Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device (CR-01-001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Integrity Applications Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Integrity Applications Ltd.
ClinicalTrials.gov Identifier:
NCT00889668
First received: April 28, 2009
Last updated: April 29, 2012
Last verified: April 2012

April 28, 2009
April 29, 2012
May 2009
October 2012   (final data collection date for primary outcome measure)
Clarke Error Grid [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00889668 on ClinicalTrials.gov Archive Site
User Satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]
Based on user questionnaire, user satisfection will be analyzed
Not Provided
Not Provided
Not Provided
 
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.

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

See Brief summary

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
Device: GlucoTrack
comparison of different glucose monitoring devices
Experimental: Experimental
subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.
Intervention: Device: GlucoTrack
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
10 Years and older
No
Contact: Sagit Saadon, MA +972 (8) 675-7878
Israel
 
NCT00889668
CR-01-001 CTIL
Yes
Integrity Applications Ltd.
Integrity Applications Ltd.
Not Provided
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
Integrity Applications Ltd.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP