Near-Infrared Spectroscopy for Blood Glucose Measurements
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females between the ages of 18 and 65
- •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
- •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)