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Managing of Missed Meal Bolus by HCL Systems

NCT06230276 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-01-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zdeněk Šumník

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-09-30
Completion
2024-12-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06230276 on ClinicalTrials.gov