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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Mellitor.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mellitor
ClinicalTrials.gov Identifier:
NCT00746642
First received: September 3, 2008
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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%.


Condition Intervention
Diabetes Mellitus
Device: Mellitor device for glucose measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study

Resource links provided by NLM:


Further study details as provided by Mellitor:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746642

Contacts
Contact: Hanna Levy, Dr. (972)-4-638-8837 hanna@qsitemed.com

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Hanna Levy, Dr.    (972)-4-638-8837    hanna@qsitemed.com   
Sponsors and Collaborators
Mellitor
Investigators
Principal Investigator: Roi Eldor, MD Hadassah Medical Organization, Jerusalem
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy - study director, Melitor
ClinicalTrials.gov Identifier: NCT00746642     History of Changes
Other Study ID Numbers: MS-EV -1.0
Study First Received: September 3, 2008
Last Updated: June 2, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Mellitor:
glucose measurements

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014