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

This study is currently recruiting participants.
Verified April 2012 by Integrity Applications Ltd.
Sponsor:
Information provided by (Responsible Party):
Integrity Applications Ltd.
ClinicalTrials.gov Identifier:
NCT00889668
First received: April 28, 2009
Last updated: April 29, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
 Device: GlucoTrack
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Integrity Applications Ltd.:

Primary Outcome Measures:
  • Clarke Error Grid [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • User Satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]
    Based on user questionnaire, user satisfection will be analyzed


Estimated Enrollment: 180
Study Start Date: May 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

See Brief summary

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889668

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

Locations
Israel
Soroka University Medical Center Recruiting
Beer-Sheva, Israel
Contact: Adi Gluzberg     +972-52-6401020     adi_g@medicsense.com    
Principal Investigator: Ilana Harman-Boehm, MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Integrity Applications Ltd.
ClinicalTrials.gov Identifier: NCT00889668     History of Changes
Other Study ID Numbers: CR-01-001 CTIL
Study First Received: April 28, 2009
Last Updated: April 29, 2012
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on June 18, 2013