Type 2 DiabetesNCT04658082
A Pilot Trial of the Non-invasive H.G.R Glucometer
A study testing H.G.R (GWave) non-invasive glucometer in people with Type 2 Diabetes, run by Prof. Amir Tirosh at 1 site in Israel.
Trial summary
A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- H.G.R (GWave) non-invasive glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Oct 2020to 1 Dec 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- HbA1c of 6.0-8.0% .
Who cannot join
- Participants under the age of 18 years
- pregnant women or patients with normal blood glucose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial to Evaluate the Precision and Accuracy of the Non-invasive H.G.R Glucometer
A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.
The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.
- Conditions
- Type 2 Diabetes
- Being tested
- H.G.R (GWave) non-invasive glucometer
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.G.R (GWave) non-invasive glucometerDevice
Glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Non invasive glucose monitor | Other | Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab Receives: Device: H.G.R (GWave) non-invasive glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between core lab and non invasive glucose measurements
difference between core lab and non invasive glucose measurements
Measured: 3 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start7 Oct 2020
- Primary completion16 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Amir Tirosh
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Amir Tirosh, Sheba Medical Center
- Investigators
- Amir Tirosh, MD PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658082
- Sponsor's protocol ID
- Sheba-19-6335-at-ctil
- Status last verified
- May 2022
- First submitted
- 1 Dec 2020
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Evaluate the Precision and Accuracy of the Non-invasive H.G.R Glucometer
- ClinicalTrials.gov ID
- NCT04658082
- Acronym / sponsor ID
- Sheba-19-6335-at-ctil
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Prof. Amir TiroshOther government
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Dec 2020 (actual)
- 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.
A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.
The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non invasive glucose monitor | Other | Device: H.G.R (GWave) non-invasive glucometerSingle arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- HbA1c of 6.0-8.0% .
Key exclusion criteria (2 listed)
- Participants under the age of 18 years
- pregnant women or patients with normal blood glucose.
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 |
|---|---|---|
| H.G.R (GWave) non-invasive glucometerGlucose tolerance test | Device | Non invasive glucose monitor |
Primary outcome
difference between core lab and non invasive glucose measurements
Time frame: 3 HOURS
difference between core lab and non invasive glucose measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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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.
Amir Tirosh, MD PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.G.R (GWave) non-invasive glucometer in people with Type 2 Diabetes, run by Prof. Amir Tirosh 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between core lab and non invasive glucose measurements (time frame: 3 HOURS). 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 23 May 2022.