Noninvasive Transcutaneous Glucometer Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168076
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Information provided by:
InLight Solutions

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01168076

United States, New Mexico
InLight Solutions
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC

Responsible Party: Jeff Way, InLight Solutions 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