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Sponsored by: |
Mellitor |
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Information provided by: | Mellitor |
ClinicalTrials.gov Identifier: | NCT00746642 |
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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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%.
Condition | Intervention |
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Diabetes Mellitus |
Device: Mellitor device for glucose measurement |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Glucose measurements using "Mellitor" device.
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Device: Mellitor device for glucose measurement
Glucose measurement using "Mellitor" device
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B: Active Comparator
Glucose measurements conducted by using gold standard, "Yellow Springs" glucose analyzer
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Device: Mellitor device for glucose measurement
Glucose measurement using "Mellitor" device
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hanna Levy, Dr. | (972)-4-638-8837 | hanna@qsitemed.com |
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Roi Eldor, MD | Hadassah Medical Organization, Jerusalem |
Responsible Party: | Melitor ( Dr. Hanna Levy - study director ) |
Study ID Numbers: | MS-EV -1.0 |
Study First Received: | September 3, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00746642 |
Health Authority: | Israel: Ethics Commission |
glucose measurements |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |