Make Our Checks Matter

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1

Every time we test our blood sugar, we make crucial, life-sustaining decisions based upon that result. If the accuracy and precision of those results are compromised, so is our diabetes care. Let’s make our blood sugar checks matter.

Please take a look at the StripSafely Campaign, aiming to raise the voices in the diabetes online community for blood glucose test strips that are accurate.

The FDA acknowledges there is a problem with some meters and test strips manufacturers not delivering the level of accuracy for which they were approved. The FDA does not currently have a plan to protect People With Diabetes (PWD) from bad strips. StripSafely is a campaign to encourage Congress to make sure the FDA creates a plan to keep PWD safe.

To be clear: We are not seeking to promote any particular brand of meter or strips. We simply want strips that are accurate, precise, and protected.

If you agree and want to raise your voice, go to www.StripSafely.com. Take the Quiz. See what you know about strip accuracy and maybe learn a little more. Be inspired to write a letter to Congress, asking them to pressure the FDA to protect the integrity of strips. We’ll make easier with starter letters that outline some of our concerns. Please build from them by adding your personal experiences to show why accurate strips are important in your life with diabetes. Consider asking for:

  • Congress and the FDA to keep people with diabetes safe.
  • Meters that deliver the same accuracy our lives,
  • that they show in FDA approval.
  • Random sampling of strips sold to consumers to insure that all brands deliver at accuracy standards.
  • The tightening of the current accuracy standard to +/- 15%.

After sending your letter to Congress and the FDA

  • Share your letter in a blog post or the social media of your choice.
  • Please feel free to use the StripSafely images in social media.
  • Please link the URL www.StripSafely.com
  • The hashtag is #StripSafely

Thanks for reading all of this and for everything you do as part of this community,

StripSafely.


Bennet & Kimball Dunlap
Consultant, Writer,Creator - Your Diabetes May Vary

RN Diabetes Advocate
Kerri Sparling
Creator, Editor, Consultant – Sixuntilme
Christel Marchand Aprigliano
Diabetes Advocate, Connector & Innovator – thePerfectD
Kelly L. Close
Editor in Chief - diaTribe
Cherise Shockley
Founder and CEO – Diabetes Community Advocacy Foundation
Scott Johnson
Diabetes Advocate, Writer, Speaker, Consultant – ScottsDiabetes.com
Manny Hernandez
Diabetes Advocate, Nonprofit Executive – Diabetes Hands Foundation
Mila Ferrer
Diabetes Advocate-Writer-Tv Host- Translator – Jaime-DulceGuerrero.com
Lorraine Sisto
Diabetes Community Advocate – ThisIsCaleb.com
Meri Schuhmacher
Advocate – Our Diabetic Life
(Want to add your name? Email MeToo@StripSafely.com)
2

A good idea, except, I wonder why you settle for +/- 15%? It is interesting, really it is malpractice, to require that we check our cgm reading with a meter reading that can be at best 20% off and likely more than that. So we are calibrating with an inaccurate scale and then asked to dose ourselves with insulin based on an inaccurate meter reading. Why not ask for +/- 5%? Are lab values accurate? If so, then why can't meters be accurate?

Ask for +/- 5% accuracy and I will sign up and send letters to all the congressional reps in my state, even though they are all idiots. And speaking of that, I do think you are not choosing the best political time to do this given the current interests of Congress and the Senate. I do not know when would be a good time, however. Best of luck to you.

3

I saw this posted on FB today ...my question is " Canada " related ...would Health Canada wait till FDA junps on the band wagon ...who knows !!??

4

I really support this effort, but I would add to this effort a call for the CDC (or another agency) to establish a National Glucose Meter Standardization Program (NGMSP) which would do for glucose meters what the National Glycohemoglobin Standardization Program (NGSP) has done for the A1c test.

It isn't enough for the FDA to establish minimum standards. Our government has a public health duty to give us transparency into the accuracy of these test products. Such a program would establish a national reference standard for blood sugar testing and then evaluate glucose meter products against that standard on a regular basis just like the NGSP does with the A1c. Through the efforts of the NGSP, the accuracy of the A1c test has moved from +/- 15% in 2007 to it's current level of +/- 6%. It is amazing how much transparency can influence industry to change.

We have a right to know what meters are accurate rather than just accepting a minimum level of performance that puts us in danger. And when we know which meters are accurate we can use that information to force industry to change.

5

Nell +/-5% would rock. Getting there is a series of steps. The next practical step is adopting the next ISO standard and it is a 15% range. The issues in my mind is not allowing the 'standard' to slip. While the new ISO is 15% the reality is low quality but cheap strips may be influencing auctions at CMS and form there the private insurance market. Insurance prescription manager see the price not the quality and we risk falling to accuracy outside of the 20%.

Please - Write Congress Today. Ask for better. If we don't who will.

6

You'll never get perfect accuracy because:

1. There is a delay with whole blood, matching blood plasma
2. The ratio of Plasma/Whole is not constant (most meters use 1.12)
3. Things like vitamins, anemia and dehydration have an effect

Today's meter are probably as good as possible with current technology, or at least fairly close. Currently, the most accurate meter at low BGs (where it matters most) appears to be the Contour Next series.

7

Studies show that there is significant variation between devices / strips. Today’s good meters are fairly good. Cheap devices from low cost, dare I say cheap, are shown in studies to fair to meet the standards they were approved for. See the citations section on StripSafely.com

8

37 Years Type 1. I went 15/18 years before I tested one time. This situation has many different angles.
1. Part of the problem is that this glucose reading is not a stable stationary number, the reading in your finger will be different than the reading in your toe, or brain, or arm.
2. We wish it was like a thermometer. If you take your temperature, you can be pretty positive that that is the number. Imagine how messed up we would be if thermometers were 20% off, so your temperature could be 84, or 120, or 98.6.
3. These strips might not ever, no matter how much we scream, bug congress, or bother the drug companies, work they way we want them.
4. The drug companies hold much of the blame. Test strips area huge money making business and because of that they will take a long time to go away, what we need is an alternative.
5. With all the technology out there, there is no reason that I should not be able to wear a watch, look down at my wrist, and say 91, ten minutes later, 97, after meal 144, just by looking at my wrist. Doctors should be chiding us for not looking at our wrist enough not sticking our finger, getting a reading and using a maybe inaccurate number to make decisions on future path regarding food, or medication.
6. Because it is such a big business, if this technology ever existed, the drug companies would buy it up, hide it, and try to figure out how to make money off of it. It might exist already, but after you buy the watch, no more income.
7. The meters need to go away, I need to know my glucose level 30 times a day, not 1, 3, 6 or even 12 times a day.

9

I compare the readings of my Arriva Plus with my cheapy Walmart prime meter. The #'s are within 1 or 2 pts. So either they're both very inaccurate or equally accurate.

10

Please pardon my overeducated ■■■, but I ran a 30 part sample for a 6-sigma statistical analysis. Read up on statistics and the 6-sigma acceptance criteria that is used in all kinds of manufacturing. Read also some of the information on ISO-9000 certification. I hope that none of the companies that market glucose meters are ISO-9000 certified, because they are selling defective products and lying to the ISO folks.

The results of the analysis reveal that my glucose meter might be able to reach 6-sigma limits of say, plus or minus 30 mg/dl.... On a good day. Which means that If my blood glucose is 100 mg/dl, the meter might read 70 mg/dl, or it might read 130 mg/dl. The inaccuracy of this system is so bad, there should be green, yellow, and red lights on it instead of numbers. The numbers are meaningless.

As long as the glucose meter manufacturers and the drug companies have Congress in their financial grasp, there isn't much that is going to change. The fact that these blood sucking leeches overcharge for the test strips is now and will continue to be a travesty.

I would encourage anyone with that might be curious to read up on how to conduct a 30 part sample and then follow through with the statistical analysis. The results will surprise you.

Good luck.

Rock

11

"The meters need to go away, I need to know my glucose level 30 times a day, not 1, 3, 6 or even 12 times a day."

That's kind of what I get with my CGMS. Is it totally accurate or current? No. Is it enough to give me a general ballpark and to see how I'm trending? Yes. Unfortunately Medicare won't cover the cost of CGMS supplies in the US. I don't know about the UK or Canada.

12

A 9 month test of meter and strip accuracy was conducted by Dr, Richard k. Bernstein of "Diabetes Solution" book, and he concluded that the Abbot Freedom Freestyle Lite meters and strips are the most accurate. I got the meter and strips from my doctor and my blood sugar numbers using these have made me do the "Happy Dance", of course it has helped that I'm eating a low carb diet also. But really, I love the results with my new meter and I'll not go back to the ones I used previously (very highly ranked by all of my previous doctors).

13

A wrist-type accurate meter would sure be welcomed,but I always take my sugar in the parking lot from a finger tip and it's never that far off from the lab results taken from a vein 10 minutes later. The results on the Abbot Freedom meter are encouraging.

14

It's not quite clear to me what we are asking for. To stop sales of cheaper meters? I looked at the underlying studies, and the analysis looked quite informative. Indeed, I see why my insurance covers the meters that they do: They were among the most accurate commonly available brands.
But if I did not have insurance, I am sure I would be using one of the Walmart or other cheaper brands, accepting a lower level of accuracy. But still better than Benedict's Reagent, or not? Maybe I am missing something?

15

Stop the sales of meters that fail to make FDA existing accuracy standards. Nothing wrong with affordable if they make the grade. But cheap by means of failing to make the accuracy grade is no value.

16

I'm not at all sure accuracy is an issue here. I've used a lot of different BG meters because for a long time I had to pay for each strip, and the costs of the well known strips were three or four times that of the cheap ones. For me testing more often is far more important than the accuracy.

Given the way health care legislation works in the US I suspect this is a campaign funded by certain BG meter manufacturers who figure they can put the cheap guys out of business. Or maybe it's a way to stop us importing strips from outside the US - we can still do that, and still claim tax exemption [IRC], because they are non-prescription medical supplies.

John Bowler

17

Walmart Prime's are $10/50. My Accu-Chek's are $65/50 Costco. Fortunately,my insurance allows 300/90 days for $40.00. I always run out as I test 4x day and fall back on the cheapies. As I mentioned,the results are almost exactly the same.

18

We have 20 million diabetic patients in US, maybe 20-50% more than that. 10% of that number are type 1, so that is potential for a lot of test strips. 30 years ago very few people were testing at all, so there is improvment in treatment. Diabetic children today will probably have it much better when they get to be old like I am. In China they have 92 million diabetic patients, and India probably close to same number. So there are roughly 150 million people that need to use this product on a daily basis, but a good number probably do not test as much, still it is a huge money making endeavor for the test strip companies. We as consumers, happy to be able to have any input into our own treament, accept whatever is sold to us. Do China and India use these strips as well. Is there any other method. CGM sound fantastic, if you have insurance, if you can afford it. Right now there is no incentive whatsoever for the drug companies to change.

19

Jbowler

Pharma has not put money into StripSafely. I have. Diabetes Hands Foundation has as well.

See the about page at www.StipSafely.com.

This is about accuracy for PWDs. More precisely inaccuracy. Keeping strips that FAIL to meet +- 20 % 95% of the time out of the market.

I could care less who makes strips. I do care that the strips meet the performance level they were spproved for.

4 million people talk insulin and base the dosing of that drug on strips, Including two teens in my home.

Less costly strips would be great. Cheap strips that sacrifice any pretense of precision just to be cheap are no value for anyone.

Like so much of diabetes care this issue is complex. There is am outline here
http://www.stripsafely.com/?page_id=63

In part “Dr. Barry Ginsberg of Diabetes Technology Consultants, Wyckoff, NJ said, “We are developing a two-tier system of ‘haves and ‘have- nots.’ The have-nots are because CMS is going to competitive bidding, with prices that will be difficult if not impossible for branded-meter manufacturers to meet. The have-nots will be stuck with meters that met 20% standards several years ago but probably couldn’t meet 40% standards in post market analyses today.”9”

Value is actionable information.

20

On the 'StripSafely' web site I can only find one page that has any references. That is the 'Issues' page and it has 10 references. Those ten references reduce to just one - the meeting on May 21, 2013 sponsored by the Diabetes Technology Society which invited two experts who had tested blood glucose meters. A referenced text, costing $85 from "The Gray Sheet" (less than one vial of some test strips so I figured I'd buy it) doesn't say much more. The multivu summary is free and better:

http://www.multivu.com/mnr/61870-diabetes-technology-society-inaccurate-blood-glucose-monitors-risky

Two other links are irrelevant. The EU link is about changing EU regulation of *all* medical devices. They pretty much say regulation is ineffective. The worries about competitive bidding in ObamaCare are part of the ongoing debate about ObamaCare and, being hypothetical, are essentially a political statement.

So there is *one* reference. Of course, we also have the research previously referenced in discussions on tudiabetes.org, which, if I remember correctly, found maybe one or two meters out of the 15-20 tested being out of range by the current US standards.

The actual studies (three of them, two by the same EU based author) are, however, all available from the DTS web site (thank you DTS!) The two September articles are available for free here:

http://www.journalofdst.org/September2012/PDF/VOL-6-5-ORG2-FRECKMANN.pdf
http://www.journalofdst.org/September2012/PDF/VOL-6-5-ORG3-BAUMSTARK.pdf

The January 2013 article by Brazg is in the archives, but must be purchased ($55), see here:

http://www.journalofdst.org/January2013/

There is also a criticism (in the strict sense, an analysis) by Andreas Pfützner ($55). I believe DTS will make these all free in due course (but it looks like it could take up to a year.)

I haven't analyzed the original papers yet, I will probably do so, but I do note that the EU author was using DIN (German) or ISO standards, not the US ones.

Meanwhile the references StripSafely give refer to quotes by journalists and pundits, never directly to the original authors. I have three issues with the StripSafely Issues (;-) page:

1) 'cheap'; the first and most prominent attribute which is presented in quotes (aka scare quotes). The reference is number (3), to CloseConcerns, yet the attributed article is not on the web site given (according to Google - the link provided is just to the head of the site). I traced the article title (via Google) back to an abstract of the original DTS meeting produced by the journal. (Google yourself using the title). The word 'cheap' does not occur in that abstract.

This alone makes me extremely suspicious of the StripSafely site: four separate attributes are to the CloseConcerns website, but they are all to the same article. I cannot find that article on the CloseConcerns website, or, for that matter, on the diatribe web site (diatribe.us). When I search for the article name I find only an abstract.

At this point I went back to other commenters on the original source - the May symposium - looking for a 'cheap' source. On the multivu summary I found David Klonoff, using 'some low-cost meters'. He is president of DTS, but in this context he was apparently summarizing. There is a substantial semantic difference between 'some low-cost meters' and the end rendition 'cheap', the latter implies 'all'. Please see the multivu quotes of the Klonoff interview, or buy the Gray Sheet summary which has different quotes but not the 'low-cost' one.

2) Competitive bidding; a full two paragraphs of the article after the CloseConcerns 'cheap' attack are devoted to competitive bidding in ObamaCare. Once again this is primarily attributed to "Close Concerns". I maintain that this is an irrelevant to the issue of the accuracy of BG meters and is, IMO, a political discussion.

3) 'Asia[n]'; this is racist. There is no credible attribute to the whole paragraph, the reference to the EU issue is to the EU press release which asserts a general lack of regulation and cites breast implants and hip replacements as the evidence. The paragraph reads like it was written by a lobbyist; it sandwiches two unrelated and unattributed statements that are barely meaningful between an irrelevant anchor sentence.

There are too many issues here with regard to how or why this web site was constructed for me to be able to offer any constructive criticism. I think tudiabetes.org needs to step back from this and ask itself what the real issue is.

John Bowler