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| Name | Class |
|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | OTHER |
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The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnitest 3 | Experimental | Blood glucose monitoring system |
|
| Omnitest 5 | Experimental | Blood glucose monitoring system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood glucose monitoring system (Omnitest 3) | Device |
| ||
| Blood glucose monitoring system (Omnitest 5) |
| Measure | Description | Time Frame |
|---|---|---|
| System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment | up to 7 hours | |
| User Performance of blood glucose monitoring system indicated by patient | up to 7 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | Germany |
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| Device |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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