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NCT01511861 Clinical Trial

Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Diabetes Mellitus Clinical Trial

Official title:
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01511861
Other study ID # gluco02
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2010
Est. completion date December 2021

Study information
Verified date February 2020
Source GlucoVista
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 137
Est. completion date December 2021
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Edith Wolfson Medical Center Holon

Sponsors (1)
Lead Sponsor Collaborator
GlucoVista

Country where clinical trial is conducted

Israel, 

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