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.
What?!
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.
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It wouldn’t surprise me if that function is still present but hidden in the US units because that would be a simpler and cheaper solution than rewriting the software. If someone can track it down, the universal unlocking code would probably work.
Lets count the recent Abbott let downs.
The Navigator issue – they took the best technology and decided – Nah US doesnt need it, and its fun to string customers along for years thinking it will come back.
Freestyle test strip changes, All of us with integrated freestyle meters can no longer get strips. Nah Abbot doesn’t care about those customers, not worth going through the FDA to get approval to use newer strips in older meters. ( Im breaking the law using the new strips in my Cozmonitor )
This insulinx thing is last straw – Ive been a loyal freestyle user for at least 12 years – 12x365x7 = over $30 grand in strips. Plus 2+ years of navigator hardware and sensors. Lets add another $10k .. And what they are telling me is that they don’t really value the discerning loyal Diabetic , they are targeting the low end of the market, with no focus on loyalty or features or accuracy….
Well Abbott – I got the message, My cozmo pump is out of warranty this month and Ill be switching to a new pump and new strips before too long.. Good riddance.
Great review and great revealing of Abbott. I’m convinced they really couldn’t give a crap about people who use their products.
My daughter, T1, and 10 years old now, has used Abbott Freestyle strips in her OmniPod PDM for three years now. Abbott introduced new butterfly Freestyle strips. we have to use them, they stopped making the older ones without the butterfly.
There is one HUGE problem – they do not read correctly – not even within the +-20% variability of meter readings. They are consistently reading low – so that you are treating lows that are not lows, and underestimating dosing when they are high, because they are WAY higher than the meter reads. I’ve changed the code on the strips in her PDM from the standard ’16′ to ’17′ which brings the meter reading closer in line with others when compared. Many other bloggers and DOCers have noticed the same thing. I wrote to them TWICE so far – with NO RESPONSE, about their products. They really could care less. I’m surprised someone doesn’t sue them, maybe that would get their attention.
They also will not even think about making their products Mac compatible for download. Nope. Won’t even touch that one with a 10 foot pole. They dismiss it. Everyone owns a PC I guess. We don’t. But in this age – 2012, why wouldn’t you simply make the product Mac compatible? It would require $ and a programmer, that’s why, and they don’t care.
I’m not surprised they don’t care about InsuLinx. I’m not at all surprised by their response. You are lucky you got a ‘regards’ as I have nothing after a year.
And Abbott, I hope you are reading every comment. I meant every word. You treat customers like crap. If you care to contact me, I’m right here.
Abbott you let us all down.
We have the technology but lag behind the world. Aren’t any of you diabetic???
I think you need more user interface wih your “creative” research team!
Have a look at RapidCalc as a possible way of addressing the need for dose calculation. It does not yet connect to a BG meter, but when it does it will do everything that the “smart meters” do plus a lot more such as not having to test before recording a dose, transmission of results electronically and photo food diary.
Whilst I have a financial interest to disclose, the benefits seen with real patients justify spreading the message.
Thanks
Ian
Wonder if it could have to do w bonus calculator patents in the US? Lawsuits of this nature lead to the demise is Cosmo,
About all I can say because I’m crying is “I know.”
Does this meter have any better accuracy as some of the new meter are claiming? I know the new Roche Nano supposedly is held to a little higher standard.
Sounds like they are scared of getting into a patent fight over computer algorithm technology and having to pay royalties to someone else. Of course if there are minimal sales because of this difficiency, this is the least of their problems.
Im so shocked i seen this advertised (Im form the Uk) and when i turned on the monitor and tried to set up the calculator it asks for a code which my NHS nurse does not know either
HOw the hell do i set this up!!! was looking forward to having a insulin count but looks like i am gunna go back to a easy diabetic one touch ultra monitor and lots of guess work
what a crap monitor
Great outing Wil. I read the first few paragraphs with true glee thinking here was a meter that would give me something really useful and then was slammed by the fact that it doesn’t, but oh yes, Abbott chose to give it to the European Union. Their response sounds lawyer-led and in “lockdown” like the calculator feature.
If you want another story of how Abbott Diabetes cares way more about the bottom line than their patients, here’s a doozy.
Abbott had a comprehensive patient assistance program for American PWDs. If you were uninsured and had an income below their threshold, you could submit an application along with a prescription from your doc and receive test strips for FREE. This was a boon for uninsured diabetics, as test strips would otherwise run you $70-$200 a month, even with coupons/Rx discount cards. At the clinic where I work, we had enrolled many patients in their program. In my involvement with ACT1 Diabetes supply exchange for uninsured patients, we constantly told people to apply as we added them to our waiting list.
Then, in January 2011, we started getting notifications that the patient assistance program would still provide strips for existing patients, but was not accepting new patients…at the moment. We called to ask when. “Call back in a month” they said. We called back in a month, “No new patients….call back in April.” We called in April. “No, the program is not accepting new patients at this time. Call us in June.”
Before that time, though, we received letters that all of our patients would be discharged from the program. The reason? There was too much demand.
Yes, ladies and gentlemen– instead of at least serving SOME of the population who needs test strips, they shut the program down to serve NONE.
This leaves anyone who needs test strips at a loss. Roche restructured their Accu-Chek program so that it would at least assist some patients, but still leaves gaping holes in the rural US. And everyone else (OneTouch, Bayer, and yes, Abbott) offer coupons for 25-40% off….which still leaves a hefty chunk of change to be paid by the patient.
Now that I see this, I really want to know: what the heck are they spending money on, if they’re cost-cutting and deflecting patients in all these ways?
Thanks for the callout! I think Abbott is playing games here, yet their press people are holding the line as if this were still 1985 and they could control what we read about in the big, bad world of the Internet.
Sorry folks, it doesn’t work like that anymore. And, guess what, with tools like Google and Bing Translate, even investor presentations and press releases made in non-English language countries like Sweden and Germany are still at our fingertips.
However, Abbott is in the process of splitting itself into two different companies, so maybe they’ve been preoccupied about keeping their jobs lately. But, the fact that they are trying to sell this scaled-down version of a product here as if it were an innovation is kind of funny, yet simultaneously sad, too. Any bets on whether Abbott’s share of this business goes up, down or stays the same? Well, those decisions are based on getting it covered by insurance formularies, but this product looks a bit like a dud.
Thank you for your review….the drug companies disappoint me more and more….
Speaking as someone who has been taking mealtime insulin for less than two years(by pen), I find the whole concept of having to input my insulin into a calculator (even IF it’s also a blood glucose monitor) WAAAY too much work. If I trust myself to inject the insulin in my body, I will continue to trust myself with the necessary calculations. If I’m not sure, do I reach for a calculator? No. I take out a piece of paper and do it the right, old-fashioned way, by hand.
I live north of most of you (Canada). I actually use most new meters, including the Abbott Insulinx. the Dose calculator function is good, quite fast and simple to use (much easier than calculating your own dose by hand, plus it does IOB) but not as flexible as an insulin-pump dose calculator. I use a Medtronic-Minimed Paradigm Veo (that you also don’t have yet) therefore I’ve not much use for the dose calculator and have switched off this function. In a sense, works like a meter plus a few added extra’s. I like it a lot, one of my favorite meters.
At first, I was inclined to think this feature-omission was to protect Abbott from the frivolous US court system when, inevitably, someone takes too much or too little insulin, but after reading other comments, I’m inclined to agree that it may be a patent-related issue.
I bet it won’t be long before we see resellers advertising “imported” meters, just like we see a market for imported, unlocked cell-phones. Can these outside-the-US report blood gluocose in mg/dl, or only mmol/L? That, really, is the only showstopper I can foresee.
I’m sure they have their reasons for not selling the full-featured meter in the US (more justifiable than simple maliciousness). I can’t imagine what that may be, but their response to you is absolute bullsh–. There’s no reason to hide the truth.
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This is a real shame. Thanks Wil for pushing Abbott for a real answer and doing the gumshoe work on this. Other makers may decide that the FDA didn’t like the calculator stuff, I hope they stumble across this post as they consider this.
I’m struggling without a pump at present, Cozmo is dead and Tandem is not yet shipping. I could really do with a meter that does exactly these types of calculations. For shame on Abbott, no wonder they don’t want to talk about it.
I’m sorry that Abbott are taking this attitude in the USA and particularly for their rubbish response. I live in UK and am lucky enough to have one of these meters. Yes, I have the code and I find that invaluable as my ratios do change from time to time and being able to tweak the meter is essential (can’t imagine having to run to the DSN to ask her to do this – that’s if I didn’t have to wait 6 months for an appointment!). It is indeed a good little meter and the IOB feature is excellent, something I could never figure when manually working out doses.
Maybe Abbott thinks people in the US aren’t smart enough to use a meter like this properly?
I’ve stayed away from Abbott for the 20 years I’ve had T1, and I’ll continue to stay away………..they sure make a convincing case that I’m making the right choice.
Abbott is another manufacturer in diabetes and medical products that has become complacient, vs trying to innovate, and just milking the cash cow, they did not even TRY to submit the bolus calc to the FDA.. Will not forget when i suggested they offer meters with meal tagging and features the competition has, and got a “well you can do with our software” which did not work with windows 7 or even vista at the time…
Why would you buy a device like this overseas (and risk not being able to unlock it) when you can download plenty of apps for your iPhone or Android phone that accomplish the same thing?
Take a look at this one, for example: http://felixsoftware.org/apps
The algorithm included with the Abbott device isn’t anything special, you know.
Oh, and your iPhone or Android phone actually comes with a real touch screen (not a low-res, low-contrast, gray-on-gray LCD).
Hi Wil-’Am a PWD 1, 52 years duration and anxiety about insulin adjustment has plagued me for many years. My thoughts included: Your mind is not an insulin pump (used one for ten years, on and off, currently off), your mind becomes baffled while low (anxiety over the low increases the confusion), so how could you possibly think clearly enough to make proper insulin adjustments, and why has NO ONE involved in my care, until mucho recently (last few months) suggested I might do so, even though my boDy is X insulin sensitive. Your columns have given me the courage to realize that my mind’s great, that human beings invented insulin pumps, and that there is now available greater interpersonal communications between diabetes educators and PWD’s.
Even after this long, there lots more to learn and experience in my life. Thanks for being a part of it!
Short of driving across the border, does anyone know if there anyway to get one of the Canadian (rest of the world) versions shipped to America? I have been looking at various Canadian blogs and it seems to be a pretty good product. Funny thing I learned, the Canadian version uses regular teststrips, not specially marketed strips.
I drive across the border and get them. I have a Licentiate from the MCC if that helps? This is a great meter. I would drive to Canada to get it.
As much as I love new meters with new features, I looked around and Abbott has the US version in several online resellers. The kicker is that the strips are $83 for a box of 50 strips. While I’ve never paid full price for strips (I strips for free from my healthcare provider), it appears that Abbott is using this as a platform to increase the price of its strips (same with the Lifescan Verio). I actually like the Verio (except its size) but see no reason for the increase in strip price. Honestly, while I use a OneTouch Mini as my only machine now, I really liked the Contour USB more and would like to see more competition in that realm.
Not a great deal of improvement on the one thing that matters… better readings.
Hi I have got one of the free meters, gave it to my French doctor for Diabetes, and she did not know or seemed not to bother about the code. The Pharmacist here had never seen one, the test strips are “different” to the UK and rest of the EU but “the same” just a different name. I have contacted Abbot UK about both the things, so the calculator frankly is a con. The machine is good for the basic stuff, certainly less problems than my old machine or the really old one where I had to cut my finger to get enough blood to fill the hole. As soon as I hack the code I will put it on here. It has five digits so out of 6 there cannot be that number of variances, that is unless someone else has done it!
The code is CAA!C and of course the meter is no better than any other meter unless the calculator is set up. However, once it is set up (and tweaked) to your ratios then it’s a very helpful meter.
My experience with the Abbott products have been overly positive. I am living in the EU and could order the Insulinx for free. Although i have been satisfied with my current meter (Abbott Freestyle lite), I am curious how it performs. Other meters that i have tested since using the Abbott meters have never impressed me.
I have been very satisfied using Abbott’s Freestyle meters over the last 6 years (using a Freestyle Lite for the last 4 years). The positives for me are:
I never experience failure of the test strips (because the meter provides you enough time to add blood, in case the initial drop was not large enough), due to the test strip port light my better half is not waking up during night-time testing, the required blood drop size is small, readings have been very consistent for me …
When i asked their customer service about where to buy a PC connection cable to download the meter’s data to my PC, they quickly send me one without charge nor further questions.
In summary, my experiences with their products do not fit with the somewhat harsh comments on Abbott that are given here.
I am a new diabetic using a one touch ultra2 meter. I am constantly adjusting my lantus solstar insulin dose. Received a new meter from free style insulinx to help me with insulin amount. I am not sure how or if its possible to set this meter up to be able tell me how much insulin to give me. Any help or insight to setting up this meter would be greatly appreciated. I am in the US.
As a USA resident I do not have access to the InsuLinx calculator mode.
However I’ve been using GluCool for Android and with only one number to have to manually log into GluCool, I’m very happy. With the ability to calculate my dosage and track carbs and what not, it is very easy to use.
Even if the InsuLinx calculator does become available in the USA, I may stick with my One Touch Ultra2 anyway.
Here in germany, they are giving away the FreeStyle for free. There has been an advertising campaign in radio as well. So I got mine a week ago, including this Insulin calculation.
And here my results of the german jury: “failed” . It sucks in so many aspects, worst of all this clumsy, hardly ever readable display. There is more to say …
Dear american fellows, no reason to be envious.
I got this meter with very high hopes as well! At first I thought it may be the answer to the OmniPod meter with compatible Freestyle test strips used with the OmniPod pump. Of course if you don’t use the pump the meter will not record anything but the blood glucose.
Well I went through the trouble of setting it up to print/save reports only to find that it prints out in microscope form. It says you can output to Excel, but you need to buy the Adobe add on to do that, unless you have the full version. Once you do finally get it into Excel, it is not converted to data for you. Instead it is all formatted as the report would be. . not what I wanted
Why can’t there be a meter that records everything and helps with the insulin to carb ratio. Isn’t there a data analyst diabetic out there that could do this and help us?
If you go on http://www.eBay.co.uk you can buy one of these meters. Not cheap, they run about $50 shipped over here by Royal Mail.
The first thing I noticed was that the US Insulinx meter uses FreeStyle Insulinx test strips and the UK Insulinx meter uses FreeStyle Lite test strips. The FreeStyle Insulinx test strips do not have a code on the bottle, truly no code, while the FreeStyle Lite strips do have a code, it is automatic too, but they print it on the bottle. I might note that the UK box says use only with Freestyle Lite Test Strips, and the US meter says Use Only With Freestyle Insulinx test strips. The Strips look Identical side by side. I used the UK meter with the different test strips on the same drop of blood and got the same reading, well this suprised the hell out of me. The unlock code, provided by my UK connection was CAA1C and it worked perfectly.
Once setup, it does bolus calculations perfectly, both adjusting a standard bolus and a carb counting bolus.
The screen is abysmal but ok in bright overhead light. Screen response is ok, the numbers are all you care about so who cares what it looks like. UK reads in mmol/l, US in mg/dl, no way to switch.
The reason I use it is for logging. The bolus calculator keeps track of carbs I input, the US meter does not.
I am getting right handy at converting mmol/l to mg/dl.
Whoever wrote the report software just doesn’t understand either Diabetics, Endos, or unfortunately, computers. Ghod is it bad! However, after 40 years in the computer business, I can make it work well enough to get a report out of it, barely.
For us Insulin Resistant types, it won’t allow you to input a Basal over 50, so multiple entries are required. Haven’t tried to find the limits of the Bolus side yet.
It works for me.