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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451334
First Posted: March 23, 2007
Last Update Posted: March 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

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.


Condition Phase
Diabetes Phase 2 Phase 3

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement

Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 40
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451334


Locations
Israel
Assaf-Harofeh Medical Center Not yet recruiting
Zrifin, Israel, 70300
Contact: Hanna Levy, PhD    +972-6-388-837    hanna@qsitemed.com   
Principal Investigator: Shai Efrati, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Shai Efrati, MD
  More Information

ClinicalTrials.gov Identifier: NCT00451334     History of Changes
Other Study ID Numbers: GS-01
First Submitted: March 22, 2007
First Posted: March 23, 2007
Last Update Posted: March 23, 2007
Last Verified: November 2006