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GlucoClearTM System ICU Study

NCT02094859 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2014-03-24

No results posted yet for this study

Summary

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).

Conditions

  • Accurate Blood Glucose Monitoring in Critical Care Setting

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • 95 bis boulevard Pereire

    collaborator UNKNOWN

  • 75017 Paris - France

    collaborator UNKNOWN

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Luc Foubert, MD, PhD · Onze-Lieve-Vrouwziekenhuis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Austria
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094859 on ClinicalTrials.gov