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Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

NCT ID: NCT00433758

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Gestational Diabetes

Keywords

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Diabetes Blood glucose monitoring Non invasive Blood glucose monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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GlucoTrack

GT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with Type 1, Type 2, or Gestational Diabetes
* Above the age of 10

* Patients requiring dialysis
* Participation in other clinical investigations within the previous month.
* Pregnancy(excluding patients that intend to participate in the gestational group)
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integrity Applications Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ilana Harman-Boehm, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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IA-A2-2007-01-CTIL

Identifier Type: -

Identifier Source: org_study_id