Accurate Blood Glucose Monitoring in Critical Care Setting
Conditions
Keywords
Glucose Monitoring
Brief 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).
Detailed description
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.
Interventions
None listed
Sponsors
MedPass International
95 bis boulevard Pereire
75017 Paris - France
Edwards Lifesciences
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 15/20% Performance | During 72 hours of anticipated Sensor dwell time | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12/12.5% Performance | During 72 hours of anticipated Sensor dwell time | 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. |
Countries
Austria, Belgium
Outcome results
None listed