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Cnoga TensorTip Combo

Device Name:TensorTip Combo
Manufacturer:

OBL: Cnoga Medical Ltd., 5 Tarshish Street, North Industrial Park, Caesarea 3088900, ISRAEL.

OEM: OK Biotech Co. Ltd., 91 Sec. 2, Gongdao 5th Road, Hsinchu City 30070, TAIWAN PRC.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Cnoga TensorTip Combo is a clinically validated blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the Cnoga TensorTip Combo, to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

Pfützner A, Strobl S, Demircik F, Redert L, Pfützner J, Pfützner AH, Lier A. Evaluation of a New Noninvasive Glucose Monitoring Device by Means of Standardized Meal Experiments. J Diabetes Sci Technol. 2018 Nov;12(6):1178-1183. Epub: 2018 Feb 16. doi: 101177/1932296818758769. PMID: 29451016. Available from: PMC6232728.

Ad Hoc protocol Healthy (n=14), T1DM (n=6) and T2DM (n=16)

After appropriate individual calibration of the noninvasive technology, both the noninvasive and the invasive Cnoga TensorTip-Combo components tracked tissue and blood glucose values reliably, respectively. This may enable patients with diabetes to monitor their glucose levels frequently, reliably and, most of all, pain-free.

Relevant Publications

Segman YJ. Device and Method for Noninvasive Glucose Assessment. J Diabetes Sci Technol. 2018 Nov;12(6):1159-1168. Epub: 2018 Mar 24. doi: 10.1177/1932296818763457. PMID: 29575926. Available from: PMC6232732.

Measurements from the Cnoga TensorTip Combo are compared to those from Roche Accu-Chek Performa, Ascensia Contour, Abbott FreeStyle and Abbott i-STAT, though not in a formal validation.