Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings

NCT01168089 | Completed

• 1 other identifier: ILS-06-078
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Luminous Medical, the Sponsor is developing a glucose monitor for the critical care setting. The Sponsor's ultimate goal is to provide a near-continuous blood glucose monitor that automatically measures glucose. In this study, Luminous will evaluate the performance of the near-infrared measurement in blood samples collected from patients in the intensive care unit setting.

Conditions

Critical Care

Eligibility Criteria

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

Study Population

i. Sample size is to include up to 50 subjects ii. Group will include nondiabetics as well as people with Type I and Type II diabetes. iii. Group will nominally be half male, half female. iv. Subjects must be 18 years or older to participate.

You may qualify if:

• i. 18 years of age or older ii. Bodyweight greater than 100 lbs iii. Hematocrit \> 28% iv. Must not be pregnant v. Must have a pre-existing blood access line

You may not qualify if:

• i. Rare blood type or antibodies identified ii. Minor status (less than 18 yrs of age) iii. Bodyweight \< 100 lbs (45.45 kg) iv. Hematocrit \< 28%
• \. Blood samples will not be collected for study purposes if a patient's hematocrit drops below 28%.
• v. Limited autonomy vi. Enrollment in other studies requiring large volume blood sampling vii. Pregnancy viii. Jehovah's witness ix. Unavailability of an existing arterial or venous access line was placed for the scheduled procedure in the volunteer. An access line will not be placed for the sole purpose of this study.

Sponsors & Collaborators

• InLight Solutions: lead
• Luminous Medical: collaborator

Study Sites (1)

InLight Solutions

Albuquerque, New Mexico, 87106, United States

Location

Related Links

• Related Info
• Related Info

Study Officials

• Mark Rohrscheib, M.D.

  UNMHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 22, 2010

Record last verified: 2008-02

Locations

US (1)