This trial is active, not recruiting.

Conditions type 1 diabetes mellitus, type 2 diabetes mellitus, gestational diabetes
Treatment glucotrack
Sponsor Integrity Applications Ltd.
Start date December 2006
End date December 2008
Trial size 142 participants
Trial identifier NCT00433758, IA-A2-2007-01-CTIL


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

Clarke Error Grid
time frame: Clarke Error Grid

Eligibility Criteria

Male or female participants at least 10 years old.

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)

Additional Information

Official title Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device
Principal investigator Ilana Harman-Boehm, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Integrity Applications Ltd..