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El ensayo clínico NCT02685449 para Diabetes tipo 1 está desconocido. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad Médica de VarsoviaInsulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Fase IV 70 Aleatorizado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT02685449 está diseñado para estudiar el tratamiento de Diabetes tipo 1. Es un estudio intervencionista de Fase IV. Su estado actual es: desconocido. El estudio se inició el 1 de febrero de 2016, con el objetivo de reclutar a 70 participantes. Dirigido por la Universidad Médica de Varsovia, se espera que finalice el 1 de agosto de 2018. Los datos se actualizaron por última vez en ClinicalTrials.gov el 29 de julio de 2016.
Resumen
This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.
Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.
Descripción detallada
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from p...
Mostrar másTítulo oficial
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Condiciones médicas
Diabetes tipo 1Otros ID del estudio
- Białko_5h
Número del NCT
Inicio del estudio (real)
2016-02
Última actualización
2016-07-29
Fecha de finalización (estimada)
2018-08
Inscripción (prevista)
70
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Desconocido
Palabras clave
diabetes type 1
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Doble ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador placebogroup A On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by th...Mostrar más | Insulin glulisine A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial Insulin aspart A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial Insulin lispro A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial |
Comparador activogroup B On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by th...Mostrar más | Insulin glulisine A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial Insulin aspart A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial Insulin lispro A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 30 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 60 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 90 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 120 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 150 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 180 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 210 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 240 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 270 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 300 minutes after the meal |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Hypoglycemia episodes | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms | 5-hour study period |
Glucose Area Under the Curve (AUC) | Measurements based on CGMS | 5-hour study period |
Mean amplitude of glycemic excursion | measurements based on SMBG | 5-hour study period |
The difference between the maximum and baseline glucose level | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 5-hour study period |
Criterios de elegibilidad
Criterios de edad
Niño, Adulto
Edad mínima
10 Years
Criterios de sexo
Todos
- duration of type 1 diabetes longer than 12 months
- insulin pump therapy longer than 3 months
- written informed consent by patients and parents
- insulin requirement more than 0,5 units/kg/day
- diabetes related complications (e.g. nephropathy)
- chronic kidney diseases
- any disease judged by the investigator to affect the trial
- withdrawal of consent to participate in the study
Universidad Médica de Varsovia79 estudios activos para explorarContactos centrales del estudio
Contacto: Kamila Indulska, 48223179421
Contacto: Katarzyna Dżygało, 48223179538, [email protected]
1 Centros del estudio en 1 países
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Contacto, +48223179421
Kamila Indulska, Subinvestigador
Katarzyna Dżygało, Investigador principal
Reclutando