Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
7 de noviembre de 2019 actualizado por: Korey Hood, Stanford University
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
92
Fase
- No aplica
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.
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado
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Florida
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Tampa, Florida, Estados Unidos, 33620
- University of South Florida
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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-
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
2 años a 6 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
To be eligible for the study, a child must meet the following criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- Time since diagnosis of at least six months
- Age between 2 and 6 years at enrollment
- Parental consent to participate in the study
- No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
- If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
- Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod
To be eligible for the study, a parent must meet the following criteria:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- Age of 18.0 years or older
- Parent comprehends written English
- Parent understands the study protocol and signs the informed consent document
- Parent has access to a personal computer to upload diabetes devices and send to research team
The presence of any of the following is an exclusion for the study:
- Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of 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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Reducción de angustia
Identificar y reducir los síntomas de angustia y las preocupaciones de los padres.
Proporcionar estrategias para obtener apoyo social.
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Educación y capacitación para reducir la angustia
|
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Experimental: Developmental Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
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Education and training related to use of CGM in this age group
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Experimental: Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
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Education and training on the use of remote monitoring
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Experimental: Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
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Education and training on reducing fear of hypoglycemia
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Comparador de placebos: No Intervention
Serves as the control group comparator.
No intervention provided.
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No intervention - serves as the control group
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time spent in blood glucose range
Periodo de tiempo: Change over 6 months
|
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome.
This measure will be used as a primary outcome and derived from objective data downloads.
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Change over 6 months
|
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Pediatric Quality of Life Inventory
Periodo de tiempo: Change over 6 months
|
This is a measure of health-related quality of life.
It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
|
Change over 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
A1c
Periodo de tiempo: Change over 6 months
|
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes.
Collected through a blood sample.
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Change over 6 months
|
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Problem Areas in Diabetes
Periodo de tiempo: Change over 6 months
|
This measure captures areas that are reported as problems for people with diabetes.
Participants in the study report on daily problems with diabetes via this measure.
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Change over 6 months
|
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Diabetes Distress Scale
Periodo de tiempo: Change over 6 months
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This measure is widely used to capture the psychological distress experienced in relation to diabetes.
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Change over 6 months
|
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Patient Health Questionnaire 9
Periodo de tiempo: Change over 6 months
|
This is a widely used measure that captures depressive symptoms.
It is reported by the participants.
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Change over 6 months
|
|
State-Trait Anxiety Inventory
Periodo de tiempo: Change over 6 months
|
This is a widely used measure of anxiety symptoms.
It is reported by the participant.
|
Change over 6 months
|
|
Pittsburgh Sleep Quality Index
Periodo de tiempo: Change over 6 months
|
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
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Change over 6 months
|
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Hypoglycemic Fear Survey
Periodo de tiempo: Change over 6 months
|
People with diabetes worry about hypoglycemia.
This measure captures those worries and is reported by participants.
|
Change over 6 months
|
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Hypoglycemic Confidence Questionnaire
Periodo de tiempo: Change over 6 months
|
Hypoglycemia needs to be managed in various daily situations.
This questionnaire captures confidence of the participants in those various situations.
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Change over 6 months
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Glucose Monitoring System Satisfaction Survey
Periodo de tiempo: Change over 6 months
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This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
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Change over 6 months
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General and diabetes-specific technology use
Periodo de tiempo: Change over 6 months
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This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
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Change over 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Linda DiMeglio, MD, Indiana University
- Investigador principal: Kimberly Driscoll, PhD, University of Colorado, Denver
- Investigador principal: Henry Rodriguez, MD, University of South Florida
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 (Actual)
15 de agosto de 2016
Finalización primaria (Actual)
1 de abril de 2019
Finalización del estudio (Actual)
1 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
25 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
25 de julio de 2016
Publicado por primera vez (Estimar)
28 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
7 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 37360
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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