The Use of Faster Acting Aspart in Type 1 Diabetes Patients

Type 1 Diabetes Clinical Trial

Official title:

The Use of Faster Acting Aspart in Type 1 Diabetes Patients: Multi-centre Real-world Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711382
• Other study ID #: Fiasp real-world data
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data on switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of switching from traditional mealtime insulin to Fiasp in a "real-world" clinical practice setting in people with type 1 diabetes in Belgium.

Description:

The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dl) at 6 and 12 months. Secondary endpoints included change in HbA1c, BMI, insulin doses, time below range (T<70 and T<54 mg/dl) and time above range (T>180 and T>250 mg/dl).

Retrospective analysis Two-center study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: January 1, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes patients

• Duration of diabetes > 2 years

• Using CGM for > 6 months

Exclusion Criteria:

• Using SMBG

• Pregnancy

• Using glucocorticoids or immunosuppressive agents

• Active oncological problem

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin
• Time in Range
• Type 1 Diabetes

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Range	Time in target range at 12 months	12 months
Secondary	Time in Range	Time in target range at 6 months	6 months
Secondary	Change in HbA1c	Change in HbA1c	6 months & 12 months
Secondary	Change in weight	Change in weight	6 months & 12 months
Secondary	Change in insulin doses	Change in insulin doses	6 months & 12 months
Secondary	Time below range	Change in time below range	6 months & 12 months
Secondary	Time above range	Change in time above range	6 months & 12 months
Secondary	Coefficient of variation	Change in coefficient of variation	6 months & 12 months