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: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Magdalena Dymińska, MD; Phone Number: +48 223179538; Email: m.dyminska91@gmail.com
• Study Contact Backup: Name: Agnieszka Szypowska, Prof.; Phone Number: +48 223179539; Email: agnieszka.szypowska@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2023

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 (ACTUAL): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: August 1, 2019

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: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; 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