Tag Archives: Kelly Close

#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.

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#MasterLab: What I learned, and what I experienced. (part 2)

MasterLab

I was fortunate enough to attend the Diabetes Advocates MasterLab in Orlando last week. I was there thanks to a scholarship provided by Diabetes Hands Foundation. My thanks to everyone who made this event possible, and made it possible for me to attend.
 
 
Wow, there was a lot in yesterday’s post. And that only covered half the day! Today, I’ll cover the afternoon presentations at MasterLab.

A lot of what I got out of the afternoon talks is how great we do when we all work together on something important. And how much we miss out when we don’t. I also picked up a lot of important information. Let’s begin:
 
 
The afternoon started with Kelly Close and Adam Brown from DiaTribe, the PWDs source for detailed information on a variety of topics that touch our lives. Kelly and Adam gave us a lot of that detailed information, including why it’s so important to not only have a good A1c, but why it’s important that your good A1c includes a lot of time spent with your BGs in a good range. Did you know that an A1c under 7 percent sometimes means that the patient could have wildly different BG numbers over the time span that that A1c covers? Just look at these examples:

A1cSlide

Obviously, we don’t want to have a BG trend that goes up and down a lot. So when people get excited about advocating for better devices, drugs, and therapies, we need to keep in mind the importance of making sure those devices, drugs, and therapies help keep us in range for longer, safer periods of time than they do today.

They also shared this with us… check it out (you may have to zoom the picture to see everything):
Common

Yes, Type 1s and Type 2s have a lot in common. Including the fact that Type 1s can benefit from typically Type 2 medications like Metformin. And Type 2s can benefit from typically Type 1 medications like insulin. That’s not just opinion anymore. That’s a fact. When I saw that part of the presentation, it caused me to really think hard about my long-held feelings of never wanting to consider Metformin or Victoza. Time for a new point of view, Stephen.

Kelly and Adam shared a wealth of information in a short amount of time. Again, I encourage you to check out the presentation slides and the videos (once they’re posted at diabetesadvocates.org/masterlab) to get a look at their talk. I promise you it will be well worth your time.
 
 
I met Manny Hernandez earlier in the day, and when I did, he mentioned that he thought I would get a lot out of the talk by Rebecca Wilkes Killion, patient representative and voting member with the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee.

He was right.

Rebecca, a Type 1 herself, has been sitting on panels that review new and existing drugs since 1999. She lends the very important patient voice to what is being discussed. Knowing that not all of us live close to Washington, D.C., she offered five pointers on making an impact and getting the attention of decision makers wherever we are:

1. Membership has its privileges– We didn’t ask for a diabetes diagnosis. Don’t be afraid to share your story, be vocal when the moment calls for it, and hold people accountable for their actions or inactions when it comes to your diabetes.

2. Stand in your own truth– Be authentic. She mentioned interacting with the media: If your story is real and authentic, they’ll pick up on that. I think of this as using the term “staying within yourself”. Don’t try to be who you’re not. Your story is compelling just as it is. Just tell it honestly.

3. Cut to the chase– We often think of this as developing an “elevator speech”. If you were on an elevator with someone for less than thirty seconds, how would you tell your story before you reached your destination? Brevity works.

4. Visual aids– Data, photos, anything that would help people grasp your message right away can be extremely important in making sure that your input is considered in the decision-making process.

5. Own your space– “As a diabetes advocate, you have a position that is hard fought”. You know who you are, and what you live with every day. Don’t let someone back you off your spot. No one knows more about your diabetes than you do.
 
 
After that, the fabulous Kerri Sparling talked about mobilizing the Diabetes Community. As an example, she shared with us the amazing success of the Spare A Rose, Save A Child campaign. How’s this for a visual aid?

SARinfographic

Over 1,000 tweets? $27,000-plus raised? Children’s lives were saved. How big is that? Whether you know it or not, if you tweeted, blogged, donated, or made cookies to help get donations, you are a diabetes advocate. Kerri’s plea, and mine too: Keep being a diabetes advocate.

Finally, we were joined by David Lee Strasberg, son of the great Lee Strasberg, and creative director and CEO of The Lee Strasberg Theatre and Film Institute. Another Person With Diabetes. David talked to us about how to get that big grant, how to raise money for your walk team, or how to get your congressman to sign on to an important piece of legislation. When we need something, how do we go about getting it? David says there are four keys to the perfect ask:

1. Relationship: It begins with acknowledgement of the other person and the issue at hand, and includes sharing a story that helps connect you with the person you’re asking.

2. A vision: Simple enough, right? Be sure to state your vision clearly. Not in a “mission statement” kind of way. More like, “I want people with diabetes to have access to keep their CGMs when they turn 65” kind of vision. Make it clear what you intend to do with what you get from the person you’re asking.

3. Opportunity: Look for the right opportunity to ask and be ready to seize it when it appears.

4. Make a clear ask: Don’t be vague about what you want. Be sure that the person you’re asking knows without a doubt what you need them to do.

After David’s talk, we broke off into small groups and practiced The Art of the Ask. I gave my pitch, and you know what I got wrong? That last one. I thought I had it all down, and it turned out that when I was finished, people liked my idea but weren’t clear about what I really wanted them to do. Oh well… Now I know what I have to work on.

All of this that I’ve described, plus what I described yesterday, really only scratches the surface of an extraordinary day spent learning all parts of the diabetes advocacy landscape. I don’t know if this experience will make me a better advocate. But I know I’m a smarter advocate. And I know I’m going to try hard to be a better advocate in the future.

Tomorrow, a little more about the experience and some of the people I met at MasterLab.
 
 
 

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