A Phase 4 interventional study of Insulin Glulisine and Insulin Aspart in Diabetes Mellitus, Type 1, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Treatment
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 72 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
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 · Drug: Insulin Aspart · Drug: Insulin Lispro
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 · Drug: Insulin Aspart · Drug: Insulin Lispro
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Also known as: Apidra
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Also known as: NovoRapid
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Also known as: Humalog, Liprolog
Postprandial Glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)
Time frame: 90 minutes after the prandial bolus
Hypoglycemia Episodes
Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms
Time frame: 3-hours after the prandial bolus
Glucose Area Under the Curve (AUC)
Measurements based on Continuous Glucose Monitoring System (CGMS)
Time frame: 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
Time frame: 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
Time frame: 3-hours after the prandial bolus
Glycemic rise (GR)
a difference between baseline and the maximum glucose value based on CGMS
Time frame: 3-hours after the prandial bolus
Peak glucose level (PG)
the maximum value of glycemia during 3 hours of postmeal time based on CGMS
Time frame: 3-hours after the prandial bolus
Time to glucose peak
based on CGMS
Time frame: 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
Time frame: 3-hours after the prandial bolus
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw