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Noninvasive Transcutaneous Glucometer Development

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ClinicalTrials.gov Identifier: NCT01168076
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
InLight Solutions

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

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

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Noninvasive Transcutaneous Glucometer Development
Study Start Date : December 2001
Actual Primary Completion Date : January 2008
Actual Study Completion Date : December 2008

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Those with Type 1 and 2 diabetes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168076


Locations
United States, New Mexico
InLight Solutions
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
Investigators
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jeff Way, InLight Solutions
ClinicalTrials.gov Identifier: NCT01168076     History of Changes
Other Study ID Numbers: ILS-01-007
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: February 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases