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October 5, 1999

Hypoglycemia, Research: Monitoring

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Question from Florida, USA:

My post adolescent Type 1 diabetic son (diagnosed since age 5) has had 4 major hypoglycemic reactions in the last 6 months. A combination of changes in lifestyle, physical activity, schedules (just entering college), eating patterns, etc., have contributed. Although he monitors frequently, he is still presenting these life-threatening situations. Last night was his latest — unfortunately he was driving and ended up only in a (luckily) moderate auto accident, with no physical injuries.

We understand there is a “GlucoWatch” waiting approval from FDA. My need is now, and desperate. He lives alone, and does not wish to compromise his independence. Though as a parent, I am very afraid for him. Two of his previous reactions he was alone, and it was circumstantial that someone came by to visit and his door was open, and found him in shock, unresponsive.

I find it hard to wait for this GlucoWatch to be FDA approved and market available, maybe over a year. Do you know of anyone that may have a GlucoWatch (as a test sample, etc.) that is no longer needed. I would pay whatever they wanted, just to assure that another reaction is eliminated.

Also, if there is another product out there that can alarm when someone is a low, I would attempt to use whatever is available.

Answer:

From: DTeam Staff

The situation with the GlucoWatch is that all clinical trials with the present model have been completed: it is part of the FDA regulations that all instruments in clinical trial use be withdrawn until approval is or is not granted. It would certainly appear though that approval will be awarded and that the instruments will be available commercially early in the new year (2000). It does have both a high and a low alarm.

In the meantime your son obviously needs to compile a comprehensive profile of his blood sugars and with the help of his diabetes team to review how food intake, exercise and the patterns of insulin type and dose can be better adjusted to avoid these severe hypoglycemic episodes.

DOB