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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Insulin Glulisine
* Drug: Insulin Aspart
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPF<br>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<br>* A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.<br>* Other names: Apidra;Drug: Insulin Aspart<br>* A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.<br>* Other names: NovoRapid;Drug: Insulin Lispro<br>* A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.<br>* Other names: Humalog, Liprolog;|
| Experimental: 30%IC<br>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<br>* A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.<br>* Other names: Apidra;Drug: Insulin Aspart<br>* A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.<br>* Other names: NovoRapid;Drug: Insulin Lispro<br>* A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.<br>* Other names: Humalog, Liprolog;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal