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| Name | Class |
|---|---|
| MAC Clinical Research | OTHER |
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Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.
This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LifeScan BGMSs | Experimental | OneTouch Verio, OneTouch Select Plus and OneTouch Ultra Blood Glucose Monitoring Systems (BGMSs) tested using subject capillary blood and compared to a reference instrument (YSI 2900). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OneTouch Verio | Device | OneTouch Verio Blood Glucose Monitoring System. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). | Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). | Less than 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
> Participants not enrolled in the LifeScan Patient Registry
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC Clinical Research | Manchester | 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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| OneTouch Select Plus |
| Device |
OneTouch Select Plus Blood Glucose Monitoring System. |
|
| OneTouch Ultra | Device | OneTouch Ultra Blood Glucose Monitoring System. |
|