Managing of Missed Meal Bolus by HCL Systems - Trial NCT06230276
Access comprehensive clinical trial information for NCT06230276 through Pure Global AI's free database. This phase not specified trial is sponsored by Zdeněk Šumník and is currently Recruiting. The study focuses on Diabetes Mellitus, Type 1. Target enrollment is 45 participants.
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Study Focus
enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
Interventional
other
Sponsor & Location
Zdeněk Šumník
University Hospital, Motol
Timeline & Enrollment
N/A
Jan 01, 2024
Dec 01, 2024
Primary Outcome
Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
Summary
The goal of this interventional study is to compare glycemic outcomes after missed meal bolus
 in children and adolescents with type 1 diabetes (CwD) treated by one of the three most
 common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem
 Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:
 
 - Do the glycemic outcomes (area under the curve of glucose concentration change, maximal
 glucose rise from baseline, time to maximal glucose rise from baseline, CGM parameters)
 vary after missed meal bolus among different types of HCL systems?
 
 - Does the type of insulin analog influence glycemic outcomes after a missed meal bolus?
 
 Participants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2
 kcal/ml) for breakfast during eight different days under predetermined conditions. They will
 administer premeal bolus only for half of these meals.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06230276
Non-Device Trial