Diabetes Mellitus Clinical Trial
Official title:
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liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be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%.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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