With the excitement over Diabetes Blog Week, I was brought right back down to earth again with two important pieces of news.
One of these stories you probably know already, and one you may not know about at all:
Asante Solutions, makers of the Snap insulin pump (I did the 30 day trial of the Snap last summer), has closed up shop. They left a message on their website Friday saying that they were no longer in business.
This comes as a shock to many, including me. I was so happy with my trial of the Snap last year that I was ready to sign up with Asante the very minute they were approved to use Novolog cartridges (their product only used cartridges filled with Humalog). It was an easy pump to use, it had all of the regular features you’d expect on a pump, plus a couple of extras including its own flashlight, and those glass-filled cartridges filled with Humalog. No more filling reservoirs doesn’t seem like that big of a deal until you actually don’t have to do it anymore. Now, with such a unique feature, Snap users can only use the pump as long as the insulin they have on hand lasts. Unless someone figures out how to refill the used cartridges, which, I don’t even want to think about right now.
It was a big deal last August when Asante announced a partnership of sorts with Dexcom to integrate the Dex mobile app into the Snap architecture. Now that is all for naught, many previously happy pump users have to go searching again, and through the insurance paperwork gauntlet again, and over 100 employees are out of a job.
If you’re a Snap user, you do have an option to transition to the Animas Vibe system. According to Asante’s going out of business announcement, “Animas is graciously offering a limited time offer to all existing Snap users to transition to the Animas Vibe pump.”
No word yet on what that offer might be. To get on your local rep’s call sheet with Animas, call 877-937-7867, extension 1562.
Let’s talk about something better: The U.S. Food and Drug Administration is seeking our input again!
The FDA has prepared draft guidance on collecting and submitting patient preference information, so FDA can consider the benefit-risk thinking of patients using medical devices like insulin pumps and CGMs.
From the introduction of this document, in FDA’s own words:
”FDA believes that patients can and should bring their own experiences to bear in helping the Agency to evaluate the risk-benefit profile of certain devices.”
I’m all for that. Once the draft is finalized, it will become the new standard for how FDA thinks about patient preferences when reviewing the devices we use to help us live better lives.
One thing the draft guidance won’t do: It won’t change review standards for safety and effectiveness, and it won’t create extra burden on sponsors of premarket submissions of devices to FDA.
Still, pretty exciting that we’re being asked for our feedback, that our input will result in edits to existing benefit-risk guidance already in place, and that FDA plans to take it seriously during reviews.
We have until August 17 to leave comments on this guidance, and I, along with some others, are still going over this to try and better understand it (it’s 35 pages long). Hopefully, more information will be forthcoming (he said all officially-sounding).
To get a look at the draft guidance and leave a comment, CLICK HERE.
When was the last time anyone ever asked you to talk about what you like or don’t like about your devices? Asked you what you can live with, and what you can’t? Here’s your chance.
Expect to hear more about this soon.