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June 16, 2000

Research: Monitoring

Question from Del Rio, Texas, USA:

In December of 1999, the FDA Advisory Committee recommended approval of the GlucoWatch for persons over the age of 18. Are they looking toward the use for those under 18?

Answer:

I am not personally involved with the research studies on the GlucoWatch. From what I understand, right now it is only being evaluated and approved for adults. It is apparently too big in its present form to fit on the wrist of a small child. If it receives approval for adults, hopefully the company will try to develop a smaller version and go through all the testing (and time and expense) to make a product suitable for young children (who obviously would tremendously benefit from such a device). A product that gives wrong readings could be more dangerous than no product at all.

There are technical issues for use small children that must be worked out — in addition to the fact that the FDA requires extra testing for approval in children even if the product appears to be suitable for children. Obviously, the market for such a device in children would be large and hopefully help to speed the process.

TGL

[Editor’s comment: Studies of the GlucoWatch in children under 18 are planned.

JSH]