Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device

Type 2 Diabetes Mellitus Clinical Trial

— CR-01-001  

Official title:

Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00889668
• Other study ID #: CR-01-001 CTIL
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 28, 2009
• Last updated: April 29, 2012
• Start date: May 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2012
• Source: Integrity Applications Ltd.
• Contact: Sagit Saadon, MA
• Phone: +972 (8) 675-7878
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

See Brief summary

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Type 1or 2 Diabetes

• Anatomically suitable earlobe

Exclusion Criteria:

• Subjects requiring dialysis

• Any conditions that may hamper good contact between the PEC and the earlobe

• Pregnancy

• Nursing mothers

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

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

Intervention

Device:
• GlucoTrack
comparison of different glucose monitoring devices

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		one year	Yes
Secondary	User Satisfaction	Based on user questionnaire, user satisfection will be analyzed	one year	No