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The Use of Faster Acting Aspart in Type 1 Diabetes Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04711382
Enrollment
438
Registered
2021-01-15
Start date
2018-01-29
Completion date
2021-01-01
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin, Time in Range, Type 1 Diabetes

Keywords

fast acting insulin, glucometrics

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

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time in Range12 monthsTime in target range at 12 months

Secondary

MeasureTime frameDescription
Change in HbA1c6 months & 12 monthsChange in HbA1c
Change in weight6 months & 12 monthsChange in weight
Change in insulin doses6 months & 12 monthsChange in insulin doses
Time in Range6 monthsTime in target range at 6 months
Time above range6 months & 12 monthsChange in time above range
Coefficient of variation6 months & 12 monthsChange in coefficient of variation
Time below range6 months & 12 monthsChange in time below range

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026