MANAGE Automated Glucose Monitoring

NCT02211300 | Unknown DMC

• 1 other identifier: 2002055
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 4

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

Keywords

glucose monitoring; OptiScanner

Outcome Measures

Primary Outcomes (1)

• Primary Accuracy Endpoint

  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%.

  Accurancy up to 72 hours of monitoring per subject

Secondary Outcomes (1)

• Secondary Accuracy Endpoint

  Accuracy up to 72 hours of subject monitoring

Other Outcomes (1)

• Number of Adverse events

  up to 72 hours of subject monitoring

Study Arms (1)

Optiscanner values vs YSI

EXPERIMENTAL

Matched samples up to 12 times per 24 hour period

Device: The OptiScanner; Device: YSI 2300 STAT Plus™

Interventions

The OptiScanner DEVICE

treatment of blood glucose per standard of care

Also known as: OptiScanner, Yellow Springs Instrument

Optiscanner values vs YSI

YSI 2300 STAT Plus™ DEVICE

Optiscanner values vs YSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• OptiScan Biomedical Corporation: lead

Study Sites (4)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

Providence Heart and Vascular Institute

Portland, Oregon, 64111, United States

RECRUITING

Hermann Memorial Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Nohra E, Buckman S, Bochicchio K, Chamieh J, Reese S, Merrill C, Schuerer D, Bochicchio GV. Results of a near continuous glucose monitoring technology in surgical intensive care and trauma. Contemp Clin Trials. 2016 Sep;50:1-4. doi: 10.1016/j.cct.2016.07.007. Epub 2016 Jul 6.

  PMID: 27394384 DERIVED

Study Officials

• Grant V Bochicchio, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Stanley A Nasraway, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Anthony Furnary, MD

  Providence St. Vincents Medical Center

  PRINCIPAL INVESTIGATOR

• Linda Moore, MD

  Hermann Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Deyette, RN

CONTACT

510-342-5836; ddeyette@optiscancorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: August 7, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

US (4)