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Hybrid Artificial Pancreas in Home Setting (AP Hybrid)

5 de noviembre de 2015 actualizado por: University Hospital, Montpellier

Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

Descripción general del estudio

Descripción detallada

During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

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

      • Montpellier, Francia, 34000
        • CHU Montpellier
      • Padova, Italia
        • University of Padova
      • Amsterdam, Países Bajos
        • University of Amsterdam

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

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age ≥ 18 et < 70 years old
  2. Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
  3. Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
  4. BMI < 35 kg/m²
  5. Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
  6. Trained in carbohydrate counting
  7. HbA1c > 7.5 % and < 10%
  8. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
  9. Willing to undergo all study procedures
  10. Informed consent signed

Exclusion criteria:

  1. Pregnancy or breast feeding, or intention to be pregnant during the study duration
  2. Use of a medication that significantly impacts glucose metabolism, e.g. steroids
  3. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
  4. Patient plans to go abroad during the trial period
  5. Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
  6. Patient does not hold any nearby party for assistance if needed
  7. Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
  8. Presence of any malignant disease, unless considered as cured for more than 10 years
  9. History of acute cardiovascular event during the prior year
  10. History of diabetic keto-acidosis during the prior 6 months
  11. Renal insufficiency with creatinin > 150 μmol/L
  12. Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
  13. Impaired cognitive or psychological abilities which may result in defective adherence to study conditions

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: HYBRID-OPEN

Patients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.

During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
Experimental: OPEN-HYBRID

Patients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period
Periodo de tiempo: during 2 months-hybrid period and during 2 months-open period
during 2 months-hybrid period and during 2 months-open period

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Low Blood Glucose Index (LBGI)
Periodo de tiempo: for each period of 2 month (hybrid period and open period)
for each period of 2 month (hybrid period and open period)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Eric ER RENARD, MD, 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.

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 2014

Finalización primaria (Actual)

1 de junio de 2015

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2014

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2014

Publicado por primera vez (Estimar)

2 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de noviembre de 2015

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

5 de noviembre de 2015

Última verificación

1 de noviembre de 2015

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. .

Ensayos clínicos sobre Diabetes mellitus tipo 1

Ensayos clínicos sobre HYBRID

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