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

Primary Purpose

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
GlucoTrack
Sponsored by
Integrity Applications Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 1 Diabetes Mellitus focused on measuring Glucose monitoring, GlucoTrack, Self glucose monitoring

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soroka University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.

Outcomes

Primary Outcome Measures

Clarke Error Grid

Secondary Outcome Measures

User Satisfaction
Based on user questionnaire, user satisfection will be analyzed

Full Information

First Posted
April 28, 2009
Last Updated
April 29, 2012
Sponsor
Integrity Applications Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00889668
Brief Title
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
Acronym
CR-01-001
Official Title
Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrity Applications Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

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
Keywords
Glucose monitoring, GlucoTrack, Self glucose monitoring

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
GlucoTrack
Intervention Description
comparison of different glucose monitoring devices
Primary Outcome Measure Information:
Title
Clarke Error Grid
Time Frame
one year
Secondary Outcome Measure Information:
Title
User Satisfaction
Description
Based on user questionnaire, user satisfection will be analyzed
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sagit Saadon, MA
Phone
+972 (8) 675-7878
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Harman-Boehm, MD
Organizational Affiliation
Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer-Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adi Gluzberg
Phone
+972-52-6401020
Email
adi_g@medicsense.com
First Name & Middle Initial & Last Name & Degree
Ilana Harman-Boehm, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device

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