Status:
COMPLETED
Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
Lead Sponsor:
Medical University of Warsaw
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
10-18 years
Phase:
PHASE4
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 diabete...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04019821
Start Date
January 1 2020
End Date
April 1 2023
Last Update
November 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital
Warsaw, Poland