Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

February 18, 2020 updated by: GlucoVista

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Edith Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with diabetes mellitus type 1 or type 2.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlucoVista

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • gluco02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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