| Trial ID: | L2938 |
| Source ID: | NCT04772729
|
| Associated Drug: |
Insulin Faster Aspart (Fiasp, Novo Nordisk)
|
| Title: |
Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes type1|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Insulin faster aspart (Fiasp, Novo Nordisk)
|
| Outcome Measures: |
Primary: Glycaemia difference in time in range (TIR) 70-180mg/dl, at week 4 of the study|Glycaemia difference in time in range (TIR) 70-180mg/dl, at week 8 of the study | Secondary: Glycaemia difference in time below range (TBR), at weeks 4 and 8 of the study|Glycaemia difference in time above range (TAR), at weeks 4 and 8 of the study|Glycaemia difference in the coefficient of variation (CV), at weeks 4 and 8 of the study|Difference in the average glycemia levels + standard deviation, at weeks 4 and 8 of the study|Difference in Total Daily Dose (TDD) of insulin, at weeks 4 and 8 of the study|Difference in the basal rate of insulin, at weeks 4 and 8 of the study
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Warsaw
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE4
|
| Enrollment: |
77
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-01
|
| Completion Date: |
2024-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2021-02-26
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04772729
|
