Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
Glucose monitoring, GlucoTrack, Self glucose monitoring
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
Detailed description
See Brief summary
Interventions
DEVICEGlucoTrack
comparison of different glucose monitoring devices
Sponsors
Integrity Applications Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1or 2 Diabetes * Anatomically suitable earlobe
Exclusion criteria
* Subjects requiring dialysis * Any conditions that may hamper good contact between the PEC and the earlobe * Pregnancy * Nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clarke Error Grid | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Satisfaction | one year | Based on user questionnaire, user satisfection will be analyzed |
Countries
Israel
Contacts
Primary ContactSagit Saadon, MA
Outcome results
None listed