ICU/CCU Patients Requiring Blood Glucose Monitoring
Conditions
Keywords
glucose monitoring, OptiScanner
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 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.
Interventions
DEVICEThe OptiScanner
treatment of blood glucose per standard of care
DEVICEYSI 2300 STAT Plus™
Sponsors
OptiScan Biomedical Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Accuracy Endpoint | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Accuracy Endpoint | 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. |
Other
| Measure | Time frame |
|---|---|
| Number of Adverse events | up to 72 hours of subject monitoring |
Countries
United States
Contacts
Primary ContactDana Deyette, RN
Outcome results
None listed