As you may know, JDRF has been circulating a petition to ask the FDA to speed the development/approval of an artificial pancreas. (More specifically, the FDA is expected to issue guidelines related to diabetes technologies, and JDRF wants those guidelines to make the approval process as fast and streamlined as possible.) Today’s the last day to sign it — if you’re interested, here’s the petition link:
I don’t like signing things that I don’t understand, so here’s what JDRF is actually asking for:
1. short-term in-hospital evaluation of artificial pancreas systems, followed by
2. clinical outpatient trials no more than three months long
In other words, JDRF wants FDA to simplify and speed up the process of approving the devices that would be necessary for the development of an artificial pancreas system — that is, a closed loop monitor and insulin pump that would be able to manage blood sugar without input from the user.
JDRF (and many other Type 1s) are really frustrated at the glacial speed at which the FDA has been progressing with diabetes technology. For example, Minimed’s Veo pump includes a feature where it will shut off insulin delivery if its accompanying glucose monitoring system senses hypoglycemia. Your blood sugar’s low? Your pump automatically shuts itself off. Seems like a no-brainer. It was approved in Europe more than two years ago, but is not available here. Similarly, Animas and Dexcom have gotten approval in Europe for the Animas Vibe, which will incorporate the Dexcom CGM in a way similar to Minimed’s integrated pump/CGM — but the FDA has not. I’m all for high standards and scientific proof of effectiveness, but there’s a time when these hurdles hamper rather than help.
Anyway, if you’re interested, here’s the full text of the JDRF petition. Remember, today’s the last day!
“Whereas, an artificial pancreas represents the most revolutionary advance in treating type 1 diabetes since the discovery of insulin,
Whereas FDA obstacles have kept a low glucose suspend device, the precursor to an artificial pancreas, from being available to patients in the U.S.
Whereas, availability of an artificial pancreas is a top priority for the type 1 diabetes community because of its potential to improve safety and transform the lives of people with the disease,
Therefore, we the undersigned, urge the FDA to issue guidance by December 1st adopting outside clinical recommendations allowing short term in-hospital evaluation of artificial pancreas systems followed by outpatient trials no more than three months long.”