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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00746642
• Other study ID #: MS-EV -1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: September 3, 2008
• Last updated: June 2, 2009
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2009
• Source: Mellitor
• Contact: Hanna Levy, Dr.
• Phone: (972)-4-638-8837
• Email: hanna[@]qsitemed.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Mellitor device for glucose measurement
Glucose measurement using "Mellitor" device

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Mellitor

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.		during glucose measurements	No