Integrity Applications GlucoTrack DF-F (V2)
Device Name:
GlucoTrack DF-F v2 (Note: 2 of 2)
Manufacturer:
Integrity Applications, 19 Ha’Yahalomim St., Ashdod, ISRAEL.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Ear
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Description:
The Integrity Applications GlucoTrack DF-F (V2) is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the ear. It is intended for self-measurement and home use.
Assessment:
The technology used in the Integrity Applications GlucoTrack DF-F (V2), to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Bahartan K, Horman K, Gal A, Drexler A, Mayzel Y, Lin T. Assessing the Performance of a Noninvasive Glucose Monitor in People with Type 2 Diabetes with Different Demographic Profiles. J Diabetes Res. 2017;2017:4393497. Epub: 2017 Dec 20. doi: 10.1155/2017/4393497. PMID: 29527535. Available from: PMC5750487.

Ad Hoc protocol General population

Lin T, Mayzel Y, Bahartan K. The accuracy of a non-invasive glucose monitoring device does not depend on clinical characteristics of people with type 2 diabetes mellitus. J Drug Assess. 2018;7(1):1-7. Epub: 2018 Jan 11. doi: 10.1080/21556660.2018.1423987. PMID: 29372110. Available from: PMC5769775. eCollection 2018.

Ad Hoc protocol General population