Trials / Unknown
UnknownNCT02211300
MANAGE Automated Glucose Monitoring
MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- OptiScan Biomedical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects. Accuracy Hypothesis: The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH). Safety Hypothesis: The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The OptiScanner | treatment of blood glucose per standard of care |
| DEVICE | YSI 2300 STAT Plus™ |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-09-01
- Completion
- 2015-12-01
- First posted
- 2014-08-07
- Last updated
- 2015-06-29
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02211300. Inclusion in this directory is not an endorsement.