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

NCT ID: NCT01247649

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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

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Type 1 Diabetes

Keywords

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Continuous glucose monitoring system Non invasive Type 1 diabetes Dielectric spectroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Physical Logic Continuous Glucose Monitoring System

Intervention Type DEVICE

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

Interventions

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Physical Logic Continuous Glucose Monitoring System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Revital Nimri, Dr

Role: PRINCIPAL_INVESTIGATOR

Schenider Children's Medical

Locations

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Schneider Children's Medical center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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rmc006039ctil

Identifier Type: -

Identifier Source: org_study_id