A Phase 4 interventional study of Insulin faster aspart (Fiasp, Novo Nordisk) in Diabetes type1 and Diabetes Mellitus, Type 1, sponsored by Medical University of Warsaw. Status unknown. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-02-26.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 77 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.
Drug: Insulin faster aspart (Fiasp, Novo Nordisk)
Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks.
Drug: Insulin faster aspart (Fiasp, Novo Nordisk)
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.
Also known as: Insulin aspart (Novo Rapid, Novo Nordisk)
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw