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Clinical Trials/NCT01511861
NCT01511861UnknownNot Applicable

Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

GlucoVista1 site in 1 country137 target enrollmentStarted: November 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
137
Locations
1

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diabetes Mellitus type one or type two.
  • Patients that are using Insulin.

Exclusion Criteria

  • Vascular diseases
  • Pregnant and lactating women.
  • Exclusive use of long term Insulin.

Investigators

Sponsor
GlucoVista
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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