Diabetes Mellitus, Type 1
Conditions
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.
Interventions
OTHERenteral 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
Zdeněk Šumník
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 4 hour after a meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 hours after a meal | — |
| 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. | 4 hours after a meal | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) |
| 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 | 4 hours after a meal | insulin analogs - aspart and ultra-rapid lispro |
| 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. | 4 hours after a meal | — |
| 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 | 4 hours after a meal | insulin analogs - aspart and ultra-rapid lispro |
| 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 | 4 hours after a meal | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) |
| 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. | 4 hours after a meal | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (\> 13.9 mmol/L; \>250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (\< 3.0 mmol/L; \<54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) |
| 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 | 4 hours after a meal | insulin analogs - aspart and ultra-rapid lispro |
Countries
Czechia
Contacts
Primary ContactAlžbeta Šantová, MD
Outcome results
None listed