Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

December 6, 2012 updated by: VeraLight, Inc.

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

Study Overview

Status

Unknown

Conditions

Detailed Description

The objectives of this study are

  • collect subject data on a near-infrared spectroscopy-based glucose meter
  • evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
  • collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92108
        • Recruiting
        • Accelovance Inc.
        • Principal Investigator:
          • Amber Brassfield, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females 18-50 years of age selected from the community 30% with no history of Diabetes 70% with diagnosis of Type I, Type II or Gestational Diabetes

Description

Inclusion Criteria:

  • Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
  • Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.

Exclusion Criteria:

  • Severe heart disease as evidenced by peripheral edema (self reported)
  • Currently taking Lasix (self reported)
  • Liver disease as evidenced by jaundice (self reported)
  • Receiving dialysis or having known renal compromise (self reported)
  • Skin damage at optical sampling site
  • Scars, tattoos, rashes or other disruption/discoloration on the right index finger
  • Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
  • Current chemotherapy, or chemotherapy within the past 12 months (self reported)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continuing validation of near infrared spectroscopy-based glucose meter algorithm
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VeraLight, Inc.

Collaborators

InLight Solutions

Investigators

  • Principal Investigator: Amber Brassfield, RN, Accelovance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (ESTIMATE)

December 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VL-240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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