The relative accuracy of blood glucose meters has of course been in the spotlight of late, since the FDA held a hearing to “crack down” on this issue last Fall. Funny, but I always assumed this had more to do with the technology inside the meter than the test strips themselves. Silly me.
One of this year’s buzzwords at the ADA Conference in Orlando last week was the “PQQ Enzyme” {glucose dehydrogenase (GDH)-pyrroloquino-linequinone (PQQ)} –…
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By
AmyT on
March 31, 2010
Today, Sanofi-Aventis announced that it’s getting into the glucose meter manufacturing business, by partnering with a small company known for highly accurate meter technology, AgaMatrix (makers of WaveSense products, based on a patented electrochemistry formula).
Reports say the new Sanofi-branded meters will be out later this year, and that this move is part of a larger strategy to help Sanofi offer a “full diabetes management solution” — beyond its insulins, Lantus and Apidra, and the…
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By
AmyT on
March 24, 2010
More details on the recent FDA Hearings on the accuracy of blood glucose monitoring devices: I was surprised by the report from patient advocate Ellen Ullman on Monday, noting that patient interests seem to be grossly underrepresented, and lots of experts seem to believe that the status quo of +/- 20% error margin is all that any of us need (or can handle). Grrrrr….
See Dear FDA over at “Your Diabetes May Vary” for an…
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By
AmyT on
March 22, 2010
Many of you may know that the FDA held a two-day Public Hearing on the issue of Glucose Meter Accuracy late last week. Dozens of experts gathered at the Washington DC Hilton/Gaithersburg Hotel to lend testimony.
The issue at hand, according to FDA statements, is that:
“Glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been approved for this use. There is currently no consensus…
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