I just got home from the 2014 Medtronic Diabetes Advocate Forum (twitter: #medtronicDAF), a yearly event where Medtronic invites a group of diabetes advocates (including Karmel!) to its headquarters in Northridge CA to meet its diabetes team, learn about new products, and brainstorm with each other. (Medtronic pays for guests’ transportation, hotel and food, but does not pay for any subsequent coverage of the event. All views are my own.) It was my first year at the forum and I found it fascinating, so wanted to share a bit of the experience for people who were not there.
After a welcome dinner, we started the two-day conference with a presentation on the latest Medtronic diabetes products — namely, the recently approved MiniMed 530G with Enlite system, which is a combination pump/continuous glucometer with “low glucose suspend.” (It temporarily shuts off basal insulin delivery if the CGM indicates that your blood sugar is low and you are not responding.) The 530G is one step on the long path toward the end game of diabetes technology: a fully closed loop system (i.e. “artificial” or “virtual” pancreas) that could manage your diabetes for you, with little or no input required.
Medtronic has gotten some flak for using the terminology “artificial pancreas” on its 530G promotional material, since – for as great as it is – low glucose suspend is a far cry from a fully closed loop system. For what it’s worth, Medtronic definitely recognizes that this is not an artificial pancreas and apologized for any misperception. The good news (in my opinion) is that the terminology the FDA used in its approval – namely “artificial pancreas device system with threshold suspend” – creates a bureaucratic/logistical category for future products that go beyond threshold suspend. I’m hoping that having this conceptual foundation in place will simplify the path going forward.
And what might these future products be? Well, as was repeatedly emphasized, the path toward a fully automated system is a marathon, not a sprint, and there will be numerous steps along the way. The first is to get US approval for a predictive threshold suspend system – whereas the 530G shuts off when you’ve already reached your target low, a predictive system would shut off when the CGM indicates that you are approaching your target low (thereby potentially avoiding the low altogether). Medtronic is going to be launching a predictive system in Europe soon, and has begun the clinical trials necessary to apply for approval/clearance in the US. A quick note to FDA: from a patient perspective, this is a no-brainer and I hope that the process is smooth.
Next would be a partially closed loop system that would manage your basals at night to try to keep you in range as you slept. The reason for this approach is that nighttime has fewer variables than other times of day – you’re not exercising or eating – and so it’s the low-hanging fruit where closed-loop systems are involved. This system would allow you to put your pump/CGM on autopilot as you slept, in hopes that the result would be at least 8 hours a day of glucoses in a good range (and would prevent nighttime lows).
And next would be what I would still call a “partially closed loop” system – one in which you would have to bolus for meals (since today’s insulins are simply not fast enough to keep up with food in real-time) and then your pump/CGM would make any corrections afterwards. There was some discussion about whether such a system would count as a truly “artificial pancreas” – and my opinion (as well as most people present) was that it would not. Frankly, for someone who obsessively monitors their blood sugar after meals and makes miniscule adjustments all the time, I don’t feel like this would give me much of an advantage beyond what I’m doing now. While I think it is an extremely important step toward a true artificial pancreas, I very much hope that no one thinks of it as the final goal.
In order for these things to happen, we need better sensors and better algorithms – that is, the computations that the pump uses to decide how much insulin to dose. My hope – and something that Medtronic is actively working on as well – is that eventually pump algorithms will be “smart,” meaning that they will learn from your mistakes. As opposed to today’s Bolus Wizard feature, which requires input from the user to create any sort of customization, a “smart” system would keep track of patterns itself and make adjustments, eventually resulting in a level of customization that would provide better control. I find this particular idea extremely exciting – I would love to be able to outsource some of the thinking that goes into every correction dose.
In addition to learning more about future technology, we also had a breakout session about Medtronic’s new StartRight program, which is available to every new pump user. Basically, you get paired up with your own pump educator, who stays in touch with you, providing education and support, through the first few months of using an insulin pump, beginning even before you open the box (in fact, they even try to be on the phone with you when you open the box for the first time). I think this is a great idea – starting on pump therapy can be a very emotionally exhausting experience, and apparently there are times when people get so freaked out that they send back the box without even trying the system at all. Hopefully this new program will help ease that transition, as well as provide training on how to take advantage of all the features of the pump (and CGM).
I was also particularly fascinated by a session about government and private payer coverage for insulin pumps and continuous glucose monitoring systems. That probably warrants a separate post, but basically (and these editorial views are my own!), CMS – the Centers for Medicare and Medicaid Services — has a seriously f’d up attitude when it comes to diabetes care. This includes the perspective that continuous glucose monitoring “lacks a medical purpose” since at the moment it requires finger sticks for calibration. (This is why CGMs are not covered by Medicare or most state Medicaids.) As someone who believes strongly that there is a “medical purpose” in a device that can prevent me from dying in my sleep from a severe low, I hope to work with Medtronic, other patient advocates and other companies to change this attitude. This also underscores the need for even better sensors.
In addition to a group brainstorm on social media advocacy efforts, we also heard an amazing presentation by Dr. Francine Kaufman, chief medical officer at Medtronic Diabetes (and one of the country’s foremost pediatric endocrinologists). I’d met Dr. Kaufman in passing and heard many mentions of her name, but I’d never seen her talk. Now that I have, I am questioning my purpose in life – the number of philanthropic projects and outreach efforts she is involved in is truly amazing. Her talk also reminded me of how easy it is for us in the US (and other developed countries) to forget just how privileged we are when it comes to diabetes care. I’m not talking about access to pumps; I’m talking about insulin – Dr. Kaufman does a lot of work with Type 1 children in Haiti, among other seriously underserved populations, and told us that the mortality rate for kids in Haiti (or many areas in sub-saharan Africa) with Type 1 diabetes is about 80 percent in the first year after diagnosis. Eighty percent.
If you’re interested in learning more – and helping – please check out two of the programs she’s involved in: Insulin for Life, which sends donated insulin and other diabetes supplies to developing nations (and just began a program here in the United States), and the International Diabetes Federation’s Life for a Child program, which has a similar aim (money donated to Life for a Child goes to established diabetes centers in developing countries so that they can provide care and supplies to children with Type 1 diabetes).
We closed out the conference with an interactive session led by David Strasberg, son of Lee Strasberg, the creator of the Method Acting technique. As someone who once refused to be the narrator in her kindergarten class play because she preferred the role of an apple tree, I have never been one for acting workshops. But David – who has Type 1 diabetes himself and whose son also has Type 1 – focused instead on the art of the “ask” – a very useful tool for anyone involved in diabetes advocacy. I had my doubts going in (see tree reference above) but it ended up being a surprisingly useful (and at times emotional) session.
And on that note, one of the nicest things about the entire event was the sense of community between the diabetes advocates present and the team at Medtronic. I think that a lot of companies struggle to figure out the best way to interact with their customers, and that Medtronic – along with several other diabetes companies, including Sanofi – do a really nice job of engaging with the community in a way that feels authentic and heartfelt. I didn’t feel like I was being pitched something; I felt like I’d been given a chance to learn about things that interest me (why am I so captivated by insurance codes?), give feedback, ask questions, and – perhaps even better – meet a bunch of other advocates in person. I’m particularly excited about spreading the word about some of the advocacy and fund-raising ideas we came up with, including promoting Lee Ann Thill’s amazing Diabetes Art Day (coming up fast on February 3 – please participate, including taking her pre- and post-survey!), and an effort – details coming soon – to raise $10,000 by Valentine’s Day for Insulin for Life, to help get donated diabetes supplies to those who need them the most.
While the conference was exhausting, I left inspired and extremely grateful for all the people working behind the scenes to make life with diabetes easier for us all.
If you have any questions you’d like me to pass on to the Medtronic team, please leave them in the comments section. Or, if you’d prefer to contact them directly, tweet a message to @MDT_diabetes – they actively monitor the feed.