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

• Conditions: Diabetes

• Registration Number: NCT00451334
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed 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 Timeline

• Status Verified: 2006-11
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Last Update Submitted: 2007-03-22
• Study First Posted: 2007-03-23
• Last Update Posted: 2007-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male/Female aged 18 and up.
• Subject was diagnosed as a diabetes patient or healthy subject.
• Subject able to comprehend and give informed consent for participation in this study.
• Signed Informed Consent Form

Exclusion Criteria

• Pregnancy or breast feeding.
• Patients treated with steroid.
• Concomitant Coumadin use
• Recent (within the last 3 months) myocardial infarction or CVA (stroke).
• Any chronic unstable disease within the last 3 months.
• Acute bleeding disorders.
• HIV positive.
• Hepatitis B/C positive.
• BMI>37
• Needing emergency surgery
• Known cognitive or psychiatric disorder
• Physician objection
• Concurrent participation in any other clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zrifin, Israel