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Near-Infrared Spectroscopy for Blood Glucose Measurements

This study has been completed.
Sponsor:
Collaborator:
Luminous Medical
Information provided by:
InLight Solutions
ClinicalTrials.gov Identifier:
NCT01168115
First received: July 21, 2010
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

The purpose of this study is to evaluate the performance of a near-infrared transmission measurement in blood samples collected from healthy volunteers. We propose that NIR spectroscopic blood glucose measurements in healthy patients are as accurate as handheld glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood samples spiked with pharmacological interferents to test if the spectroscopic glucose measurement is affected by common medications.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Near-Infrared Spectroscopy for Blood Glucose Measurements

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Further study details as provided by InLight Solutions:

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

Luminous Medical is developing an automated glucose measurement system that addresses the rapidly growing clinical demand for tight glycemic control in the intensive care unit (ICU), operating room (OR), and intermediate care units. The system automatically measures glucose and other analytes by spectroscopically analyzing blood as it passes through a disposable Sensor Set. Our unique optical measurement does not chemically interact with blood, is insensitive to sensor fouling, and, unlike a biosensor, does not require frequent recalibration.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Males and females between the ages of 18 and 65

Criteria

Inclusion Criteria:

  • Males and females between the ages of 18 and 65
  • Healthy
  • Not currently pregnant
  • Hematocrit >38%

Exclusion Criteria:

  • Pregnancy (Self Reported)
  • Females that have given birth 6 weeks prior (self reported)
  • Anemia (hematocrit <38%) Hematocrit is checked via a capillary fingerstick and a blood hematocrit reader.
  • Under the age of 18 or over the age of 65.
  • Diagnosed with Type I or II Diabetes (Self-Reported).
  • Donated blood (>25 mls) in the last 8 weeks
  • Heart rate >100 beats per minute
  • Weigh less than 110 lbs.
  • Currently taking anticoagulants (ex: coumadin)
  • Abnormal blood pressure (diastolic >90)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168115

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: Ries Robinson, InLight
ClinicalTrials.gov Identifier: NCT01168115     History of Changes
Other Study ID Numbers: ILS-07-386
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 23, 2013