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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1228-4256 | Other Identifier | World Health Organisation (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two-week period closest to and before index date, Two-week period closest to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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Participants with type 1 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure 1452 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37450196 | Derived | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | Latest measurement between Week -12 and index date, measurement closest to Week 26 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |