Clinical trial NCT06230276: Managing of Missed Meal Bolus by HCL Systems
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 45
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: 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.
timeFrame: 4 hour after a meal
Secondary outcomes:
measure: Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
timeFrame: 4 hours after a meal
measure: Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
timeFrame: 4 hours after a meal
measure: Difference in CGM parameters 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
timeFrame: 4 hours after a meal
measure: 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 using different types of insulin analogs
timeFrame: 4 hours after a meal
measure: Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs
timeFrame: 4 hours after a meal
measure: Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs
timeFrame: 4 hours after a meal
measure: Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin ultra-rapid lispro
timeFrame: 4 hours after a meal
measure: Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin aspart.
timeFrame: 4 hours after a meal
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Motol University Hospital
Study officials:
References: