Managing of Missed Meal Bolus by HCL Systems

Last updated: January 19, 2024
Sponsor: Zdeněk Šumník
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast

Clinical Study ID

NCT06230276
1B_23N01
  • Ages 9-19
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • children with type 1 diabetes (CwD) 9.00-18.99 years old

  • use of continuous glucose monitoring (CGM) >70% of the time 14 days before a regular check-up in the outpatient clinic

  • HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) >3 months

  • duration of T1D >2 years

  • baseline HbA1c level <58 mmol/mol (7.5%)

  • weight > 30 kilograms

  • without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids…)

  • signed informed consent form with the study

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 01, 2024

Connect with a study center

  • Motol University Hospital

    Prague, 15006
    Czechia

    Active - Recruiting

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