OrSense’s CE approved non-invasive glucose monitoring technology was tested to establish accurate performance in multiple settings and over a wide range of patient populations. These trials included over 450 patients, accounting for over 130,000 glucose paired readings. OrSense’s devices measured glucose continuously for up to 24 hours. The OrSense system participated in several major studies covering multiple applications. The first study, a hyperinsulinemic, hypoglycemic blinded study, focused on establishing the system’s performance at low glucose levels. The second group of studies included a multi-site study evaluated system performance in hospital intensive care unit and in the operating room.. The third group of studies assessed up to 24 hours of continuous monitoring in a home like setting

HYPERINSULINEMIC HYPOGLYCEMIC BLINDED STUDY 

This trial established product performance in the most challenging condition – hypoglycemia – where accurate performance is essential for ensuring clinically acceptable outcomes. The system displayed high accuracy and an excellent correlation with the reference devices - gold-standard lab measurement systems.

OrSense’s NBM100G hypoglycemic blinded study results - Clarke Error Grid
Region A:79%, B:20%, C:0%, D:1%, E:0% Median Absolute Error 8mg/Dl (13.2%)
Ref: Kononenko et al., 5th Diabetes Technology Meeting, Nov 2005

HOSPITAL INTENSIVE CARE UNIT AND OPERATING ROOM

Tight glycemic control in hospital critical care units has emerged as a key medical need in recent years. OrSense´s non-invasive continuous monitoring solution is optimally suited for this setting. OrSense’s NBM systems participated in a multi-site study in both intensive care and operating room units. The system was tested on over 30 diabetic and non diabetic patients for up to 24 hours. In this configuration, OrSense's multi-parameter system reported in parallel continuous, non-invasive hemoglobin and oxygen saturation readings

HOME CARE SCENARIO STUDY

This set of trials established accurate product performance in a similar environment to its intended use, i.e. patient's self-monitoring of blood glucose at home. OrSense’s device was used continuously, 8-24 hours per day, for up to 10 days per patient, with daily calibration. Trials were performed at the Sansum Medical Center, Santa Barbara, California and at the Sheba Medical Center – Center of Advanced Technology – Ramat Gan, Israel.