Type 1 DiabetesNCT04711382
The Use of Faster Acting Aspart in Type 1 Diabetes Patients
An observational study of Type 1 Diabetes and Insulin, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Type 1 Diabetes, Insulin, Time in Range
- How many people
- 438 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2018to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult type 1 diabetes patients, with a duration of diabetes of > 2 years
Who may be able to join
- Type 1 diabetes patients
- Duration of diabetes > 2 years
- Using CGM for > 6 months
Who cannot join
- Using SMBG
- Pregnancy
- Using glucocorticoids or immunosuppressive agents
- Active oncological problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Type 1 Diabetes, Insulin, Time in Range
- Keywords
- fast acting insulin, glucometrics
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Time in target range at 12 months
Measured: 12 months
Secondary outcomes (7)
Time in Range
Time in target range at 6 months
Measured: 6 months
Change in HbA1c
Change in HbA1c
Measured: 6 months & 12 months
Change in weight
Change in weight
Measured: 6 months & 12 months
Change in insulin doses
Change in insulin doses
Measured: 6 months & 12 months
Time below range
Change in time below range
Measured: 6 months & 12 months
Time above range
Change in time above range
Measured: 6 months & 12 months
Coefficient of variation
Change in coefficient of variation
Measured: 6 months & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start29 Jan 2018
- Primary completion14 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711382
- Sponsor's protocol ID
- Fiasp real-world data
- Status last verified
- Dec 2020
- First submitted
- 12 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Faster Acting Aspart in Type 1 Diabetes Patients: Multi-centre Real-world Experience
- ClinicalTrials.gov ID
- NCT04711382
- Acronym / sponsor ID
- Fiasp real-world data
- Conditions
- Type 1 Diabetes, Insulin, Time in Range
- Keywords
- fast acting insulin, glucometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult type 1 diabetes patients, with a duration of diabetes of > 2 years
Key inclusion criteria (3 listed)
- Type 1 diabetes patients
- Duration of diabetes > 2 years
- Using CGM for > 6 months
Key exclusion criteria (4 listed)
- Using SMBG
- Pregnancy
- Using glucocorticoids or immunosuppressive agents
- Active oncological problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time in Range
Time frame: 12 months
Time in target range at 12 months
7 secondary outcomes
Time in Range
Time frame: 6 months
Change in HbA1c
Time frame: 6 months & 12 months
Change in weight
Time frame: 6 months & 12 months
Change in insulin doses
Time frame: 6 months & 12 months
Time below range
Time frame: 6 months & 12 months
Time above range
Time frame: 6 months & 12 months
Coefficient of variation
Time frame: 6 months & 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Insulin, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.