Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device (CR-01-001)

April 29, 2012 updated by: Integrity Applications Ltd.

Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.

Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.

The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

See Brief summary

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Recruiting
        • Soroka University Medical Center
        • Contact:
        • Principal Investigator:
          • Ilana Harman-Boehm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1or 2 Diabetes
  • Anatomically suitable earlobe

Exclusion Criteria:

  • Subjects requiring dialysis
  • Any conditions that may hamper good contact between the PEC and the earlobe
  • Pregnancy
  • Nursing mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.
Device: GlucoTrack
comparison of different glucose monitoring devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clarke Error Grid
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Satisfaction
Time Frame: one year
Based on user questionnaire, user satisfection will be analyzed
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrity Applications Ltd.

Investigators

  • Principal Investigator: Ilana Harman-Boehm, MD, Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 29, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-01-001 CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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