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The Use of Faster Acting Aspart in Type 1 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711382
Recruitment Status : Completed
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
University Hospital, Antwerp

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
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

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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 : January 29, 2018
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Time in Range [ Time Frame: 12 months ]
    Time in target range at 12 months


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult type 1 diabetes patients, with a duration of diabetes of > 2 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711382


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Universitaire Ziekenhuizen Leuven
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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT04711382    
Other Study ID Numbers: Fiasp real-world data
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: December 2020

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases