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O estudo clínico NCT02685449 para Diabetes tipo 1 está desconhecido. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade de Ciências Médicas de VarsóviaInsulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Fase IV 70 Randomizado
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O estudo clínico NCT02685449 procura avaliar tratamento para Diabetes tipo 1. Este é um estudo intervencionista de Fase IV. Seu status atual é: desconhecido. O estudo começou em 1 de fevereiro de 2016 e pretende incluir 70 participantes. Coordenado por a Universidade de Ciências Médicas de Varsóvia e deve ser concluído em 1 de agosto de 2018. Essas informações foram atualizadas no ClinicalTrials.gov em 29 de julho de 2016.
Resumo
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.
Descrição detalhada
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 maisTítulo oficial
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Condições médicas
Diabetes tipo 1Outros IDs do estudo
- Białko_5h
Número NCT
Data de início (real)
2016-02
Última atualização postada
2016-07-29
Data de conclusão (estimada)
2018-08
Inscrição (estimada)
70
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Desconhecido
Palavras-chave
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
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 mais | 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 ativogroup 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 mais | 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
10 Years
Sexos elegíveis
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
Universidade de Ciências Médicas de Varsóvia79 estudos clínicos ativos para explorarContato central do estudo
Contato: Kamila Indulska, 48223179421
Contato: Katarzyna Dżygało, 48223179538, [email protected]
1 Locais do estudo em 1 países
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Contato, +48223179421
Kamila Indulska, Subinvestigador
Katarzyna Dżygało, Investigador principal
Em recrutamento