Managing of Missed Meal Bolus by HCL Systems (NOELLE)

Z

Zdeněk Šumník

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06230276
1B_23N01

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

9 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Intervention with and without premeal bolus
Experimental group
Treatment:
Other: enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast

Trial contacts and locations

1

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Central trial contact

Alžbeta Šantová, MD

Data sourced from clinicaltrials.gov

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