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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPF | Active Comparator | 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). |
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| 30%IC | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glulisine | Drug | A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemia | Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG). | 30 minutes after meal |
| 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). | 90 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). | 150 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warsaw Medical University | Warsaw | Poland |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Aspart | Drug | A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial. |
|
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| Insulin Lispro | Drug | A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial. |
|
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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 |
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 |
| Time in target postprandial glycemia | Time spent in the target range between 70 and 180 mg/dL based on CGMS | 5 hours study period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |