Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
Primary Purpose
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
GlucoTrack
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Blood glucose monitoring, Non invasive Blood glucose monitoring
Eligibility Criteria
Inclusion Criteria:
- Patients with Type 1, Type 2, or Gestational Diabetes
- Above the age of 10
Exclusion Criteria:
- Does not meet inclusion criteria
- Patients requiring dialysis
- Participation in other clinical investigations within the previous month.
- Pregnancy(excluding patients that intend to participate in the gestational group)
Sites / Locations
- Soroka University Medical Center
Outcomes
Primary Outcome Measures
Clarke Error Grid
Secondary Outcome Measures
Full Information
NCT ID
NCT00433758
First Posted
February 8, 2007
Last Updated
March 17, 2008
Sponsor
Integrity Applications Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00433758
Brief Title
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
Official Title
Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Integrity Applications Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels
Detailed Description
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. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. 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. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed.
The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes
Keywords
Diabetes, Blood glucose monitoring, Non invasive Blood glucose monitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
GlucoTrack
Intervention Description
GT
Primary Outcome Measure Information:
Title
Clarke Error Grid
Time Frame
Clarke Error Grid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Type 1, Type 2, or Gestational Diabetes
Above the age of 10
Exclusion Criteria:
Does not meet inclusion criteria
Patients requiring dialysis
Participation in other clinical investigations within the previous month.
Pregnancy(excluding patients that intend to participate in the gestational group)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Harman-Boehm, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84141
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
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