Skip to main content
OpenTrials
Completed

NCT Number: NCT04124302

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus 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

Warsaw Medical University

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • duration of type 1 diabetes longer than 12 months
  • insulin pump therapy longer than 3 months
  • treated by the same type of insulin longer than 3 months
  • written informed consent by patients and parents

Exclusion criteria

  • celiac disease
  • diabetes related complications (e.g. nephropathy)
  • any disease judged by the investigator to affect the trial
  • withdrawal of consent to participate in the study

Treatment and study plan

insulin glulisine

Drug

A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Other names: Apidra

insulin aspart

Drug

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

Other names: NovoRapid

Insulin Lispro

Drug

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

Other names: Humalog, Liprolog

Primary outcomes

  1. Postprandial glycemia

    Time frame: 30 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  2. Postprandial glycemia

    Time frame: 60 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  3. Postprandial glycemia

    Time frame: 90 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  4. Postprandial glycemia

    Time frame: 120 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  5. Postprandial glycemia

    Time frame: 150 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  6. Postprandial glycemia

    Time frame: 180 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  7. Postprandial glycemia

    Time frame: 210 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  8. Postprandial glycemia

    Time frame: 240 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  9. Postprandial glycemia

    Time frame: 270 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

  10. Postprandial glycemia

    Time frame: 300 minutes after meal

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

Secondary outcomes

  1. Glucose Area Under the Curve (AUC)

    Time frame: 5 hours study period

    Measurements based on Continuous Glucose Monitoring System (CGMS)

  2. The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)

    Time frame: 5 hours study period

    Measurements based on SMBG

  3. Hypoglycemia Episodes

    Time frame: 5 hours study period

    Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms

  4. Time in target postprandial glycemia

    Time frame: 5 hours study period

    Time spent in the target range between 70 and 180 mg/dL based on CGMS

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2019
Registry last updated
Nov 18, 2025

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.