TY - JOUR
T1 - Continuous noninvasive glucose monitoring technology based on "occlusion spectroscopy"
AU - Amir, Orna
AU - Weinstein, Daphna
AU - Zilberman, Silviu
AU - Less, Malka
AU - Perl-Treves, Daniele
AU - Primack, Harel
AU - Weinstein, Aharon
AU - Gabis, Ef
AU - Fikhte, Boris
AU - Karasik, Avraham
PY - 2007/7
Y1 - 2007/7
N2 - 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.
AB - 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.
KW - Noninvasive glucose monitoring
KW - Occlusion spectroscopy
KW - Self-monitoring of blood glucose
UR - http://www.scopus.com/inward/record.url?scp=62449149289&partnerID=8YFLogxK
U2 - 10.1177/193229680700100403
DO - 10.1177/193229680700100403
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AN - SCOPUS:62449149289
SN - 1932-2968
VL - 1
SP - 463
EP - 469
JO - Journal of diabetes science and technology
JF - Journal of diabetes science and technology
IS - 4
ER -