NCT01168115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
Last Updated

July 22, 2010

Status Verified

January 1, 2008

Enrollment Period

11 months

First QC Date

July 21, 2010

Last Update Submit

July 21, 2010

Conditions

Healthy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males and females between the ages of 18 and 65

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InLight Solutions

Albuquerque, New Mexico, 87106, United States

Location

Related Links

Study Officials

  • Mark Rohrscheib, M.D.

    UNMHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 22, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 22, 2010

Record last verified: 2008-01

Locations

US(1)