Diabetes type1Phase 4NCT04772729
Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?
A Phase 4 study testing Insulin faster aspart (Fiasp, Novo Nordisk) in people with Diabetes type1 and Diabetes Mellitus, Type 1, run by Medical University of Warsaw.
Trial summary
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes type1, Diabetes Mellitus, Type 1
- What is being tested?
- Insulin faster aspart (Fiasp, Novo Nordisk)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2024
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥1 year of a history of type 1 diabetes;
- treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
- using continuous glucose monitoring system for at least 1 month;
- HbA1c<8%;
- consent to participate in the study obtained from the parent and the patient (>16 years of age).
Who cannot join
- diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
- concomitant medical problems which might significantly affect glucose levels;
- the withdrawal of the consent to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.
- Conditions
- Diabetes type1, Diabetes Mellitus, Type 1
- Being tested
- Insulin faster aspart (Fiasp, Novo Nordisk)
- Keywords
- CGM, continuous glucose monitoring system, TIR, Time In Range, insulin aspart, insulin faster aspart
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin faster aspart (Fiasp, Novo Nordisk)Drug
Also called Insulin aspart (Novo Rapid, Novo Nordisk)
Duration of the study: 10 weeks.
It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.
W0: The study will start with a 2-week run-in period in order to normalize glycemia.
W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.
W2: after 2 weeks, diabetology telephone consultation (washout period).
W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.
W4: after 2 weeks, diabetology telephone consultation (washout period).
W5: after 2 weeks, diabetology telephone consultation.
W6: the results obtained throughout the study will be discussed with the patient and the parent.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Aspart | Active comparator | Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks. Receives: Drug: Insulin faster aspart (Fiasp, Novo Nordisk) |
| Insulin Fiasp | Experimental | Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks. Receives: Drug: Insulin faster aspart (Fiasp, Novo Nordisk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemia difference in time in range (TIR) 70-180mg/dl
Measured: at week 4 of the study
Glycaemia difference in time in range (TIR) 70-180mg/dl
Measured: at week 8 of the study
Secondary outcomes (6)
Glycaemia difference in time below range (TBR)
Measured: at weeks 4 and 8 of the study
Glycaemia difference in time above range (TAR)
Measured: at weeks 4 and 8 of the study
Glycaemia difference in the coefficient of variation (CV)
Measured: at weeks 4 and 8 of the study
Difference in the average glycemia levels + standard deviation
Measured: at weeks 4 and 8 of the study
Difference in Total Daily Dose (TDD) of insulin
Measured: at weeks 4 and 8 of the study
Difference in the basal rate of insulin
Measured: at weeks 4 and 8 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cross-over, open-label, randomized study.
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Szypowska, Prof., Study chair, Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772729
- Sponsor's protocol ID
- TIR: Fiasp vs. Asp
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?
- ClinicalTrials.gov ID
- NCT04772729
- Acronym / sponsor ID
- TIR: Fiasp vs. Asp
- Conditions
- Diabetes type1, Diabetes Mellitus, Type 1
- Keywords
- CGM, continuous glucose monitoring system, TIR, Time In Range, insulin aspart, insulin faster aspart
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Feb 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.
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cross-over, open-label, randomized study.
| Arm | Type | Receives |
|---|---|---|
| Insulin Aspart | Active comparator | Drug: Insulin faster aspart (Fiasp, Novo Nordisk)Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks. |
| Insulin Fiasp | Experimental | Drug: Insulin faster aspart (Fiasp, Novo Nordisk)Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ≥1 year of a history of type 1 diabetes;
- treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
- using continuous glucose monitoring system for at least 1 month;
- HbA1c<8%;
- consent to participate in the study obtained from the parent and the patient (>16 years of age).
Key exclusion criteria (3 listed)
- diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
- concomitant medical problems which might significantly affect glucose levels;
- the withdrawal of the consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin faster aspart (Fiasp, Novo Nordisk)Also: Insulin aspart (Novo Rapid, Novo Nordisk)Duration of the study: 10 weeks. It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations. W0: The study will start with a 2-week run-in period in order to normalize glycemia. W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined. W2: after 2 weeks, diabetology telephone consultation (washout period). W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation. W4: after 2 weeks, diabetology telephone consultation (washout period). W5: after 2 weeks, diabetology telephone consultation. W6: the results obtained throughout the study will be discussed with the patient and the parent. | Drug | Insulin Aspart, Insulin Fiasp |
Primary outcome
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time frame: at week 4 of the study
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time frame: at week 8 of the study
6 secondary outcomes
Glycaemia difference in time below range (TBR)
Time frame: at weeks 4 and 8 of the study
Glycaemia difference in time above range (TAR)
Time frame: at weeks 4 and 8 of the study
Glycaemia difference in the coefficient of variation (CV)
Time frame: at weeks 4 and 8 of the study
Difference in the average glycemia levels + standard deviation
Time frame: at weeks 4 and 8 of the study
Difference in Total Daily Dose (TDD) of insulin
Time frame: at weeks 4 and 8 of the study
Difference in the basal rate of insulin
Time frame: at weeks 4 and 8 of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Agnieszka Szypowska, Prof. study chair
Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin faster aspart (Fiasp, Novo Nordisk) in people with Diabetes type1 and Diabetes Mellitus, Type 1, run by Medical University of Warsaw.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Kowalczyk, MD (+48 223179538, emilia.kowalczyk@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemia difference in time in range (TIR) 70-180mg/dl (time frame: at week 4 of the study). The study lists 2 primary outcomes in all. 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 26 Feb 2021.