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De klinische studie NCT02685449 voor Diabetes type 1 is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Medische Universiteit van WarschauInsulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Fase 4 70 Gerandomiseerd
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De klinische studie NCT02685449 onderzoekt behandeling bij Diabetes type 1. Deze Fase 4 interventioneel-studie heeft de status onbekend. Het doel is om 70 deelnemers te includeren vanaf 1 februari 2016. De studie wordt geleid door Medische Universiteit van Warschau en de voltooiing is gepland op 1 augustus 2018. Laatste update op ClinicalTrials.gov: 29 juli 2016.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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...
Toon meerOfficiële titel
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Aandoeningen
Diabetes type 1Andere studie-ID's
- Białko_5h
NCT-ID
Startdatum (Werkelijk)
2016-02
Laatste update geplaatst
2016-07-29
Verwachte einddatum
2018-08
Inschrijving (Geschat)
70
Studietype
Interventioneel
FASE
Fase 4
Status
Onbekend
Trefwoorden
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
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Dubbelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Placebo-comparatorgroup 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...Toon meer | 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 |
Actieve comparatorgroup 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...Toon meer | 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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
10 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
Medische Universiteit van Warschau79 actieve klinische studies om te verkennenCentraal Contactpersoon
Contact: Kamila Indulska, 48223179421
Contact: Katarzyna Dżygało, 48223179538, [email protected]
1 Studielocaties in 1 landen
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Contact, +48223179421
Kamila Indulska, Subonderzoeker
Katarzyna Dżygało, Hoofdonderzoeker
Rekruterend