- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01247649
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Petach-Tikva, Israel, 49202
- Schneider Children's Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
Time Frame: up to 24 weeks
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Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels
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up to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Revital Nimri, Dr, Schenider Children's Medical
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rmc006039ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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