Continuous noninvasive glucose monitoring technology based on "occlusion spectroscopy"

Orna Amir, Daphna Weinstein, Silviu Zilberman, Malka Less, Daniele Perl-Treves, Harel Primack, Aharon Weinstein, Ef Gabis, Boris Fikhte, Avraham Karasik

Research output: Contribution to journalArticlepeer-review

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 effcacy 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.

Original languageEnglish
Pages (from-to)463-469
Number of pages7
JournalJournal of diabetes science and technology
Volume1
Issue number4
DOIs
StatePublished - Jul 2007

Keywords

  • Noninvasive glucose monitoring
  • Occlusion spectroscopy
  • Self-monitoring of blood glucose

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