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Near Infrared Spectroscopy for Blood Glucose Measurement in Critical Care Settings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168089
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Luminous Medical
Information provided by:
InLight Solutions
  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:


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

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.

  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Jeff Way, InLight Solutions
ClinicalTrials.gov Identifier: NCT01168089     History of Changes
Other Study ID Numbers: ILS-06-078
First Submitted: July 21, 2010
First Posted: July 22, 2010
Last Update Posted: July 22, 2010
Last Verified: February 2008