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Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

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ClinicalTrials.gov Identifier: NCT01511861
Recruitment Status : Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
GlucoVista

Brief Summary:

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 or disease
Diabetes Mellitus

Study Type : Observational
Estimated Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources





Information from the National Library of Medicine

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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.

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

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

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