Three Top Patient Takeaways from ADA 2015

Twitter summary: Putting the patient in the equation – new considerations and conversations at #2015ADA

What a ride! This year the American Diabetes Association’s (ADA) 75^th Scientific Sessions included groundbreaking clinical trial results, the latest updates on diabetes technology, compelling discussions on diabetes overall, and of course, a trip to the Boston waterfront filled with many friendly faces all working in diabetes.

But what was THE most exciting part of this weeklong conference? Well, that’s a big question, but in my view, three areas stood out: an increased attention on behavior change, smarter treatments for reducing the burden of managing diabetes, and heart safety trials that emphasized that diabetes drugs are safe.

An increased attention on behavior change

There were two words that I kept hearing over and over again: behavior change. From a standout keynote lecture by AgaMatrix founder Sonny Vu discussing how digital wearables can help drive behavior change, a compelling symposium on "Novel Technologies for Behavior Change," and a hot off the press position statement by ADA, AADE, and AND on diabetes self-management education - to name only a few! - this ADA saw more discussions of behavior change than ever before.

While I remain thankful for the therapies and technologies to manage diabetes, it’s high time to start focusing more on behavior change. We’ve had researchers and clinicians who have worked in this area for years as a “labor of love,” but now we’d like to see more focus and more funding so that people understand it isn’t just about products.

At ADA I spoke on behavior change from a patient perspective: Investing in Behavior Change (slides are found here). As things stand, where are we? So many factors, like our toxic food environment, poor city design, the lack of actionable feedback from data and devices, inadequate transportation, inadequate access to healthcare professionals – our moods! – all of these complicate our ability to modify our behavior and improve outcomes.

No surprise, behavior experts all agree that more needs to be done, but they don’t agree on the best way to reach patients. Before ADA, Adam Brown and I informally asked a number of behavioral experts what they would do with $10 billion in diabetes – which is just 4% of the total amount we spend on diabetes every year in this country. What did they say?

Well, a bunch of things. First, they can’t even imagine HAVING $10 billion, given how little funding goes into behavior research these days. In their view, even $500,000 would be game changing.  

Second, we learned there are many places in which the researchers would love to put research dollars. Some of it is in training more psychologists, some of it is online help to patients, some of it is “bricks and mortar” centers, some of it is running major diabetes awareness campaigns. We need more “pilots” funded so we can show the impact of behavior change. We need to keep asking for more research and keep informing our doctors and nurses that they really can affect behavior change. I’m eager to learn more about how we can better focus on this major unmet need, because we’re now past the point of where incremental changes are going to cut it. We need to shoot for the moon.

Smarter treatments can reduce the patient and provider hassles of managing diabetes

This ADA also saw a great deal of focus on ways to reduce the daily burden and hassle of managing diabetes. I was particularly encouraged to see tremendous progress in artificial pancreas research, where experts agree that it’s a matter of “when” and not “if” these systems will reach patients. Indeed, JDRF’s Dr. Aaron Kowalski pointed out that the first hybrid closed loop systems (patients still bolus for meals, but the system takes care of the rest) could come to market in the ~2017-2018 timeframe.

With a timeline in sight, researchers are now turning their heads to the “how”:

• How do we design these systems optimally so a broad spectrum of patients will want to use them? (i.e., Should control algorithms reside on a smartphone or in a pump? How customizable should systems be?)

• How do we prove the benefits of closed-loop devices to providers and ensure their lives will become easier, not harder? (i.e., How much time will it take to train patients?)

• How do we show closed-loop systems will save the healthcare system money and convince insurers to pay for them? (i.e., Can we conduct studies long enough to show reductions in very infrequent events, like severe hypoglycemia?)

After participating in several clinical trials of closed-loop systems myself, I know first-hand how impactful this technology can be. But I also understand the nervousness, the hassles, and the learning curve that comes along with adopting any new device. A year ago, there wasn’t enough experience outside of carefully controlled hospital settings to really look at this. But at this year’s ADA, talks shifted to the key conversations about living with the systems in the real world. For instance, Dr. Jill Weissberg Benchell discussed some of the human aspects of living with the Bionic Pancreas (e.g., peace of mind, worry, trust, comfort, and the hassle of carrying around the equipment). The overall take was very positive, though the work was a great reminder that devices must go beyond better time in range, A1c, or hypoglycemia (all of which are absolutely mission critical).

We hope and expect that the lessons from these and other studies are incorporated before these products are on the market, to help make them as great as they can be, to manage sky-high expectations, and to make clinicians’ lives easier. We all want this field to be a vibrant market, but a lot has to go right. The JDRF/NIH hold an event each ADA on the closed-loop: last year’s was called “The Last Mile,” and this year’s “The Last 100 Yards.” That’s a lot of growth in one year (!). And you know what? Next year, it may only be 80 yards. Why? The closer we get, the more real-world challenges and business complexities we have to face. But after this year’s ADA, I feel assured that researchers and manufacturers are thinking very hard, and it’s exciting to think about multiple systems on the market in a few years.

I was also encouraged by developments on the drug side this ADA. Intarcia’s novel ITCA-650 for type 2 diabetes continues to impress with its once-yearly implantable exenatide pump. Imagine, instead of once-daily or once-weekly injections, only needing to have one simple procedure a year? That could be transformational and could also make clinicians’ lives a lot easier. Indeed, Dr. James Gavin said that this was the most exciting of all potential future therapies. 

Also on the therapy front – new data from the basal insulin/GLP-1 agonist combination drug Xultophy really proved just how effective new combinations can be. Compared to Lantus, Xultophy had better A1cs, weight loss instead of weight gain, and less nocturnal hypoglycemia. It’s no surprise that some experts are saying that this drug should be the first injectable offered to type 2 patients, and I hope that one day it may be available for type 1 diabetes as well. For now, we in the US have to wait patiently, as it won’t be approved here for some time.

I know that as we look for improvements in drugs and devices, we’re also looking for help on behavior change – some of these products alone will be easier to use, take, and prescribe and that can prompt some behavior change. For example, if some are minimally invasive once-yearly therapies, that may be easier than twice-daily injections that aren’t so fun – right? For sure other changes like telephone calls rather than visits for those who don’t need visits – all that is good. We also need to make sure, of course, that other elements of behavior change are addressed – not just using and taking medicine or using devices but also making sure that patients are feeling less anxiety about diabetes management.  

Heart safety trials show diabetes drugs are safe

Some big news at ADA also came from two large heart safety trials that presented their results on the safety of Januvia (a DPP-4 inhibitor) and Lyxumia (a GLP-1 agonist). These kinds of trials, also called CVOTs, or cardiovascular outcome trials, study patients on a drug over a long period to understand the impact on the heart, like heart attacks and strokes. These heart studies became a mandatory part of the FDA drug approval process back in 2008. Following concerns that Avandia increased the risk of heart attacks (that were subsequently overturned), the FDA decided that all diabetes drugs should prove they are heart safe.

The headline from these results? The results were neutral, which means that these common diabetes drugs are safe for the heart – we can breathe a huge sigh of relief for that one. We’d also have liked to have seen the trials be longer so they could show if any sort of cardiovascular benefit existed – that said, such trials are very long and expensive. 

What would you like to say to a diabetes researcher about the state of diabetes? I’d love to hear your thoughts – let us know!

very best,

Kelly L. Close