Diabetes Mellitus, Type 1
Conditions
Keywords
diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal
Brief summary
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.
Interventions
DRUGInsulin Glulisine
A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
DRUGInsulin Aspart
A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
DRUGInsulin Lispro
A kind 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 12 months * insulin pump therapy longer than 3 months * treated by the same type of insulin longer than 3 months * written informed consent by patients and parents
Exclusion criteria
* celiac disease * diabetes related complications (e.g. nephropathy) * any disease judged by the investigator to affect the trial * withdrawal of consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycemia | 30 minutes after meal | Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Episodes | 5 hours study period | Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms |
| Glucose Area Under the Curve (AUC) | 5 hours study period | Measurements based on Continuous Glucose Monitoring System (CGMS) |
| The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE) | 5 hours study period | Measurements based on SMBG |
| Time in target postprandial glycemia | 5 hours study period | Time spent in the target range between 70 and 180 mg/dL based on CGMS |
Countries
Poland
Outcome results
None listed