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

NCT04772729 | Unknown Phase 4

• 1 other identifier: TIR: Fiasp vs. Asp
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes type1; Diabetes Mellitus, Type 1

Keywords

CGM; continuous glucose monitoring system; TIR; Time In Range; insulin aspart; insulin faster aspart

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Insulin Aspart

ACTIVE COMPARATOR

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)

Insulin Fiasp

EXPERIMENTAL

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)

Interventions

Insulin faster aspart (Fiasp, Novo Nordisk) DRUG

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.

Also known as: Insulin aspart (Novo Rapid, Novo Nordisk)

Insulin Aspart; Insulin Fiasp

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Agnieszka Szypowska, Prof.

  Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland

  STUDY CHAIR

Central Study Contacts

Emilia Kowalczyk, MD

CONTACT

+48 223179538; emilia.kowalczyk@uckwum.pl

Agnieszka Szypowska, Prof.

CONTACT

+48 223179539; agnieszka.szypowska@uckwum.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cross-over, open-label, randomized study.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 26, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share