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Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement

2014-08-27 03:39:30 | BioPortfolio

Summary

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.

Primary Goal

* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Secondary Goal

* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Description

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.

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Conditions

Diabetes

Location

Assaf-Harofeh Medical Center
Zrifin
Israel
70300

Status

Not yet recruiting

Source

Assaf-Harofeh Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:30-0400

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Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

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