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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00451334
First received: March 22, 2007
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00451334     History of Changes
Other Study ID Numbers: GS-01
Study First Received: March 22, 2007
Last Updated: March 22, 2007
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on October 16, 2014