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Università di medicina di VarsaviaInsulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Fase IV 70 Randomizzato
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La sperimentazione clinica NCT02685449 è uno studio interventistico di Fase IV volto a esaminare il trattamento per Diabete tipo 1, attualmente sconosciuto. Avviato il 1 febbraio 2016, prevede di arruolare 70 partecipanti. Sotto la guida di l'Università di medicina di Varsavia, dovrebbe concludersi entro il 1 agosto 2018. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 luglio 2016.
Sommario breve
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.
Descrizione dettagliata
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...
Mostra di piùTitolo ufficiale
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Patologie
Diabete tipo 1Altri ID dello studio
- Białko_5h
Numero NCT
Data di inizio (effettiva)
2016-02
Ultimo aggiornamento pubblicato
2016-07-29
Data di completamento (stimata)
2018-08
Arruolamento (previsto)
70
Tipo di studio
Interventistico
FASE
Fase IV
Stato
Sconosciuto
Parole chiave
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
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore 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...Mostra di più | 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 |
Comparatore attivogroup 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...Mostra di più | 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 |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Età minima
10 Years
Sessi idonei
Tutti
- 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
Università di medicina di Varsavia79 studi clinici attivi da esplorareContatti principali dello studio
Contatto: Kamila Indulska, 48223179421
Contatto: Katarzyna Dżygało, 48223179538, [email protected]
1 Centri dello studio in 1 paesi
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Contatto, +48223179421
Kamila Indulska, Sub-investigatore
Katarzyna Dżygało, Investigatore principale
In arruolamento