Type 1 DiabetesNCT01247649
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
A study testing Physical Logic Continuous Glucose Monitoring System in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Physical Logic Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Feb 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing an inform consent form
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Age > 18 years old
- Willing to perform all study related procedures
Who cannot join
- Known or suspected allergy to the sensor or one of its components
- Psychiatric disorder
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Patients who are not willing or are not capable of performing the protocol requirements
- Participating in another study that includes investigational drug or investigational equipment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.
Read the detailed description
The non invasive continuous glucose sensing system of Physical Logic is based on a vector network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. This method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium.
The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact.
Study objective:
To evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.The glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue.
During the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:
- Conditions
- Type 1 Diabetes
- Being tested
- Physical Logic Continuous Glucose Monitoring System
- Keywords
- Continuous glucose monitoring system, Non invasive, Type 1 diabetes, Dielectric spectroscopy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Logic Continuous Glucose Monitoring SystemDevice
Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each Receives: Device: Physical Logic Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Revital Nimri, Dr, Principal investigator, Schenider Children's Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247649
- Sponsor's protocol ID
- rmc006039ctil
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2010
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
- ClinicalTrials.gov ID
- NCT01247649
- Acronym / sponsor ID
- rmc006039ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous glucose monitoring system, Non invasive, Type 1 diabetes, Dielectric spectroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Nov 2010 (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.
The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.
Detailed description
The non invasive continuous glucose sensing system of Physical Logic is based on a vector network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. This method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium.
The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact.
Study objective:
To evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.The glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue.
During the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Physical Logic Continuous Glucose Monitoring SystemPatients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signing an inform consent form
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Age > 18 years old
- Willing to perform all study related procedures
Key exclusion criteria (6 listed)
- Known or suspected allergy to the sensor or one of its components
- Psychiatric disorder
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Patients who are not willing or are not capable of performing the protocol requirements
- Participating in another study that includes investigational drug or investigational equipment
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 |
|---|---|---|
| Physical Logic Continuous Glucose Monitoring SystemPatients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each | Device | Study group |
Primary outcome
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
Time frame: up to 24 weeks
Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Related trials for Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Recruiting
T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Type 1 Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
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.
Revital Nimri, Dr principal investigator
Schenider Children's Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Logic Continuous Glucose Monitoring System in people with Type 1 Diabetes, run by Rabin 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 6 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: stopped early, as of the sponsor's last update on 20 Nov 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.
Are results available for this study?
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument) (time frame: up to 24 weeks). 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 20 Nov 2012.