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- Ensayo clínico NCT02750267
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
22 de junio de 2017 actualizado por: Mark DeBoer, MD, University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies.
Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues.
During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use.
Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery.
However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use).
These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings.
It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents.
In this sense, young children require a device that is not user-centered as much as family-centered.
A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia Center for Diabetes Technology
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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
5 años a 9 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes,
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel.
All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system).
Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission.
Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Experimental: Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission.
Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission.
As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Periodo de tiempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Periodo de tiempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Percent of Time Sensor Glucose Readings Are >150 mg/dL
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Percent of Time Sensor Glucose Readings Are >180 mg/dL
Periodo de tiempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Percent of Time Sensor Glucose Readings Are >250 mg/dL
Periodo de tiempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Percent of Time Sensor Glucose Readings Are >400 mg/dL
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Periodo de tiempo: 72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Maximum)
Periodo de tiempo: 72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Minimum)
Periodo de tiempo: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Periodo de tiempo: 72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Mean BG (as Measured by CGM)
Periodo de tiempo: 68 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Hypoglycemia Area Under the Curve <60
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hypoglycemia Area Under the Curve <70 mg/dL
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hyperglycemia Area Under the Curve >180
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Hyperglycemia Area Under the Curve >250 mg/dL
Periodo de tiempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Periodo de tiempo: 68 hours
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All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
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68 hours
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End of Night Blood Glucose
Periodo de tiempo: 72 hours
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All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
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72 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de mayo de 2016
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
20 de abril de 2016
Publicado por primera vez (Estimar)
25 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18888
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Not yet determined
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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