The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.
Overview
- Phase
- Phase 4
- Intervention
- Insulin Glulisine
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Medical University of Warsaw
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Postprandial glycemia
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: Insulin Glulisine
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).
Intervention: Insulin Aspart
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).
Intervention: Insulin Lispro
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).
Intervention: Insulin Glulisine
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).
Intervention: Insulin Aspart
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).
Intervention: Insulin Lispro
Outcomes
Primary Outcomes
Postprandial glycemia
Time Frame: 300 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Secondary Outcomes
- Glucose Area Under the Curve (AUC)(5 hours study period)
- The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)(5 hours study period)
- Hypoglycemia Episodes(5 hours study period)
- Time in target postprandial glycemia(5 hours study period)