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This study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients’ inflow and meeting eligibility criteria.
* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.
Primary Endpoint Parameter
• Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology. Safety will be established by paucity of adverse events. Adverse Events occurrence will be documented throughout the study.
Secondary Endpoint Parameters
Efficacy of the GlucoSat technology will be assessed by:
- Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device. Inter device variability should be within 15%.
- Patient satisfaction questionnaire.
- Physician satisfaction will be assessed by questionnaire.
Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective
Assaf-Harofeh Medical Center
Not yet recruiting
Assaf-Harofeh Medical Center
Published on BioPortfolio: 2014-08-27T03:39:30-0400
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