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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1316-4217 | Other Identifier | World Health Organization (WHO) |
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This study looks at overall impact of the use of DuraTouch® in terms of ease, convenience to use and satisfaction in participants with either type 1 or type 2 diabetes.The study will last for about 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DuraTouch® (Insulin injection) | Participants will subcutaneously inject the insulin prescribed by the doctor using DuraTouch® according to routine clinical practice at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DuraTouch® | Device | Participants will subcutaneously inject the insulin using DuraTouch®. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant rating the ease of use, convenience and satisfaction with the device | Rating score on a 5-point Likert-type response scale. 1=Not at all easy/convenient/satisfied, 5=Extremely easy/convenient/satisfied. | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant rating the ease of preparing the device for use and ease of injection | Rating score on a 5-point Likert-type response scale. 1=Not at all easy, 5=Extremely easy. | At week 12 |
| Participant rating the confidence of using the device correctly and confidence in the device delivering the correct full dose |
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Inclusion Criteria:
Exclusion Criteria:
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Study population included participants with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) who require insulin injection.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ginemedica Sp. z o.o. Sp.k | Wroclaw | Kuyavian-Pomeranian Voivodeship | 50-414 | Poland | ||
| CenterMed Krakow Sp. z o.o. |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Rating score on a 5-point Likert-type response scale. 1=Not at all confident, 5=Extremely confident. |
| At week 12 |
| Participant rating ease to learn how to use the device | Rating score on a 5-point Likert-type response scale. 1=Very difficult, 5=Very Easy. | At week 12 |
| Krakow |
| Lesser Poland Voivodeship |
| 31-530 |
| Poland |
| Diabetolog praktyka lekarska - Bartosz Bednarkiewicz | Lubin | Lower Silesian Voivodeship | 59-300 | Poland |
| Centrum Medyczne Ekamed sp. z o.o. | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Gabinet Lekarski Internistyczny Iwona Towpik | Zielona Góra | Lubusz Voivodeship | 65-034 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji - Klinika Chorob Wewnetrznych, Endokrynologii i Diab | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Diabetica sp. z o.o. | Nysa | Opole Voivodeship | 48-300 | Poland |
| Poradnia Diabetologiczna. Niepubliczny Zaklad Opieki Zdrowotnej Lege Artis | Bialystok | Podlaskie Voivodeship | 15-404 | Poland |
| NZOZ Gdanska Poradnia Cukrzycowa Sp. z o.o | Gdansk | Pomeranian Voivodeship | 80-858 | Poland |
| "Santa Familia PTG tódz | Lodz | Pomeranian Voivodeship | 90-302 | Poland |
| Diab Serwis POPENDA Spólka Jawna | Chorzów | Silesian Voivodeship | 41-500 | Poland |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |