I read with interest your comments regarding your views on the Diasensor 1000 non-invasive blood glucose monitor. I have a problem with your answer that you would NOT recommend this product and the reasons that were given. First of all, it is true that the product is not yet ready for distribution in this country (thanks to the FDA - that's an entirely different matter) however, it is being assembled and shipped to England and shortly to Korea. The company is in the process of producing the first 30 production models for distribution to candidates for the follow-on FDA trials. An additional 2,500 units will be made and probably end up overseas, unless the FDA moves more quickly than it has in the past.
I recently flew up to Pittsburgh to see the R&D site, the manufacturing area and the calibration center. I watched as a diabetic patient went through her calibration. Yes, I actually saw the machine working. In fact, I even had my own skin calibrated to the machine.
The machine only needs to be calibrated up front, over a day or two period - and then only once a year or so. Calibration centers are planned for all over the U.S.A. The calibration procedure no longer requires 30 or so finger sticks just a simple venapuncture. Since an individuals' calibration is stored on a PCMCIA card (like the little credit card sized deal in your computer) the machine will work with different individuals who then only have to insert this card before the reading. Unlike invasive monitors, the machine will be unaffected by false and inaccurate readings for dehydration conditions. As to the size, well, my ten year old son does not have a problem with the fact that he will have to come into the house for his blood test. Sure, we will not be able to take the current model "on the road" with us. However, we have found that we do 80-90% of our testing in the home. In addition, as more data becomes available on the current technology, the hope is to bring down the size and cost of these machines.----Remember what the first computers and calculators looked like!!!!
I was particularly struck by your comments that you were not satisfied that the machine did not work for everyone. The current machine is an order of magnidude or two better than the model that was presented to the FDA. The accuracy range versus the industry standard YSI (Yellow Springs Instrument) blood glucose test machine is in the range of 85-95%. This exceeds that of some invasive monitors and is clearly equal to all current monitors available to the public today.
As for the fact that the machine does not work for everyone, this is true. Much of this has to do with the apparent differences in human skin thickness, reflectivity and absorption of near infrared (IR) light. No correlation has been determined to correspond to age, sex, race or any other obvious factors. However, once again, the new production model is many times more sensitive and able to include more people than the beta model put before the FDA. I realize that it still may not work for everyone but that is certainly not a reason to withhold this technology from those who can benefit from it.
I'm not a doctor or a scientist. Just a parent who wants to do what he can for his child. I welcome all comments to:
Ronald Neil Brenners
2313 Dunwick Drive
Plano, Texas 75023
It's good to learn that the Diasensor has already had improvements in its design since the model that the FDA Advisory Panel rejected.
We would like to point out that an Advisory Panel of diabetes experts was appointed by the FDA to review the data as presented. It was not the FDA, but diabetes experts, that looked at the information.
As we stated previously, the concept is really exciting.
The interested reader needs to look at the new issue of Diabetes Forecast, May 1996, pages 71-72, in the section "Eye on Business," and read the article entitled "FDA Advisory Panel Fails to Recommend Biocontrol's Noninvasive Meter For Approval."
Original posting 19 Apr 96
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