Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

Study Overview
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Brief Summary
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The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).

Official Title
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Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index 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 12months, insulin pump therapy longer than 3 months, written informed consent to participate in the study signed by parents (and patient older than 16 years). Exclusion Criteria: celiac disease, diabetes related complications (e.g. nephropathy), BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex, withdrawal of consent to participate in the study, comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.

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: Normal Bolus<br>Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR). | Drug: Insulin Glulisine<br>* A type 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 type 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 type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.<br>* Other names: Humalog, Liprolog;|
| Experimental: Super Bolus<br>Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time. | Drug: Insulin Glulisine<br>* A type 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 type 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 type 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) | 90 minutes after the prandial bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia Episodes | Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms | 3-hours after the prandial bolus | 
| Glucose Area Under the Curve (AUC) | Measurements based on Continuous Glucose Monitoring System (CGMS) | 3-hours after the prandial bolus | 
| Mean amplitude of glycaemic excursion (MAGE) | MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations | 3-hours after the prandial bolus | 
| Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus | measured by SMBG | 3-hours after the prandial bolus | 
| Glycemic rise (GR) | a difference between baseline and the maximum glucose value based on CGMS | 3-hours after the prandial bolus | 
| Peak glucose level (PG) | the maximum value of glycemia during 3 hours of postmeal time based on CGMS | 3-hours after the prandial bolus | 
| Time to glucose peak | based on CGMS | 3-hours after the prandial bolus | 
| Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L) | based on CGMS | 3-hours after the prandial bolus | 

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