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

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: NCT00889668
Recruitment Status : Unknown
Verified April 2012 by Integrity Applications Ltd..
Recruitment status was:  Recruiting
First Posted : April 29, 2009
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):
Integrity Applications Ltd.

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Device: GlucoTrack Phase 1 Phase 2

Detailed Description:
See Brief summary

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
Study Start Date : May 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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

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

Secondary Outcome Measures :
  1. User Satisfaction [ Time Frame: one year ]
    Based on user questionnaire, user satisfection will be analyzed

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:

  • 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

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): NCT00889668

Contact: Sagit Saadon, MA +972 (8) 675-7878

Soroka University Medical Center Recruiting
Beer-Sheva, Israel
Contact: Adi Gluzberg    +972-52-6401020   
Principal Investigator: Ilana Harman-Boehm, MD         
Sponsors and Collaborators
Integrity Applications Ltd.
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

Responsible Party: Integrity Applications Ltd. Identifier: NCT00889668     History of Changes
Other Study ID Numbers: CR-01-001 CTIL
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Integrity Applications Ltd.:
Glucose monitoring
Self glucose monitoring

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