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FDA to Review GlucoWatch on December 6, 1999

GlucoWatch Imagine that there were a product that tested your blood sugar automatically, every 15 minutes. Imagine that the product alarm if your blood sugar reading were too low or too high. Imagine that product were the size of a large wristwatch, and could be worn around your arm. Imagine the the product were non-invasive. Science fiction? No, the GlucoWatch.

On December 6, 1999, at the Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD, the Clinical Chemistry and Clinical Toxicology Devices Panel of the FDA will hold a meeting to determine if the GlucoWatch should be approved for sale in the United States. The public is invited and selected individuals will be allowed to make brief presentations to the committee.

A team of physicians from the Barbara Davis Center (Denver, Colorado), led by Dr. Satish Garg, published the results of a study on the effectiveness of the GlucoWatch. Their study, Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with type 1 diabetes (Diabetes Care 1999 Oct;22(10):1708-14), confirmed "... the accuracy and precision of glucose values as determined using the GlucoWatch biographer in clinic and home settings."

Your presence at this meeting can help convince the FDA committee to permit sale of the product without changes, keeping in place the alarm feature that will make the most difference for everyone with diabetes. If you would like to attend, to listen or to present, please contact Sonia Cooper via e-mail at Sonia has volunteered to coordinate attendance for anyone who would like to attend.

Letter from Children with Diabetes

The following letter from Jeff Hitchcock, President of Children with Diabetes, will be read at the meeting by Sonia Cooper:

Veronica J. Calvin
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850

Dear Ms. Calvin,

I would like to offer the following in support of FDA approval of the GlucoWatch sensor.

Please take an imaginative journey with me, as I paint a picture of what living with diabetes is like.

I want you all to pretend that you are at the Kennedy Center for a night out at the symphony. You and your spouse have the best seats in the house, and the people who would be in front of you didn't make it so you have a clear view of the stage. It's a perfect night.

The director lifts the baton, pauses, and begins. You see the baton flow through the air, see the bows pressed against strings, but hear nothing. You're confused. Then a few moments into the piece, you hear a fleeting note and then return to silence. A few minutes later, you hear one more note but frustratingly return immediately to silence. Again, in a few minutes, you hear another note, and then the piece ends.

This is the life of a person with diabetes. Each day, through finger stick blood tests, a person with diabetes hears but a few notes of his body's symphony. From those few notes, he must make decisions about how much food to eat, how much insulin to inject, and how to integrate exercise into the day. With but a few blood sugar values to go by, he is essentially deaf to his body. If only he could hear more often, he could make better choices.

The management of diabetes is as much about information as it is about insulin and nutrition. The last 20 years has seen a revolution in the quality of diabetes self-management through the availability and affordability of in-home blood glucose monitors. These wondrous devices allowed the first fleeting notes of the body's symphony to be heard. But like a deaf person regaining his hearing, we who live with diabetes hunger to hear more.

The Cygnus GlucoWatch offers us the opportunity to hear more of our body's symphony. Instead of four to six notes a day, we can hear dozens, and what a difference that will make. With more information, we can and will make better decisions about our care. And with better decisions will come improved blood sugar control and, as a result, a reduced risk of complications.

I urge the committee to understand the importance of the GlucoWatch to the millions of people with diabetes who manage their own care and make their own decisions, based on the few blood tests they perform each day. By approving this device, you will not only open their ears to more of their body's symphony, but you will also lay the foundation for even better technology that will one day allow people with diabetes to hear the entire symphony of their body, all day long. That will be sweet music to the ears of everyone who lives with diabetes.

Thank you.

Jeff Hitchcock
President, Children with Diabetes

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Last Updated: Thursday February 27, 2014 19:28:21
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