Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
CR-01-001
1 other identifier
interventional
180
1 country
1
Brief Summary
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics. The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels. The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2009
Typical duration for phase_1
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
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMay 1, 2012
April 1, 2012
3.4 years
April 28, 2009
April 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clarke Error Grid
one year
Secondary Outcomes (1)
User Satisfaction
one year
Study Arms (1)
Experimental
EXPERIMENTALsubjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.
Interventions
Eligibility Criteria
You may qualify if:
- Type 1or 2 Diabetes
- Anatomically suitable earlobe
You may not qualify if:
- Subjects requiring dialysis
- Any conditions that may hamper good contact between the PEC and the earlobe
- Pregnancy
- Nursing mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soroka University Medical Center
Beersheba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilana Harman-Boehm, MD
Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
May 1, 2012
Record last verified: 2012-04