NCT04711382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

January 12, 2021

Last Update Submit

January 12, 2021

Conditions

Type 1 DiabetesInsulinTime in Range

Keywords

fast acting insulinglucometrics

Outcome Measures

Primary Outcomes (1)

  • Time in Range

    Time in target range at 12 months

    12 months

Secondary Outcomes (7)

  • Time in Range

    6 months

  • Change in HbA1c

    6 months & 12 months

  • Change in weight

    6 months & 12 months

  • Change in insulin doses

    6 months & 12 months

  • Time below range

    6 months & 12 months

  • +2 more secondary outcomes

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Type 1 diabetes patients
  • Duration of diabetes \> 2 years
  • Using CGM for \> 6 months

You may not qualify if:

  • Using SMBG
  • Pregnancy
  • Using glucocorticoids or immunosuppressive agents
  • Active oncological problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

January 29, 2018

Primary Completion

December 14, 2020

Study Completion

January 1, 2021

Last Updated

January 15, 2021

Record last verified: 2020-12

Locations

BE(1)