Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes
An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise in Adults With Type-1 Diabetes
Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.
The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Quebec
-
Montreal, Quebec, Canadá, H2W 1R7
- Institut de recherches cliniques de Montreal
-
-
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.
- Ongoing 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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
|
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
|
|
Comparador activo: Dual-hormone closed-loop system
In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
|
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
Periodo de tiempo: 18:00 hours to 19:30 hours
|
18:00 hours to 19:30 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Decrease in glucose levels during each exercise
Periodo de tiempo: 18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
|
Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise).
|
18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
|
|
Area under the curve of plasma glucose levels < 4 mmol/L
Periodo de tiempo: 15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Percentage of time of plasma glucose levels < 4 mmol/L
Periodo de tiempo: 15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Periodo de tiempo: 15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Decremental area under the curve from the start of the exercise for 90 minutes.
Periodo de tiempo: 18:00 to 19:30
|
18:00 to 19:30
|
|
|
Percentage of time-in-target defined as between 4 and 10 mmol/L
Periodo de tiempo: 15:30 hours to 19:30 hours
|
15:30 hours to 19:30 hours
|
|
|
Mean time (minutes) to the first hypoglycemic event during the exercise period
Periodo de tiempo: 18:00 to 19:00
|
18:00 to 19:00
|
|
|
The amount of dextrose infused
Periodo de tiempo: 15:30 to 19:30
|
15:30 to 19:30
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (Estimar)
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
Otros números de identificación del estudio
- CLASS-06
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. .