Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study

June 2, 2009 updated by: Mellitor

Most patients with diabetes mellitus have to measure their blood glucose levels quite often, in order to maintain a proper glycemic control. Current methods of self-monitoring of blood glucose are invasive, painful, uncomfortable, and only allow occasional, from time-to-time, measurements. Real-time continuous monitoring would provide a helpful tool for improvement of glycemic control, thus decreasing the incidence of hypoglycemia and improving glucose control. The Mellitor sensor is a new concept of continue glucose monitoring device. The Mellitor device is an implantable continuous glucose monitoring sensor that is intended for detection episodes of hyperglycemia and hypoglycemia in diabetic patients, and facilitates both acute and long-term therapy adjustments. This study was design in order to evaluate glucose measurement capabilities by the Mellitor sensor that is being developed. Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.

Study Design

This study is an ex-vivo comparative study. 20 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.

Study Goal

Study objective is to evaluate the feasibility of the Mellitor Sensor technology for glucose level measurement.

Study Endpoint

Mellitor technology feasibility will be established by comparing Mellitor glucose measurements results, based on transudate/exudates liquid withdrawal for other medical reasons, to "gold standard, Yellow Springs" glucose analyzer, or a comparable, calibrated and approved device using the same transudate/exudates liquid. Interdevice variability should be within 10%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/Female aged 18 and up.
  • Subject was scheduled for transudate/exudate liquid withdrawal.
  • Subject able to comprehend and give informed consent for participation in this study.
  • Signed Informed Consent Form

Exclusion Criteria:

  • Known cognitive or psychiatric disorder.
  • Subjects with HIV.
  • Subject refuses to sign inform consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Glucose measurements using "Mellitor" device.
Device: Mellitor device for glucose measurement
Glucose measurement using "Mellitor" device
ACTIVE_COMPARATOR: B
Glucose measurements conducted by using gold standard, "Yellow Springs" glucose analyzer
Device: Mellitor device for glucose measurement
Glucose measurement using "Mellitor" device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mellitor technology feasibility will be established by comparing Mellitor glucose measurements results to "gold standard, Yellow Springs" glucose analyzer, or a comparable. Interdevice variability should be within 10%.
Time Frame: during glucose measurements
during glucose measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mellitor

Investigators

  • Principal Investigator: Roi Eldor, MD, Hadassah Medical Organization, Jerusalem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2010

Study Completion (ANTICIPATED)

October 1, 2010

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (ESTIMATE)

September 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MS-EV -1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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