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Accurate Blood Glucose Monitoring in Critical Care Setting clinical trials

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NCT ID: NCT02094859 Completed - Clinical trials for Accurate Blood Glucose Monitoring in Critical Care Setting

GlucoClearTM System ICU Study

Start date: April 2013
Phase: N/A
Study type: Observational

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).