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Noninvasive Transcutaneous Glucometer Development

NCT ID: NCT01168076

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-12-31

Study Completion Date

2008-12-31

Brief Summary

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The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.

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Detailed Description

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The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.

Conditions

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Healthy Prediabetic State (IGT) Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Healthy
* Type I diabetics
* Type II diabetics
* Impaired glucose tolerance

Exclusion Criteria

* Minor status (\<18 years of age)
* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InLight Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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InLight Solutions

Principal Investigators

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Mark Rohrscheib, M.D.

Role: PRINCIPAL_INVESTIGATOR

UNMHSC

Locations

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InLight Solutions

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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http://www.inlightsolutions.com

Related Info

Other Identifiers

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ILS-01-007

Identifier Type: -

Identifier Source: org_study_id

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