There's a lot of fuss and excitement about the newest diabetes device approved for people in the U.S.: Medtronic's long-awaited 530G system and Enlite sensor... But at the same time, there's a significant amount of frustration by PWDs (people with diabetes) and others in the know who feel they're being misled on a number of fronts about this new device.
Let me preface this by saying: Many are very excited about this being a huge step forward in eventually achieving the closed-loop dream. The 'Mine is on that boat, because we feel the 530G's ability to automatically shut off insulin between 60 and 90 mg/dL is a key step forward.
However, we (all) have to be honest about what this product actually is and is not -- and the vendor's enthusiasm cannot fuel too-pushy sales pitches and marketing efforts.
First off, this device is NOT an artificial pancreas, but rather just one piece of the puzzle required to eventually create one. Unfortunately, Medtronic's been sitting back and riding the PR wave of mainstream media jumping all over that exciting term, without correcting misconceptions. More on that in a moment.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
Perhaps more importantly for patients themselves, there are some questionable access issues underway: with the 530G systems being shipped starting Oct. 10, the company has decided it will start phasing out stand-alone pumps and no longer offer the older Paradigm Revels to most adult type 1s who have commercial insurance and could be covered for the new device. Huh?
A Potential Customer: Me
As noted the other day, I'm shopping around for my next insulin pump. Despite being a longtime Medtronic pumper, I got tired of waiting for the 530G and just recently bought the Dexcom G4. And "recently" means that my 30-day return window for the G4 passed just before Medtronic got its long-awaited approval. Figures.
This got me thinking: Could I just get a new Medtronic pump itself?
I picked up my phone and called Medtronic to ask about buying a new pump. Two different reps in the course of an hour told me the same thing: No, I can no longer just order a stand-alone pump. My insurance now REQUIRES me to get the newest device.
I asked them to repeat this, to make sure I understood correctly, given the incredibly ridiculous nature of that statement.
I phoned my insurance company to check that claim. And two different people told me: No, that's not true. Generally speaking, I have coverage for whatever physician-prescribed, FDA-approved device is still on the market and considered "reliable" -- all of the pre-authorization, medical necessity, and dollar-specific coverage issues aside, of course.
I called Medtronic back. A third rep gave the same answer about no stand-alone pump orders, and when pressed, explained that the company's now restricting sales of Revels to type 2s, those type 1s with government insurance like military, Medicare and Medicaid, and of course those 16 and younger since the new 530G isn't pediatric-approved.
What? So a "regular" adult type 1 is now forced to order the 530G combo system, or nothing at all?!
Confused and angry, I reached out to Medtronic execs, who told me that the customer service reps were "misinformed" that this was an insurance requirement, rather than an internal Medtronic strategy to push most of us to the 530G, and the company's now "re-training" their reps to clarify this information.
Jeff Hubauer, Medtronic's VP and general manager of the company's insulin delivery business, said Medtronic wants to "transition people to the combined 530G system," and will be encouraging customers with financial incentives like surveys, discounts, and other offers. And a letter to distributors from Medtronic's U.S. Sales division leader, Mike Gill, shows that what the rep told me on the phone is actually true for the most part: Paradigm Revel pumps will only be supplied to those with type 2, federally-covered type 1s, and pediatric pumpers 16 and younger.
So short answer: No, I cannot get a stand-alone Medtronic pump to use with my Dexcom G4.
For those curious: the new 530G has a basic retail cost of $7,350 for the pump/CGM system itself without any sensors, compared to the $6,699 cost for the Paradigm Revel pump. For those with in-warranty Revel pumps who might not be eligible for a free upgrade, word is there's a $399 upgrade cost. But as Hubauer says, Medtronic will be making some special promotional offers soon.
Which brings me to my next
Late last year and in early 2013, people were told that buying the Paradigm Revel pump (the latest at the time) would automatically sign them up for a New Technology Guarantee Program. Once the 530G got approved, those in the program would be upgraded at no cost to the newest device. Parents of kids younger than 16 heard the same promise. Yet, with the now-approved 530G not being labeled for use with anyone younger than 16, those parents are being told the "guarantee" won't be honored.
Here's the thing: It's no surprise that the 530G isn't approved for kids. When Medtronic submitted the new system to FDA in June 2012, they didn't even seek pediatric approval because they hadn't yet completed clinical studies in kids using this device. The company execs tell us now that the FDA was insistent from the very beginning that those studies be done, and of course they want this pediatric-approved. But when people were buying new pumps and CGMs prior to the 530G approval, under the belief that they would be upgraded for free, Medtronic knew that wasn't going to be possible. And they said nothing, because -- who knows, the FDA could have just decided to approve the 530G for younger kids without having the clinical data to support that, because other pumps are approved for kids 7 and up? NOT.
Hubauer insists the company can't talk about labeling before FDA approval, and all Medtronic is doing now is complying with the rules.
Well, thanks. Remind me not to ask before FDA approval whether your devices will actually deliver insulin, as we wouldn't want you to be held to any promises ahead of time. No matter how obvious...
And that leads me to the last issue.
The 530G isn't an Artificial Pancreas, even if it is a first step along that AP Pathway.
Sure, I get it. The FDA created a whole new category of device that it calls, "OZO: Artificial Pancreas Device System, Threshold Suspension," which falls under that big Artificial Pancreas umbrella. And we get it that everyone's excited about moving towards an Artificial Pancreas, including the FDA, JDRF and the patient community.
But that's all it is -- a component. No matter how the FDA officially categorizes this new 530G system, Medtronic knew full well that the mainstream media and general public would gloss over the nuances and just see the words "Artificial Pancreas" in big flashing lights. And now we PWDs have to deal with the aftermath of the world at large thinking we can just plug into this new device and be on our way, worry-free.
Still, Medtronic went ahead and used an unqualified "Artificial Pancreas" label for its new system knowing this was somewhat deceiving language in the interest of creating marketing hype. Grrr.
Here's just one of hundreds of resulting headlines:
The FDA Has Approved The First Artificial Pancreas, appearing in Popular Science
We aren't the first to gripe about this. Check out this excellent infographic that tech guru and type 1 D-blogger Scott Hanselman posted last week, illustrating all the crap we type 1s deal with every day:
Scott's caption: If I get this new pump that news outlets are incorrectly calling an artificial pancreas will anything in this cycle change? No.
(See also: Leighann D-Mom's post on this topic)
As a potential customer and someone who's living with type 1 myself, I am disappointed in how Medtronic handled all of this. The company won't seem to admit that it did anything wrong in promoting the product before or after approval -- even if customers feel misled. And some most certainly do. Wow!
I do appreciate that they took some time to create an online Q&A, but it's so very understated that it falls short given the initial confusion that came with all the news excitement.
Overall, the point is that amid all this excitement about a new device, it's important to remember that there are real people on the other end trying to get straight answers. For me, and anyone else who may have explored options directly following the 530G's approval, who knows how many different stories were floated by sales reps and what PWDs decided based on what we were told?
Bottom line: I'm not impressed.
Let's please just keep it real, even if we are excited.