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Posts tagged ‘artificial pancreas’

Congress Listens!

“You need a time out!” Luke said, as I snarled and stomped down stairs. He was right. I’d just gotten back from four days of glad-handing, schmoozing, and pitching T1 research funding in Washington DC, and I was exhausted and having a toddler-class melt down.

But it was so worth it. Every year, JDRF brings advocates to DC to lobby their state legislators  on one or two specific points, and it’s an antidote to cynicism. JDRF takes a couple days to bring the advocates together before turning them lose on the Hill, and these are all some extraordinary people. Some have lost children to T1, some immediate family, many live with it themselves, and all have harrowing stories – yet they positively radiate joy and enthusiasm. I wish there had been more time just to hear everyone’s stories and meet more bloggers in person. I briefly met Karen and Jeanne and hope to meet Moira, Hallie, and Kathy some other time.

There were glimpses of DC’s underbelly. One morning, as we waited in line to get into one of the Congressional buildings, we saw a lobbyist flap down the stairs past us, with his garish tie, trenchcoat, and all. He cackled, “Don’t bother going in – we got all the money, and there’s nothing left!” DC humor.

But we were there as volunteers, and staffers visibly softened when we explained we were there for children, siblings, parents, friends, or ourselves. Sympathy doesn’t always break down along party lines – often it’s a staffer’s or legislator’s personal connection that turns an office into a supporter. Not all legislative offices genuinely back continued research funding, but most find the “ROI” pretty compelling. One third of Medicare costs currently go to diabetes, and one out of three Americans born this year will develop diabetes. Most will develop Type 2, but Type 1 rates are doubling every 20 years, and the average age of diagnosis keeps dropping (Luke will soon be typical).

Last year, lobbying (from the ADA and the National Indian Health Board as well as JDRF) renewed the Special Diabetes Program, which provides $150 million annually for research. It has helped reverse retinopathy, stopped T1 from progressing in trials, funded smart insulin development, and moved the Artificial Pancreas closer to reality. All this will disappear unless Congress votes to renew the SPD this year (hint – you can help in minutes).

Friday, as we arrived, we heard that the FDA just approved Artificial Pancreas out-patient trials that will run till 2014. Thanks to the 100,000+ signatures JDRF gathered, and thanks to Congress urging the FDA to move ahead “expeditiously” with a framework for the trials, we’ve come to the point where someone like Sen. Shaheen’s granddaughter might get a real vacation from diabetes.

And my son won’t have to put me in time-out when I come home, exhausted but happy.

A few random images (thanks to Brendy, the other WA delegate, who helped me overcome my aversion to cameras!):

Brendy deep in the glamorous part of lobbying - writing notes in the crowded cafeteria

We brave the tunnels under the Hill

Latte = strong coffee + lightener?!

Some legislators are roughing it...

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!

No Tricks, All Treats!

While everyone’s posting great ways to raise Diabetes Awareness this month and still wading through all the great Halloween pix from last month, there’s another (wonky) reason to celebrate: the FDA is allowing Medtronic to move ahead with in-home trials of its low-glucose suspend technology! You know – the one already in use in every country that sells Medtronic pumps. We’re catching up, people!

If you’re one of the 100,000+ who’ve signed JDRF’s petition telling the FDA to get a move on, pat yourself on the back – and if you haven’t, there’s time till December 1st: http://takeaction.jdrf.org/site/PageNavigator/APAC.html

The other small reason to celebrate is that out-patient trials of the artificial pancreas in France and Italy showed great results. Participants had near normal blood sugars after eating out at a restaurant and letting the AP manage their blood sugars for 24 hours. More on JDRF’s blog.

Trick-or-treat a few years (please, not decades) down the line, with no parental oversight involved? Sweet!!!

Sign the Petition: Tell the FDA to Get a Move On!

Here’s another opportunity to tell the FDA to get a move on with its consideration of the artificial pancreas (the nitty gritty: guidance around out-patient trials) – take a minute and add your name to the petition!

http://takeaction.jdrf.org/site/PageNavigator/APAC.html

The first phase of the artificial pancreas, a pump that suspends insulin during low blood sugar, is already approved and in use in EVERY COUNTRY where pumps are sold, EXCEPT THE US. The FDA is concerned that allowing pumps to suspend insulin during a low could cause high blood sugar afterwards - or DKA.

Well, Medtronic has sold 55,000 units of its first-phase artificial pancreas, the Veo, with no recorded incidents of DKA, and many annecdotal and documented incidents of dangerous low blood sugars averted.

In the US, the next step is out-patient trials of the artificial pancreas. The JDRF proactively submitted proposed guidance around these trials to the FDA, and the FDA responded with guidance that is cumbersome (like requiring every version of every separate CGM to go through trials to prove safety and effectiveness) and could drag trials to a halt.

The FDA is risk-averse, does not fully understand that regulating blood sugars is a dangerous process as it is (the FDA believes that allowing any automatic regulation of blood sugar is inherently dangerous), and really, really needs to hear from everyone that lives are at stake.

Please take a minute to sign the petition.

If that made you feel good (it should!) there are a few other things you can do:

If you want to help the JDRF in its efforts to get the artificial pancreas into our hands:  

  • Sign up to become an advocate (you’ll get emails asking for help with online campaigns – takes maybe an hour of your time a year and has a huge impact).
  • Sign up for the Promise to Remember Me campaign: meet with your state legislators in person and tell them what the artificial pancreas could mean for you, your family, or your loved ones. The focus of the Promise campaign this year is on getting the FDA moving – your legislators need to hear from you! They have many other things pulling at their attention right now – we need to keep this on their radar, and in-person meetings are very effective at doing that.
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