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

Diabetes Clinical Trial

— GS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00451334
• Other study ID #: GS-01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 22, 2007
• Last updated: March 22, 2007

Study information

• Verified date: November 2006
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,