Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

March 17, 2008 updated by: Integrity Applications Ltd.

Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device

The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. 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. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed.

The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters.

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

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, 84141
        • Soroka University Medical Center

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:

  • Patients with Type 1, Type 2, or Gestational Diabetes
  • Above the age of 10

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Patients requiring dialysis
  • Participation in other clinical investigations within the previous month.
  • Pregnancy(excluding patients that intend to participate in the gestational group)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

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

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

December 1, 2006

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Estimate)

March 18, 2008

Last Update Submitted That Met QC Criteria

March 17, 2008

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA-A2-2007-01-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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