Status:
COMPLETED
Normal Versus Dual Wave Insulin Bolus for High-protein Food
Lead Sponsor:
Medical University of Warsaw
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-18 years
Phase:
PHASE4
Brief Summary
Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glu...
Detailed Description
The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is...
Eligibility Criteria
Inclusion
- duration of type 1 diabetes longer than 12 months
- insulin pump therapy longer than 3 months
- written informed consent by patients and parents
- patients must be willing to wear a glucose sensor for two days
- insulin requirement more than 0,5 units/kg/day
Exclusion
- concomitant dietary restrictions (e.g. celiac disease or food allergy)
- diabetes related complications (e.g. nephropathy)
- any disease judged by the investigator to affect the trial
- withdrawal of consent to participate in the study
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02276859
Start Date
October 1 2014
End Date
September 1 2015
Last Update
January 31 2018
Active Locations (1)
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1
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, Poland, 01-184