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

Primary Purpose

Diabetes type1, Diabetes Mellitus, Type 1

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Insulin faster aspart (Fiasp, Novo Nordisk)

Sponsored by

Medical University of Warsaw

About this trial

This is an interventional treatment trial for Diabetes type1 focused on measuring CGM, continuous glucose monitoring system, TIR, Time In Range, insulin aspart, insulin faster aspart

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Insulin Aspart

Insulin Fiasp

Arm Description

Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.

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

Outcomes

Primary Outcome Measures

Glycaemia difference in time in range (TIR) 70-180mg/dl

Glycaemia difference in time in range (TIR) 70-180mg/dl

Secondary Outcome Measures

Glycaemia difference in time below range (TBR)

Glycaemia difference in time above range (TAR)

Glycaemia difference in the coefficient of variation (CV)

Difference in the average glycemia levels + standard deviation

Difference in Total Daily Dose (TDD) of insulin

Difference in the basal rate of insulin

Full Information

NCT ID

First Posted

January 25, 2021

Last Updated

February 22, 2021

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT04772729

Brief Title

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

Official Title

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?

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 1, 2021 (Anticipated)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Warsaw

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes type1, Diabetes Mellitus, Type 1

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

A cross-over, open-label, randomized study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Insulin Aspart

Arm Type

Active Comparator

Arm Description

Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.

Arm Title

Insulin Fiasp

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin faster aspart (Fiasp, Novo Nordisk)

Other Intervention Name(s)

Insulin aspart (Novo Rapid, Novo Nordisk)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Glycaemia difference in time in range (TIR) 70-180mg/dl

Time Frame

at week 4 of the study

Title

Glycaemia difference in time in range (TIR) 70-180mg/dl

Time Frame

at week 8 of the study

Secondary Outcome Measure Information:

Title

Glycaemia difference in time below range (TBR)

Time Frame

at weeks 4 and 8 of the study

Title

Glycaemia difference in time above range (TAR)

Time Frame

at weeks 4 and 8 of the study

Title

Glycaemia difference in the coefficient of variation (CV)

Time Frame

at weeks 4 and 8 of the study

Title

Difference in the average glycemia levels + standard deviation

Time Frame

at weeks 4 and 8 of the study

Title

Difference in Total Daily Dose (TDD) of insulin

Time Frame

at weeks 4 and 8 of the study

Title

Difference in the basal rate of insulin

Time Frame

at weeks 4 and 8 of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emilia Kowalczyk, MD

Phone

+48 223179538

Email

emilia.kowalczyk@uckwum.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Agnieszka Szypowska, Prof.

Phone

+48 223179539

Email

agnieszka.szypowska@uckwum.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agnieszka Szypowska, Prof.

Organizational Affiliation

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

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

No

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

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