MedTrace Logo

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

NCT02685449 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes type1

Interventions

DRUG

Insulin glulisine

A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial

DRUG

Insulin aspart

A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial

DRUG

Insulin lispro

A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Katarzyna Dżygało · Department of Pediatrics, Warsaw Medical University

  • Kamila Indulska · University of Alberta

  • Agnieszka Szypowska · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2018-08-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685449 on ClinicalTrials.gov