Clinical Study of the Intravenous Blood Glucose System in Hospitalized

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Blood Glucose

Clinical Trial Details

NCT number	NCT00906490
Study type	Observational
Source	Edwards Lifesciences
Contact
Status	Completed
Phase	N/A
Start date	June 2009
Completion date	May 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms