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Discontinued program
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The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.
Design: Non-randomized, non-treatment, prospective, open label Study.
The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System.
After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours.
Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period.
After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlucoClear System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucoClear System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 15/20% Accuracy | 15/20% Accuracy: The proportion of GlucoClear glucose measurements 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 12/15% Trend Accuracy | 12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is < 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL). | During 72 hours of anticipated Sensor dwell time. |
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Inclusion Criteria:
Exclusion Criteria:
Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study
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Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit stay of at least 24 hours.
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