It looks like a duck. It quacks like a ... Oh. Wait a minute. It doesn't quack at all. So why is Abbott Diabetes calling it a duck? (That's a metaphorical question, just so you know.)
The metaphoric duck we're talking about lives over in Europe and is quacking along just fine. Its real name is the Abbott Freestyle InsuLinx glucose meter, and it was introduced in Europe in May 2011 and Canada this May, but here in the United States...? Well, there is no quacking.
If you drive north across our border, or hop a jet across the pond, you'll find the innovative InsuLinx that has healthcare providers here in the U.S. very excited. Why? Because it's the first glucometer that has, as Abbott Canada puts it, a "mealtime insulin calculator based on insulin pump technology."
That's right, the InsuLinx crunches insulin-to-carb ratios, calculates correction factors, and even has active insulin tracking (a.k.a. Insulin on Board, or IOB).
Think about it! Now, with this device, PWDs with pens and syringes can have the same mistake-reducing math assistance that pumpers get, and they get that critical anti-insulin stacking safety feature of pump-like intelligence built into their meters.
Say it with me folks: WOW! And InsuLinx received FDA clearance here in the States this Spring, so many of us who've been watching this have probably been thinking "Sign me up!..."
But, not so fast. There's more to this story...
Not All InsuLinx's are Created Equal
Something is missing. And I don't mean just 28 pages of the owner's manual. InsuLinx USA (the one submitted to the FDA) doesn't have the insulin calculator built in. Same meter. Same name. Identical in every way to the naked eye, but it's a neutered version. Press releases that trumpeted the insulin calculator elsewhere have glossed over the missing feature in the States.
Instead, the company only hailed the FreeStyle InsuLinx as its "first blood glucose monitor to feature a touch-screen interface, automated logbook, personalization preferences, and USB connectivity for plug-and-play reports."
Apparently, Abbott doesn't know about the Internet (where we PWDs can find out about anything launching in other countries).
So we wondered, did the risk-adverse FDA put the kibosh on the InsuLinx? Or did Abbott do it themselves? Naturally, we went to Abbott and asked. After some initial delays in getting a response, we heard back from Abbott Diabetes Care's director of public affairs Jeff Christensen:
"The availability of certain functions in our products in different geographies reflects the local needs and environment."
Seriously? That's their explanation?!
So American PWDs don't need help with their insulin calculations? They don't need Insulin on Board tracking? We don't buy it.
We pressed some more, writing back to Christensen with a follow-up email that simply asked: "Seriously?"
His response: "Thank you for your follow-up question. What I originally sent to you is our complete statement."
This was now signed "regards," downgraded from "best regards" on the previous email. Ironic that he works for Abbott Diabetes Care. I couldn't help wondering at that moment whether Abbott cares for its customers in the U.S. the same as it does for those outside this country?
I mean, clearly there must be a business reason for the difference in product features here. Why can't they at least be transparent and tell us what's going on?
To make sure we hadn't gotten a rogue operative, we also contacted Ann E. Smith at Abbott Corporate Public Affairs. She replied, "You have our statement that was provided by my colleague, Jeff Christensen." She also signed off "regards."
If there's more than one way to skin a cat, there must be more than one way to pluck a duck. We searched the FDA's website for the original application for 510 (k) approval to sell InsuLinx in the U.S. These documents show that Abbott made no attempt to get U.S approval for the insulin calculator function.
So the FDA didn't kill the meter-based insulin calculator. They never even got a chance to review it.
This is just sad.
Who's Risk-Adverse Now?
Big Pharma likes to whine that the FDA is too risk-adverse, and slows down the approval of innovative technologies for PWDs. But in this case, Abbott themselves seem to be the risk-adverse ones. Why?
By the logic of their representatives' statement about "local needs and environment," we American PWDs don't need this technology. Of course, that's a total crock. If they had chosen to be honest, they probably would have told us it was one of two things:
- Abbott feared the FDA might slow down the InsuLinx approval here if they pushed the feature through, or...
- They were afraid of the liability issues around the technology.
I'm sure the suits and ties worried that someone would enter information wrong, get bad results, and kill themselves -- which is actually the same worry that would trip up the FDA, of course. Let's be honest, that could happen. But whoever said injecting insulin is 100% safe? As it is now, waaaaaaay too many American PWD's just "wing it" with their insulin doses. A calculator built into their meters would increase safety overall, not reduce it.
Our friend and fellow D-blogger Scott Strumello recently wrote about how many companies avoid the FDA and go overseas for approval first. We've seen that from many different companies lately, and it would seem Abbott is playing that game, too.
But if this happened to be a liability concern, we wondered how this is handled in other places where the full-fledged InsuLinx is available? In Canada, users can purchase the meter over the counter, but the insulin calculator is "locked" and requires an unlock code from their healthcare provider. Once they have the code, they can set up, or modify, the insulin calculator themselves.
In the UK, diabetes specialist nurses (the English version of CDEs) issue and program the meters for the patients. According to chatter on the web, there's only one code and it works for all meters, so it's not a very well-guarded secret. The code will probably unlock your luggage, too.
InsuLinx (Lite)... Is Anything Going For It?
The neutered meter for the U.S. market does have a few cool features, especially the test strip port light for nighttime testing that many FreeStyle meters share. The software for downloading date will work on a PC or a MAC -- a good feature we hope is a new trend! It also has some nice data tracking and messaging features, if you can get enough strips to make the data crunching worthwhile.
On the con side, Abbott makes a big deal out of the fact InsuLinx has a touch screen, but anyone who uses Apple-style screens is in for a major letdown. The InsuLinx screen is a low-res, low-contrast, grey-on-grey LCD that's almost impossible to read, and not very responsive to touch, either. This is no t:slim.
To add insult to injury, the Abbott press release on the introduction of the InsuLinx to the U.S. includes a flat-out lie. It quotes Heather L. Mason, senior VP of diabetes care, saying the InsuLinx "represents Abbott's latest advancement in delivering innovative products for people with diabetes. We are excited to make this product available to diabetes patients in the United States."
Outside of our country, that would be true. Here at home? There's nothing much innovative about the InsuLinx, and it certainly isn't the latest advancement. It's just another me-too meter. And I don't think that would be overly vexing, if weren't for the fact that everywhere else, it's groundbreaking. My feeling on the InsuLinx U.S.A.? I think it's a lame duck.
Of course this isn't the first time Abbott has let down PWDs here in the States. Does the name "Navigator" ring a bell? That continuous glucose monitor is still available overseas, just not here in the U.S.
It seems as if Abbott has a whole bunch of ducks in the water, just not here in our local waters... so let's stop pretending they are the same and call them what they are: Lame Ducks.
Note, Roche also has a bolus calculating meter in the European Union (and not here), called the Aviva Expert, which is related to the meter that comes with their current pump, but set up for people using multiple daily injection therapy.