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Strip Safely: Managing Expectations.

I didn’t expect my pancreas to stop producing insulin.  That was a monkey wrench tossed into my life just before starting second grade, leaving my childhood intact, but including synthetic insulin.  Since my diagnosis, I’ve been managing expectations.  Will I be able to graduate high school?  (Yes.)  Will I be able to make friends, have fun, find love?  (Yes.)  Will I be able to have a family?  (Yes.)

I’m able to say YES because I work hard to manage my diabetes, and the two most important things I do as person with type 1 diabetes are testing my blood sugar and taking my insulin.

I am expected to be a compliant/adherent patient.  I am expected to be the safe and conscientious operator of a moving vehicle, with my daughter buckled into her car seat in the back.  I expect to wake up in the morning.

Compromised results on my glucose meter are unexpected.  For the first twenty-six years of my life with diabetes, I’ve had tattered confidence in my islet cells but strong confidence in the results on my glucose meters.  The result on my meter matters.  This single point of data is what I base all of my diabetes decisions on.  How much insulin do I need to correct this high blood sugar?  How much insulin do I want to take for this meal?  Is my blood sugar at a range that’s safe for driving a car?  Is my blood sugar at a range that’s safe enough to go to sleep?

These are the questions I’m used to asking, but a new one has cropped up recently:  Are my strips safe?

My friend Jeff Hitchcock, father of a daughter with diabetes, explained this new issue most succinctly, in a letter to his Senator, “In 2013, as part of a process of competitive bidding, CMS chose a non-US provider of test strips that resulted in a 72% reduction in the price to be paid for glucose monitoring test strips. With considerable evidence showing that non-branded glucose test strips do not meet current accuracy guidelines required by FDA, those of us in the diabetes community are fearful that the glucose test strips from the winning bidder, as well as others from outside the United States that will be new to our marketplace, will not be sufficiently accurate to allow the safe dosing of insulin.  Compounding this concern is the absence of any regulatory rule that requires FDA to monitor incoming glucose test strips on a routine basis to ensure that the strips meet the accuracy requirements that were required for marketing approval in the United States.”

My glucose meter results need to be accurate.  I expect to be able to trust them.  I use them to make insulin dosing decisions, Dexcom calibrations, and to offer peace of mind before I close my eyes at night.

Since giving birth to my daughter, I’ve worried just a bit before going to bed, especially when my husband is traveling for work.  The fear of not waking up wasn’t one that nagged at me until I pictured my daughter, laying in her crib and crying, and my body unresponsive to her needs.  It’s a thought that makes my stomach turn and my knees weak almost instantly, and even though I realize it’s a dramatic scenario, it remains one that haunts me.  And not without reason.

But diabetes can bring that sort of unexpected moment into your life.  It’s a disease laced with ambiguity and fear, tempered by the hope that our efforts are indeed best, and that our bodies can sustain the blood sugar radar blips and continue our lives without compromising.

In 2013, we should not be moving backwards in terms of diabetes care.  We should be moving forward.  Please contact your representatives and encourage them to require the FDA to, as Jeff stated in his letter, “ensure that all glucose test strips sold in the United States meet the minimum accuracy requirements required by FDA. We are not asking for a change in price. We are not asking for support for any particular company. We are simply asking that the advances seen in the care over the past several decades of people with type 1 [and type 2] diabetes are not reversed due to inaccurate blood glucose test strips flooding the United States market.”

This issue of compromised test strips not only affects the people who have diabetes, but it also affects every, single person who loves a person with diabetes.  If test strip results are inaccurate, managing diabetes becomes near-impossible.  And the expectations we have, as people with diabetes, go from ones of hope to ones fear.

NOW IS THE TIME TO DO SOMETHING.

6 Comments Post a comment
  1. Yes.

    Now is the time.

    I hope this message get repeated a lot in the next few weeks. On 9.9 the Diabetes Technology Society is having a second meeting on strips. The first really clearly defined the issue.

    Now is the time to ask policy leaders to have staff at that meeting.

    In the next few weeks we the DOC can be heard. We can blog, tweet and encourage each other to ask our Congress member to have a heath policy aide at the meeting. We can attract media attention and maybe they can report on 9.9.

    Now is the time to act to keep meter accuracy form going backwards.

    We can make a difference on 9.9 if we start acting now.

    08/14/13; 2:17 pm
  2. It is so disheartening to know THIS is something we have to add to the list of items we are fighting for. I remember as a kid the transition from BG pee tests to at-home blood testing was immense. The transition from the blood wipe-off strips where you visually got a BG range to at-home meters and later portable meters was also incredible and gave me faith and hope. When I think that these meters and strips that I’ve come to trust with my life have such a wide tolerance for inaccuracies, I want to kick someone. Come on FDA! Thanks for spreading the word, Kerri.

    08/14/13; 2:17 pm
  3. Very timely blog post Kerri…

    Sky News — Diabetes: Glucose Testing Strips Recalled

    08/14/13; 2:30 pm
  4. Karen #

    Thanks for posting this. I was all set to write letters a few weeks ago and life just got in the way. Thank you for the gut-wrenching reminder.

    08/14/13; 5:43 pm
  5. Dan #

    Hi Kerri,
    An excellent article. Next is the issue to address the needs of all diabetics. Any discussion concerning trips stripes needs to come from the individuals who use the product. Next the lower price should not be the generally accepted method. Cost is a factor, however, the better approach is the lowest a best product. Now, how can we as diabetics define best. There is a need for improvement of the product. meaning more precise accuracy in the readings of our blood glucose level.
    Now, I need to get to the real question for diabetic users. How would you answer the question to supply information that the product was “bad”. Some of the programs which upload the results from our blood glucose levels transfer the blood glucose test strip information Meaning the code numbers. What is key is the fact that the code numbers are just like the VIN Number on your auto. Why, if the FDA continues on this path, it can become difficult and take time to document the failures. Someone will get hurt based upon a poor choice. Hope this helps. Feel free to contact me if this is not clear. As always have a great day.
    Dan

    08/15/13; 10:19 am
  6. This post is spot on. I really hope that we can get better accuracy!! Thank you Kerri for being such an awesome voice for us Diabetics!

    08/15/13; 5:37 pm

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