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Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings

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ClinicalTrials.gov Identifier: NCT01168089
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Collaborator:
Luminous Medical
Information provided by:
InLight Solutions

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.

Condition or disease
Critical Care

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings
Study Start Date : April 2008
Primary Completion Date : April 2008
Study Completion Date : April 2008

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jeff Way, InLight Solutions
ClinicalTrials.gov Identifier: NCT01168089     History of Changes
Other Study ID Numbers: ILS-06-078
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: February 2008