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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Warsaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPF; Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).	Drug: Insulin Glulisine; A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.; Other Names: Apidra; Drug: Insulin Aspart; A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.; Other Names: NovoRapid; Drug: Insulin Lispro; A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.; Other Names: Humalog, Liprolog
Experimental: 30%IC; Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).	Drug: Insulin Glulisine; A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.; Other Names: Apidra; Drug: Insulin Aspart; A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.; Other Names: NovoRapid; Drug: Insulin Lispro; A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.; Other Names: Humalog, Liprolog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	60 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	120 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	180 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	210 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	240 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	270 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	300 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	30 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	90 minutes after meal
Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	150 minutes after meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Area Under the Curve (AUC)	Measurements based on Continuous Glucose Monitoring System (CGMS)	5 hours study period
The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)	Measurements based on SMBG	5 hours study period
Hypoglycemia Episodes	Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms	5 hours study period
Time in target postprandial glycemia	Time spent in the target range between 70 and 180 mg/dL based on CGMS	5 hours study period

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: diabetes type 1; postprandial glycemia; prandial insulin requirement; insulin bolus; insulin pump therapy; mixed meal
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Insulin, Short-Acting; Insulin Aspart; Insulin Lispro; insulin glulisine
• Other Study ID Numbers: Mixed Meal Bolus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No