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

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


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.


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




Assaf-Harofeh Medical Center


Not yet recruiting


Assaf-Harofeh Medical Center

Results (where available)

View Results


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).

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

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The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.

Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin.

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Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...

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