9 Responses

  1. Scott S
    Scott S January 22, 2014 at 11:26 am | | Reply

    While the FDA issued separate guidance, at present, no companies make any products specifically aimed at the clinical care market, and its unclear whether that market is big enough to justify doing so (although the profit margins might be better, so one never knows if that could happen in the future). The industry has 2 possible approaches: the first is that they aim for one standard for both consumer and clinical care, which would mean we all get the tighter standards. The alternative is that they could have the looser standards which could theoretically NOT be used in a clinical care setting, which might piss off many hospital procurement agents. However, the big unknown is what will industry decide?

  2. Bruce
    Bruce January 22, 2014 at 4:33 pm | | Reply

    Left my two cents

  3. Richard
    Richard January 22, 2014 at 9:02 pm | | Reply

    I think the test meters should be replaced with a more accurate constant reading that would be less costly than strips. The technology is available, why not make use of it?

  4. Bennet
    Bennet January 23, 2014 at 8:05 am | | Reply

    Thanks Amy

    Can I play with your chord / music metaphor?

    In all fairness I think FDA has been trying to sing the song of better standards for quite some time, clearly since 2010. Maybe better put that they have been crafting a symphony and StripSafely is a Punk Rock tune.

    Regulations is a long slow symphony. If anything is striking a chord it is that the all the community will be more successful by singing out of the same hymnal and in harmony. That means all the community PWDs, FDA, Industry, payers and CMS.

    Speaking of harmony. Catherine, at ASweetLife, has a nice piece that
    is a melodious companion to your piece here:

    There are some real strengths in FDA proposals we can sing along with. Lets be sure to sing out loud an clear that insulin is a very dangerous drug and to quote Catherine’s piece, “inaccurate meters cannot be used directly for making therapy adjustments.”

    Thanks Amy for this great piece and thanks for the sing along metaphor.

    (also you never want to hear me try to sing) LOL

  5. Richard
    Richard January 23, 2014 at 9:46 pm | | Reply

    What I am talking about is a CGM that is for a long term installation that does not require calibration.

  6. John
    John January 25, 2014 at 4:14 pm | | Reply

    This is nonsense. All meters need to be held to the same standards. There should be no more than a 1-3% margin of error. It’s 2014 and we need to stop making excuses for WHY we can’t do something.

    The logic of testing at home vs in a hospital and it being more important to be accurate in a hospital is ignorant. Last I checked when in the hospital you are surrounded by caregivers to respond to an incident. Not the same at home or in the car and etc where a person may be alone for several hours and deliver too much bonus based on an erroneous number. Unacceptable!

  7. Diabetes Mine & ASWeetLife on FDA’s Draft Meter Guidance – StripSafely

    [...] friends of StripSafely,  Amy Tenderich and Catherine Price have outstanding posts on FDA’s new glucose meter draft [...]

  8. FDA Docket Extended! We Need You. | Diabetes Hands Foundation

    [...] Amy Tenderich at Diabetes Mine [...]

  9. Amitabh Srivastav
    Amitabh Srivastav August 28, 2014 at 3:39 am | | Reply

    I agree with John. +/-15% accuracy for OTC Glucometers is absurd. The Fasting Blood sugar recommended range for type2 NON-insulin dependant DM is 70 to 100. The +/- 15% accuracy will actually give 30% range to the manufacturer and will not give any confidence to the user of such device about his blood glucose status.
    Another issue is very high cost of test strips. I feel that there has to be some standardization in these test strips to enable cost reduction while increasing accuracy.

Leave a Reply