Skip to main content
OpenTrials
Completed

NCT Number: NCT00906490

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Glucose

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington Hospital Center (WHC), Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Blood Glucose monitoring system

Device

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

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.

    Time frame: During 72 hours of anticipated Sensor dwell time

Secondary outcomes

  1. Accuracy of Device against YSI (Blood Glucose Analyser)

    Time frame: During 72 hours of anticipated Sensor dwell time

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • DexCom, Inc.
  • Medical Device Consultants, Inc.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 21, 2009
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.