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

Phase 4

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro

• Registration Number: NCT04124302
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Posted: 2019-10-11
• Study Start: 2019-11
• Primary Completion: 2021-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPF	Insulin Glulisine	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).
IPF	Insulin Aspart	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).
30%IC	Insulin Glulisine	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).
IPF	Insulin Lispro	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).
30%IC	Insulin Aspart	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).
30%IC	Insulin Lispro	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).

Primary Outcome Measures

Name	Time	Method
Postprandial glycemia	300 minutes after meal	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia Episodes	5 hours study period	Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms
Glucose Area Under the Curve (AUC)	5 hours study period	Measurements based on Continuous Glucose Monitoring System (CGMS)
The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)	5 hours study period	Measurements based on SMBG