Use of Mellitor Sensor for Continuous Glucose Monitoring - An Ex-Vivo Study
1 other identifier
interventional
20
1 country
1
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 Transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the Mellitor sensor.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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 4, 2009
June 1, 2009
7 months
September 3, 2008
June 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
A
EXPERIMENTALGlucose measurements using "Mellitor" device.
B
ACTIVE COMPARATORGlucose measurements conducted by using gold standard, "Yellow Springs" glucose analyzer
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known cognitive or psychiatric disorder.
- Subjects with HIV.
- Subject refuses to sign inform consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mellitorlead
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roi Eldor, MD
Hadassah Medical Organization, Jerusalem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 4, 2008
Study Start
October 1, 2009
Primary Completion
May 1, 2010
Study Completion
October 1, 2010
Last Updated
June 4, 2009
Record last verified: 2009-06