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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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Glucose measurements using "Mellitor" device. |
|
| B | Active Comparator | Glucose measurements conducted by using gold standard, "Yellow Springs" glucose analyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mellitor device for glucose measurement | Device | Glucose measurement using "Mellitor" device |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Levy, Dr. | Contact | (972)-4-638-8837 | hanna@qsitemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Roi Eldor, MD | Hadassah Medical Organization, Jerusalem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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