Skip to main content
OpenTrials
Completed

NCT Number: NCT01678235

Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, 01-184, Poland

About this study

Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes mellitus
  • CSII for at least 3 months
  • Duration of diabetes > 1 years
  • Informed consent

Exclusion criteria

  • Concomitant dietary restrictions (e.g. celiac disease or food allergy)
  • Diabetes related complications
  • Baseline hyperglycemia >150 mg/dl
  • Any disease judged by the investigator to affect the trial

Treatment and study plan

insulin glulisine

Drug

Other names: Apidra®

insulin aspart

Drug

Other names: NovoRapid®

Primary outcomes

  1. Postprandial glycemia

    Time frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast

Secondary outcomes

  1. Hypoglycemia episodes

    Time frame: 3-h study period

    Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms

  2. Glucose Area Under the Curve (AUC)

    Time frame: 3-h study period

    based on continuous glucose monitoring system

  3. Mean amplitude of glycemic excursion (MAGE)

    Time frame: 3-h study period

  4. Difference between the maximum and baseline glycemia

    Time frame: 3-h study period

Other outcomes

  1. Questionnaire: Glycemic Index Knowledge

    Time frame: each subject was asked to fullfill the questionnaire before entering the study (day one)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 3, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.