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

February 8, 2007
March 17, 2008
December 2006
Not Provided
Clarke Error Grid [ Time Frame: Clarke Error Grid ]
Clarke Error Grid
Complete list of historical versions of study NCT00433758 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • Gestational Diabetes
Device: GlucoTrack
GT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
142
December 2008
Not Provided

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)
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00433758
IA-A2-2007-01-CTIL
Yes
Not Provided
Integrity Applications Ltd.
Not Provided
Principal Investigator: Ilana Harman-Boehm, MD Soroka University Medical Center
Integrity Applications Ltd.
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP