Status:
COMPLETED
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
Lead Sponsor:
Edwards Lifesciences
Collaborating Sponsors:
DexCom, Inc.
Medical Device Consultants, Inc.
Conditions:
Blood Glucose
Eligibility:
All Genders
18+ years
Brief 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 compa...
Detailed 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, a...
Eligibility Criteria
Inclusion
- ICU ≥ 24 hours
- sign ICF
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00906490
Start Date
June 1 2009
End Date
May 1 2010
Last Update
August 20 2013
Active Locations (5)
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1
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, United States, 20010
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
3
International Diabetes Center (IDC), Methodist Hospital
Minneapolis, Minnesota, United States, 55416
4
Providence Heart and Vascular Institute
Portland, Oregon, United States, 97225