| Title | Continuous noninvasive glucose monitoring technology based on "occlusion spectroscopy". | | Author(s) | Amir O, Weinstein D, Zilberman S, Less M, Perl-Treves D, Primack H, Weinstein A, Gabis E, Fikhte B, Karasik A | | Institution | OrSense Ltd. , Nes Ziona, Israel. | | Source | J Diabetes Sci Technol 2007 Jul; 1(4):463-9. | | 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. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 19885108 |
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