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MANAGE Automated Glucose Monitoring

NCT02211300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2015-06-29

No results posted yet for this study

Summary

The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects.

Accuracy Hypothesis:

The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH).

Safety Hypothesis:

The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.

Conditions

  • ICU/CCU Patients Requiring Blood Glucose Monitoring

Interventions

DEVICE

The OptiScanner

treatment of blood glucose per standard of care

DEVICE

YSI 2300 STAT Plus™

Sponsors & Collaborators

  • OptiScan Biomedical Corporation

    lead INDUSTRY

Principal Investigators

  • Grant V Bochicchio, MD, MPH · Washington University School of Medicine

  • Stanley A Nasraway, MD · Tufts Medical Center

  • Anthony Furnary, MD · Providence St. Vincents Medical Center

  • Linda Moore, MD · Hermann Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02211300 on ClinicalTrials.gov