title: Continuous noninvasive glucose monitoring technology based on "occlusion spectroscopy".
abstract: BACKGROUND
  A truly noninvasive glucose-sensing device could revolutionalize diabetes treatment by leading to improved compliance with recommended glucose levels, thus reducing the long-term complications and cost of diabetes. Herein, we present the technology and evaluate the efficacy of a truly noninvasive device for continuous blood glucose monitoring, the NBM (OrSense Ltd.).
  
  
  METHODS
  In vitro analysis was used to validate the technology and algorithms. A clinical study was performed to quantify the in vivo performance of the NBM device. A total of 23 patients with type 1 (n = 12) and type 2 (n = 11) diabetes were enrolled in the clinical study and participated in 111 sessions. Accuracy was assessed by comparing NBM data with paired self-monitoring of blood glucose meter readings.
  
  
  RESULTS
  In vitro experiments showed a strong correlation between calculated and actual glucose concentrations. The clinical trial produced a total of 1690 paired glucose values (NBM vs reference). In the paired data set, the reference glucose range was 40-496 mg/dl. No systematic bias was found at any of the glucose levels examined (70, 100, 150, and 200 mg/dl). The mean relative absolute difference was 17.2%, and a Clarke error grid analysis showed that 95.5% of the measurements fall within the clinically acceptable A&B regions (zone A, 69.7%; and zone B, 25.7%).
  
  
  CONCLUSIONS
  This study indicates the potential use of OrSense's NBM device as a noninvasive sensor for continuous blood glucose evaluation. The device was safe and well tolerated.
authors.affiliation: OrSense Ltd., Nes Ziona, Israel. orna@orsense.com
authors.forename: Orna
authors.initials: O
authors.lastname: Amir
authors.forename: Daphna
authors.initials: D
authors.lastname: Weinstein
authors.forename: Silviu
authors.initials: S
authors.lastname: Zilberman
authors.forename: Malka
authors.initials: M
authors.lastname: Less
authors.forename: Daniele
authors.initials: D
authors.lastname: Perl-Treves
authors.forename: Harel
authors.initials: H
authors.lastname: Primack
authors.forename: Aharon
authors.initials: A
authors.lastname: Weinstein
authors.forename: Efi
authors.initials: E
authors.lastname: Gabis
authors.forename: Boris
authors.initials: B
authors.lastname: Fikhte
authors.forename: Avraham
authors.initials: A
authors.lastname: Karasik