Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Primary Purpose
Type 1 Diabetes
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physical Logic Continuous Glucose Monitoring System
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 1 Diabetes focused on measuring Continuous glucose monitoring system, Non invasive, Type 1 diabetes, Dielectric spectroscopy
Eligibility Criteria
Inclusion Criteria:
- Signing an inform consent form
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Age > 18 years old
- Willing to perform all study related procedures
Exclusion Criteria:
- Known or suspected allergy to the sensor or one of its components
- Psychiatric disorder
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Patients who are not willing or are not capable of performing the protocol requirements
- Participating in another study that includes investigational drug or investigational equipment
- Pregnancy
Sites / Locations
- Schneider Children's Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01247649
First Posted
November 21, 2010
Last Updated
November 18, 2012
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01247649
Brief Title
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Official Title
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
sponsor decision
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Continuous glucose monitoring system, Non invasive, Type 1 diabetes, Dielectric spectroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Physical Logic Continuous Glucose Monitoring System
Intervention 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
Primary Outcome Measure Information:
Title
Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)
Description
Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signing an inform consent form
Type 1 diabetes diagnosed at least 12 months prior to study inclusion
Age > 18 years old
Willing to perform all study related procedures
Exclusion Criteria:
Known or suspected allergy to the sensor or one of its components
Psychiatric disorder
Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
Patients who are not willing or are not capable of performing the protocol requirements
Participating in another study that includes investigational drug or investigational equipment
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Revital Nimri, Dr
Organizational Affiliation
Schenider Children's Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical center
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
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