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

NCT00906490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-08-20

No results posted yet for this study

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.

Conditions

  • Blood Glucose

Interventions

DEVICE

Intravenous Blood Glucose monitoring system

Insertion of blood glucose monitoring sensor into peripheral vascular IV line.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Medical Device Consultants, Inc.

    collaborator INDUSTRY

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Grand Bochicchio, MD · University of Maryland Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906490 on ClinicalTrials.gov