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Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings

This study has been completed.
Sponsor:
Collaborator:
Luminous Medical
Information provided by:
InLight Solutions
ClinicalTrials.gov Identifier:
NCT01168089
First received: July 21, 2010
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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.


Condition
Critical Care

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InLight Solutions:

Estimated Enrollment: 50
Study Start Date: April 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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%

1. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168089

Locations
United States, New Mexico
InLight Solutions
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
Luminous Medical
Investigators
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jeff Way, InLight Solutions
ClinicalTrials.gov Identifier: NCT01168089     History of Changes
Other Study ID Numbers: ILS-06-078
Study First Received: July 21, 2010
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013