Glucowatch Monitor Approved

Glucowatch Monitor Approved

GLUCOWATCH MONITOR APPROVED

On December 6, 1999, the U.S. Food and Drug

Administration's Clinical Chemistry and Clinical Toxicology Devices Panel, part of the

FDA's Medical Devices Advisory Committee, met for a final review of the Cygnus GlucoWatch

Biographer. They voted to recommend approval of the machine for marketing in the United

States.

Although final FDA approval, after this committee

vote, is a formality, the age of trouble-free noninvasive glucose monitoring is not here

just yet. What has been achieved?

The GlucoWatch reduces--it does not

eliminate--the need for finger-stick blood glucose testing. It utilizes a consumable pad,

the "sensor," which must be replaced every 12 hours. Each new pad requires

"calibration," which requires a conventional finger-stick glucose monitoring

test.

The GlucoWatch does indeed provide repeat

monitoring--but up to once every 20 minutes--but it is not "continuous

monitoring." What it does offer is a programmable low-glucose alarm, that will sound

an alert if the wearer drops below a user-determined level, helping to avert hypos.

Final pricing is not set, but the company expects

to charge about $250 for the hardware (which should last 3 to 5 years, they say), and $4

each for the sensor pads. As the GlucoWatch utilizes continuous low voltage electricity to

work, you can expect to go through a lot of AAA batteries too.

The device avoids the need to draw blood for each

reading by establishing a chemical coupling through the skin. It reads not blood glucose,

but interstitial fluid glucose, roughly analogous to the "sweet" in your sweat.

It works, but some 10% of test users reported minor skin irritation at the test site.

Does the GlucoWatch work? The FDA thinks so. Has

it been tested on children? Not yet. Is it for everyone? No, it represents incremental

improvement, and an expansion of our glucose testing options. Is it available for sale

yet? No, but VOICE OF THE DIABETIC will tell you when it becomes commercially available.

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EYE STUDIES SEEK VOLUNTEERS

Carolina Eye Associates, an eye physicians' group

serving the Carolinas, east Tennessee, north Georgia, and tidewater Virginia, is

participating in several trials of investigational treatments for diabetic eye

complications. They are seeking volunteers, and you may qualify. Those accepted will

receive free examinations and eye care for the duration of the study.

One study is of an investigational medication for

non-surgical treatment of vitreous hemorrhage. As the majority of these cases follow

proliferative diabetic retinopathy, this medication is of great interest.

The new medication, called Vitrase, is designed

to help clear blood from the vitreous without vitrectomy surgery. They need volunteers, 18

years or older, who have recently experienced bleeding in the back of the eye.

Another study is of an investigational drug to

treat diabetic macular edema. For this study, free pre-screenings are offered, with

detailed eye examination--and the patient will be informed of the results, and appropriate

physician reference provided. Those found eligible will be more fully informed about the

study. For information about either of the above studies, call: 1-800-451-2752.

A number of sites in the U.S. are participating

in the next study, of a new way to "seal" bleeding retinal capillaries without

laser surgery. The condition is called "wet AMD," and the new treatment utilizes

a combination of chemicals and focused light. This study, called "Photopoint" is

seeking men and women over age 50, who have been diagnosed with wet AMD, and who have not

had prior laser treatment. If you are interested in this study, please call:

1-800-451-2752, or (919) 781-2127.

BLINDNESS BOOK AVAILABLE

The National Federation of the Blind has a

resource for people who are newly blind, losing vision, or experiencing visual impairment.

Packed with hints and tested advice, this book, IF BLINDNESS COMES, is available in large

print, 2-track (music) or 4-track (NLS format) audiocassette, free of charge from:

National Federation of the Blind Materials Center, 1800 Johnson Street, Baltimore, MD

21230; telephone: (410) 659-9314. The Materials Center is open 12:30pm to 5pm Eastern

Standard Time, weekdays.