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NCT06230276

Managing of Missed Meal Bolus by HCL Systems

How do the Currently Available HCL Systems Manage Missed Meal Bolus? The Comparison of Glycemic Outcomes After Missed Meal Bolus Between MiniMed 780G, Tandem Control-IQ and Ypsomed CamAPS
Zdeněk Šumník·ClinicalTrials.gov·otherRecruiting
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Study focus
Disease/Condition
Diabetes Mellitus, Type 1
Drug/Device/Intervention
enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Zdeněk Šumník
Funder
University Hospital, Motol
Location
Prague, Czech
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2024
End date
Dec 01, 2024
Enrollment
45 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06230276
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.