What are the main differences between Type 1 and Type 2 in terms of non-invasive reading?
Type 1 diabetics may have very low glucose levels such as 25mg/dL. This is very difficult to recognize non-invasively.
In addition, blood glucose in Type 1 diabetics may go up or down relatively fast that may cause additional issues in recognizing glucose levels non-invasively .
Summarizing these two basic facts, Type 1 diabetics fluctuate in comparison to Type 2.
Why are we restricting the Combo Glucometer sales to patients with a minimum glucose level of 70 mg/dl?
Some diabetes patients may have very low glucose levels such as 25mg/dL.
This is very difficult to quantify in a non-invasive method.
In addition, high fluctuations of blood glucose may cause difficulties in recognizing glucose levels.
What about children?
The Combo Glucometer has undergone extensive clinical trials in Israel and the U.S.
Cnoga Medical has conducted clinical trials only on adults. The current device configuration was not tested on children, therefore we are currently restricting sales only for adults.
Cnoga Medical is committed to find a non-invasive solution for children and we hope that in the near future our unique technology will also serve diabetic children as well.
Why does our Combo-Glucometer need personal calibration?
Personal calibration is a tailored solution that reduces some of the difficulties in a universal calibration solution.
Universal calibration uses a single scale for all patients while personal calibration uses a single scale for each individual.
For example, if a patient has readings in the interval [A, B] of glucose levels between 80mg/dL to 220mg/dL, the same interval may be suitable in the range of 40mg/dL to 325mg/dL for another patient.
One of the most difficult tasks in having a universal calibration is to normalize all scales to a single scale in order to use a universal calibration.
Nonetheless, in the future we may introduce cluster calibration which means that the device may be calibrated by groups of patients.
What it takes to perform personal calibration?
This is an easy process performed by the patient when receiving the device for the first time.
Full instructions can be found in our CGM manual (Combo-Glucometer User Manual).
To summarize, in order to use the device non-invasively, the patient needs to “teach” the device all it needs in order to measure glucose levels.
The procedure is easy and needs no technical expertise. The patient will need to perform between 50 to 100 reading cycles – each cycle consists of 2 invasive readings (using the supplied strips, lancets and the invasive add-on) and one non-invasive reading.
Once the device has accumulated sufficient data, a message will be displayed that the device has completed the calibration. From then on, the patient can measure glucose levels non-invasively.
Why is it so difficult to measure glucose non-invasively?
Scientists have not yet found a single light wavelength or light wavelength band transmitted from outside the human body into the blood tissue that is absorbed ONLY by blood glucose.
If this was feasible, then non-invasive 1-1 glucose readings would have been a simple task.
Therefore, more complicated methods and algorithms are being used to overcome the ambiguity in non-invasive glucose readings.
The meaning of Ambiguity is that there is no single order in non-invasive glucose readings.
What about Certifications and Registration? Is the CE mark enough?
Every country is responsible for the well-being of its citizens and therefore, under the local laws and regulations, they try to make sure that usage and import of medical devices is under tight control so as not to endanger its citizens.
All medical devices need to be under the supervision of this regulatory body and so the CE mark was introduced.
Every medical device that is imported and sold in the EU countries needs to be tested and approved for use and given a CE number.
Cnoga Medical devices are approved for marketing in the following countries:
- Brazil – ANVISA Certification
- Israel – AMAR Certification
- China – CFDA certification
- Europe – CE certification