Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2

The purpose of the study is to evaluate the utility of a novel approach to non-invasive glucose sensing. The testing for each patient includes fingerstick and alternate site capillary blood measurements taken nearly simultaneously with a series of near-infrared spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral data are converted to a prediction of tissue glucose using a proprietary pre-defined universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up to 6 visits per patient over a period of up to 4 months.

Inclusion criteria

• Are between the ages of 12-75 years
• Have been diagnosed with type 1 diabetes mellitus
• Use insulin to treat your diabetes
• Agree and are able to follow the study plans as described in this informed consent form.

Exclusion criteria

• Are a pregnant woman or nursing mother
• Have skin conditions that could cause a problem wearing a glucose sensor on your abdomen (stomach area) and/or having spectral data measured from your forearm with the non-invasive device.
• Are currently taking part in another clinical study
• Have taken part in this study before
• Have experienced severe hypoglycemia (an episode of low blood sugar that you were unable to treat yourself - e.g., seizure, coma, unconsciousness) any time within the past six months
• Have any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent you from completing the study