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

This study has been completed.
Sponsor:
Collaborators:
DexCom, Inc.
Medical Device Consultants, Inc.
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00906490
First received: May 20, 2009
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Blood Glucose
Device: Intravenous Blood Glucose monitoring system

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Accuracy of Device against YSI (Blood Glucose Analyser) [ Time Frame: During 72 hours of anticipated Sensor dwell time ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intravenous Blood Glucose monitoring system
    Insertion of blood glucose monitoring sensor into peripheral vascular IV line.
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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute care facility patient with a minimum of 24 hour ICU stay.

Criteria

Inclusion Criteria:

  • ICU ≥ 24 hours
  • sign ICF

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906490

Locations
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
Sponsors and Collaborators
Edwards Lifesciences
DexCom, Inc.
Medical Device Consultants, Inc.
Investigators
Principal Investigator: Grand Bochicchio, MD University of Maryland Medical School
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00906490     History of Changes
Other Study ID Numbers: 2008-11
Study First Received: May 20, 2009
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Edwards Lifesciences:
Glucose Monitoring
Accurate Blood Glucose Monitoring in critical care setting

ClinicalTrials.gov processed this record on April 23, 2014