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The Use of Faster Acting Aspart in Type 1 Diabetes Patients

Sponsor
University Hospital, Antwerp (Other)
Overall Status
Completed
CT.gov ID
NCT04711382
Collaborator
Universitaire Ziekenhuizen Leuven (Other)
438
Enrollment
1
Location
35.1
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    438 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Use of Faster Acting Aspart in Type 1 Diabetes Patients: Multi-centre Real-world Experience
    Actual Study Start Date :
    Jan 29, 2018
    Actual Primary Completion Date :
    Dec 14, 2020
    Actual Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Time in Range [12 months]

      Time in target range at 12 months

    Secondary Outcome Measures

    1. Time in Range [6 months]

      Time in target range at 6 months

    2. Change in HbA1c [6 months & 12 months]

      Change in HbA1c

    3. Change in weight [6 months & 12 months]

      Change in weight

    4. Change in insulin doses [6 months & 12 months]

      Change in insulin doses

    5. Time below range [6 months & 12 months]

      Change in time below range

    6. Time above range [6 months & 12 months]

      Change in time above range

    7. Coefficient of variation [6 months & 12 months]

      Change in coefficient of variation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Antwerp University Hospital Edegem Antwerp Belgium 2650

    Sponsors and Collaborators

    • University Hospital, Antwerp
    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Antwerp
    ClinicalTrials.gov Identifier:
    NCT04711382
    Other Study ID Numbers:
    • Fiasp real-world data
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Antwerp
    fast acting insulin
    glucometrics
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jan 15, 2021