Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels 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.
The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Fase
- Fase 2
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 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, 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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
|
Comparador activo: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in plasma glucose levels 1 hour after the meal
Periodo de tiempo: 1 hour
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Periodo de tiempo: 1 hour
|
1 hour
|
|
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Periodo de tiempo: 2 hours
|
2 hours
|
|
Plasma glucose level 1 hour after the meal.
Periodo de tiempo: 1 hour
|
1 hour
|
|
Plasma glucose level 2 hours after the meal.
Periodo de tiempo: 2 hours
|
2 hours
|
|
Glycemic peak in the 3 hours following the meal.
Periodo de tiempo: 3 hours
|
3 hours
|
|
Change in plasma glucose levels 2 hours after the meal.
Periodo de tiempo: 2 hours
|
2 hours
|
|
Peak time of glucose levels over the 4 hours following the meal.
Periodo de tiempo: 4 hours
|
4 hours
|
|
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Periodo de tiempo: 4 hours
|
4 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 10 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 10 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 13.9 mmol/L
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 13.9 mmol/L
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Standard deviation of plasma glucose levels.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Standard deviation of sensor glucose levels.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Coefficient of variance of plasma glucose levels.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Coefficient of variance of sensor glucose levels.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Total insulin delivery.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Mean plasma glucose level.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Mean sensor glucose level.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Mean plasma insulin concentration.
Periodo de tiempo: 11 hours
|
11 hours
|
|
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Periodo de tiempo: 11 hours
|
11 hours
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
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
- Efectos fisiológicos de las drogas
- Agentes Gastrointestinales
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Hormonas
- Pancrelipasa
Otros números de identificación del estudio
- CLASS-FiAsp
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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