Skip to main content
OpenTrials
Completed

NCT Number: NCT04711382

The Use of Faster Acting Aspart in Type 1 Diabetes Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Time in Range

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time in Range

    Time frame: 12 months

    Time in target range at 12 months

Secondary outcomes

  1. Time in Range

    Time frame: 6 months

    Time in target range at 6 months

  2. Change in HbA1c

    Time frame: 6 months & 12 months

    Change in HbA1c

  3. Change in weight

    Time frame: 6 months & 12 months

    Change in weight

  4. Change in insulin doses

    Time frame: 6 months & 12 months

    Change in insulin doses

  5. Time below range

    Time frame: 6 months & 12 months

    Change in time below range

  6. Time above range

    Time frame: 6 months & 12 months

    Change in time above range

  7. Coefficient of variation

    Time frame: 6 months & 12 months

    Change in coefficient of variation

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.