GlucoClearTM System ICU Study

Design: Non-randomized, non-treatment, prospective, open label Study.

After providing written informed consent, subjects meeting Inclusion/Exclusion Criteria will be connected to the System for a maximum of 72 hours.

For the purposes of this clinical Study, the System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study Subjects or the Study Site Personnel. There will be no treatment of any Subject based on the output of the System. Diabetes management decisions throughout this Study (if applicable) will be conducted according to hospital procedures.

• 1 set of laboratory measurements will be drawn per Subject for baseline.
• A maximum of 82 blood samples will be drawn per Subject during the 72 hour monitoring session including.

• Up to 75 blood samples drawn for comparative glucose measurement on laboratory analyzers. Blood samples will be taken from the sampling catheter in the peripheral vein in the contralateral extremity (relative to placement of the System) with no more than 25 samples taken within one day (00:00 to 23:59) for glucose measurement on laboratory analyzers (e.g., Yellow Springs Instrument glucose analyzer (YSI), Radiometer blood analyzer);
• Up to three (3) sets of laboratory measurements; and
• Up to 4 other blood samples, as needed. One week (7 + 3 days) after Sensor removal, subjects will be contacted for a follow-up assessment and document any subsequent adverse events.

Inclusion criteria

• ≥ 18 years
• ICU ≥ 24 hours
• Signed consent

Exclusion criteria

• Transplant patient
• Brain injury/surgery patient
• End stage medical conditions or diseases
• Restricted venous access
• History of HIT
• Contraindication for anti-coagulation or bleeding disorder
• Positive pregnancy test
• In other drug, device, or biologic study