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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-5037 | Other Identifier | WHO |
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This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoPen Echo® | Device | Prescribed insulin treatment delivered by NovoPen Echo® |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of technical complaints related to adverse reactions | after 12-18 weeks (end of study) |
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Inclusion Criteria:
Exclusion Criteria:
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Any child or adolescent with type 1 diabetes who has just started using NovoPen Echo® is eligible. The selection of the patients will be at discretion of the individual physician.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mississauga | L4W 4XI | Canada | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21406015 | Result | Hansen B, Lilleore SK, Ter-Borch G. Needle with a novel attachment versus conventional screw-thread needles: a preference and usability test among adults with diabetes and impaired manual dexterity. Diabetes Technol Ther. 2011 May;13(5):579-85. doi: 10.1089/dia.2010.0214. Epub 2011 Mar 15. | |
| 22640459 | Result | Adolfsson P, Veijola R, Huot C, Hansen HD, Lademann JB, Phillip M. Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study. Curr Med Res Opin. 2012 Sep;28(9):1455-63. doi: 10.1185/03007995.2012.698258. Epub 2012 Jul 27. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Espoo |
| FI-02600 |
| Finland |
| Novo Nordisk Investigational Site | Kfar Saba | 44425 | Israel |
| Novo Nordisk Investigational Site | Malmö | 202 15 | Sweden |
| Novo Nordisk Investigational Site | Malmö | SE-202 15 | Sweden |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |