Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

• Conditions: Diabetes Mellitus

• Registration Number: NCT01511861
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2012-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 137

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel