Diabetes Mellitus, Type 1, Diabetes type1
Conditions
Keywords
CGM, continuous glucose monitoring system, TIR, Time In Range, insulin aspart, insulin faster aspart
Brief summary
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.
Interventions
DRUGInsulin 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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A cross-over, open-label, randomized study.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* ≥1 year of a history of type 1 diabetes; * treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months; * using continuous glucose monitoring system for at least 1 month; * HbA1c\<8%; * consent to participate in the study obtained from the parent and the patient (\>16 years of age).
Exclusion criteria
* diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI); * concomitant medical problems which might significantly affect glucose levels; * the withdrawal of the consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemia difference in time in range (TIR) 70-180mg/dl | at week 4 of the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Glycaemia difference in time below range (TBR) | 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 |
| Difference in the average glycemia levels + standard deviation | at weeks 4 and 8 of the study |
Contacts
Primary ContactEmilia Kowalczyk, MD
Backup ContactAgnieszka Szypowska, Prof.
Outcome results
None listed