- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895515
Effect of Fiasp® in Type 1 Diabetes Treatment
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
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden, 141 86
- Novo Nordisk INvestigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in mean sensor glucose
Time Frame: Two-week period closest to and before index date, Two-week period closest to Week 26
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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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
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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. |
Two-week period closest to and before index date, Two-week period closest to Week 26
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Proportion with CV lesser than 36%
Time Frame: Two-week period closest to Week 26
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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. |
Two-week period closest to Week 26
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Change in Glycated Haemoglobin A1c (HbA1c)
Time Frame: Latest measurement between Week -12 and index date, measurement closest to Week 26
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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 |
Latest measurement between Week -12 and index date, measurement closest to Week 26
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1218-4510
- U1111-1228-4256 (OTHER: World Health Organisation (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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