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This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject POCT glucometer measurement | Experimental | Blood glucose measurement POCT glucometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood glucose measurement: POCT | Diagnostic Test | measurement of blood glucose concentration using 5 different POCT glucometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197 | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eckhard Salzsieder, PhD | Institut fur Diabetes Karlsburg GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes Karlsburg GmbH | Karlsburg | Mecklenburg-Vorpommern | 17495 | Germany |
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| Label | URL |
|---|---|
| Blood sugar | View source |
| ISO 15197 | View source |
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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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| blood glucose measurement: reference | Diagnostic Test | measurement of blood glucose concentration using 2 different laboratory analyzer |
|