MANAGE Automated Glucose Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE

Conditions
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ICU/CCU Patients Requiring Blood Glucose Monitoring

Intervention / Treatment
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* Device: The OptiScanner
* Device: YSI 2300 STAT Plus™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optiscanner values vs YSI<br>Matched samples up to 12 times per 24 hour period | Device: The OptiScanner<br>* treatment of blood glucose per standard of care<br>* Other names: Yellow Springs Instrument;Device: YSI 2300 STAT Plus™<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Accuracy Endpoint | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose monitoring, OptiScanner