Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 1
- Sponsor
- GlucoVista
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
- Last Updated
- 7 years ago
Overview
Brief Summary
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:
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels
- The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
Time Frame: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay
Time Frame: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value
Time Frame: will be assessed after second experimental day
Secondary Outcomes
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels(The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.)