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

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?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1; Diabetes type1
• Intervention / Treatment: Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

• Study Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emilia Kowalczyk, MD; Phone Number: +48 223179538; Email: emilia.kowalczyk@uckwum.pl
• Study Contact Backup: Name: Agnieszka Szypowska, Prof.; Phone Number: +48 223179539; Email: agnieszka.szypowska@uckwum.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin Aspart; 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); 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.; Other Names: Insulin aspart (Novo Rapid, Novo Nordisk)
Experimental: Insulin Fiasp; 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); 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.; Other Names: Insulin aspart (Novo Rapid, Novo Nordisk)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Chair: Agnieszka Szypowska, Prof., Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: CGM; continuous glucose monitoring system; insulin aspart; TIR; Time In Range; insulin faster aspart
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart
• Other Study ID Numbers: TIR: Fiasp vs. Asp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No