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Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Phase 4 70 Randomisiert

Unbekannter Status
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT02685449 untersucht Behandlung im Zusammenhang mit Diabetes Typ 1. Diese interventionsstudie der Phase 4 hat den Status unbekannter status und startete am 1. Februar 2016. Es ist geplant, 70 Teilnehmer aufzunehmen. Durchgeführt von Medizinische Universität Warschau wird der Abschluss für 1. August 2018 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Juli 2016 aktualisiert.
Kurzbeschreibung
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.

Ausführliche Beschreibung
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...

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Offizieller Titel

Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.

Erkrankungen
Diabetes Typ 1
Weitere Studien-IDs
  • Białko_5h
NCT-Nummer
NCT02685449
Studienbeginn (tatsächlich)
2016-02
Zuletzt aktualisiert
2016-07-29
Studienende (vorauss.)
2018-08
Geplante Rekrutierung
70
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Unbekannter Status
Stichwörter
diabetes type 1
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Placebo-Vergleichspräparatgroup 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...Mehr anzeigen
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
Aktives Vergleichspräparatgroup 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...Mehr anzeigen
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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
10 Years
Zugelassene Geschlechter
Alle
  • 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
Medical University of Warsaw logoMedizinische Universität Warschau
Zentrale Studienkontakte
Kontakt: Kamila Indulska, 48223179421
Kontakt: Katarzyna Dżygało, 48223179538, [email protected]
1 Studienstandorte in 1 Ländern
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Kontakt, +48223179421
Kamila Indulska, Prüfarzt
Katarzyna Dżygało, Hauptprüfer
Offene Rekrutierung