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

NCT ID: NCT00746642

Last Updated: 2009-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

Brief Summary

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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A

Glucose measurements using "Mellitor" device.

Group Type: EXPERIMENTAL

Mellitor device for glucose measurement

Intervention Type: DEVICE

Glucose measurement using "Mellitor" device

B

Glucose measurements conducted by using gold standard, "Yellow Springs" glucose analyzer

Group Type: ACTIVE_COMPARATOR

Mellitor device for glucose measurement

Intervention Type: DEVICE

Glucose measurement using "Mellitor" device

Interventions

Mellitor device for glucose measurement

Glucose measurement using "Mellitor" device

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mellitor

INDUSTRY

Sponsor Role: lead

Responsible Party

Melitor

Principal Investigators

Roi Eldor, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization, Jerusalem

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Hanna Levy, Dr.

Role: CONTACT

hanna@qsitemed.com

(972)-4-638-8837

Facility Contacts

Hanna Levy, Dr.

Role: primary

hanna@qsitemed.com

(972)-4-638-8837

Other Identifiers

MS-EV -1.0

Identifier Type: -

Identifier Source: org_study_id