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This study assesses the system accuracy and performance evaluation by the user of a blood glucose monitoring system pursuant to ISO 15197
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject glucometer measurement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucometer Test | Diagnostic Test | blood glucose measurement using finger tip capillary blood using BGM and reference method |
|
| 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 in accordance with DIN EN ISO 15197, section 6.3 | Day 1 |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor in accordance with DIN EN ISO 15197, section 8 | 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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| 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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