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This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject glucometer measurement | Experimental | Blood glucose measurement BGM for personal use |
|
| glucometer measurement | Experimental | evaluation of repeatability measurement precision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood glucose measuremen subject | Diagnostic Test | measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197 | 1 Day |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerstin Rebrin, 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 |
optional: age, blood glucose levels and hematocrit of subjects
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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 measuremen reference | Diagnostic Test | measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood |
|