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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Bolus | Active Comparator | 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). |
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| Super Bolus | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glulisine | Drug | A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glycemia | Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG) | 90 minutes after the prandial bolus |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska, Prof. | Department of Pediatrics, Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38257156 | Derived | Kowalczyk-Korcz E, Dyminska M, Szypowska A. Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial. Nutrients. 2024 Jan 16;16(2):263. doi: 10.3390/nu16020263. | |
| 35351180 | Derived | Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4. |
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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 type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial. |
|
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| Insulin Lispro | Drug | A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial. |
|
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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 |
| 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 |