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)

Views: 2543

Tags: FDA, StripSafely, advocacy, blood test, glocuse meter, glucometer

Comment by Nell on July 1, 2013 at 7:42pm

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.

Comment by nel on July 1, 2013 at 10:02pm

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 !!??

Comment by Brian (bsc) on July 2, 2013 at 4:40am

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.

Comment by BadShoe on July 2, 2013 at 5:35am

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.

Comment by Alan on July 6, 2013 at 1:15pm

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.

Comment by BadShoe on July 6, 2013 at 6:33pm
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
Comment by gburger on July 7, 2013 at 10:41am

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.

Comment by 2tall63 on July 7, 2013 at 11:09am

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.

Comment by Rock on July 7, 2013 at 12:03pm

Please pardon my overeducated ass, 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

Comment by Darian A. Caplinger on July 7, 2013 at 12:20pm

"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.

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