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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02855307
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H2W 1R7
- Institut de Recherches Cliniques de Montreal
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Problems with venous access.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
Se utilizará el análogo de insulina de acción rápida habitual del paciente.
El sensor de glucosa Dexcom G4 Platinum se utilizará para medir los niveles de glucosa.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
Comparador activo: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
Se utilizará el análogo de insulina de acción rápida habitual del paciente.
El sensor de glucosa Dexcom G4 Platinum se utilizará para medir los niveles de glucosa.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
Comparador activo: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
Se utilizará el análogo de insulina de acción rápida habitual del paciente.
El sensor de glucosa Dexcom G4 Platinum se utilizará para medir los niveles de glucosa.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Periodo de tiempo: From 9:30 to 11:30 (120 minutes)
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From 9:30 to 11:30 (120 minutes)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Periodo de tiempo: From 8:00 to 10:50 (170 minutes)
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Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
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From 8:00 to 10:50 (170 minutes)
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Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Decremental area under the curve from the start of the exercise
Periodo de tiempo: From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
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Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 10 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Mean plasma glucose levels
Periodo de tiempo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
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Standard deviation of glucose levels
Periodo de tiempo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Coefficient of variation of glucose levels
Periodo de tiempo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Mean time (minutes) to the first hypoglycemic event
Periodo de tiempo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 1
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Insulina
- Insulina, Globina Zinc
- Hormonas
Otros números de identificación del estudio
- CLASS-16
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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