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Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

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ClinicalTrials.gov Identifier: NCT01745900
Recruitment Status : Unknown
Verified December 2012 by VeraLight, Inc..
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Sponsor:
Collaborator:
InLight Solutions
Information provided by (Responsible Party):
VeraLight, Inc.

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

Condition or disease
Insulin Dependent Diabetes Non Insulin Dependent Diabetes Gestational Diabetes

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
Estimated Enrollment : 125 participants
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
Study Start Date : December 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources




Primary Outcome Measures :
  1. Continuing validation of near infrared spectroscopy-based glucose meter algorithm [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Amber Brassfield, RN Accelovance

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01745900     History of Changes
Other Study ID Numbers: VL-240
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

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

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