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FDA approves continuous glucose monitor for children

Discussion in 'Parents of Children with Type 1' started by Ellen, Apr 19, 2007.

  1. Ellen

    Ellen Senior Member

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    Hopefully this will help with reimbursement issues.

    FDA approves continuous glucose monitor for children
    See the article on the web:
    http://www.endocrinetoday.com/200704/fda.asp

    From Endocrine Today

    Diabetes

    FDA approves continuous glucose monitor for children

    Continuous glucose monitoring system indicated for children aged 7 to 17 years.

    by Katie Kalvaitis
    ENDOCRINE TODAY STAFF WRITER[​IMG] April 2007
    The Real-Time Continuous Glucose Monitor from Medtronic has been approved for use in children, and according to the company, pediatric-sized models of Medtronic systems will be available soon.
    [​IMG]
    Janet H. Silverstein
    The device is now indicated for children aged 7 to 17 and was previously only available for adults.
    “It is a major step forward,” said Janet H. Silverstein, MD, chief, division of endocrinology, University of Florida, Gainesville, and a member of the Endocrine Today editorial board. “It will benefit both health care providers and their patients. The glucose trend arrows and alarms will provide a sense of comfort that hypoglycemia will not go unrecognized. It is really going to be good for parents who get up all the time because they are worried about nocturnal hypoglycemia in their children.”
    The devices use directional arrows and display real-time blood glucose levels and trend graphs. Warning alarms alert parents and patients when blood glucose levels drop dangerously or rise above preset levels, even when children are sleeping.
    “This technology will give us information that will allow us to make much smarter insulin dose adjustments. It is not just going to be discrete points in time, but rather a good glucose profile during the course of the day,” Silverstein said.
    Silverstein envisions a gradual introduction of the pediatric continuous glucose monitors; the interest is there, but she does not foresee the device replacing fingerstick measurements just yet.
    The continuous glucose monitors show the effects that diet, exercise, medication and lifestyle have on blood glucose levels, and may reduce the duration of hypoglycemic events and lower HbA1c levels by as much as two percentage points, according to Medtronic.
    With a new approval, there may still be issues and barriers to overcome, such as insurance coverage. Mark A. Sperling, MD, professor, department of pediatrics, Children’s Hospital of Pittsburgh, called the FDA approval a good step, however. “This is the first step in the right direction so we can have a fully programmable closed-loop device, a so-called artificial pancreas,” said Sperling, also a member of the Endocrine Today editorial board.
     
  2. Aprilsmom

    Aprilsmom Approved members

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    This is totally awesome in more than one way. Dr. Silverstein is my daughter's doctor at Shands in Gainsville and she is also awesome(sorry, I just had to throw that in!!)
     
  3. Ellen

    Ellen Senior Member

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    Becky, glad to hear that. Not to start any rumors, but I heard she was not particularly pump savvy or pump friendly as a ped endo. Has that changed?
     
  4. Aprilsmom

    Aprilsmom Approved members

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    Ah, you are correct, although she is not dead set against it. She just like to give the body a little time, as she puts it to adjust.
     
  5. Mama2H

    Mama2H Approved members

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    The approval was a few weeks ago I believe as that is what I based my barage to the insurance on. I am so glad we are getting closer to everyone being able to get one!
     
  6. Jen Jen

    Jen Jen Approved members

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    I don't care for Dr. Silverstein in the slightest. Actually, in all honesty, I can't stand her. I do not recommend letting her give any child the 'D' chat about taking care of themselves, seen more than one child traumatised by it. When I received it from her back in the day(I was going to die a horrible death, all kinds of stuff you just don't threaten, or appear to threaten at least, a teen with an a1c of 6.0% with, there are risks and complications and such, but brutal information to a kid or teen in the way it was presented, was not appropriate), I just told her to kiss somewhere where the sun don't shine and did my own thing which proved to be better(Who'd have thunk you could adjust your own insulin dosage to different things, such as food, stress, anything that might affect BGs up or down, eh?). I went to her for quite a few years(just to get the prescriptions), and there were quite a few battles between her and I. She tends to get stuck behind the times, she's not too fond of new stuff, or strong willed patients with too much knowledge and nerve to use that knowledge. She may have changed over the last few years and actually got past the 80s.... But to each their own.

    Dr. Muir still at Shands? He was alright, better with kids and teens, just curious if he's moved on or still there.
     
    Last edited: Apr 20, 2007
  7. badshoe

    badshoe Approved members

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    ... but how do you really feel Jen Jen? LOL
     

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