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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1288-8138 | Other Identifier | World Health Organization (WHO) |
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This study looks at how a mobile based app called 'Dose Check' used along with Tresiba helps to control blood sugar level in participants with type 2 diabetes mellitus. Participants will get Tresiba as prescribed by the study doctor or participants will continue already prescribed treatment with Tresiba. Participants will also be prescribed to use Dose Check app by the study doctor and will be asked to install the Dose Check app in their mobile phone, which will support participants with the correct dose of Tresiba. This study will last for about 6 to 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec + dose check | Participants will be treated with commercially available insulin degludec used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Drug | Participants will be treated with commercially available insulin degludec used with Dose Check app according to local label and routine clinical practice at the discretion of the treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured in percentage point. | From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks]) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants reaching individual HbA1c target set by physician | Measured as number of participants (yes/no). | end of study visit (week 26 [-4 to +8 weeks]) |
| Participants reaching physician set individual fasting blood glucose (FBG) target |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with T2DM and aged less than or equal to 21 years.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sulaiman Al Habib- Al Qassim | Buraidah | Al Qassim | 51431 | Saudi Arabia | ||
| Almoosa Specialist Hospital |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
Measured as number of participants (yes/no).
| From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks]) |
| Time to physician set individual FBG target from first reported FBG | Measured in weeks. | From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks]) |
| Participants achieving target level FBG according to clinical guidance | Measured as number of participants (yes/no). | From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks]) |
| Change in laboratory measured FPG | Measured in milligrams per deciliter (mg/dL). | From baseline (week 0) to end of study visit(week 26 [-4 to +8 weeks]) |
| Ihsaa |
| 22141 |
| Saudi Arabia |
| Saudi airlines Medical Services | Jeddah | 21231 | Saudi Arabia |
| Saudi German Hospital | Jeddah | 23521 | Saudi Arabia |
| My clinic | Jeddah | Saudi Arabia |
| Saudi German Hospital | Khamis Mushait | 62451 | Saudi Arabia |
| Al Mowasat Khobar | Khobar | 34234 | Saudi Arabia |
| Sulaiman Al Habib- Al Khobar | Khobar | 34423 | Saudi Arabia |
| King Fahad Hospital of the University | Khobar | 34445 | Saudi Arabia |
| Al Hammadi | Riyadh | 11564 | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Group- Olaya | Riyadh | 11643 | Saudi Arabia |
| King Fahd Medical City, Riyadh, KSA | Riyadh | 12231 | Saudi Arabia |
| Al Hammadi | Riyadh | 12474 | Saudi Arabia |
| Dr. Sulaiman Al Habib Medical Group- Swedi | Riyadh | 12987 | Saudi Arabia |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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