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

Not Applicable

Terminated

• Conditions: Type 1 Diabetes
• Interventions: Device: Physical Logic Continuous Glucose Monitoring System

• Registration Number: NCT01247649
• Lead Sponsor: Rabin Medical Center

Brief Summary

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-21
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-24
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-18
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	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

Primary Outcome Measures

Name	Time	Method
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)	up to 24 weeks	Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels

Trial Locations

Locations (1)

Schneider Children's Medical center; 🇮🇱 Petach-Tikva, Israel