746642
Last Update Posted: 2009-06-04
Recruiting status is unknown
All Genders accepted | 18 Years + |
20 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study
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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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%.
Eligibility
Relevant conditions:
Diabetes Mellitus
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Hanna Levy, Dr.
hanna@qsitemed.com
(972)-4-638-8837
Data sourced from ClinicalTrials.gov