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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Zdeněk Šumník · Academic / Other
• Sex: All
• Age: 9 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast	Participants who are already treated by one of the HCL systems (MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS) 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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-09-30
• Completion: 2024-12-01
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Czechia