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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
| Medical Device Consultants, Inc. | INDUSTRY |
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The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter systems are currently used in the hospital environment to measure blood glucose values. The YSI is an accepted reference standard for assessing POC meter accuracy.
The secondary objective of this study is to evaluate the performance of the IVBG System as compared with the YSI under various conditions in the operating room (OR), intensive care unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU.
Subjects will have their glucose values collected from the IVBG System and compared with paired plasma glucose measurements obtained using theYSI with comparative blood samples collected from a CVC, an arterial line or a peripheral vein.
POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Blood Glucose monitoring system | Device | Insertion of blood glucose monitoring sensor into peripheral vascular IV line. |
| Measure | Description | Time Frame |
|---|---|---|
| A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197. | During 72 hours of anticipated Sensor dwell time |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Device against YSI (Blood Glucose Analyser) | During 72 hours of anticipated Sensor dwell time |
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Inclusion Criteria:
Exclusion Criteria:
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Acute care facility patient with a minimum of 24 hour ICU stay.
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| Name | Affiliation | Role |
|---|---|---|
| Grand Bochicchio, MD | University of Maryland Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center (WHC) | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of Maryland School of Medicine |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| International Diabetes Center (IDC), Methodist Hospital | Minneapolis | Minnesota | 55416 | United States |
| Providence Heart and Vascular Institute | Portland | Oregon | 97225 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |