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  #1   ^
Old Tue, Dec-17-02, 18:29
doreen T's Avatar
doreen T doreen T is offline
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Thumbs up FDA approves over-the-counter diabetes test .. (HbA1c)

Last Updated: 2002-12-17 16:28:20 -0400 (Reuters Health)

WASHINGTON (Reuters) - A test that helps people with diabetes monitor their blood sugar levels can be sold over-the-counter, the US Food and Drug Administration said on Tuesday.

The FDA said it had cleared nonprescription sales of the test, called Metrika A1c Now.

"Over-the-counter status means that the test can now be purchased without a prescription and used at home, with results on the spot, making it readily available to people with diabetes," the agency said in a statement.

The test, made by privately held Metrika, Inc., of Sunnyvale, California, looks for levels of glycated hemoglobin in the blood. It helps patients and doctors monitor blood levels of sugar over time, as opposed to instant tests--now often available over the counter--that take an instant snapshot of levels.

"Glycated hemoglobin is a unique substance created as a result of interaction between hemoglobin and glucose," the FDA said. Hemoglobin is the stuff that makes blood red, and the reading helps patients know what their average blood sugar level was over the past 90 to 120 days.

It is useful in monitoring how well insulin or other diabetes medications are working.

To use the test, the patient pricks his or her finger and puts a drop of blood into a monitor, which reads the levels within eight minutes.

"Unlike some other products, there is no need to send the sample back to the physician to get results," the FDA said. "The patient gets the results on the spot."

An estimated 17 million Americans have diabetes, most of them type-II diabetes associated with obesity and a lack of exercise. "Many of them may find the new home glycated hemoglobin test helpful," the FDA said.
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  #2   ^
Old Wed, Dec-18-02, 19:16
Rodney's Avatar
Rodney Rodney is offline
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Stats: 185/190/170 Male 5' 10"
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Default Hemoglobin A1C

Hey High Blood Sugar Folks,

I think a self test for HA1C is a great idea!!! It is WAY to hard to get a doctor to do the most basic things, like routine bloodwork. It's fine if THEY want a certain test, but don't YOU ask for one. If this test really becomes widely available, and at a reasonable price, it will allow US to take charge of our own diet and insulin control. YEAH!
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  #3   ^
Old Wed, Dec-18-02, 19:30
Lisa N's Avatar
Lisa N Lisa N is offline
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Plan: Bernstein Diabetes Soluti
Stats: 260/-/145 Female 5' 3"
Progress: 63%
Location: Michigan

If it's accurate, it will be a good tool for diabetics. But most (if not all) diabetics should be monitoring their blood sugars daily or at least every other day and already have a pretty good idea how well controlled their blood sugars are. For a while, I was testing 5 times a day but now that I've gotten good control I've backed off to once a day alternating fastings with 2 hour post prandials.
I've always seen the A1C test as the doctor's way to verify whether or not the patient is reporting their blood sugars accurately and controlling their blood sugars consistently instead of just the few days before a doctor visit.
The A1C also can't and shouldn't replace daily self-testing. It gives you an average and doesn't show how high your highs or low your lows were.

Last edited by Lisa N : Wed, Dec-18-02 at 19:34.
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  #4   ^
Old Mon, Jan-20-03, 04:47
kjturner kjturner is offline
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Plan: Bernstein/Atkins
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Location: Georgia


Reasonably priced too.
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