Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

VeraLight

Status: Unknown

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01745900

VL-240

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)