Accurate Blood Glucose Monitoring in Critical Care Setting Clinical Trial
Official title:
GlucoClearTM System ICU Study
Verified date | March 2014 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Graz | Graz | |
Belgium | Onze-Lieve-Vrouwziekenhuis | Aalst |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences | 75017 Paris - France, 95 bis boulevard Pereire, MedPass International |
Austria, Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |