Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178 participants
OBSERVATIONAL
2020-01-03
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure 1452
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Stockholm, , Sweden
Countries
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References
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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.
Other Identifiers
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U1111-1228-4256
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-4510
Identifier Type: -
Identifier Source: org_study_id
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