Diabetes Mellitus Type 1 Clinical Trial
Official title:
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic
goal that can be achieved with a true non-invasive device offering the likelihood of
continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary
blood from the fingertips, from venous/arterial line blood samples and from a daily
calibrated Subcutaneous Blood Glucose Monitor (SBGM) which 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 CGM-305 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. The safety of the Glucometer CGM-305 in evaluating blood glucose levels
2. The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
n/a
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