The Use of Faster Acting Aspart in Type 1 Diabetes Patients

NCT ID: NCT04711382

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 438 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2021-01-01

Brief 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.

Detailed 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

Conditions

Type 1 Diabetes; Insulin; Time in Range

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

Fiasp real-world data

Identifier Type: -

Identifier Source: org_study_id