Diabetes Clinical Trial
— GSOfficial title:
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
NCT number | NCT00451334 |
Other study ID # | GS-01 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 2/Phase 3 |
First received | March 22, 2007 |
Last updated | March 22, 2007 |
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 |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Israel | Assaf-Harofeh Medical Center | Zrifin |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
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