Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00433758
• Other study ID #: IA-A2-2007-01-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: February 8, 2007
• Last updated: March 17, 2008
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2007
• Source: Integrity Applications Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Device:
• GlucoTrack
GT

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Integrity Applications Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clarke Error Grid		Clarke Error Grid