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 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:
- The safety of the Glucometer GM-205 in evaluating blood glucose levels
- The accuracy of the Glucometer GM-205 in evaluating blood glucose levels
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device|
- assess the accuracy of the Glucometer GM-205 blood glucose [ Time Frame: the study is consist of two parts, each part lasts a few hours. ] [ Designated as safety issue: No ]
To assess the accuracy of the Glucometer GM-205 blood glucose readings as evaluated by:
- Mean relative error when compared to venous blood glucose measured by a laboratory device and SBGM (home use glucometer)
- Correlation with values measured by glucose hexokinase based assay
- Clark error grid with measurements of venous blood as the comparing value
- The safety of the Glucometer GM-205 in evaluating blood glucose levels [ Time Frame: the study is consist of two parts, each part lasts a few hours. ] [ Designated as safety issue: Yes ]
Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity.
The study will evaluate safety by assessing:
- Device related adverse events: local and systemic effects of the Glucometer GM-205 including: redness, burns, pain , or other complications.
- General adverse events: Adverse events not directly related to the Glucometer GM-205 device but are related to the study procedure (i.e clamping), such as: local infection, blood clot, bleeding, hypoglycemia.
|Study Start Date:||September 2012|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|controlled type one diabetes mellitus.||
Device: Glucometer GM-205
The study procedure consists of two days trial. Each day consists of 4-6 hours, during which, hyper and hypoglycaemic clamp will be done. The first day will be used to calibrate the non-invasive Glucometer GM-205 for the specific patient.. The calibration will be done using the hexokinase assay (YSI 2300 STAT Plus) from the venous. During the second day, hyper and hypo glycemic clamp will be done and the results of blood glucose level reading from the non-invasive
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508065
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Hadassah Medical Organization|