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Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

This study is currently recruiting participants.
Verified December 2012 by VeraLight, Inc.
Sponsor:
Collaborator:
Inlight Solutions Inc.
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01745900
First received: December 4, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition
Insulin Dependent Diabetes
Non Insulin Dependent Diabetes
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Continuing validation of near infrared spectroscopy-based glucose meter algorithm [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745900

Contacts
Contact: Amber Brassfield, RN 619-291-2845
Contact: Amber Brassfield, RN 619-366-1129

Locations
United States, California
Accelovance Inc. Recruiting
San Diego, California, United States, 92108
Principal Investigator: Amber Brassfield, RN            
Sponsors and Collaborators
VeraLight, Inc.
Inlight Solutions Inc.
Investigators
Principal Investigator: Amber Brassfield, RN Accelovance Inc.
  More Information

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01745900     History of Changes
Other Study ID Numbers: VL-240
Study First Received: December 4, 2012
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VeraLight, Inc.:
Diabetes
Gestational Diabetes
Female

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

ClinicalTrials.gov processed this record on June 18, 2013