Diabetes Mellitus, Type 1NCT03895515
Effect of Fiasp® in Type 1 Diabetes Treatment
An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Sweden.
Trial summary
Fiasp® is a meal-time insulin that has been available in Sweden since June 2017. This study will investigate the effectiveness of Fiasp® in treating Type 1 Diabetes Mellitus. The study will be based on blood sugar measurements that the participants have uploaded to the Diasend® database and on existing data in their… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Fiasp®
- How many people
- 178 participants
- Where
- 1 siteSweden
- Study dates
- 3 Jan 2020to 21 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with type 1 diabetes
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study (beyond identification of potential participants by searching for patients with type 1 Diabetes diagnosis, Fiasp® prescription information and electronic medical record (EMR) data to identify continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use
- Age greater than or equal to 18 years at the time of signing informed consent
- Switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. Switch must have occurred greater than or equal to 26 weeks prior to data collection and during 01 September 2017 to 31 August 2018
- Treated with basal-bolus insulin regimen throughout the 26 weeks prior to Fiasp® initiation
- Treated with the same basal insulin, i.e. no records of switching the basal insulin, during the 26 weeks prior to Fiasp® initiation or the 26 weeks after Fiasp® initiation
- Diagnosed with type 1 diabetes for greater than or equal to 12 months prior to Fiasp® initiation
- Use of CGM/FGM during the 26 weeks prior to Fiasp® initiation and the 26 weeks after Fiasp® initiation
- Use of the same CGM/FGM device during the full 26-week period after Fiasp® initiation.
Who cannot join
- Previous participation in this study. Participation is defined as signed informed consent
- Participation in clinical study with receipt of any investigational medicinal product known to affect glucose control during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients prescribed any other glucose-lowering drugs than insulins (anatomical therapeutic chemical [ATC] class A10B), including oral and injectable drugs, as addition to their insulin treatment during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
- Use of Fiasp® as bolus insulin during the 26-week period prior to Fiasp® initiation
- Use of any insulin with an insulin pump (i.e. continuous subcutaneous insulin infusion) during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fiasp® (Fast-acting Insulin Aspart) in Type 1 Diabetes Patients Using Continuous Glucose Monitoring / Flash Glucose Monitoring in Real-world Clinical Practice in Sweden. A Non-interventional, Retrospective Chart and Database Review Study
Fiasp® is a meal-time insulin that has been available in Sweden since June 2017. This study will investigate the effectiveness of Fiasp® in treating Type 1 Diabetes Mellitus. The study will be based on blood sugar measurements that the participants have uploaded to the Diasend® database and on existing data in their electronic medical records. The study does not require any additional visits to the study doctor.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Fiasp®
- 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.
Fiasp®Drug
Participants receive treatment with Fiasp® according to routine clinical practice. All treatment decisions, including assignment of participants to Fiasp® treatment, were made independently of the study and prior to the participants' inclusion in the study.
| Study group | Role | What they receive |
|---|---|---|
| Fiasp® | Participants with type 1 diabetes who have switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. Receives: Drug: Fiasp® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of time spent in glycaemic target range (TIR)
Measured in percentage point.
The change in percentage of TIR was defined as a blood glucose level of 3.9 to 10.0 mmol/L after initiation of Fiasp® treatment. Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Secondary outcomes (8)
Change in mean sensor glucose
Measured in mmol/L
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in glycaemic variability (GV) (measured as coefficient of variation [CV])
Measured in percentage point
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)
Measured in percentage point
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)
Measured in percentage point
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)
Measured in percentage point
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)
Measured in percentage point
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Time frame description:
From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to and before index date, Two-week period closest to Week 26
Proportion with CV lesser than 36%
Proportion of participants with/without GV corresponding to a CV lesser than 36%
Time frame description:
Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Measured: Two-week period closest to Week 26
Change in Glycated Haemoglobin A1c (HbA1c)
Measured in mmol/mol
Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.
Measurement closest to Week 26 will be identified from a period ranging between 12 weeks after index date and 32 weeks after index date
Measured: Latest measurement between Week -12 and index date, measurement closest to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start3 Jan 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895515
- Sponsor's protocol ID
- NN1218-4510
- Other IDs
- U1111-1228-4256
- Status last verified
- Apr 2022
- First submitted
- 27 Mar 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Lind M, Catrina SB, Ekberg NR, Gerward S, Halasa T, Hellman J, Hess D, Londahl M, Qvist V, Bolinder J. Fast-Acting Insulin Aspart in Patients with Type 1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study. Diabetes Ther. 2023 Sep;14(9):1563-1575. doi: 10.1007/s13300-023-01444-y. Epub 2023 Jul 14.
PubMed 37450196
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fiasp® (Fast-acting Insulin Aspart) in Type 1 Diabetes Patients Using Continuous Glucose Monitoring / Flash Glucose Monitoring in Real-world Clinical Practice in Sweden. A Non-interventional, Retrospective Chart and Database Review Study
- ClinicalTrials.gov ID
- NCT03895515
- Acronym / sponsor ID
- NN1218-4510
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 29 Mar 2019 (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.
Fiasp® is a meal-time insulin that has been available in Sweden since June 2017. This study will investigate the effectiveness of Fiasp® in treating Type 1 Diabetes Mellitus. The study will be based on blood sugar measurements that the participants have uploaded to the Diasend® database and on existing data in their electronic medical records. The study does not require any additional visits to the study doctor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiasp® | – | Drug: Fiasp®Participants with type 1 diabetes who have switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with type 1 diabetes
Key inclusion criteria (8 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study (beyond identification of potential participants by searching for patients with type 1 Diabetes diagnosis, Fiasp® prescription information and electronic medical record (EMR) data to identify continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use
- Age greater than or equal to 18 years at the time of signing informed consent
- Switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. Switch must have occurred greater than or equal to 26 weeks prior to data collection and during 01 September 2017 to 31 August 2018
- Treated with basal-bolus insulin regimen throughout the 26 weeks prior to Fiasp® initiation
- Treated with the same basal insulin, i.e. no records of switching the basal insulin, during the 26 weeks prior to Fiasp® initiation or the 26 weeks after Fiasp® initiation
Key exclusion criteria (6 listed)
- Previous participation in this study. Participation is defined as signed informed consent
- Participation in clinical study with receipt of any investigational medicinal product known to affect glucose control during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients prescribed any other glucose-lowering drugs than insulins (anatomical therapeutic chemical [ATC] class A10B), including oral and injectable drugs, as addition to their insulin treatment during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
- Use of Fiasp® as bolus insulin during the 26-week period prior to Fiasp® initiation
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 |
|---|---|---|
| Fiasp®Participants receive treatment with Fiasp® according to routine clinical practice. All treatment decisions, including assignment of participants to Fiasp® treatment, were made independently of the study and prior to the participants' inclusion in the study. | Drug | Fiasp® |
Primary outcome
Change in percentage of time spent in glycaemic target range (TIR)
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Measured in percentage point. The change in percentage of TIR was defined as a blood glucose level of 3.9 to 10.0 mmol/L after initiation of Fiasp® treatment. Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018. Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
8 secondary outcomes
Change in mean sensor glucose
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in glycaemic variability (GV) (measured as coefficient of variation [CV])
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)
Time frame: Two-week period closest to and before index date, Two-week period closest to Week 26
Proportion with CV lesser than 36%
Time frame: Two-week period closest to Week 26
Change in Glycated Haemoglobin A1c (HbA1c)
Time frame: Latest measurement between Week -12 and index date, measurement closest to Week 26
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 7 Apr 2022.
- Derived from this study: PubMed 37450196Lind M, Catrina SB, Ekberg NR, Gerward S, Halasa T, Hellman J, Hess D, Londahl M, Qvist V, Bolinder J. Fast-Acting Insulin Aspart in Patients with Type 1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study. Diabetes Ther. 2023 Sep;14(9):1563-1575. doi: 10.1007/s13300-023-01444-y. Epub 2023 Jul 14.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Reporting Anchor and Disclosure 1452 study director
Novo Nordisk A/S
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 Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Sweden.
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 8 inclusion and 6 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 7 Apr 2022. 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 Sweden. 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?
Change in percentage of time spent in glycaemic target range (TIR) (time frame: Two-week period closest to and before index date, Two-week period closest to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895515, which also lists 1 linked publication.
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 7 Apr 2022.