Tag Archives: FDA

And then there’s the real world.

May 19, 2015 – 10:50 am

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.

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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The FDA has prepared draft guidance on collecting and submitting patient preference information, so FDA can consider the benefit-risk thinking of patients using medical devices like insulin pumps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.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , , | Comments (1)

More Diabetes UnConference News, and FDA doings too.

March 27, 2015 – 9:38 am

I know I’ve written a lot about The Diabetes UnConference, but I need to share this bit of exciting news:

First: There will be another Diabetes UnConference in Las Vegas next year!
Details are still being worked out, but it will be in Las Vegas, and it will be in March 2016. For me, this is very encouraging. There were many people from the western part of the USA who attended this year, and I know at least a couple would not have made the trip had it not been so close. So I’m glad that adults living with diabetes in Nevada, Arizona, California, Utah, and other western states will have something relatively close to go to. But that’s not all….

Second: There will be an East Coast version of the Diabetes UnConference in the Fall of 2016!
Again, it’s still in the planning stages, and there isn’t much to tell yet, but for all of you who can’t quite make the trip to Vegas next year, know that there will be an East Coast UnConference in the fall. More to come on that development. But wait… that’s not all…

Third: Both editions of the 2016 Diabetes UnConference will include separate “Adult T3/People without Diabetes” sessions! Some parts of the UnConference will offer opportunities for both People With Diabetes and People Without Diabetes to interact, but there will also be a separate space and special sessions so People Without Diabetes can experience the UnConference too, sharing among their tribe, peer-to-peer (still adults only).

Hard to imagine next year already, but it already looks like it will be great.

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Advocacy Opportunities:

The U.S. Food and Drug Administration (FDA) is holding a couple of public meetings in April.

The first, on April 14, is a meeting of the Endocrinologic and Metabolic Advisory Committee, which will go over outcomes of research on patients using the Type 2 medications Saxagliptin and Alogliptin. The public is welcome to attend, but you must register. To do that, and to get all of the information on this Advisory Committee meeting, CLICK HERE.

Also, one week later on April 21, there will be a public workshop titled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment”. This workshop is really a forum to discuss possible risks (or not risks) of devices after they’ve been approved by the FDA. This is not specifically diabetes related, but hey, we wear devices, right? There is also an opportunity for patients (that’s me) to submit comments, and even speak at this public workshop. Looks very interesting to me. Want to attend? CLICK HERE.
 
 
There you have it. Exciting doings in the diabetes world, both in the near future, and next year. Enjoy your weekend!
 
 
 

By StephenS | Posted in Advocacy, Events | Also tagged , , , | Comments (0)

Friday Reminders.

March 6, 2015 – 11:18 am

A couple of quick Friday updates before I go back and park myself in front of the nearest space heater:

The FDA Office of Minority Health Will Host a Webinar About Commenting to a Docket. Want to learn more about adding your voice to a U.S. Food and Drug Administration docket concerning your health (HELLO, Advocacy)? Efforts from the Diabetes Online Community to add the voice of the patient to FDA considerations has been extremely helpful and is absolutely necessary. Find out how to do it, and why it’s important for you to add your voice, during a webinar hosted by the FDA’s Office of Minority Health on March 25 from 2:00 p.m. to 3:00 p.m. Eastern time.

For more information, and to register for the webinar, CLICK HERE
 
 
#DBlogCheck Day is back this Tuesday! Spearheaded by Christopher Snider of A Consequence of Hypoglycemia and the Just Talking Podcast, D-Blog Check-in Day is a day when we spend time commenting on every blog, Twitter feed, Instagram member, and so on that we see, even if we just say “check”. As Chris says, it’s not about page views; it’s about saying I’m here and I support you. It’s about continuing to build community.

CLICK HERE to find out more, and don’t forget to link your posts there on Tuesday.

Be sure to check in, leave a comment, and boost the spirit of someone bravely telling their story.
 
 
Finally… If you live in the USA, don’t forget to move your clocks ahead one hour this weekend. That also means please remember to update the time on your diabetes devices. I know I’m getting older, because this “Spring Forward” event seems to happen earlier every year.

If only Spring would come along with the change…
 
 
 

By StephenS | Posted in Like these links | Also tagged , , , , | Comments (2)

Got two minutes?

December 10, 2014 – 1:51 pm

Hi… I just have a couple of minutes during a very busy day, but I need to ask your help once again.

The U.S. Food and Drug Administration is asking us for our take on insulin bolus calculators. This goes back to the public workshop that I attended back in November.

Specifically, they’re looking to us for feedback on bolus calculators. As we know, they’re helpful for people to perform (or double-check) their insulin boluses prior to delivery. During the workshop’s panel discussion, Adam Brown of diaTribe did a fantastic job describing how someone using a bolus calculator, even an imperfect one, was better off than someone using no calculator at all.

Fortunately, Bennet Dunlap has prepared a super-helpful post over at Strip Safely that will help you get everything you need to comment simply and effectively on this docket. Go there, and you can perform your Wednesday dose of diabetes advocacy in a couple of minutes.

The FDA would like you to consider these questions with regard to bolus calculators:

1. How can patients and providers be confident that the insulin bolus values obtained from the calculators are accurate and appropriate for their use?

2. What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management?

3. How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners?

4. How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients?

Okay… I don’t have a lot of time, so I encourage you to visit Strip Safely and view Bennet’s post. The docket is only open for a little while longer, so time is of the essence.

Don’t forget to tell your story! It’s important to convey your role as a patient or a caregiver of a patient, since no one understands our diabetes the way we do. To get links and additional talking points, go to Bennet’s post. For the record,

Here is the link to the request for comments

Here is the link to comment
 
 
Thanks again for your help, your continued help, in getting the important facts and the right message to the FDA. Happy Wednesday!
 
 
 

By StephenS | Posted in Advocacy | Also tagged , | Comments (0)

Like These Links.

December 2, 2014 – 2:31 pm

A few quick hits for you today, since my life has become crazy in the last few days:

– First, the reason why things are so crazy: I developed a major tooth problem over the weekend, which necessitated my first trip to a dentist in about ten years. More on that later. But a root canal is in my very near future, and because of that, my pump decision has been put on hold until 2015. I think my new gravatar is going to be me crossing my fingers, hoping my Medtronic Revel™ pump holds out. If it doesn’t, I’m back on MDI until I can save some money.
 
 
– Speaking of insulin pumps: I have two things to tell you about. First, as many of you know, Asante, makers of the Snap pump, will let you try out their pump for up to 30 days. They’ll even throw in a voucher to cover the Humalog cartridges that go with it. And if you decide to try the Snap pump this month, mention Diabetes Hands Foundation, and Asante will make a donation to DHF. Win-Win! To find out more, go to http://snappump.com/landing/dhf

Something else made its way to my inbox… During the month of December, Tandem, makers of the t:slim pump, are offering up to $400.00(US) toward the out-of-pocket cost of the t:slim as part of a pump exchange program. I’m a little short on details, but if you contact your local t:slim rep or call 877-801-6901, I’m sure they can fill you in.
 
 
– Your response to the open docket on Food and Drug Administration Activities for Patient Participation in Medical Product Discussions (Docket number FDA-2014-N-1698) has been tremendous. People have blogged and reblogged and shared via Facebook and Twitter and other avenues, and that has caused a noticeable spike in comments added to the docket. Last I checked there were 106 comments submitted so far. Thanks Strip Safely, Diabetes Mine Diabetes Hands Foundation and Diabetes Advocates, Christel Aprigliano, Bennet Dunlap, The Type 2 Experience, and everyone who has shared this far and wide.

If you haven’t left your comment yet, you still have until December 4th. That’s two days from this publication.

It takes a village, and this village rocks.
 
 
So… what’s new in your world?
 
 
 

By StephenS | Posted in Like these links | Also tagged , , , , , , , | Comments (1)