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

NCT04124302 | Completed Phase 4

• 1 other identifier: Mixed Meal Bolus
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes type 1; insulin bolus; prandial insulin requirement; postprandial glycemia; insulin pump therapy; mixed meal

Outcome Measures

Primary Outcomes (10)

• 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).

  60 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).

  120 minutes after meal

• Postprandial glycemia

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

  150 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

Secondary Outcomes (4)

• Glucose Area Under the Curve (AUC)

  5 hours study period

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

  5 hours study period

• Hypoglycemia Episodes

  5 hours study period

• Time in target postprandial glycemia

  5 hours study period

Study Arms (2)

IPF

ACTIVE COMPARATOR

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; Drug: Insulin Aspart; Drug: Insulin Lispro

30%IC

EXPERIMENTAL

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; Drug: Insulin Aspart; Drug: Insulin Lispro

Interventions

Insulin Glulisine DRUG

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

Also known as: Apidra

30%IC; IPF

Insulin Aspart DRUG

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

Also known as: NovoRapid

30%IC; IPF

Insulin Lispro DRUG

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

Also known as: Humalog, Liprolog

30%IC; IPF

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Warsaw Medical University

Warsaw, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: October 11, 2019
• Study Start: October 1, 2019
• Primary Completion: March 27, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2025

Record last verified: 2024-03

Locations

PL (1)