The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Duration of the study: 10 weeks. It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations. W0: The study will start with a 2-week run-in period in order to normalize glycemia. W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined. W2: after 2 weeks, diabetology telephone consultation (washout period). W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation. W4: after 2 weeks, diabetology telephone consultation (washout period). W5: after 2 weeks, diabetology telephone consultation. W6: the results obtained throughout the study will be discussed with the patient and the parent.
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time frame: at week 4 of the study
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time frame: at week 8 of the study
Glycaemia difference in time below range (TBR)
Time frame: at weeks 4 and 8 of the study
Glycaemia difference in time above range (TAR)
Time frame: at weeks 4 and 8 of the study
Glycaemia difference in the coefficient of variation (CV)
Time frame: at weeks 4 and 8 of the study
Difference in the average glycemia levels + standard deviation
Time frame: at weeks 4 and 8 of the study
Difference in Total Daily Dose (TDD) of insulin
Time frame: at weeks 4 and 8 of the study
Difference in the basal rate of insulin
Time frame: at weeks 4 and 8 of the study
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