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Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

This study is currently recruiting participants.
Verified January 2012 by GlucoVista
Sponsor:
Information provided by (Responsible Party):
GlucoVista
ClinicalTrials.gov Identifier:
NCT01511861
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.

The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.

The primary objectives of the trial are to determine:

  1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test
  2. Creating database of glucose levels readings utilizing the Glucometer GM-205.

Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlucoVista:

Estimated Enrollment: 100
Study Start Date: November 2010
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with diabetes mellitus type 1 or type 2.

Criteria

Inclusion Criteria:

  1. Diabetes Mellitus type one or type two.
  2. Patients that are using Insulin.

Exclusion Criteria:

  1. Vascular diseases
  2. Pregnant and lactating women.
  3. Exclusive use of long term Insulin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511861

Locations
Israel
Edith Wolfson Medical Center Recruiting
Holon, Israel
Contact: Julio Wainstein         vainstein@wolfson.health.gov.il    
Sponsors and Collaborators
GlucoVista
  More Information

No publications provided

Responsible Party: GlucoVista
ClinicalTrials.gov Identifier: NCT01511861     History of Changes
Other Study ID Numbers: gluco02
Study First Received: January 13, 2012
Last Updated: January 18, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013