Status:
UNKNOWN
MANAGE Automated Glucose Monitoring
Lead Sponsor:
OptiScan Biomedical Corporation
Conditions:
ICU/CCU Patients Requiring Blood Glucose Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 glu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02211300
Start Date
April 1 2014
End Date
December 1 2015
Last Update
June 29 2015
Active Locations (4)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Washington University School of Medicine
St Louis, Missouri, United States, 63108
3
Providence Heart and Vascular Institute
Portland, Oregon, United States, 64111
4
Hermann Memorial Hospital
Houston, Texas, United States, 77030