We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511861
First Posted: January 19, 2012
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlucoVista
  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
Official Title: Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Resource links provided by NLM:


Further study details as provided by GlucoVista:

Estimated Enrollment: 137
Study Start Date: November 2010
Estimated Study Completion Date: January 2018
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511861


Locations
Israel
Edith Wolfson Medical Center
Holon, Israel
Sponsors and Collaborators
GlucoVista
  More Information

Responsible Party: GlucoVista
ClinicalTrials.gov Identifier: NCT01511861     History of Changes
Other Study ID Numbers: gluco02
First Submitted: January 13, 2012
First Posted: January 19, 2012
Last Update Posted: December 1, 2016
Last Verified: November 2016

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