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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink | Other |
| |
| Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek FlexLink | Device | Insulin pump device used for 4-weeks under real life conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of kinked cannulas | 8 weeks | |
| Pump settings, including insulin dosage | 8 weeks | |
| Device satisfaction/preference as assessed by patient surveys |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Amstutz | Roche Diagnostics GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aschaffenburg | 63739 | Germany | ||||
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| Accu-Chek FlexLink Plus | Device | Insulin pump device used for 4-weeks under real life conditions |
|
| 8 weeks |
| Investigator assessment of patient device use | At Baseline and Week 4 |
| Incidence of adverse events | 8 weeks |
| Insulin set replacement pattern | 8 weeks |
| Berlin |
| 01627 |
| Germany |
| Berlin | 13597 | Germany |
| Rostock | 18057 | Germany |
| Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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