Diabetes and the FDA: A First-Ever Live Chat

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Ain’t no party like an FDA party.

I’m being serious. This Monday, March 31st, the FDA’s Courtney Lias and StripSafely.com‘s Bennet Dunlap will be hosting a live chat about blood glucose meters — and you’re invited.

Lias is the director of the division of toxicology and medical devices at the Food and Drug Administration (that’s the FDA department that oversees blood glucose meters, pumps, CGMs and other diabetes technologies). As I’ve mentioned before, I’ve heard Lias speak and have been extremely impressed by her desire to engage with the patient community — she seems truly committed to listening to and connecting with the people who depend on the technologies that her department oversees. If you ask me, that’s pretty darn cool.

And Bennet, should you not already know him, is one of the masterminds behind StripSafely.com. Father of two kids with Type 1, personally at risk of developing Type 2 himself, he writes the blog YourDiabetesMayVary and is a tireless advocate for people with diabetes. Spend five minutes with him and you’ll walk away not just with a StripSafely lapel pin, but with a newfound belief in the power and importance of patient engagement. (Bennet was one of the instigators behind last week’s push to encourage Arizona’s house of representatives to reinstate insulin pump coverage for adult Medicaid recipients — an effort that, thanks to the participation of people like you, appears to have been successful!)

Bennet, too, is pretty darn cool. And he’s really, really involved in the really, really important effort to figure out a way to ensure the accuracy of blood glucose meters and test strips. This is a big issue at the moment, not just because of the issues with test strip coverage caused by Medicare’s recently rolled out (and disastrous) competitive bidding program for diabetes mail order supplies, but because of ongoing accuracy issues with meters, and the lack of a post-market surveillance program.

So here’s why I’m excited: on Monday, March 31st between 1:30 and 2:30 Eastern time, Dr. Lias and Bennet are joining together to host a ground-breaking live online chat about glucose monitors and test strips! You can read more about the chat — and sign up for it — here. To quote from the FDA’s announcement: 

  • “Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes?
  • Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?

    When you participate in this friendly online chat, you will:

    • Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter-expert and others in the diabetes community.
    • Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.
    • Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.

    Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.”

Translation: this is your chance to communicate with (and ask questions directly to) the FDA about its approach toward the medical technologies and devices that we rely on each day. (Note: this is not about diabetes drugs, just devices.) It’s the first event of its kind, and I encourage everyone who can to sign up  — and bring some questions!
 
Also, if you haven’t done so already, tomorrow’s chat is a great opportunity to figure out what you’d like to say in your comments about the FDA’s new draft guidance for blood glucose meters — a document which outlines the FDA’s new proposed standards that products would have to meet before being cleared for sale. The period for public comment closes April 7 and it is very important for us in the patient community to submit our thoughts and suggestions, so that they can be considered by the FDA when it drafts its official guidance documents. I’ve explained this in more detail and listed some of my own draft comments — which you can feel free to crib from — in my previous run-down of the FDA’s draft guidance; you can also learn more at StripSafely.com. According to Bennet, there are already at least 318 comments on the draft guidance comments — let’s see if we can reach 500! (Many of those 318 are likely from test strip manufacturers, so it’s especially important for us to add patient voices to the mix.)
 
In short: Monday marks the first-ever patient/FDA live chat on diabetes, and will give you a chance to ask your own questions about how the government regulates blood glucose meters and other diabetes devices, and have your suggestions heard. It’s free, it’s from 1:30-2:30 eastern, and it’s going to be great.
 
You can sign up here.
 
Will you join me?

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