DiabetesGSNCT00451334
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
An observational study of Diabetes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf-Harofeh Medical Center
Zrifin, 70300
Hanna Levy, PhD, +972-6-388-837, hanna@qsitemed.com
Shai Efrati, MD
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Shai Efrati, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451334
- Sponsor's protocol ID
- GS-01
- Acronym
- GS
- Status last verified
- Nov 2006
- First submitted
- 22 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
- ClinicalTrials.gov ID
- NCT00451334
- Acronym / sponsor ID
- GS / GS-01
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai Efrati, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2007.