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

Blood Glucose Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906490
• Other study ID #: 2008-11
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: August 16, 2013
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2013
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Device:
• Intravenous Blood Glucose monitoring system
Insertion of blood glucose monitoring sensor into peripheral vascular IV line.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	International Diabetes Center (IDC), Methodist Hospital	Minneapolis	Minnesota
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Washington Hospital Center (WHC)	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Edwards Lifesciences	DexCom, Inc., Medical Device Consultants, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Accuracy of Device against YSI (Blood Glucose Analyser)		During 72 hours of anticipated Sensor dwell time	No