Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG

Clalit Health Services

Status: Terminated

Conditions: Type 1 Diabetes

Treatments: Device: Physical Logic Continuous Glucose Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT01247649

rmc006039ctil

Details and patient eligibility

About

The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

Full 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:

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signing an inform consent form
2. Type 1 diabetes diagnosed at least 12 months prior to study inclusion
3. Age > 18 years old
4. Willing to perform all study related procedures

Exclusion criteria

1. Known or suspected allergy to the sensor or one of its components
2. Psychiatric disorder
3. Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
4. Patients who are not willing or are not capable of performing the protocol requirements
5. Participating in another study that includes investigational drug or investigational equipment
6. Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Study group

Experimental group

Description:

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

Treatment:

Device: Physical Logic Continuous Glucose Monitoring System