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

NCT ID: NCT00889668

Last Updated: 2012-05-01

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

PHASE1/PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-10-31

Brief Summary

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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. 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

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See Brief summary

Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

GlucoTrack

Intervention Type DEVICE

comparison of different glucose monitoring devices

Interventions

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GlucoTrack

comparison of different glucose monitoring devices

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Integrity Applications Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilana Harman-Boehm, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sagit Saadon, MA

Role: CONTACT

+972 (8) 675-7878

Facility Contacts

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Adi Gluzberg

Role: primary

+972-52-6401020

Other Identifiers

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CR-01-001 CTIL

Identifier Type: -

Identifier Source: org_study_id

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