MANAGE Automated Glucose Monitoring (MANAGE IDE)

June 25, 2015 updated by: OptiScan Biomedical Corporation

MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Stanley Nasraway, MD
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Grant Bochicchio, MD
    • Oregon
      • Portland, Oregon, United States, 64111
        • Recruiting
        • Providence Heart and Vascular Institute
        • Contact:
        • Principal Investigator:
          • Anthony Furnary, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Hermann Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Laura Moore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent by participant or his/her legally authorized representative
  • At least 18 years old
  • Admitted to the ICU or CCU
  • Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by Investigator)
  • Requires blood glucose monitoring; and
  • A vascular access device that can be dedicated for connection to the OptiScanner is either already in-place, is planned to be placed for another purpose or can, in the opinion of the Investigator be safely placed exclusively for use in this study, and another access device is in place or can be placed for manually drawing samples to be evaluated using the YSI Analyzer. Note that CVCs should not be placed solely for the purposes of conducting this study. Refer to section 1.2.7 for details regarding vascular access devices and guidelines for selection and placement.

Exclusion Criteria:

  • Pregnant or nursing
  • In the Investigator's opinion the subject cannot safely tolerate the amount of saline required to be given to the subject (up to 360 mL per day)
  • Hematocrit less than 15% or greater than 60%

  • Subjects that require placement of an additional vascular access line will be excluded if they do not have a suitable access site free from any of the following conditions:

    • Peripheral vascular disease
    • History of placement site neuropathy or chronic pain
    • History of placement extremity coagulopathy or clot formation
    • History of vascular surgery on the same extremity as catheter placement
  • Any medical condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study, including but not limited to a high risk of complications associated with vascular access; or
  • Participation in any other investigational drug or device study in the last 30 days and/or while enrolled in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optiscanner values vs YSI
Matched samples up to 12 times per 24 hour period
Device: The OptiScanner
treatment of blood glucose per standard of care
Other Names:
  • OptiScanner
  • Yellow Springs Instrument
Device: YSI 2300 STAT Plus™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Accuracy Endpoint
Time Frame: Accurancy up to 72 hours of monitoring per subject
The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.
Accurancy up to 72 hours of monitoring per subject

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Accuracy Endpoint
Time Frame: Accuracy up to 72 hours of subject monitoring
The "population CV" will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the "population CV" is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.
Accuracy up to 72 hours of subject monitoring

Other Outcome Measures

Outcome Measure
Time Frame
Number of Adverse events
Time Frame: up to 72 hours of subject monitoring
up to 72 hours of subject monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OptiScan Biomedical Corporation

Investigators

  • Principal Investigator: Grant V Bochicchio, MD, MPH, Washington University School of Medicine
  • Principal Investigator: Stanley A Nasraway, MD, Tufts Medical Center
  • Principal Investigator: Anthony Furnary, MD, Providence St. Vincents Medical Center
  • Principal Investigator: Linda Moore, MD, Hermann Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2002055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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