The Use of Faster Acting Aspart in Type 1 Diabetes Patients

Completed

• Conditions: Type 1 Diabetes; Insulin; Time in Range

• Registration Number: NCT04711382
• Lead Sponsor: University Hospital, Antwerp

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

Study Timeline

• Study Start: 2018-01-29
• Status Verified: 2020-12
• Primary Completion: 2020-12-14
• Study Completion: 2021-01-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in Range	12 months	Time in target range at 12 months

Secondary Outcome Measures

Name	Time	Method
Time in Range	6 months	Time in target range at 6 months
Change in HbA1c	6 months & 12 months	Change in HbA1c
Coefficient of variation	6 months & 12 months	Change in coefficient of variation
Change in weight	6 months & 12 months	Change in weight
Time above range	6 months & 12 months	Change in time above range
Time below range	6 months & 12 months	Change in time below range
Change in insulin doses	6 months & 12 months	Change in insulin doses

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium