Noninvasive Transcutaneous Glucometer Development

This study has been completed.
Sponsor:
Information provided by:
InLight Solutions
ClinicalTrials.gov Identifier:
NCT01168076
First received: July 21, 2010
Last updated: NA
Last verified: February 2008
History: No changes posted

July 21, 2010
July 21, 2010
December 2001
January 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Noninvasive Transcutaneous Glucometer Development
Noninvasive Transcutaneous Glucometer Development

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Those with Type 1 and 2 diabetes

  • Healthy
  • Prediabetic State (IGT)
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168076
ILS-01-007
Not Provided
Jeff Way, InLight Solutions
InLight Solutions
Not Provided
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC
InLight Solutions
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP