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| ID | Type | Description | Link |
|---|---|---|---|
| IDT-1340-BE | Other Identifier | Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm |
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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 test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnitest 3 | Active Comparator | Blood glucose monitoring system |
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| Omnitest 5 | Experimental | Blood glucose monitoring system |
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| Omnitest 5D | Experimental | Blood glucose monitoring system |
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| 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 6 hours | |
| User performance of blood glucose monitoring systems indicated by patient [questionnaire] | up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Jendrike, Dr. med. | Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft | Ulm | 89081 | Germany |
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| Device |
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| Blood glucose monitoring system (Omnitest 5D) | Device |
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| 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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