction questionnaire
Baseline and month 3

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Elaine Chow, Department of Medicine and Therapeutics, The Chinese University of Hong Kong

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 (Estimado)

31 de agosto de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de agosto de 2026

Publicado por primera vez (Actual)

27 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

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

24 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

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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