Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

Not Applicable

• Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Gestational Diabetes

• Registration Number: NCT00433758
• Lead Sponsor: Integrity Applications Ltd.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Status Verified: 2007-09
• Last Update Submitted: 2008-03-17
• Last Update Posted: 2008-03-18
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clarke Error Grid	Clarke Error Grid

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer-Sheva, Israel