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

Phase 4

• Conditions: Diabetes type1; Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

• Registration Number: NCT04772729
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Study Start: 2021-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Aspart	Insulin faster aspart (Fiasp, Novo Nordisk)	Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.
Insulin Fiasp	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.

Primary Outcome Measures

Name	Time	Method
Glycaemia difference in time in range (TIR) 70-180mg/dl	at week 8 of the study

Secondary Outcome Measures

Name	Time	Method
Glycaemia difference in the coefficient of variation (CV)	at weeks 4 and 8 of the study
Difference in the basal rate of insulin	at weeks 4 and 8 of the study
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
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