Accurate Blood Glucose Monitoring in Critical Care Setting Clinical Trial
Official title:
GlucoClearTM System ICU Study
The primary purpose of this Study is evaluation of the safety and performance of the
GlucoClear System (System).
The primary safety objective will be assessed by:
• Evaluation of any serious adverse device effects upon Sensor insertion through Sensor
removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.
The primary performance objective will be evaluated using the following criteria:
15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197
15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator
values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).
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.
;
Time Perspective: Prospective