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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 438

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult type 1 diabetes patients, with a duration of diabetes of > 2 years

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	Time in target range at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	Time in target range at 6 months	6 months
Change in HbA1c	Change in HbA1c	6 months & 12 months
Change in weight	Change in weight	6 months & 12 months
Change in insulin doses	Change in insulin doses	6 months & 12 months
Time below range	Change in time below range	6 months & 12 months
Time above range	Change in time above range	6 months & 12 months
Coefficient of variation	Change in coefficient of variation	6 months & 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: fast acting insulin; glucometrics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Fiasp real-world data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No