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临床试验/NCT01168115
NCT01168115已完成不适用

Near-Infrared Spectroscopy for Blood Glucose Measurements

InLight Solutions1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究者

发起方
InLight Solutions
申办方类型
Industry

研究点 (1)

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