Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
Completed
Conditions studied: Blood Glucose
In brief
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.
Key facts
- Study ID
- NCT00906490
- Run by
- Edwards Lifesciences
- People needed
- 100
- Starts
- 2009-06-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2013-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ICU ≥ 24 hours
- sign ICF
You may not qualify if…
- transplant Pt
- brain injury/surgery
- DKA
- end stage disease
- restricted venous access
- hx of HITT
- contraindication for anti-coagulation Tx
- positive pregnancy test
- in other drug, device, or biologic study
Where it is running
- Washington Hospital Center (WHC) — Washington D.C., District of Columbia, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- International Diabetes Center (IDC), Methodist Hospital — Minneapolis, Minnesota, United States
- Providence Heart and Vascular Institute — Portland, Oregon, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.