Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device (CR-01-001)
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
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
|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.|
- Clarke Error Grid [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- User Satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]Based on user questionnaire, user satisfection will be analyzed
|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)|
subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.
comparison of different glucose monitoring devices
See Brief summary
|Contact: Sagit Saadon, MA||+972 (8) 675-7878|
|Soroka University Medical Center||Recruiting|
|Contact: Adi Gluzberg +972-52-6401020 firstname.lastname@example.org|
|Principal Investigator: Ilana Harman-Boehm, MD|
|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|