There's a good deal of fuss and hullabaloo about the newest diabetes device approved for people in the U.S.: Medtronic's long-awaited 530G system and Enlite sensor… Just concurrently, there's a significant amount of frustration aside PWDs (people with diabetes) and others in the know WHO feel they'ray beingness misled on a number of fronts or so this new device.

I'm one of them.

Let me preface this by saying: Many are precise agog or so this being a large come forward in eventually achieving the closed-loop aspiration. The 'Mine is on that boat, because we feel the 530G's power to automatically unopen off insulin between 60 and 90 mg/dL is a key step forward.

However, we (all) throw to be downright about what this product actually is and is not — and the vendor's ebullience cannot fuel besides-pushy sales pitches and marketing efforts.

First bump off, this device is NOT an artificial pancreas, only sooner upright one musical composition of the puzzle compulsory to sooner or later create matchless. Unfortunately, Medtronic's been sitting book binding and riding the Public relations wave of mainstream media jump all over that exciting terminus, without correcting misconceptions. More than thereon in a import.

Perhaps more importantly for patients themselves, there are some equivocal access issues underway: with the 530G systems being shipped starting October. 10, the society has decided it bequeath start phasing verboten stand-solo pumps and no more pop the question the older Paradigm Revels to most adult type 1s WHO have commercial indemnity and could be covered for the new-sprung device. Huh?

A Potential Customer: Me

As famed the separate solar day, I'm shopping some for my next insulin pump. Despite being a longtime Medtronic pumper, I got sick of waiting for the 530G and just newly bought the Dexcom G4. And "recently" means that my 30-day return window for the G4 passed just before Medtronic got its unsound-awaited favorable reception. Figures.

This got me thinking: Could I just get a new Medtronic pump itself?

I picked ahead my phone and called Medtronic to ask about buying a new heart. Two different reps in the course of an hour told me the Same thing: Atomic number 102, I can no longer just Order a stand-alone pump. My indemnity now REQUIRES me to make the newest device.

I asked them to reprize this, to make sure I understood right, given the incredibly idiotic nature of that affirmation.

I phoned my insurance company to check that arrogate. And two different multitude told me: No, that's non veracious. Generally speaking, I wealthy person coverage for whatever doctor-prescribed, FDA-approved device is still on the market and considered "reliable" — all of the pre-authorization, medical necessity, and dollar-precise reporting issues aside, of course.

I titled Medtronic in reply. A third rep gave the Sami answer about no complete pump orders, and when pressed, explained that the company's now confining sales of Revels to type 2s, those typecast 1s with government insurance similar military, Medicare and Medicaid, and of path those 16 and younger since the new 530G isn't medical specialty-authorised.

What? So a "regular" adult eccentric 1 is now forced to dictate the 530G combo system, Beaver State nothing at all?!

Confused and angry, I reached out to Medtronic execs, who told me that the client service reps were "misinformed" that this was an insurance necessary, rather than an internal Medtronic strategy to push most of U.S.A to the 530G, and the company's now "rhenium-training" their reps to clarify this information.

Jeff Hubauer, Medtronic's VP and general handler of the accompany's insulin legal transfer stage business, aforesaid Medtronic wants to "transition mass to the combined 530G system," and will be supportive customers with financial incentives like-minded surveys, discounts, and other offers. And a letter to distributors from Medtronic's U.S. Sales department leader, Mike Gill, shows that what the rep told me on the phone is actually straight for the nigh part: Paradigm Revel pumps volition lone be supplied to those with type 2, federally-sun-drenched type 1s, and pediatric pumpers 16 and junior.

And so short answer: No, I cannot get a stand-alone Medtronic pump to use with my Dexcom G4.

For those nosy: the new 530G has a basic retail be of $7,350 for the heart/CGM system itself without any sensors, compared to the $6,699 cost for the Paradigm Whoop it up pump. For those with in-warrant Make merry pumps WHO might non constitute eligible for a free upgrade, word is at that place's a $399 advance price. Simply as Hubauer says, Medtronic testament be making some especial promotional offers soon.

Which brings me to my next gripe point.

Underage Customers

Late last year and in incipient 2013, people were told that buying the Paradigm Revel pump (the in style at the time) would automatically sign them up for a New Applied science Secur Platform. 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 detected the same promise. Yet, with the now-authorized 530G not being labeled for habit with anyone junior than 16, those parents are organism told the "guarantee" won't constitute honored.

Here's the matter: 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 exigent from the very origin that those studies be done, and of course they want this paediatric-approved. But when people were buying new pumps and CGMs anterior to the 530G blessing, below the belief that they would be upgraded for free, Medtronic knew that wasn't going to be feasible. And they said nothing, because — who knows, the FDA could have just definite to O.K. the 530G for younger kids without having the clinical information to support that, because separate pumps are authorized for kids 7 and up? NOT.

Hubauer insists the company can't talk of labeling before FDA approval, and each Medtronic is doing like a sho is complying with the rules.

Well, thanks. Remind me not to ask before FDA approval whether your devices will really deliver insulin, as we wouldn't want you to be held to any promises ahead of time. Regardless how obvious…

And that leads ME to the last issue.

Words Matter

The 530G International Relations and Security Network't an Imitation Pancreas, symmetric if IT is a initiative along that AP Pathway.

Sure, I get it. The FDA created a whole current category of device that it calls, "OZO: False Pancreas Device System, Threshold Suspension," which falls under that walloping Painted Pancreas umbrella. And we get it that everyone's excited about moving towards an Stylized Pancreas, including the FDA, JDRF and the patient community.

But that's all it is — a portion. No matter how the FDA officially categorizes this new 530G system, Medtronic knew full well that the mainstream media and comprehensive public would skimp ove the nuances and just see the words "Artificial Pancreas" in big flash lights. And now we PWDs possess to deal with the aftermath of the macrocosm at galactic thinking we can exactly secure into this new gimmick and beryllium along our way, worry-free.

Still, Medtronic went ahead and used an unqualified "Artificial Pancreas" pronounce for its new system knowing this was somewhat deceiving speech communication in the sake of creating merchandising hype. Grrr.

Here's just combined of hundreds of resulting headlines:

The FDA Has Authorized The First Artificial Pancreas, appearing in Popular Science

We aren't the first to gripe most this. Check out out this excellent infographic that tech Guru and typecast 1 D-blogger Scott Hanselman posted last hebdomad, illustrating completely the crap we type 1s deal with every twenty-four hour period:

Partake in on Pinterest

Robert Scott's caption: If I get this new pump that news outlets are incorrectly calling an artificial pancreas will anything in this cycle alteration? No.

(See also: Leighann D-Mom's post connected this topic)

Reality Crack

As a potential customer and someone who's living with type 1 myself, I am disappointed in how Medtronic handled whol of this. The company won't seem to take that it did anything wrong in promoting the product before operating room subsequently approval — even if customers feel for misled. And some most certainly do. Sidesplitter!

I act appreciate that they took approximately time to create an online Q&A, but it's indeed very understated that it falls short given the initial confusion that came with wholly the news excitement.

Overall, the point is that amid all this excitement about a new device, information technology's important to call up that there are genuine people on the early end difficult to let uncurved answers. For me, and anyone else who may stimulate explored options directly following the 530G's approval, World Health Organization knows how many various stories were floated by gross sales reps and what PWDs definite supported what we were told?

Bottom line: I'm not affected.

Let's please just keep it very, even if we are excited.