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Posts tagged ‘FDA’

And the FDA’s heart grew three sizes that day…!

And what happened then…?

Well…in Who-ville they say

That the FDA’s small heart grew three sizes that day!

And the minute his heart didn’t feel quite so tight,

He whizzed with his load in the bright morning light!

He brought the T:slim, iBGStar, iPro2, and the Veo!

And he… HE HIMSELF…!

Gave AP draft guidance the OK-o!

No one’s getting these in their stockings yet, but the ice may be melting as approvals for new products and trials trickle through.

Jeffrey Brewer (JDRF) just posted a thank you to everyone who helped bring about the FDA’s Artificial Pancreas guidance approval (which covers requirements for in-home AP trials), and it’s quite the list: endocrinologists, diabetes organizations (AACE, ADA, AADE, Endocrine Society), Children’s Congress participants, Congressional members (see? – they did accomplish something this year!), grass-roots advocates, petition signers, and the T1D community in general. Likely that includes YOU. 🙂

JDRF’s still waiting to see how guidance requirements will really play out when trials get underway, but they’re “cautiously optimistic.” Joshua Levy and Amy Tendrich have great analyses.

As Suess would say – with everyone making a racket, the FDA heard loud and clear,

We are here! We are here! We are here! We are here!

Tell the FDA: we need pumps that suspend during hypoglycemia!

 Bennett (Your Diabetes May Vary) just posted that the FDA is taking comments on whether to allow pumps to suspend insulin delivery when blood sugar is low.

Um, let me think….

Hell, yes!!!

Repeat after me: Dear FDA… is GREAT, but in case you just want the quick and dirty, here it is:

Proposed FDA guidance they’re seeking comment on covers:  
  • Guidelines to consider approving low glucose suspend
  • Risk of raising A1C with such a system
  • Considering studies for people under age 18

Comment (comment period closes Sept. 20), call or email your Congressional representatives to let them know about this incredibly important issue (setting aside how we feel about most of Congress right now), and sign up to meet with your representatives personally about this issue in the next month or two:

Go, DOC!!!


Here are the comments I submitted:

I am a parent of a three year old child with type 1 Diabetes, diagnosed at 14 months. He uses an insulin pump and CGM, and we rarely sleep through the night: due to the immediate danger of hypoglycemia, we usually wake up several times to check his blood sugar, especially when he’s sick, the weather changes, he’s going through a growth spurt – there are almost infinite variables that can change how much insulin the body needs, and young children need such tiny amounts that the slightest change in need can easily cause severe hypoglycemia.
If his pump were allowed to suspend based on a predictive low, it might someday save his life.
As you consider low glucose suspend and the potentially higher blood sugars it might cause, please keep in mind that a number of young people with T1D have recently passed away due to over night hypos. JDRF in-patient trials have proven that the increase in A1C from glucose suspend is negligible and is more than offset by the tighter control allowed by having an artificial pancreas – even one that just consists of glucose suspend.
In short, hypoglycemia kills IMMEDIATELY and often without warning, despite near-constant vigilence. Hyperglycemia is a long-term risk, and perversely one that is increased by NOT having glucose suspend: people with T1D often chose to let their blood sugar run higher in order to be safe, especially through the night, because there’s currently no technology to suspend insulin when that happens.
We’ve already lowered our son’s A1C 1 full point just by having the CGM – it allows us to keep slightly tighter control, knowing that the CGM will often alert us to oncoming lows.
I strongly urge the FDA to prioritize expeditious approval of glucose suspend technology, already approvied in Europe. Hypoglycemia is taking the lives of American children and adults who could be saved while we wait.