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Near-Infrared Spectroscopy for Blood Glucose Measurements

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ClinicalTrials.gov Identifier: NCT01168115
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:
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 or disease
Healthy

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Near-Infrared Spectroscopy for Blood Glucose Measurements
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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)

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): 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

Responsible Party: Ries Robinson, InLight
ClinicalTrials.gov Identifier: NCT01168115     History of Changes
Other Study ID Numbers: ILS-07-386
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: January 2008