MANAGE Automated Glucose Monitoring

Not Applicable

• Conditions: ICU/CCU Patients Requiring Blood Glucose Monitoring
• Interventions: Device: The OptiScanner; Device: YSI 2300 STAT Plus™

• Registration Number: NCT02211300
• Lead Sponsor: OptiScan Biomedical Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-29
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Signed informed consent by participant or his/her legally authorized representative
• At least 18 years old
• Admitted to the ICU or CCU
• Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by Investigator)
• Requires blood glucose monitoring; and
• A vascular access device that can be dedicated for connection to the OptiScanner is either already in-place, is planned to be placed for another purpose or can, in the opinion of the Investigator be safely placed exclusively for use in this study, and another access device is in place or can be placed for manually drawing samples to be evaluated using the YSI Analyzer. Note that CVCs should not be placed solely for the purposes of conducting this study. Refer to section 1.2.7 for details regarding vascular access devices and guidelines for selection and placement.

Exclusion Criteria

• Pregnant or nursing

• In the Investigator's opinion the subject cannot safely tolerate the amount of saline required to be given to the subject (up to 360 mL per day)

• Hematocrit less than 15% or greater than 60%

• Subjects that require placement of an additional vascular access line will be excluded if they do not have a suitable access site free from any of the following conditions:

  • Peripheral vascular disease
  • History of placement site neuropathy or chronic pain
  • History of placement extremity coagulopathy or clot formation
  • History of vascular surgery on the same extremity as catheter placement

• Any medical condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study, including but not limited to a high risk of complications associated with vascular access; or

• Participation in any other investigational drug or device study in the last 30 days and/or while enrolled in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optiscanner values vs YSI	YSI 2300 STAT Plus™	Matched samples up to 12 times per 24 hour period
Optiscanner values vs YSI	The OptiScanner	Matched samples up to 12 times per 24 hour period

Primary Outcome Measures

Name	Time	Method
Primary Accuracy Endpoint	Accurancy up to 72 hours of monitoring per subject	The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.

Secondary Outcome Measures

Name	Time	Method
Secondary Accuracy Endpoint	Accuracy up to 72 hours of subject monitoring	The "population CV" will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the "population CV" is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.

Trial Locations

Locations (4)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Providence Heart and Vascular Institute; 🇺🇸 Portland, Oregon, United States

Hermann Memorial Hospital; 🇺🇸 Houston, Texas, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States