Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients|
- 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. [ Time Frame: During 72 hours of anticipated Sensor dwell time ] [ Designated as safety issue: No ]
- Accuracy of Device against YSI (Blood Glucose Analyser) [ Time Frame: During 72 hours of anticipated Sensor dwell time ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Device: Intravenous Blood Glucose monitoring system
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.
- Blood samples collected per time point: approximately 2ml for waste and1mL for glucose measurement. In the event that a closed blood drawing system is utilized, the waste would be reduced or eliminated.
- The comparative blood samples will be drawn manually at a maximum frequency of once every four hours.
- Sample draws not to exceed 23 per subject for the duration of the study. This includes 18 comparative blood samples and 5 calibration samples to be draw as needed (e.g. recalibration). Including the partial thromboplastin time (PTT) draws described in section 3.1.2, there would be approximately 100 mL or 6.8 tablespoons drawn per subject. In the case where a closed blood drawing system is used consistently, this would be approximately 50 mL or 3.4 tablespoons per subject.
POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.
|United States, District of Columbia|
|Washington Hospital Center (WHC)|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|United States, Minnesota|
|International Diabetes Center (IDC), Methodist Hospital|
|Minneapolis, Minnesota, United States, 55416|
|United States, Oregon|
|Providence Heart and Vascular Institute|
|Portland, Oregon, United States, 97225|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Grand Bochicchio, MD||University of Maryland Medical School|