GlucoClearTM System ICU Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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GlucoClearTM System ICU Study

Conditions
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Accurate Blood Glucose Monitoring in Critical Care Setting

Participation Criteria
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Eligibility Criteria
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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

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GlucoClear System<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15/20% Performance | 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). | During 72 hours of anticipated Sensor dwell time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12/12.5% Performance | 12/12.5% Performance: Propor-tion of matched pairs meeting within ± 12 mg/dL for Compara-tor values ≤ 100 mg/dL and within ± 12.5% for Comparator values > 100 mg/dL. | During 72 hours of anticipated Sensor dwell time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose Monitoring