Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?

Study Overview
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Brief Summary
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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.

Official Title
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Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?

Conditions
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Diabetes type1, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Insulin faster aspart (Fiasp, Novo Nordisk)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A cross-over, open-label, randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Aspart<br>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)<br>* 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.<br>* Other names: Insulin aspart (Novo Rapid, Novo Nordisk);|
| Experimental: Insulin Fiasp<br>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)<br>* 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.<br>* Other names: Insulin aspart (Novo Rapid, Novo Nordisk);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, continuous glucose monitoring system, TIR, Time In Range, insulin aspart, insulin faster aspart