Recruiting

Automated Glucose Monitoring

Sponsor:

OptiScan Biomedical Corporation

Code:

NCT02211300

Conditions

ICU/CCU Patients Requiring Blood Glucose Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The OptiScanner

YSI 2300 STAT Plus™

Study Details

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.

Conditions

ICU/CCU Patients Requiring Blood Glucose Monitoring

Study ID

NCT02211300

Start date

Apr, 2014

Status verified date

Jun, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

230 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Optiscanner values vs YSI

Matched samples up to 12 times per 24 hour period

Interventions

The OptiScanner

treatment of blood glucose per standard of care

YSI 2300 STAT Plus™

Primary outcome measure

  • Primary Accuracy Endpoint [ Time Frame: Accurancy up to 72 hours of monitoring per subject ]

Central Contacts and Locations

Central contacts

Dana Deyette, RN

510-342-5836ddeyette@optiscancorp.com

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Robert Carpenter

210-632-8883rcarpenter1@tuftsmedicalcenter.org

Principal Investigator:

Stanley Nasraway, MD

Washington University School of Medicine

Recruiting

St. Louis, Missouri, United States, 63108

Contacts

Stacey Reese, MS, RN

reeses@wudosis.wustl.edu

Principal Investigator:

Grant Bochicchio, MD

Providence Heart and Vascular Institute

Recruiting

Portland, Oregon, United States, 64111

Contacts

Heather Aiona, CCRC

503-216-8770Heather.M.Aiona@providence.org

Principal Investigator:

Anthony Furnary, MD

Hermann Memorial Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Carrie Howard, CCRC

713-500-5461Carrie.L.Howard@uth.tmc.edu

Principal Investigator:

Laura Moore, MD

More Information

Sponsor

OptiScan Biomedical Corporation

Last update posted

Jun 29, 2015

Last verified

Jun, 2015

Keywords

  • glucose monitoring
  • OptiScanner

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OptiScan Biomedical Corporation on 2015-06-29.