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

Phase 1

• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Interventions: Device: GlucoTrack

• Registration Number: NCT00889668
• Lead Sponsor: Integrity Applications Ltd.

Brief 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

Detailed Description

See Brief summary

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-29
• Last Update Posted: 2012-05-01
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	GlucoTrack	subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.

Primary Outcome Measures

Name	Time	Method
Clarke Error Grid	one year

Secondary Outcome Measures

Name	Time	Method
User Satisfaction	one year	Based on user questionnaire, user satisfection will be analyzed

Trial Locations

Locations (1)

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