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

Diabetes Mellitus, Type 1 Clinical Trial

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04772729
• Other study ID #: TIR: Fiasp vs. Asp
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2021
• Source: Medical University of Warsaw
• Contact: Emilia Kowalczyk, MD
• Phone: +48 223179538
• Email: emilia.kowalczyk[@]uckwum.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 77
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemia difference in time in range (TIR) 70-180mg/dl		at week 4 of the study
Primary	Glycaemia difference in time in range (TIR) 70-180mg/dl		at week 8 of the study
Secondary	Glycaemia difference in time below range (TBR)		at weeks 4 and 8 of the study
Secondary	Glycaemia difference in time above range (TAR)		at weeks 4 and 8 of the study
Secondary	Glycaemia difference in the coefficient of variation (CV)		at weeks 4 and 8 of the study
Secondary	Difference in the average glycemia levels + standard deviation		at weeks 4 and 8 of the study
Secondary	Difference in Total Daily Dose (TDD) of insulin		at weeks 4 and 8 of the study
Secondary	Difference in the basal rate of insulin		at weeks 4 and 8 of the study