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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

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.