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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01247649
• Other study ID #: rmc006039ctil
• Status: Terminated
• Phase: N/A
• First received: November 21, 2010
• Last updated: November 18, 2012
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2012
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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:

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 weeks	No