Near-Infrared Spectroscopy for Blood Glucose Measurements

Completed

• Conditions: Healthy

• Registration Number: NCT01168115
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2008-01
• Study Start: 2008-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Last Update Submitted: 2010-07-21
• Study First Posted: 2010-07-22
• Last Update Posted: 2010-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

InLight Solutions; 🇺🇸 Albuquerque, New Mexico, United States