Integrity Applications, Inc. has set a July conference call with the FDA for further discussion regarding the company’s pre-submission supplement (including clinical trial protocol) for its GlucoTrack Model DF-F device submitted to the FDA for review on May 10.
GlucoTrack is a non-invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes that does not require pricking of the fingers to draw blood for daily glucose monitoring. It features a small sensor that clips to the earlobe and measures the wearer’s glucose level by taking measurements using three technologies. The measured signals are analyzed using a proprietary algorithm and displayed on a small handheld device the size of a mobile phone. The derived glucose measurement is also announced verbally, facilitating use by elderly and vision-impaired diabetes patients.
The protocol was modified to reflect FDA remarks and discussions with Integrity Applications during a pre-submission meeting that took place in October 2015. Following the July discussion and subject to FDA approval of the Model DF-F clinical trial protocol, the company plans to initiate the pivotal clinical study in the third quarter of 2016.
The product is experimental in the United States and is limited to investigational use. The model obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and recently received approval to market the device also to pre-diabetics.
Integrity Applications, Inc. is a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by people with diabetes. The company operates primarily through its wholly owned Israeli subsidiary, A.D. Integrity Applications, Ltd.
