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To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Navigator Continuous Glucose Monitoring System | Device | Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study. |
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Exclusion Criteria:
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Subjects recruited from clinical research centers which specialize in diabetes-related therapies.
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| Name | Affiliation | Role |
|---|---|---|
| Joe Bugler | Abbott Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Diabetes & Glandular Disease Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17337488 | Result | Weinstein RL, Schwartz SL, Brazg RL, Bugler JR, Peyser TA, McGarraugh GV. Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements. Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2. | |
| 19216686 | Result |
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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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|
| San Antonio |
| Texas |
| 78229 |
| United States |
| Ranier Clinical Research | Renton | Washington | 98055 | United States |
| McGarraugh G, Bergenstal R. Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System. Diabetes Technol Ther. 2009 Mar;11(3):145-50. doi: 10.1089/dia.2008.0047. |