Overview

Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Warsaw
Treatments:
Insulin
Insulin Aspart
Insulin glulisine
Insulin Lispro
Insulin, Globin Zinc
Criteria
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.