Type 1 Diabetes MellitusPhase 1/2CR-01-001NCT00889668
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
A Phase 1/2 study testing GlucoTrack in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Integrity Applications Ltd. at 1 site in Israel.
Trial summary
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- GlucoTrack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Oct 2012
- Phase
- Phase 1/2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1or 2 Diabetes
- Anatomically suitable earlobe
Who cannot join
- Subjects requiring dialysis
- Any conditions that may hamper good contact between the PEC and the earlobe
- Pregnancy
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
Sagit Saadon, MA contact
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Adi Gluzberg, +972-52-6401020, adi_g@medicsense.com
Ilana Harman-Boehm, MD
About this study
Official title: Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.
The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.
The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes
Read the detailed description
See Brief summary
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- GlucoTrack
- Keywords
- Glucose monitoring, GlucoTrack, Self glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoTrackDevice
comparison of different glucose monitoring devices
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device. Receives: Device: GlucoTrack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarke Error Grid
Measured: one year
Secondary outcomes (1)
User Satisfaction
Based on user questionnaire, user satisfection will be analyzed
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrity Applications Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilana Harman-Boehm, MD, Principal investigator, Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889668
- Sponsor's protocol ID
- CR-01-001 CTIL
- Acronym
- CR-01-001
- Status last verified
- Apr 2012
- First submitted
- 28 Apr 2009
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
- ClinicalTrials.gov ID
- NCT00889668
- Acronym / sponsor ID
- CR-01-001 / CR-01-001 CTIL
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- Glucose monitoring, GlucoTrack, Self glucose monitoring
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Integrity Applications Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Apr 2009 (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.
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.
The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.
The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes
Detailed description
See Brief summary
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: GlucoTracksubjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1or 2 Diabetes
- Anatomically suitable earlobe
Key exclusion criteria (4 listed)
- Subjects requiring dialysis
- Any conditions that may hamper good contact between the PEC and the earlobe
- Pregnancy
- Nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoTrackcomparison of different glucose monitoring devices | Device | Experimental |
Primary outcome
Clarke Error Grid
Time frame: one year
1 secondary outcome
User Satisfaction
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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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.
Sagit Saadon, MA contact
Ilana Harman-Boehm, MD principal investigator
Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GlucoTrack in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Integrity Applications Ltd. 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 2 inclusion and 4 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 1 May 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sagit Saadon, MA (+972 (8) 675-7878), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarke Error Grid (time frame: one year). It is what the study was designed to measure, not a finding.
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 1 May 2012.