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Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity. (DiabeloopWP6-0)

Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

  • Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:

    • Group I: patients have a meal with the usual carbohydrate intake. The meal bolus is made according to the current treatment.
    • Group II: patients have a meal with a "low" carbohydrate intake (50% reduction of carbohydrate).
    • Group III: patients have a meal with a "strong" carbohydrate intake (increase 50% of carbohydrate).
    • Group IV: patients of group IV have each meal with carbohydrate intake but their usual bolus will be omitted.
    • Inclusion visit V1: The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse. The patient will keep two sensors until the end of the study (end of V4).
    • Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™. These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested. Lunch will be taken at 1 pm. The algorithm will provide proposals insulin every 15 minutes until 6 pm.
    • Visit V4 (patient control): Patient will be fitted with two sensors dexcom G4 ™ and its insulin pump programmed according to the usual algorithm. The meal will be taken at 1h PM. Patient can leave the site at 6 pm after removal of sensors.
  • CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:

    • Group A: Patients practice an "average" physical activity(50% VO2max) with usual temporary basal reduction (usually 50% of reduction during the test and 2h next).
    • Group B: Patients practice an "intense" physical activity (75% VO2max) with usual temporary basal reduction (usually 80% of reduction during the test and 2h after).
    • Group C: patients practice an "average" physical activity (50% VO2max) but without concomitant reduction of temporary basal.
    • Inclusion visit V1 : The study will be proposed at the patients who meet the inclusion criteria. After signing the consent, the investigator shall designate one group for each patient.
    • Visit V2 : Patient will be equipped with two sensors dexcom G4 ™ and a heart rate monitor. Calibrated meal is expected at 11h 30 pm. The patient will be administered his insulin dose according to his usual algorithm. The physical test will begin three hours after the meal. It will be carried on bicycle ergometer for 30 minutes at an medium or high intensity. (Average = 50% VO2max, or high level = 75% VO2max).
    • Visit V3: The same test is repeated for each patient during this visit. Its insulin pump will be controlled by the doses proposal of the algorithm after manual validation by the investigator. These will continue until the next morning, and the patient will spend overnight in the hospital.

Tipo de estudio

Intervencionista

Inscripción (Actual)

18

Fase

  • Fase 3

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

      • Evry, Francia, 91058
        • Centre Hospitalier Sud Francilien
      • Grenoble, Francia, 38043
        • University hospital of Grenoble
      • Toulouse, Francia, 31403
        • University Hospital of Toulouse

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients with type 1 diabetes treated by external insulin pump;
  • Patients with HbA1c <8.5%.
  • Patients aged 18 years or less;
  • Patient who signed consent;
  • Patient affiliated with Social Security.

For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):

  • Patient is practicing functional insulin therapy is a fixed meal plan.

For CHSF center (test of algorithm during activity):

  • Patient able to perform moderate or intense activity during 30 minutes.

Exclusion Criteria:

  • Patients with type 2 diabetes
  • All serious diseases that could interfere with the study
  • Insulin resistance and obesity (BMI> 30 kg/m2 and / or insulin requirements> 2 U / kg / day)

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: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Proposed treatment by Diabeloop algorithm
the insulin dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor.
the intervention is applied only at the dose of insulin
Sin intervención: usual treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Time spent in glucose reference intervals
Periodo de tiempo: After the end of the tests
After the end of the tests

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia)
Periodo de tiempo: After the end of the tests
To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way.
After the end of the tests

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night.
Periodo de tiempo: After the end of the tests
  1. Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level (50 or 75%).
  2. Comparison of blood glucose 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level, in three configurations: quantitative, semi-quantitative and bolus omitted.
  3. Measuring AUC, during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night;
  4. Measure the time spent in hypoglycemia (<0.70 g / l)
  5. Measuring the number of carbohydrate ingested
After the end of the tests

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Investigador principal: Sylvia Franc, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
  • Investigador principal: Pierre-Yves BENHAMOU, Pr., CHU of Grenoble

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 marzo de 2013

Finalización primaria (Actual)

1 de junio de 2013

Finalización del estudio (Actual)

1 de julio de 2013

Fechas de registro del estudio

Enviado por primera vez

18 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

18 de diciembre de 2012

Publicado por primera vez (Estimar)

21 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de octubre de 2014

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

24 de octubre de 2014

Última verificación

1 de octubre de 2014

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. .

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