Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

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

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.

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)