Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Integrity Applications Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Integrity Applications Ltd.
ClinicalTrials.gov Identifier:
NCT00433758
First received: February 8, 2007
Last updated: March 17, 2008
Last verified: September 2007
  Purpose

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


Condition Intervention
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Gestational Diabetes
Device: GlucoTrack

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device

Resource links provided by NLM:


Further study details as provided by Integrity Applications Ltd.:

Primary Outcome Measures:
  • Clarke Error Grid [ Time Frame: Clarke Error Grid ]

Estimated Enrollment: 142
Study Start Date: December 2006
Estimated Study Completion Date: December 2008
Intervention Details:
    Device: GlucoTrack
    GT
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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433758

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

No publications provided

ClinicalTrials.gov Identifier: NCT00433758     History of Changes
Other Study ID Numbers: IA-A2-2007-01-CTIL
Study First Received: February 8, 2007
Last Updated: March 17, 2008
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 30, 2014