Diabetes Mellitus, Type 1
Conditions
Keywords
super bolus, diabetes type 1, insulin bolus, high glycemic index meal, prandial insulin requirement, postprandial glycemia, insulin pump therapy
Brief summary
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).
Interventions
DRUGInsulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
DRUGInsulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
DRUGInsulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* duration of type 1 diabetes longer than 12months, * insulin pump therapy longer than 3 months, * written informed consent to participate in the study signed by parents (and patient older than 16 years).
Exclusion criteria
* celiac disease, * diabetes related complications (e.g. nephropathy), * BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex, * withdrawal of consent to participate in the study, * comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glycemia | 90 minutes after the prandial bolus | Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Area Under the Curve (AUC) | 3-hours after the prandial bolus | Measurements based on Continuous Glucose Monitoring System (CGMS) |
| Mean amplitude of glycaemic excursion (MAGE) | 3-hours after the prandial bolus | MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations |
| Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus | 3-hours after the prandial bolus | measured by SMBG |
| Hypoglycemia Episodes | 3-hours after the prandial bolus | Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms |
| Peak glucose level (PG) | 3-hours after the prandial bolus | the maximum value of glycemia during 3 hours of postmeal time based on CGMS |
| Time to glucose peak | 3-hours after the prandial bolus | based on CGMS |
| Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L) | 3-hours after the prandial bolus | based on CGMS |
| Glycemic rise (GR) | 3-hours after the prandial bolus | a difference between baseline and the maximum glucose value based on CGMS |
Countries
Poland
Outcome results
None listed