DiabetesGoBolusNCT03450863
Study on How Fiasp® Can Influence Blood Sugar Levels of type1 Diabetic Patients in Their Daily Lives, With the Help of the Freestyle Libre® Device
An observational study of Diabetes and Diabetes Mellitus, Type 1 Diabetes, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1 Diabetes
- What is being tested?
- Fast-acting insulin aspart
- Type of treatment
- Injection or infusion
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2018to 4 Sep 2019
- 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: Adult patients with type 1 diabetes mellitus
Who may be able to join
- Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
- The decision to initiate treatment with commercially available Fiasp® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Diagnosed with T1DM at least 1 year prior to inclusion in the study
- Stable treatment by MDI/CSII for at least 6 months prior to inclusion in the study. Stable treatment is defined as not changing the treatment method, with dose adjustments allowed
- Regular (defined as usage on a monthly basis) user of Freestyle Libre® flash glucose monitoring for at least 6 months as the only continuous glucose monitoring (CGM) system actively used and availability of a full 2 weeks sensor download as "csv" file with 80% completeness of the data (if more sensor data are available, the 2 week data closest to baseline visit will be used)
- Latest HbA1c value measured in the 3 months prior to inclusion in the study between 7.5-9.5%
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Anti-diabetic treatment intensification during the last 3 months prior to inclusion in the study. Treatment intensification is defined as adding new anti-diabetic medication to previous treatment regimen
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, certain intrauterine devices), or sexual abstinence or a vasectomised partner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring
The purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment. The study will also assess how satisfied the participants are with the treatment with Fiasp® and the impact of the treatment on quality of life. The study has also been set up to learn more about how effective Fiasp® is in controlling the glucose levels during the day and night. The duration of the study is expected to be approximately 2 years. The participation is expected to be approximately 6-8 months for each patient.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1 Diabetes
- Being tested
- Fast-acting insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-acting insulin aspartDrug
Also called Fiasp®
Patients will be treated with commercially available fast-acting insulin aspart as bolus insulin (multiple daily injection [MDI]) or as insulin used in the insulin pumps (continuous subcutaneous insulin infusion [CSII]). Dosing of fast-acting insulin aspart is individual and determined by the treating physician in accordance with the needs of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Fast-acting insulin aspart | Participants will receive fast-acting insulin aspart at the treating physician's discretion as part of the usual clinical practice. The prescription and use of fast-acting insulin aspart is completely independent of this study. Total study duration for the individual patient will be approximately 24 weeks. Receives: Drug: Fast-acting insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin (HbA1c)
Measure in % point
Measured: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)
Secondary outcomes (4)
Change in Patient Reported Outcome: Impact of treatment measured by the overall score obtained from the Treatment Related Impact Measure For Diabetes (TRIM-D) questionnaire
The TRIM-D Device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change.
Measured: Baseline (week 0), end of study (week 24 ± 4 weeks)
Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment.
Measured: Baseline (week 0), end of study (week 24 ± 4 weeks)
Change in fasting plasma glucose (FPG)
Measured in mmol/L
Measured: Baseline (week 0), week 12 (±4 weeks)
Change in fasting plasma glucose (FPG)
Measured in mmol/L
Measured: Baseline (week 0), end of study (week 24 ±4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start22 Mar 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
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 DiabetesStudies 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
- Prospective
- Enrolment
- 320 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
- NCT03450863
- Sponsor's protocol ID
- NN1218-4412
- Other IDs
- U1111-1204-0620
- Acronym
- GoBolus
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Danne T, Axel Schweitzer M, Keuthage W, Kipper S, Kretzschmar Y, Simon J, Wiedenmann T, Ziegler R. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021 Mar;23(3):203-212. doi: 10.1089/dia.2020.0360. Epub 2020 Oct 21.
PubMed 32924568
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring
- ClinicalTrials.gov ID
- NCT03450863
- Acronym / sponsor ID
- GoBolus / NN1218-4412
- Conditions
- Diabetes, Diabetes Mellitus, Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 1 Mar 2018 (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 purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment. The study will also assess how satisfied the participants are with the treatment with Fiasp® and the impact of the treatment on quality of life. The study has also been set up to learn more about how effective Fiasp® is in controlling the glucose levels during the day and night. The duration of the study is expected to be approximately 2 years. The participation is expected to be approximately 6-8 months for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fast-acting insulin aspart | – | Drug: Fast-acting insulin aspartParticipants will receive fast-acting insulin aspart at the treating physician's discretion as part of the usual clinical practice. The prescription and use of fast-acting insulin aspart is completely independent of this study. Total study duration for the individual patient will be approximately 24 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with type 1 diabetes mellitus
Key inclusion criteria (7 listed)
- Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
- The decision to initiate treatment with commercially available Fiasp® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Diagnosed with T1DM at least 1 year prior to inclusion in the study
- Stable treatment by MDI/CSII for at least 6 months prior to inclusion in the study. Stable treatment is defined as not changing the treatment method, with dose adjustments allowed
Key exclusion criteria (4 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Anti-diabetic treatment intensification during the last 3 months prior to inclusion in the study. Treatment intensification is defined as adding new anti-diabetic medication to previous treatment regimen
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, certain intrauterine devices), or sexual abstinence or a vasectomised partner
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 |
|---|---|---|
| Fast-acting insulin aspartAlso: Fiasp®Patients will be treated with commercially available fast-acting insulin aspart as bolus insulin (multiple daily injection [MDI]) or as insulin used in the insulin pumps (continuous subcutaneous insulin infusion [CSII]). Dosing of fast-acting insulin aspart is individual and determined by the treating physician in accordance with the needs of the patient. | Drug | Fast-acting insulin aspart |
Primary outcome
Change in Glycated Haemoglobin (HbA1c)
Time frame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)
Measure in % point
4 secondary outcomes
Change in Patient Reported Outcome: Impact of treatment measured by the overall score obtained from the Treatment Related Impact Measure For Diabetes (TRIM-D) questionnaire
Time frame: Baseline (week 0), end of study (week 24 ± 4 weeks)
Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: Baseline (week 0), end of study (week 24 ± 4 weeks)
Change in fasting plasma glucose (FPG)
Time frame: Baseline (week 0), week 12 (±4 weeks)
Change in fasting plasma glucose (FPG)
Time frame: Baseline (week 0), end of study (week 24 ±4 weeks)
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 18 Mar 2020.
- Derived from this study: PubMed 32924568Danne T, Axel Schweitzer M, Keuthage W, Kipper S, Kretzschmar Y, Simon J, Wiedenmann T, Ziegler R. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021 Mar;23(3):203-212. doi: 10.1089/dia.2020.0360. Epub 2020 Oct 21.
- 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 and Diabetes Mellitus, Type 1 Diabetes, run by Novo Nordisk A/S at 1 site in Germany.
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 7 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 18 Mar 2020. 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 Germany. 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 Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)). 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 NCT03450863, 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 18 Mar 2020.