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

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ClinicalTrials.gov Identifier: NCT01247649
Recruitment Status : Terminated (sponsor decision)
First Posted : November 24, 2010
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Type 1 Diabetes Device: Physical Logic Continuous Glucose Monitoring System

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Study Start Date : November 2010
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

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
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


Outcome Measures

Primary Outcome Measures :
  1. Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument) [ Time Frame: up to 24 weeks ]
    Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247649


Locations
Israel
Schneider Children's Medical center
Petach-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Revital Nimri, Dr Schenider Children's Medical
More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01247649     History of Changes
Other Study ID Numbers: rmc006039ctil
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Rabin Medical Center:
Continuous glucose monitoring system
Non invasive
Type 1 diabetes
Dielectric spectroscopy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases