Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

NCT ID: NCT01511861

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlucoVista

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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gluco02

Identifier Type: -

Identifier Source: org_study_id

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