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

NCT04772729 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-02-26

No results posted yet for this study

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.

Conditions

  • Diabetes type1
  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin 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 & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Agnieszka Szypowska, Prof. · Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-03-01
Completion
2024-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772729 on ClinicalTrials.gov