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

NCT00906490 | Completed

• 1 other identifier: 2008-11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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 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

Keywords

Glucose Monitoring; Accurate Blood Glucose Monitoring in critical care setting

Outcome Measures

Primary Outcomes (1)

• 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.

  During 72 hours of anticipated Sensor dwell time

Secondary Outcomes (1)

• Accuracy of Device against YSI (Blood Glucose Analyser)

  During 72 hours of anticipated Sensor dwell time

Interventions

Intravenous Blood Glucose monitoring system DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Edwards Lifesciences: lead
• DexCom, Inc.: collaborator
• Medical Device Consultants, Inc.: collaborator

Study Sites (5)

Washington Hospital Center (WHC)

Washington D.C., District of Columbia, 20010, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

International Diabetes Center (IDC), Methodist Hospital

Minneapolis, Minnesota, 55416, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Grand Bochicchio, MD

  University of Maryland Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

US (5)