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NCT00906490 · ClinicalTrials.gov registry record

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

A clinical trial of Blood Glucose, sponsored by Edwards Lifesciences.

Completed
Registry status
100
Enrollment target
5
Study locations

NCT00906490: Completed study of Blood Glucose, sponsored by Edwards Lifesciences.

NCT00906490 is a study of Blood Glucose that has completed, run by Edwards Lifesciences. The registered enrollment target is 100 participants, above the 37-participant average among 4 other Blood Glucose trials with a reported enrollment target (170% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00906490, a study of Blood Glucose, has completed, sponsored by Edwards Lifesciences.

COMPLETED
Registry status
100 participants
Enrollment target
5
Study locations

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 Studied

Blood Glucose

Interventions

  • DEVICE Intravenous Blood Glucose monitoring system

Study Locations (5)

District of Columbia

  • Washington Hospital Center (WHC) - Washington D.C.

Maryland

  • University of Maryland School of Medicine - Baltimore

Minnesota

  • International Diabetes Center (IDC), Methodist Hospital - Minneapolis

Oregon

  • Providence Heart and Vascular Institute - Portland

Pennsylvania

  • Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2009-06
Est. Completion 2010-05
Edwards Lifesciences

57 total trials

What the finished NCT00906490 record still lists

NCT00906490 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 37-participant average among 4 other Blood Glucose trials with a reported enrollment target (170% higher).

The record links to 1 condition, with Blood Glucose appearing as the primary indexed condition, and to 1 intervention - of which Intravenous Blood Glucose monitoring system is the first listed.

NCT00906490 lists 5 locations in 5 states (District of Columbia, Maryland, Minnesota).

Frequently Asked Questions

What is clinical trial NCT00906490 about?

NCT00906490 is a clinical study titled "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 ...

What is the current status of trial NCT00906490?

This trial is currently completed. The enrollment target is 100 participants. The study started on 2009-06. Estimated completion is 2010-05.

What conditions does trial NCT00906490 study?

This clinical trial studies the following conditions: Blood Glucose.

What interventions are being tested in trial NCT00906490?

The interventions under investigation include: Intravenous Blood Glucose monitoring system (DEVICE).

Who is sponsoring clinical trial NCT00906490?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00906490 being conducted?

This trial has 5 study locations across District of Columbia, Maryland, Minnesota, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00906490, the US trial registry maintained by the National Library of Medicine. NCT00906490 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.