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Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Glucose Monitoring System. | Device | In vitro diagnostic medical device |
|
| Measure | Description | Time Frame |
|---|---|---|
| User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument. | UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional) | Up to 1 hour |
| System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument. | Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only. | Up to 1 hour |
| System Use Evaluation - HCP ( HealthCare Professional) questionnaire | Assessing use of BGMS and supporting material by subject. | Up to 1 hour |
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Summary of Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna Stewart | LifeScan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioKinetic Europe Ltd | Belfast | Antrim | BT2 7BA | United Kingdom |
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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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