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Creating Linked Inpatient CGM for Kids (CLICK) 20 App móvil Observacional

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06899503 (CLICK) es un estudio observacional para Diabetes, Continuous Glucose Monitoring System. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de enero de 2027 hasta completar 20 participantes. Dirigido por Boston Children's Hospital, se espera que finalice el 1 de enero de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de abril de 2026.
Resumen
Continuous glucose monitors (CGMs) are currently used in the inpatient setting at many hospitals for the care of patients with diabetes and for clinical research studies. This includes Boston Children's Hospital, however, the CGM data is not accessible to clinical or research teams in real-time. CGMs measure and display a patient's glucose level every 5 minutes and provide alerts for predicted or actual low or high g...Mostrar más
Descripción detallada
Continuous glucose monitors are currently used in the inpatient setting at Boston Children's Hospital (BCH) for the care of patients with diabetes and for research studies. CGMs measure and display patient's glucose level every 5 minutes and provide alerts for predicted or actual low or high glucose levels. BCH policy allows for use of Dexcom G6 and G7 CGM for glucose monitoring and insulin dosing, so long as the CGM...Mostrar más
Título oficial

CLICK: Creating Linked Inpatient CGM for Kids

Condiciones médicas
DiabetesContinuous Glucose Monitoring System
Otros ID del estudio
  • CLICK
  • IRB-P00049941
Número del NCT
Inicio del estudio (real)
2027-01
Última actualización
2026-04-03
Fecha de finalización (estimada)
2028-01
Inscripción (prevista)
20
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
Diabetes
Continuous glucose monitoring system
Android application
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Pediatric diabetic Dexcom G7 users
Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes.
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Accuracy of CGM data capture.
The accuracy of the CGM readings captured will be measured as the mean absolute relative difference (MARD) between the CGM glucose reading captured by the companion app compared to the CGM glucose reading documented in the Dexcom Clarity database within the same 5-minute interval.
The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Efficiency of CGM data capture.
Efficiency of CGM data capture, measured as the percent of CGM readings documented in Dexcom Clarity that were also captured by the companion app within the same 5-minute interval.
The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño, Adulto
Edad mínima
2 Weeks
Criterios de sexo
Todos
  • Inpatients with diabetes using a Dexcom G7 CGM
  • Technology/data sharing criteria: use of the Dexcom G7 phone app and data sharing with the BCH Dexcom Clarity Database
  • Anticipated discharge date >24 hours after study eligibility

  • Use of medications that interfere with CGM accuracy
  • Use of a Dexcom receiver to view data (rather than the typical mobile phone)
  • Enrollment in a competing clinical trial
Boston Children's Hospital logoBoston Children's Hospital
Parte responsable del estudio
Jessica Ruiz, MD, Investigador principal, Physician, Endocrinology, Boston Children's Hospital
Contactos centrales del estudio
Contacto: Jessica L Ruiz, MD, 617-355-7241, [email protected]
Contacto: Michael SD Agus, MD, 617-355-5849, [email protected]
1 Centros del estudio en 1 países

Massachusetts

Boston Children's Hospital, Boston, Massachusetts, 02115, United States
Jessica L Ruiz, MD, Contacto, 617-355-7241, [email protected]
Michael SD Agus, MD, Contacto, 617-355-5849, [email protected]