Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
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: 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 August 01, 2014