Tag Archives: Diatribe

#BeyondA1c: Consensus.

Last Friday, I was able to take the day off from work and go down to Bethesda, Maryland for another in the series of #BeyondA1c meetings staged by The diaTribe Foundation. There were 100 or more participants in the room, nearly all of them smarter than me. Okay, all of them were smarter than me.

There were multiple presentations throughout the day, from researchers, academics, advocates, and others. It was a very full day.

This was designed to build upon previous discussions on this topic at the U.S. Food and Drug Administration. Remember crashing the web server at FDA back in 2014?. How about last August’s discussions in the Great Hall on the White Oak campus?

If I were to pick a theme for this meeting, I think the theme would be consensus. Everyone in the room appears to be dedicated to the idea that A1c should not be the sole arbiter of our success or failure with diabetes. But it’s still a complex issue.

Wait… let me back up a bit, and explain to you what something like this could mean in the future.

If we (and by we I mean all of us) went beyond A1c in measuring outcomes, it could mean considering time in range as a more reliable factor, and that could mean using more advanced CGM metrics. What those might look like, I don’t think anyone knows yet.

Going beyond A1c could mean updates to medical journals and medical teachings.

Going beyond A1c could mean reconfiguring U.S. Food and Drug Administration protocols, both on the drug and the device side.

Going beyond A1c could mean manufacturers changing the wording in our drug and device packaging.

Going beyond A1c could mean a new set of measurement criteria for some clinical trials.

One of the topics that kept coming up concerned language: do we distinguish a difference between a mild hypoglycemic event (like 70 mg/dL) and a more serious one (like below 54 mg/dL)? For the record, it’s not likely that the FDA would allow the word “serious” to be used, because that word carries a very distinct definition at the FDA.

But there was consensus in the room surrounding the notion that blood glucose between 55 and 70 would constitute mild hypoglycemia, and anything under 54 should be considered severe or urgent (or, insert your word here). So, if they get the wording right, and if I can draw a mental picture right, here’s what that might mean:

My endocrinologist might still perform an A1c, but be far more interested in my CGM data when deciding whether my diabetes management is on track, and when considering drugs, devices, and other therapy. New medical professionals would need to be taught how to do this, and existing medical professionals would need to learn it too.

Those conducting clinical trials would need to show positive time in range numbers in studies featuring new drugs and devices. Drug and device makers might need to include frequency of severe hypoglycemia in packaging for their products.

FDA might need to weigh time in range and frequency of mild versus severe hypoglycemia when considering approval of something new. They would also need to consider patient input: for instance, if mild hypoglycemia were to occur as a side effect of a drug, but studies indicated that severe hypos almost never occurred, patients might say “we’re okay with mild hypos… we just want to avoid the more serious cases”.

David Lee Strasberg moderates a discussion between Kelly Close (left) and Cherise Shockley


Those are all hypotheticals, of course, but they were all discussed at this meeting. I was also thrilled that Cherise Shockley was present, and brought many of the tweets from last week’s #Beyond A1c #DSMA chat with her to show those in attendance. It made an impression, from both a social media and a person-to-person viewpoint.

That brings me to another thing I was thrilled with: lots of patient-centered talk. I kept a running count of how many times the phrase “patient reported outcomes” was said throughout the day… my final count was 16. On top of that, there was a lot of additional discussion about how we, as patients, would like to see less emphasis on A1c, and how we’re already going beyond A1c to help us manage each and every day. In this regard, medical professionals, researchers, and clinicians need to catch up to us.

I need to thank Kelly Close and the diaTribe Foundation for putting together a fantastic series of discussions, and also for bringing such incredibly dedicated people into the room. Plus, thanks for making these meetings so open and transparent, and allowing me to be there in person.

In one day, I was able to hear from Kelly Close and Adam Brown. I saw a fascinating presentation from former American Diabetes Association Chief Scientific & Medical Officer Dr. Bob Ratner… he still has the passion he always displayed at ADA. Dr. Bart Van der Schueren gave a super presentation showing the European take on how Beyond A1c is evolving on the other side of the Atlantic. JDRF’s Aaron Kowalski brought his passionate voice, as usual, to a panel discussion on standardization of data, definitions, and terminology. I sat in a working group on clinical trials led by Dr. Lori Laffel of the Joslin Diabetes Center (we both agreed later that it was like herding cats). I met representatives from the device industry and FDA who were present. Yes, it was a very full Friday, but truthfully, I hated to see it end.

If you know me at all, you know I can often be more cynical than appreciative about some things. The fact that I’m so appreciative after this event is indicative of the hard work that so many caring individuals have already put in on this cause.

I’m sure there will be more discussion. Not sure where it will lead. But that brings me back to the idea of consensus that I mentioned about 500 words ago. I really feel like we are close on this. We need to get the language figured out, set the standards, then go to the various stakeholders in all this and push it over the finish line.

Everyone in the room Friday believes in the idea of going beyond A1c. They believe we have the tools now to do so. And the imperative. Why? Patients aren’t waiting. Now it’s up to all of us to help turn consensus into conscientious change for the better.

Advertisements

#DOCasksFDA: Excitement, disappointment, perspective.

Like so many others, I looked/listened/Tweeted in on the #DOCasksFDA presentations on Monday afternoon (or morning, depending on where you live). A conversation between the diabetes community and the U.S. Food and Drug Administration, it promised to open a window to the FDA’s role in our diabetes lives.

I was quite interested in what was going to be said, and how it would be presented. There were numerous presentations by FDA staff and government policy makers, and diabetes community movers and shakers.

Let me just say this, for people who haven’t been at a gathering of this type, and especially for those catching it via the webcast: I do understand that seeing everything via a webcast is not the same as being in the room. But only a few were going to actually be in the room, and that doesn’t mean the rest of us were going to be left totally in the dark. For people who have complained for so long about being left out of the process (define your process here), this was an important step, even if it meant registering for the webcast as a participant, then having to log in as a guest, which probably meant the same thing anyway.

Twitter-KarenBittrSweet

If you don’t know this already, the response was tremendous. In fact, so many people were logged into the webcast that it overwhelmed the web servers at the FDA.

Twitter-DiabetesMine

Honestly, I thought it was possible that we just overwhelmed the meeting capacity of the Adobe® Connect session that was set up for this event. Regardless, it was almost certainly a case of a huge amount of people trying to look through a tiny keyhole all at the same time.

In a way, that’s a good thing, right? We showed the FDA how big a group we are, and how seriously we take the FDA’s role in reviewing and approving drugs and devices. This is proof positive that we have serious questions and concerns, and a big desire to know more.

Twitter-gborkman

On the other hand, it was disappointing to have a large slice of the meeting completely lost. I mean, I started work at 7:00 a.m, worked straight through without a break until the webcast began at 1:00, then worked another two hours after, just so I could take it all in live. So when the webcast went down, then just the audio came back for me, then even that went down again, I felt a real sense of loss.

Twitter-StephenSType1
 
 
Still, I think a sense of perspective needs to prevail here.

Twitter-StripSafely

This is the first time a forum like this has been live streamed between the FDA and the diabetes community. If events like this were reccurring, I would feel good knowing the worst technical problems occurred the first time around, and things got better after that. I’m bummed about missing so much, but I’m willing to forgive a little more the first time around.

Also, we did have the Twitter feed (hashtag: #DOCasksFDA) to rely on when things went awry. It’s not the same as being there, but it is something.

And the best part is that the presentations will be available soon online. I’m hoping that includes recordings of the parts of the webcast those of us not in the room missed.

Most of all, it’s important to note two important things about that afternoon:

1. The FDA is engaging with us.

Twitter-FDA-Patients

2. The diabetes community showed an amazing amount of interest, concern, and advocacy during those three hours, webcast or not. This was Tweeted by Manny Hernandez in the first half hour, and the conversation only accelerated from there:

Twitter-askmanny

Considering the technical difficulties, I hope something like this can be done again very soon. The need exists. The desire is certainly there. I am very grateful to the FDA for agreeing to do this, and for trying to solve technical problems when they happened. I’m grateful to Kelly Close, Adam Brown, and the DiaTribe team for facilitating this event. And I couldn’t be prouder of the rest of the diabetes community, who turned out in oversized numbers to voice our interest in interacting with this government agency. It can only get better from here, yes?
 
 
 

Like these links… Vacation edition.

I’ll be honest with you… I have vacation on the brain right now. Soon I’ll be off for an entire week for the first time all year. So you may not hear much from me for a while. That’s not a bad thing, right?

Especially because there are so many other great places to go to for interesting stories, and things that expand your knowledge. Consider these reading options this week:
 
 
– Kelley at Below Seven talks about how she’s often put up a happy front to help her cope with her diabetes, and how sometimes that sends a message to people that things are always rosy, when maybe they aren’t:

“I guess my main point or word of advice to others is that if someone seems really happy or bubbly, don’t necessarily think that their life is easy.”

——————————————————————————————————————
One of my favorite new blogs is written by Ally at Very Light No Sugar (Catchy!). Ally describes how she made a decision at age three to never cry at the doctor’s office. Ever. Now as an adult, she’s examining that decision and how it’s affected her life ever since:

”I see today that my mentality of always being strong was a survival tactic yet a detriment all at once. Some days I have a quick temper because it is easier to be angry than to acknowledge being scared or defeated.”

——————————————————————————————————————

– If you’re new to the Diabetes Online Community, or to diabetes in general, I hope someone has turned you on to Diatribe. Kelly Close and her amazing team do an amazing job of providing useful diabetes information (for all types) in an easy-to-read style. Find out about new drugs and devices going through clinical trials, new products hitting the market, research into things like cell encapsulation and what’s really behind your A1c, and much more. I’ve taken to printing the .pdf version and reading it on the train to and from work.

In the latest edition, find out about Abbot’s Freestyle Libre system, the approval of Eli Lilly’s new drug Trulicity for Type 2 patients, information from the Centers for Disease Control on obesity data on a state-by-state basis, and the always-interesting SUM musings from Kerri Sparling, who talks about the CGM in the Cloud phenomenon.
You don’t want to miss this or any issue of Diatribe.

No, I don’t get anything from Diatribe for saying all this. I just think you’ll find it a useful and necessary part of your life. That’s all.

——————————————————————————————————————

– Finally… here’s something to scratch your head over. Is a lack of insulin to the brain responsible for alzheimer’s? When I first read this, I remember thinking “How dare they steal my disease!”. Then I started wondering how deep the research really went, and if there really is a connection:

Is Alzheimer’s Disease Brain Diabetes?

Something for me to think about as I pack.

——————————————————————————————————————

So… What have you been reading lately?

I hope your weekend is great, and next week is even greater. Talk to you again soon!
 
 
 

%d bloggers like this: