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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLU_ASP | Experimental | 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 |
|
| ASP_GLU | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glulisine | Drug |
|
| |
| Insulin aspart |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemia | baseline, 30, 60, 90, 120 and 180 minutes after the breakfast |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire: Glycemic Index Knowledge | each subject was asked to fullfill the questionnaire before entering the study (day one) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Dżygało, MD | Department of Pediatrics, Medical University of Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Medical University of Warsaw, Poland | Warsaw | 01-184 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24412929 | Result | Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
|
|
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |