Type 2 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device
The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels
Diabetes is a leading cause of death in the Western World with medical costs increasing
annually. There is no cure for diabetes, and blood glucose monitoring is a key component in
diabetes treatment and management. Consistently high blood sugar levels can, over time, lead
to complications such as blindness, kidney disease, heart disease, and nerve damage.In
addition, low blood sugars may lead to immediate dangers. Self-monitoring of blood glucose
levels is essential to the self-management of diabetes and has become widespread over the
past decade. Blood glucose determinations are currently done by invasive methods (finger tip
pricking), followed by measuring the blood drop characteristics. Currently, there is no
commercially available reliable non-invasive glucose measurement device that being marketed.
The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous
measurement of three independent orthogonal parameters.
The rationale for development of the device is to improve the patient's quality of life by
providing a device that is easily used and provides a painless measurement method, thereby
leading to higher compliance, and to better managed diabetes
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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