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Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children (SHAN)

12 de junio de 2018 actualizado por: University Hospital, Montpellier

Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

Fase

  • Fase 2

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

  • Francia
      • Angers, Francia, 49000
        • CHU d'Angers
      • Montpellier, Francia, 34985
        • CHU Montpellier - Hôpital Lapeyronie
      • Paris, Francia, 75019
        • AP-HP, Hôpital Robert Debré
      • Tours, Francia, 37000
        • CHU de Tours, Hôpital Clocheville

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

7 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age from 7 to 12
  2. Puberty status at Prader 1
  3. Diabetes diagnosed according to WHO criteria since more than 1 year
  4. Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl
  5. At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes
  6. Treatment of diabetes by insulin pump since more than 6 months
  7. HbA1c level below 8.5%
  8. Trained in carbohydrate counting
  9. Lack of any associated disease or therapy (except insulin) affecting glucose metabolism
  10. Willingness to follow all study procedures
  11. Informed consent signed by patient and parent or legally responsible party
  12. Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria:

  1. Unwillingness of one parent or the legally responsible party to be present during all study procedures
  2. Expected use of acetaminophen-containing drugs
  3. Any disease or therapy (except insulin) affecting glucose metabolism during previous month
  4. Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
  5. Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €

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 cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Control-to-Range algorithm and Threshold Low Glucose Suspend

On this arm, patients will realize two investigational sessions:

  • the first with Control-to-Range algorithm (CTR),
  • the second with Threshold Low Glucose Suspend (TLGS).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Experimental: Threshold Low Glucose Suspend and Control-to-Range algorithm

On this arm, patients will realize two investigational sessions:

  • the first with Threshold Low Glucose Suspend (TLGS),
  • the second with Control-to-Range algorithm (CTR).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Time spent with blood glucose <70 mg/dl
Periodo de tiempo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Percent time spent with blood glucose <70mg/dl
Periodo de tiempo: over two consecutive days (48h)
over two consecutive days (48h)
Percent time spent with blood glucose level in 70-180 mg/dl range
Periodo de tiempo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 80-150 mg/dl range
Periodo de tiempo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 70-180 mg/dl range
Periodo de tiempo: over two consecutive days (48h)
over two consecutive days (48h)
Mean blood glucose level
Periodo de tiempo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights
Mean blood glucose level
Periodo de tiempo: over two consecutive days (48h)
over two consecutive days (48h)
Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia
Periodo de tiempo: during 65 hours of each investigational session
during 65 hours of each investigational session
Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system
Periodo de tiempo: during 65 hours of each investigational session
during 65 hours of each investigational session
Score of the Artificial Pancreas Acceptance Questionnaire
Periodo de tiempo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
Score of the Hypo Fear Survey
Periodo de tiempo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)

Colaboradores e Investigadores

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

Patrocinador

University Hospital, Montpellier

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.

Publicaciones Generales

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)

16 de junio de 2015

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

23 de julio de 2015

Publicado por primera vez (Estimar)

28 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de junio de 2018

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

12 de junio de 2018

Última verificación

1 de julio de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 9525 (Otro identificador: CTEP)

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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