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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Noninvasive Transcutaneous Glucometer Development

Resource links provided by NLM:


Further study details as provided by InLight Solutions:

Estimated Enrollment: 500
Study Start Date: December 2001
Study Completion Date: December 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Jeff Way, InLight Solutions
ClinicalTrials.gov Identifier: NCT01168076     History of Changes
Other Study ID Numbers: ILS-01-007
Study First Received: July 21, 2010
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014