Glucose Time-In-Range Development Evaluation

Hyperglycemia, hypoglycemia and glycemic variability are independently associated with
morbidity and mortality of critically ill patients. Blood glucose control with insulin has
the potential to decrease morbidity and mortality of intensive care unit (ICU) patients.
Blood glucose control with insulin, however, is associated with an increased risk of
hypoglycemia and may not decrease glycemic variability. In addition, blood glucose control
with insulin utilizing manual systems for glucose measurement is blood-consuming and
time-consuming, since frequent blood draws for glucose measurements are necessary in order to
achieve blood glucose control.

Automated, frequent, plasma-based glucose monitoring with the OptiScanner 5000 glucose
monitoring system has the potential to improve a patient's glucose TIR by improving all 3
domains of glycemic control: reducing hyperglycemia while at the same time preventing
hypoglycemia and reducing glycemic variability. Second, it could reduce the workloads
associated with the high number of blood samples to be obtained and analyzed.

The primary objective of this study is to observe the Time-in-Range for patients whose
glycemic control is being monitored with the OptiScanner system. A secondary objective is
assessment of the time it takes the patient to achieve in range glucose values while
connected to the OptiScanner. The study will evaluate patients requiring frequent glucose
monitoring in a Surgical ICU.

The study population includes surgical critical care patients who require blood glucose
monitoring. Subjects must have a vascular access device [i.e., Central Venous Catheters
(CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected
usage of at least 48 hours. During Phase One of the trial, patients will be connected to the
OptiScanner for up to 72 hours and the hospital's current standard of care for glucose
management will be followed. Currently glucose values are measured using point of care
glucose meters and/or by collecting a blood sample and sending it to the hospital laboratory.
Patients' glucose values are currently monitored depending on their clinical condition with
the frequency of glucose measurement typically occurring every one to four hours. Patients
enrolled in this study will still be monitored in this same manner, depending on their
clinical condition (using point of care meters and/or blood collection for the lab). The
additional continuous monitoring provided by the OptiScanner may introduce additional glucose
measurements. The clinical care team will be advised to confirm any OptiScanner glucose value
(using routine clinical care methods) before making any modifications to the patient's
clinical care based on the OptiScanner result (i.e. increase, decrease, stop insulin drip,
etc.). A research team member will be at the bedside during the patients' connection to the
OptiScanner to ensure that the clinical team does not use the OptiScanner results to direct
patient care and to observe the overall clinical care glucose management of the patient.
Clinical data will be captured on the participants.

Inclusion Criteria

1. Signed informed consent by the participant or his/her legally authorized
representative;

2. At least 18 years old;

3. Admitted to a Surgical Intensive Care Unit (SICU) or planned admission to a Surgical
ICU at time of screening

4. Expected SICU stay of at least 48 hours at the time of enrollment

5. A vascular access device available for connection to the OptiScanner is either already
in-place, or is planned to be placed with an expected usage of at least 48 hours.

Exclusion Criteria

1. Positive Human chorionic gonadotropin (HcG) (serum or urine ) in women of childbearing
potential (age < 60) who are not known to be surgically sterile and those that are
obviously pregnant.

2. Patients undergoing peritoneal dialysis within the past week.

3. Patients actively receiving intravenous immunoglobulin therapy.

4. Patients receiving intravenous administration of high dose ascorbate (IVC) for the
treatment of patients with cancer.

5. Patients following the administration of a D-Xylose absorption test < 12 hours

6. Patients being treated with Sodium Thiosulfate

7. Patients being receiving IV glycerol

8. Patients receiving substances containing maltose, or substances that can be
metabolized into maltose. These substances include Extraneal, Gamimune N, HepaGam B,
Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid.

9. Hct <15% within 24 hours of screening visit