Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).

Detailed Description
-----------------
Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).

Official Title
-----------------
The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin glulisine
* Drug: Insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus CSII for at least 3 months Duration of diabetes > 1 years Informed consent Exclusion Criteria: Concomitant dietary restrictions (e.g. celiac disease or food allergy) Diabetes related complications Baseline hyperglycemia >150 mg/dl Any disease judged by the investigator to affect the trial

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLU_ASP<br>Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin glulisine Second day: insulin aspart | Drug: Insulin glulisine<br> <br> * Other names: Apidra®;Drug: Insulin aspart<br> <br> * Other names: NovoRapid®;|
| Experimental: ASP_GLU<br>Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin aspart Second day: insulin glulisine | Drug: Insulin glulisine<br> <br> * Other names: Apidra®;Drug: Insulin aspart<br> <br> * Other names: NovoRapid®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycemia |  | baseline, 30, 60, 90, 120 and 180 minutes after the breakfast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia episodes | Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms | 3-h study period | 
| Glucose Area Under the Curve (AUC) | based on continuous glucose monitoring system | 3-h study period | 
| Mean amplitude of glycemic excursion (MAGE) |  | 3-h study period | 
| Difference between the maximum and baseline glycemia |  | 3-h study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, insulin pump, glulisine, aspart, glycemic index