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

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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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

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

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Mellitor device for glucose measurement


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Glucose measurements using Mellitor device. | Device: Mellitor device for glucose measurement<br>* Glucose measurement using Mellitor device<br>|
| Active Comparator: B<br>Glucose measurements conducted by using gold standard, Yellow Springs glucose analyzer | Device: Mellitor device for glucose measurement<br>* Glucose measurement using Mellitor device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose measurements