Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

• Conditions: Insulin Dependent Diabetes; Non Insulin Dependent Diabetes; Gestational Diabetes

• Registration Number: NCT01745900
• Lead Sponsor: VeraLight, Inc.

Brief Summary

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

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 Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-06
• Last Update Submitted: 2012-12-06
• Study First Posted: 2012-12-10
• Last Update Posted: 2012-12-10
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continuing validation of near infrared spectroscopy-based glucose meter algorithm	3 months

Trial Locations

Locations (1)

Accelovance Inc.; 🇺🇸 San Diego, California, United States