Glooko expands meter line

Glooko is has added more meters to the list they and download.

·      Bayer's CONTOUR^® NEXT EZ
·      Bayer's CONTOUR^® XT
·      GLUCOCARD^® 01
·      GLUCOCARD^® Vital^TM
·      ReliOn^® Confirm
·      ReliOn^® Prime

http://us4.campaign-archive1.com/?u=3818427fadb6a6b6db4ecc9c8&id=aed08d0498&e=1f23a1c583

Abbott InstaLinx FDA Approved

Abbott received FDA approval for their FreeStyle InsuLinx Blood Glucose Monitoring System.* It is a meter using their FreeStyle band test strips and with touch screen is also an automated logbook with software to analyze and trend data.

Here is what they said in the press release:

March 08, 2012

Alameda, California — Abbott (NYSE: ABT) today announced that it has received U.S. Food and Drug Administration (FDA) clearance for the FreeStyle InsuLinx Blood Glucose Monitoring System,[*] the first from Abbott to include a touch-screen interface, automated logbook and several personalization features designed to improve the diabetes management experience for patients. This unique device is also equipped with built-in FreeStyle Auto-Assist software that enables patients to track progress, analyze trends and easily display data for their health care providers. The FreeStyle InsuLinx System will be available to U.S. consumers within the coming months.

According to the American Diabetes Association (ADA), approximately 25.8 million people in the United States have diabetes,[**] and of those, many require insulin to manage their condition. The FreeStyle InsuLinx System is the newest addition to Abbott’s portfolio of glucose monitoring systems and is designed to use FreeStyle technology to help insulin-using patients monitor their blood glucose levels to allow them to more effectively manage their condition. Specifically, the FreeStyle InsuLinx System offers:

• Touch screen designed for ease of use
• Automated logbook that assists with tracking logged insulin doses and blood glucose levels
• Personalization features, including the ability to upload weekly messages, pre-and post-meal markers and a personal photograph to the home screen
• FreeStyle Auto-Assist software that can be uploaded to a computer via USB connectivity and is designed to help people with diabetes, health care teams and caregivers manage diabetes with reports, reminders and messages

*FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.
** American Diabetes Association: http://www.diabetes.org/diabetes-basics/diabetes-statistics/

From the News Wire: iPhone App Connects to Glucose Meters

Telcare’s New iPhone App Connects to Glucose Meters Even Oceans Apart:Telcare, the maker of the Telcare BGM cellular enabled blood glucose meter, has released an iPhone app that can gather data from the meter even if they’re physically apart. 

This not only allows you to watch your own glucose, but a parent of a diabetic child can make sure the kid takes regular readings and almost immediately know what the output is.
More

Accu-Chek Nano FDA Approved.

Roche announced that they have FDA approval for the NANO in the US.

Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Accu-Chek® Nano SmartView blood glucose monitoring system. The new Accu-Chek Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, pre- and postmeal markers and average glucose calculation. The Accu-Chek Nano meter uses Accu-Chek® SmartView test strips and will be available to customers in the first half of 2012. 

Our pals across the pond did a review of the Nano a while back: http://www.shootuporputup.co.uk/2009/06/review-roche-accu-chek-aviva-nano/

iBGStar Blood Glucose Meter for iPhone Now Approved in U.S.

From the News Wire:

iBGStar blood glucometer attachment for the iPhone, developed by AgaMatrix and commercialized by Sanofi, has received FDA approval.  The iBGStar uses the iPhone as a beautiful visualization tool to keep track of glucose readings, food and insulin intake, and exercise.http://medgadget.com/2011/12/ibgstar-blood-glucose-meter-for-iphone-now-approved-in-u-s.html

Sanofi Press Release




Prior YDMV posts on iBGStar:
http://www.ydmv.net/search?q=ibgstar

Accu-Chek Aviva Expert - UK

Here is a fascinating little piece of diabetes gear, a meter with a bolus wizard for the MDI crowd. Hop on over the Shoot Up or Put Up for a review of a device I am fairly sure nobody in the US is talking about. I'm betting heavy on the FDA's rules is the reason why.

Anyway Tim's a good enough guy, except for the puns, so here's a link the the UK review, including the  image Tim pinched from Roche and I took from him.

Little Help - Can Anemia Mess Up Diabetes Blood Glucose Readings?

Doh! I feel like Homer Simpson asking that.

Someone out there should probably hit me with dope slap upside the head.  Of course {fill in the blank - including anemia} has an impact on blood sugar. What is the name of this blog again?

How does it mess with meters?

Diabetes plays games and one is to make me feel powerless. This is one of those times and I need a little help.  I am curious does anemia mess up glucose meters? I would love some experianced feed back.

It is more than just the readings - does anemia stop the frogging meter from working at all? Does it make the meter throw off used strips like beads from a Mardi Gras float with nothing to show but error messages?

We use WaveSense Jazz meters at school. Over the past few weeks our school nurse reports increasing instances of meter errors. As in it takes 2-4-6 up to 10 strips to get a reading. This is an experienced nurse and kid with 6+ years since type 1 diagnosis. They have literally thousands of blood test between them. They know the ropes of finger pokes.

The kid had lingering cold. That with exposure to whopping cough led to a doctor visit.  The visit in turn called for a blood draw that showed nothing but low iron. Which in turn led to a more detailed blood test that isn’t back yet.

Meanwhile the nurse is getting a more and more checks that just fail to give a reading. 2-4-6-8-what don't we appreciate? Using boat loads of strips to get a single Meter Readings! Yeah BG!!

Oh and some consistency between readings would be cool too. Three days ago after a bunch of errors the nurse got a BG reading of 22. That seemed suspicious given the circumstances (a word that hear means: a lack of hypo symptoms factored in with prior tests that day, the amount of insulin on board and time since eating.) So being familiar with such circumstances, they tested again. Three minutes and another bunch of strip later the low transformed into a 308. I don’t think anyone wants to confuse a 22 and a 308. Certainly not our nurse. She is tip top.

She called and sensibly but timidly asked for another meter. I love her. No worries I could swap out one from home with fresh strips in minutes. Guess what? - That replacement had the same issues and more the next day.

Could this explains some of the resistance to checking we are seeing at home? Gee I don't know - finger pokes are not that much fun to begin with so yeah maybe having them not work could be frustrating.

So I dragged a Tru2Go ninja meter up to school today when they called (3rd day in a row!). Would a different blood electrochemical process make any difference? Yes - No problems giving a reading, we'll see what tomorrow brings.

Now I for one don’t think a kid should have to poke her finger 5-10 times to get a reading. Also all in all I would prefer not to burn through strips at a rate of 2 to 8 errors for each reading. And lastly and I know this is being really picky of me I would prefer not to see 280 point swings between hypo and hyper in three minutes.

I asked the 800 number if they were aware of any issues. The operator at the call center was sure it is temperature. I know the environment well so I know it isn't about temperature. I called WaveSense directly, they said they 'wanted to support' me in the use of their product but little else.  Nothing about low iron and strip issues. 

I can find academic articles on the subject: Error Rates Resulting From Anemia can be Corrected in Multiple Commonly Used Point-of-Care Glucometers and Anemia causes hypoglycemia in intensive care unit patients due to error in single-channel glucometers: Methods of reducing patient risk.  I guess is a very scholarly, Yes - anemia can mess up numbers. But it isn’t much more helpful than my opening Doh!  

How about any of you out there in the big wild blue yonder of the DOC? Does anyone have experience with low iron and meter errors? If so what did you do about it? (Other than cursing - Kerri says we can’t curse. I may have forgotten that.)

iPod Blood Glucose Meter from Sanofi-Aventis & Wavesense.

Sanofi-Aventis announced a BG meter for your iPod / iPhone. Just plugs right in there. This is part of Sanofi-Adventis' working with the creative folks at AgaMatrix aka WaveSense. This scores very high on the cool scale not only for the iPod connection but we here at YDMV central are big WaveSense fans and are excited to see them continue to innovate.  The meter works independently from the iPod. So it is a cool tiny meter in and of itself.

From Sanifi's http://ibgstar.com site:

The innovative iBGStar™ is the first available blood glucose meter that seamlessly connects to the iPhone® and iPod touch® allowing you to view and analyse accurate, reliable information in ‘real time’. Using the technology built into your iPhone® or iPod® touch, you can share this information with your healthcare professional while on-the-go, to help you make better-informed diabetes-related decisions together.

Of course it isn't just a meter. There is an app. From the press release, "The iBGStar™ Diabetes Manager App (available soon on the App Store℠) is a state-of-the-art digital diabetes management tool accessed from your Apple iPhone® or iPod touch® featuring:

• Intuitive User Interface
• Automated download of meter results
• Interactive Diabetes Management Reports featuring log books, trend charts, statistical analyses and more"

The ap sure looks a lot like the WaveSense ap our pal Hadi demo-ed at Friends For Life. (Hadi's brilliant little demo video of the app on a ipad - no groovy iBGsatr meter, he used a cable, is over on theBetesNOW.)

I think this is very exciting. Yes there are practical questions like does it have to come off to charge or sync the iPod? What kind of battery powers the meter and how long does it last? What strips does it use - can it take WaveSense strips or is there a proprietary twist to Sanofi branded AgaMatrix strips? Are there going to be different colors for multiple type 1 families os we can tell who's is who's? How does it deal with iPhone cases? Is there a case that hold it and the phone? Does it work with an iPad? What about multiple meters and one iPod?

OK Ok I know, it just came out and it has to go visit the FDA.

Sill cool. Way cool.

Smash-a-Meter

Feel like your meter needs a little lough love? theBetesNOW does.

WaveSense App Demo

theBetesNOW.com has a video demo of WaveSense's iPad / iPhone app is up. Cool. They taped WaveSense at Friends For Life.  Makes me want an iPad even more.  Oh and a cable as soon as they are available.  Check it out.

My review (much less cool than the video)  of the WaveSense app is here.

Red Ninjas in Theme Parks

We picked up True2Go meters at CWD. This is the son of the Sidekick meter that I wrote about at www.DisneyWithDiabetes.com ages ago. I was a big fan of the Sidekick for it's mobility and the new 2.0 version is better.

The True2Go meter twists onto the top of a can of 50 strips. With a groovy little wetsuit strap they gave us we can attach their way small lance device to the side. It brilliantly designed so that with the pokey end down the lancer works without being removed from it's holster.




There is even enough room a can of 50 strips to carry extra lancets. You know it maybe time for the semiannual change of the lancet any month now.





This is a great on the meter. True2Go Dudes put a key ring on this bad boy. It small enough to go along with every T1 driver every day. While you are at it make a way to tote around 4 glucotabs too without the gluconess getting to the strips and messing up the readings. I thinking a two ended strip can with a bottom flap for tabs.

True2go gave me a white paper on accuracy. I'll read it when we get home. In the mean time my kids are carrying these little guys around Disney World. It is one nice tight little kit.

They come in red. Dudes I got more than one T1 kid - color options would make knowing who's is on first. (We got home and the local CVS has a variety of colors. Rock On.)

In the mean time Delaney calls them Red Ninjas.

Need I say more?



- Posted using BlogPress from my iPhone

Didget III - To the Internet and Beyond

The ambition of the Didget is very impressive. Bayes has built a meter with a Nintendo component and an online community for kids. This, my third review of the Didget, looks at that internet component.

YDMV's other Didget bits can be found here:

Didget First Look

Didget II

Kids need to connect the Didget to their computer to get to the community. This may help some build the habit of connecting and downloading. Good idea. Very clever.

Bayers Diabetes tag line is Simple Wins. They use a standard USB cable to connect. That is simple. Kudos to the design team for skipping over the proprietary connector.

Maybe the plug team should sit down with the software guys. It was anything but simple to connect and register to the site. First in my lack of caffeination I tried to use my Mac with FireFox and I couldn’t load the browser extension needed. Then I used my daughter’s PC. I was doing this early and clearly needed more coffee. Every time I missed a field on the sign up form it erased three others. It wanted a little more information than I really wanted to share like my kid’s date of birth (and the drop down didn’t go back prior to 2000 unless you pick 200 and then re-drop down.)

OK I did get signed up in due course but it wasn’t simple. Much of that seemed to be for security. That is great. Kids should be secure and part of that, IMHO, is asking less.

In time and in need of Starbucks, I got in.

There are a number of sections starting with a set up screen. You can see here it is looking for the Didget serial number, building the connect habit:

After signing up there is an arcade where you can buy more games with points earned primarily from testing and testing consistently over time.

The Arcade looks like this:

For everyone concerned about making value judgments on BS, blood sugar testing and testing at least four times a day, every day over time is how the vast majority of points are earned in the game.

Another tab is a mood Ring that kids can use to express their mood with a drop down and there is a lot of choices.

Themes some are free and some need points and I didn't capture the screen.

A Tiki Mask answer machine (aka magic 8 ball). Here I ask it why it doesn't like my Mac.

A game leader board which I don’t have a picture of because it had user names on it and I will not even show a made up name of someone else’s kid on the internet.

Carb Calculator: Pick food and servings and it estimates carbs. It looks like it uses carb exchanges. For the scale and count users it may not be accurate enough. I do like the idea of making carb counting accessible to kids and in the context of their world and for a lot of kids (Your Kid May Vary) games are their space.

Kids can ask other users to be friends. I didn’t test this because well I try not to be a creepy old guy talking to kids online and that how it would have felt asking of a friend. I couldn’t see any thing about other kids than their name and a button to request being friends. There didn't seem to be a lot of users yet.

When you sign in as a parent you see completely different stuff. One piece I was impressed to see was that considered that a parent may have more than one type 1 kid. As a parent you also get a menu screen and it looks like this:

From the parent menu we geezers can view logs and such, well that is if you have been using the meter and as I said in Didget II my kids found out the Didget strips fit the Contour USB and they have been fighting over that meter. This is what the screen looks like, you can imagine numbers:

Editorializing to follow:
My older kid doesn’t see the value in a diabetes only communities online. At least that was his response to some of the big advocacy groups sites. Diabetes isn’t the only thing about him or define him and he prefers to stay in touch with his type 1 friends with Facebook and text messages. (Most of these friends are from CWD’s Friends For Life gotta get that plug in. It is a great program.)

However just because my kids isn’t into the idea doesn’t mean other kids will feel the same. Other may like it a lot, and the target demo here is younger than most Facebook users and this is a way less public place. (You have to connect a meter to get in.) In fact the value of FFL (see plug in prior paragraph) is being around and connecting with other kids with type 1. I think the value of focused community is huge. I think communities work best when one size fits the size it fits. One site doesn't fit all. People connect from the state of mind that they are in and facilitating small communities makes that possible. Marketers call it niche marketing. I think it is more significant than marketing.

Let me digress a bit here and talk right into the camera at Bayer.

Dudes (and I mean that in a non-gender specific way) - suck it up and get back to FFL. I don’t know why you stopped coming. I can guess but I don’t care why. In the words of the Beatles, “Get back to where you once belonged.” I miss your presence and I know others do to. You have some seriously strong products and families with diabetes need to see them. Rejoin the community there.

Back to the Didget and off my rant. I think this is a very significant product. It doesn't try to be the meter for everyone including your uncle with type 2. It take the idea of diabetes care and focuses on habits, specifically rewarding regular testing in the day, every day all month. The rewarding is in the context of a particular user community, kids. It maybe too old for some and too young for other and in that it is brilliant. It was made to fit one size not all.

The Didget is not a meter it is a system designed to promote the development of habits of care in kids. The system is the meter, the Nintendo game and the online components working together. Building a set of tools that are a kid focused system is brilliant.

I doubt we will be users. Our kids are part of the too old. Still I applaud the effort to bring management tools into kids' worlds. It is well conceived, focused and as such not for everyone, not even all kids. That is brilliant.


YDMV DIDGET posts:
http://www.ydmv.net/2010/05/bayer-didget-first-look.html

http://www.ydmv.net/2010/06/didget-ii.html
http://www.ydmv.net/2010/06/didget-iii-to-internet-and-beyond.html

Didget II

We have had the Didget rattling about the house for a while and I haven’t done much with it.

By design.

I opened it up read over the literature and handed it (the meter not the literature) over to Delaney. We laughed at the manual (Particularly the right side up part - Good Friend of the Blog Lorraine explains why in her review of the Didget) and then we watched Top Gear because that is what we do. After the Botswana Special, she played the game and announced it was a lot like Pokemon.

This information meant very little to me. What I know of Pokemon is the sum total this; before blood test strips, there were Pokemon cards all over the house. In fact for all I know there may still be Pokemon cards under the carpet of used strip we call the floor.

Anyway, I intentionally didn’t interact with Delaney as she used the Didget. I was curious to see what her reaction would be.

I think I should preface this next bit with - she is a few days from being a teen. I suspect that she is older than the target market for this meter-game combination.

After the initial, “It is cool!” her comment was, “It is huge.”

It is. Maybe not large enough to have it’s own moon orbiting it but I think it’s gravitational pull effects the tides.

I found it very interesting that when she discovered that the strips worked in the Contour USB she started testing with the USB. Then Connor stuck it in his pocket. Some where in this the Didget fell off the coffee table in the living room and nobody picked it up for a few days where it risked being layered into a geological strata with the strips and Pokemon cards.

My first test was this: Will the Didget hold the interest of an almost teenaged kid in my house?

No.

I think my baby daughter is too old and so experienced with meters that the game and the large meter form factor do not work for her.

So I poked around (get it poked around, diabetes, Pokemon?!? I kill myself with this stuff! - Ok ok you want to kill me too, I’ll knock it off.) I think there is a very distinct market for this thing. Connor was diagnosed at 9. Delaney at 7. We charted and used stickers as rewards for their testing the number of times they were meant to and all kinds of happy smoke blowing stuff like that. Still sticking sharp steel in their fingers got old before it became a habit.

This meter would have been crazy useful in helping build those habits and making the whole crappy newly diagnosed experience a little better - a little more of their world and less of the medical industrial complex's world.

A little then is a lot.

I am way in favor ever little bit.

With that big picture said, time fo I wish that some of the game / bonus parameters were user definable. As in Your Diabetes May Vary so how you would like to use the game interface to reinforce care behaviors may vary too.  Specifically I would like to have control over the target of 4 test per day to reach the bonus points. I would make the magic number a little higher. Say test before each meal two snacks and bedtime for the grand total of 6. Yeah that is a little nit picky but what the heck I am meant pick nits aren’t I?

From what I have read there are other aspects of the Didget ecosystem (stole that ecosystem phrase from Continua) that I hope to investigate in future post. 

Until then I am a fan of what the Didget is trying to do. Specifically demystify the freaking meter, make it common and accessible and encouraging kids to make care behaviors habits in their world.

I am fascinated but not suppressed by my kids’ using the Didget strip in the Contour USB and their little turf war over it. Bayer has stepped up their game in meter design. I love the creativity and kid appeal of the Didget and the adult sophistication of the Contour USB. Good design rocks!

I believe in options and markets that deliver choices to consumers.

If Your Diabetes May Vary so should the tools used to manage it.

Kudos to Bayer for getting that.

For more T1 parental perspectives on the Didget visit my friends and fellow T1 Bloggers:

Lorraine - This is Caleb

Leighann - D-Mom


YDMV DIDGET posts:
http://www.ydmv.net/2010/05/bayer-didget-first-look.html

http://www.ydmv.net/2010/06/didget-ii.html
http://www.ydmv.net/2010/06/didget-iii-to-internet-and-beyond.html

Bayer DIDGET: First Look

The DIDGET has landed. Here's a first pass quick look and some initial impressions. As we get some experience with it I will share more details.

First things first -  Disclosure. Bayer was kind enough to send a meter for review at no charge to my personal pocketbook. Schwing! They also sent me an extra can of strips. Bonus Schwing! I made no promises other than to speak my mind and to make full disclosure that they gave me the stuff if I wrote about it. So there ya go.

DIDGET a meter and a Nintendo game. Like the old SNL bit it a floor wax and a dessert topping. Well except DIDGET is for real. I have been interested in this meter since it was announced. I think outside the box is cool and this thing is clearly different.

DIDGET seems to be trying to reach T1 kids where they live. It says, “You’re kids, you like games here’s a care tool that tries to be fun.” A significantly different approach than, “... or you will die.” Now don’t get me wrong there is a place for, “... or you will die.” Specifically in the Top Gear Botswana special. The relevant part of that starts about 30 seconds into this:

We love top gear and the specials are just brilliant. I suggest you buy them in iTunes as the quality is way better than YouTube and this is quality TV. Watch them with your kids. It is way more fun than diabetes.

OK back to the what is inside the box, Here is the DIDGET unpacking sequence:

You have a bright kid friendly box.

It unfolds 

Inside is a pack of documentation including user guides for both the meter and game in english and spanish.

It a lot of stuff when it all gets unpacked. 

At about this point my soon to be a teen started paying attention and was psyched that it was a meter. Somehow that hadn’t sunk in.

Possibly I don’t read the user guides that well but this is the first meter that I recall having an issue with the direction it gets held to test. Anyone else ever read that in a meter manual? I feel the need to test upside down and backwards just to see if it makes any difference. This is the point of the book Delaney and I added "... or you will die" to every sentence we read in the users guide and it got to be quite funny.

Over at CWD some parents have expressed concern that the DIDGET rewards in range numbers and because that is indirectly punishing numbers that is a problem. Their point being numbers are numbers not good or bad. So what does DIDGET do?

Well we just unpacked it so the jury is still out. The book says it does give slightly higher game points for in range numbers than out of range numbers (or you will die.) More significantly the game rewards multiple test in a day up to 4 test. It also rewards consecutive days of testing with bonus points if user tests at least 3 times a day (or you will die.) Here is the section of the meter manual on game points.

We haven't been using it enough to see what the game / meter interaction is. Not that I will let a little thing like not having a clue keep me from opining on the matter. I think parental actions have a bigger effect than any game will on punishing numbers. I include passive aggressive signals in that and I am guilty of far worse than a few points in a game, like projecting instead of joking "or you will die."

More importantly (not than you will die) I think the goal, as I read it, is to support having fun and build a habit of regular testing with positive feed back. Again I think parental signals are more important than any game but I think giving families tools that reinforce the idea of positive feed back for good habits is brilliant.

On the plain old meter side of things DIDGET has two levels of settings: basic and advanced. Advanced gives you the option of before and after meal marking, after meal reminders and the above mentioned personal settings for HI and LO.

So far very good.

YDMV DIDGET posts:
http://www.ydmv.net/2010/05/bayer-didget-first-look.html
http://www.ydmv.net/2010/06/didget-ii.html
http://www.ydmv.net/2010/06/didget-iii-to-internet-and-beyond.html

FTNW: Diabetic Tests Must Be Regulated, Experts Urge

What is glycemic numeracy and are these tha same experts who figure +/- 20% is OK?

Oh and why are policy makers listed before patients?

ScienceDaily (Apr. 5, 2010) — As a benchmark for diagnosing diabetes, the importance of the A1C test must be reevaluated to improve glycemic numeracy of policy makers, patients and providers -- who must make real-world decisions. This is based on a commentary published by Wiley-Blackwell in the Journal of Diabetes.

Dear FDA II

Hi there FDA. Me again.

I don’t mean to get on your nerves and I am sorry if I am. Well not too sorry, maybe a little.

Anyway I was skimming through some websites tonight and I read a bit that seemed to relate to the whole meter accuracy thing. I used some of it here, admittedly a little out of context, but hey it still seems to make the point that treating diabetes is critical. There are real risks, so improvement to robust and reliable traditional blood glucose meters has enormous potential benefit.

Well kinda, these are the bit I lifted that from:

…critical initiative of the Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective … treatment of diabetes mellitus.


Compounding… difficulty is the trade-off between improved glycemic control and an increased risk for hypoglycemia (low blood glucose levels), which can cause seizure, coma and death.


… robustness and reliability are still in need of improvement…


… require… using a traditional blood glucose meter…

…enormous potential benefit

So FDA, in case you still can’t place those bits here's a reminder. Y’all said’m. You were talking about the artificial pancreas.

More accurate meters will help you acheive your critical path initiative. (Hey don't do it for us do it for yourself!)

Oh by the way we are artificial pancreases now.


(YDMV's note. I didn't put this on the FDA comments site. A bit flippant. Think I should?)

Dear FDA

Thank you for providing the opportunity to comment on blood glucose meter accuracy. I am the father of two insulin dependant children ages 12 and 16. The younger has been on insulin for 6 years and the older 7 years. I write today from the perspective of a parent and type 1 parent’s advocate.

In the supplementary information provided to create the frame work for this discussion the FDA notes that, “Glucose meters are used by millions of people with diabetes every day. These devices have become smaller, faster, and more accurate over the past 3 decades and now allow for better glycemic control by diabetics than in the past.”

Many of those users are families of with children with type 1, insulin dependant, diabetes. Because of this insulin dependence these families are injecting insulin either with an insulin pump or with shots also know as Multiple Daily Injection. To minimize the risk of hypoglycemia these multiple daily doses of insulin must take into consideration the child’s blood sugar at the time of injection. We can only estimate or children’s blood sugar to be with in a range of plus or minus twenty percent with current meters standards.

I hope that the FDA will consider the difference between those diabetics who have this multiple daily need for actionable accuracy in the dosing insulin in addition the needs of those diabetics who do not use insulin.

What is important in this process is the glycemic control mentioned in the FDA quote above. While meters have improved over the past three decades, current standards have had the effect of halting innovation since the standards were created. The current standard of +/- 20% was defined by ISO 15197, established in 2003.

I am unaware of standards for quality assurance. I do know that variance from strip batch to batch has been reported to be an issue. Also counterfeit strips have been a cause for concern as has interference from medications.

As the FDA’s supplementary information also notes, “Blood glucose meters are being used in clinical settings and at home in ways that are not within the intended use of the devices as evaluated by FDA. For example, glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been cleared for this use.”

Every day millions of American households are treating type 1 diabetes in children with devices that were not intended or evaluated by the FDA for that use. It isn’t that we want to use meters in ways they were not evaluated or intended to be used. It is that the FDA has not evaluated meters for this use.

We have type 1 now. It needs to be managed now.

Type 1 diabetes is a 24/7 condition that is primarily managed by the individuals and families it effects. As noted above better glycimic control is achieved with multiple daily doses of insulin. While this is done in consultation with and coaching by a care team of physicians, diabetes educators, nurses and dieticians the day to day primary care management responsibility falls on the individual and family with type 1.

We would love the support of the FDA in this daily effort. Specifically by evaluation the tools we use for the use we put them to. Further the FDA should recognize that the technological progress of the past three decades didn’t stop in the early part of that past decade. We need accuracy standards that envision our daily lives, meet the actual use of our meters and progress with technology.

I hope the FDA will establish standards quality control, clear communication of accuracy standards, interference from other drugs and safeguarding the supply system from fraud.

Clear communication of accuracy standards met in meter marketing would allow consumers and their care team to select the tool based on capability. This would facilitate physicians’ ability to prescribe tools based to the degree of control and intensity of the management program they are recommending for their patients.

I hope that the FDA will be able to look back on the most this most recent decade and say that of meters, “These devices have become smaller, faster, and more accurate over the past decade and now allow for better glycemic control by diabetics than in the past.”

Tighter accuracy standards of +/- 10% would be a positive action step on that path.


Click here for the FDA and post your two bits.

FDA-2009-N-0604
Clinical Accuracy Requirements for Point of Care Blood Glucose Meters; Public Meeting; Request for Comments

Ellen on Meter Accuracy

Good Friend of the Blog Ellen Ullman wrote this as a comment on accuracy but I upgraded it to a Guest Post:

I want significantly improved accuracy for all meters for all persons with diabetes.

It is not only the 20% inaccuracy that is permitted which I find UNacceptable, but perhaps even more so that it only has to be within that 20% above 75 mg/dl 95% of the time - NINETY-FIVE PERCENT OF THE TIME. The other 5% are considered "outliers" without explanation. To hear some in industry or academia discuss it, it felt to me as if outliers are considered nothing more than dots outside of the Clarke Error Grid A/B Zone. But I view the very same dots as flashing warning signs with alarms going off - CAUTION - because of the potential human consequences that may result from that # on the meter.

Some of us are very in tune with our bodies or our children's bodies and know enough not to dose based on a reading that seems so far beyond what we think may really be going on in the body. NOT every person with diabetes, and not every caregiver of a loved one with diabetes, has that intuition, or perhaps has ever had the education to know not to dose without checking again. Many of us are fortunate to have extra test strips to use when we question a number on a meter that doesn't seem congruent with the situation. Some people barely can afford a single test strip let alone 2-3 extra to figure out what the approximate bg value is. So what happens to the 2 yr old whose parents are underinsured, less well educated, or given the cheapest and least accurate meter on the market and the meter says, for example, 350 mg/dl prior to a meal and they give a whopping dose of insulin to correct for the 350 that had they rechecked would have discovered bg was closer to 120 mg/dl? Every single outlier is a potential disaster. It only took the memory of one seizure requiring glucagon injection in my toddler in 1989 or 1990 and the thought of how many have occurred and how many in the future may occur due to meter inaccuracy and excused outliers - to know I needed to stand up before FDA/CDRH and plead for the need for increased accuracy and the ability to compare meters based on performance accuracy. We need to eliminate every possible variable that we can in our daily journey of the diabetes roller coaster ride and tightrope walk. AND we are calibrating our CGMs based on these meters that require less than adequate precision and accuracy - what if your calibration is based on an outlier?

(Are you having Cheerios for breakfast? LOL )


Nope Ellen Just coffee. Cheerios are too hard to cook without coffee. ;)

Poke a Finger on the Invisible Hand

Mrs. YDMV and I have been splitting shifts between the home front and the hospital where they managed to pull Connor’s appendix out of a hole they cut in his bellybutton. Nice trick! Beats the heck out of a rabbit in a hat.

On my home shift I was helping the other boy edit a paper on Adam Smith’s Invisible hand. He did a nice job. I was particularly happy to see him using This American Life as a reference. I love that show.

For those of you who would rather have your appendix pulled out of your bellybutton than try to remember what a long dead economist had to say here is a quick A. Smith refresher; individuals acting in their own self interest lead the market to outcomes that are good for everyone. OK maybe that is taking old Adam a little loose but probably not much.


At the hospital it took both the Charming Mrs. YDMV and I three, maybe more, separate and fairly emphatic tries to make it clear we would manage Connor’s blood sugar with his pump and the 'log he is used to using rather than them hanging a slower insulin with their pump in his IV.


In my spare time I have been reading tweets and blogs on blood glucose meter accuracy. As usual my friend Scott has a nice bit. He advocates for lower accuracy margins of error. Another other good friend of the blog (I am shamelessly steeling that good friend of bit from Colbert even at the risk of getting on his list for swiping it) Kerri also writes on the topic today as did Kelly. Careful YDMV readers will recall I wrote a bit the other day that questioned what the heck accuracy is anyway.

I had a conversation on meters just hours before dragging Connor into the ER.  In that chat I said I was sure there are folks, like Kerri, who work at diabetes hard enough that the meter accuracy matter in her (and the soon to be adorable BSparl’s) life makes a difference.



If you have read this far without bailing out you may be asking, “What the heck does this have to do with Adam Smith?” Seriously if you are thinking that you need a life - no wait I mean - Good question! Stand by for the kind of BS (not the blood sugar kind) that made me love writing essay question’s in blue books back in college. (Do they still have blue books?)



Don’t just tell the FDA you want accuracy in your diabetes care. Tell the market. Take an invisible 2x4 in Adam Smith’s invisible hand and smack the market up side its invisible head. You want more accurate meters  - buy them. Well their strips - Never buy a meter. Let them give you the meter itself.

The market seems to be trying to supply cheap cr*p meters. The FDA has given the OK to boat loads of meters from firms over seas that may or may not meet our desired goals for accuracy. They probably don’t have the same level of phone support and who knows how issues with adverse actions are tracked. I don’t see these things as in myself interest and so we don’t use them.

Scott point out that there is a meter on the market at +/- 10%. We happen to use it. We started for the aesthetics, they made a pink meter and that mattered to a tween girl. We stay for the low blood draw, compact meter size and easy to read screen. In short they (a word that here means WaveSense) made a better product and we for our own self interested reasons use it. If a big wave (nice pun eh?) of people did too then maybe the market would move to something like WaveSense's form factor, accuracy, usability and pinkness. By then I expect WaveSense will have moved on to even more innovative products.

We didn’t let the Doc’s manage Connor’s blood sugar because we felt we could do it better. We didn’t want an insulin we didn’t have experience with in him. We didn’t know its effective time frame in him. We choose to managed his blood because doing so is in our self interest, We stayed with what we know works. Speaking of what we know, we know his pump well. If lots of parents of T1 kids also decline the hospital’s type 1 sugar management and do it well maybe the market (a.k.a. doctors there) will come to see that as a good care option and give up after the second clearly stated decline of their suggested treatment.

Choose well, as we each live Our American Life we are Adam Smith’s invisible hand.


PS speaking of invisible stuff. I have no relationship with WaveSense other than we use their stuff. Well OK I follow them on Twitter too if that counts as a relationship but they don’t say a lot and I am a highly incompetent twitter user. I did once look to see if they were publicly traded and was thinking about buying into their stock but they weren’t public so I was SOL. I have been to the Hospital’s community fundraisers and probably will go again. They did a very nice piece of surgery. They are right to be cautious about BG management. Side effects of reading this blog may include headache, blurred vision. Your dDiabetes May Vary.

What is Accuracy?

At some point in learning to live with diabetes comes the discovery that the number on the blood glucose meter has range of plus or minus twenty percent. That tends to horrify people.
The FDA is having hearings this week on meter accuracy. Good friend of the blog Ellen Ullman is testifying for patients. Yay Ellen! LY/MI!
Ellen has me thinking about accuracy. My thoughts didn’t fit in a tweet. (I am a wee bit wordy - I know it is a schock) She asked at what cost more accuracy; higher co-pay, bigger meters, more blood, and slower response time, all of the above?

All that begs the question that I am really trying to come to grips with: Would tighter variance standard for meters, +/- 15% or 10% result in better health outcomes? Or are there other issues in the whole of T1 care that present greater opportunities for better care?

Well first off what is better care? Lower A1C? Less BG variance? I think most folks would say well it is both low A1C and less glucose variance. Will a tighter margin of error in meters achieve those results?

I suspect that there are many variables in diabetes that are not with in the 20% margin of our meters. How about carb counting? Consider a bowl of spagetti. Are the sources of my information, portion control and actual consumption within 20%. Is the actual sugar content of a tomato that was used to make the pasta sauce that tight? The blend of wheat in the spaghetti? Did the manufacturer vary the high fructose corn syrup to achieve the brand’s signature taste because the tomatoes weren’t as ripe? Is that food label really that accurate? I have no idea.

How about the impact of my activity? Did the effect of the gym on BG vary? Do habits about getting to the gym?

Is the insulin fresh? Did it get too hot? Is the set working well? Air in the tube? How accurate is the amount of insulin drawn into a needle? How is the stress? What is the weather? How early did I pre-bolus.

Assuming all of that is dead on the money, how often am I testing? Those numbers are a point in time. They have no indication of any change in the direction of BG or the rate of that change at the time. And if those numbers vary from the goal is that variation the result of a bolus issue or a basal issue?




Head ready to explode yet?



Is there anyone on God’s Green earth (and I will grant you there is extra green today ‘cause it is St Pat’s - I don’t thing the green die matters but the beer is another story) who has all this figured out to +/- 20%?

So my two bits are this: Accuracy is promoting better outcomes. In that definition, I wish everything varied less.

I think good (a word that means highly automated, very unobtrusive, dirt simple and probably working though a wireless connection between all diabetes devices) analytical tools that can incorporate the whole scope of life with type 1, including the information from meters, could have a more positive effect on outcomes in living lives’ with type 1 than accuracy range of +/- of 10% vs 20%.

The real magic IHMO is in living lives’ with type 1, not dominating lives with diabetes.