Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device (CR-01-001)
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Clarke Error Grid [ Time Frame: one year ]
- User Satisfaction [ Time Frame: one year ]Based on user questionnaire, user satisfection will be analyzed
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 ClinicalTrials.gov identifier (NCT number): NCT00889668
|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|