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NCT04711382 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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