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Question:

Do you have any thoughts on the Biocontrol Diasensor 1000 non-invasive glucose sensor, and whether, if approved for sale, it will be useful for kids with diabetes?

Answer:
Yes, we do; No, it won't. There are just too many unresolved problems at the present time:

  • As we understand it, the calibration method used requires several blood samples every month at different levels of sugar in order to set the machine's calibration correctly: obviously difficult to do in kids!
  • And the calibration every month (at their facility) will probably involve a financial charge, as well as a major investment of time and effort!
  • And the size and weight of the device are outlandish for kids (or for adults!).
  • And it works only half the time in the relatively few people for whom it does work.
  • Plus, if there's several people with diabetes, they'll each need their own machine: the calibration is individualized to each person, and under no circumstance could a single machine be shared.

We have to remember that people's lives depend on accurate readings, and until the manufacturers can get reliability that is in the range of 95% (rather than 35%), it's just not worth using (or approving, according to the FDA Advisory Panel). We don't feel at all comfortable with a claim that it would benefit "8, 200, 2000, or 2 million people" if two times as many get nowhere with the same device.

Sorry to have to be discouraging; the concept is really exciting, but the practical implementation is still quite a few years off. We're all waiting for better models; several companies are working on similar devices (some quite publicly, and some quite quietly), and we'll keep waiting for a device meeting strict criteria for accuracy and reproducibility, ease of calibration, small size and weight, ruggedness, and low cost.

Original posting 21 Mar 96

  
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Last Updated: Tuesday April 06, 2010 15:08:52
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