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Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433758
Recruitment Status : Unknown
Verified September 2007 by Integrity Applications Ltd..
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2007
Last Update Posted : March 18, 2008
Information provided by:
Integrity Applications Ltd.

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Gestational Diabetes Device: GlucoTrack Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device
Study Start Date : December 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: GlucoTrack

Primary Outcome Measures :
  1. Clarke Error Grid [ Time Frame: Clarke Error Grid ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00433758

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Soroka University Medical Center
Beer-Sheva, Israel, 84141
Sponsors and Collaborators
Integrity Applications Ltd.
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Principal Investigator: Ilana Harman-Boehm, MD Soroka University Medical Center

Layout table for additonal information Identifier: NCT00433758     History of Changes
Other Study ID Numbers: IA-A2-2007-01-CTIL
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: September 2007

Keywords provided by Integrity Applications Ltd.:
Blood glucose monitoring
Non invasive Blood glucose monitoring

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications