Tag Archives: test strips

#StripSafely Update. And a question.

August 5, 2013 – 9:34 am

Safety of the test strips we use, and the meters we plug them into, is a great big deal to everyone living with diabetes. It also means a lot to the people who love me and count on me to be there for them.

So I aligned my views with those in the Diabetes Online Community who also believe that A) The 20 percent +/- factor that’s currently allowed for test strips is NOT NEARLY GOOD ENOUGH, and B) The fact that the FDA has no post-approval mechanism in place to verify the continued accuracy of test strips they approved earlier, or pull them from the market if they’re not, IS NOT OKAY.

As a measure of support, and to help in getting these wrongs righted, I wrote my elected officials in Washington. U.S. Representative Dutch Ruppersberger, D-MD, and U.S. Senators Barbara Mikulski and Ben Cardin, also D-MD, received e-mails from me expressing my concern and asking them to assist.

That was nearly three weeks ago.

But hey– a week ago I received an e-mail response from Senator Mikulski, the longest-serving woman in United States Senate history. I’ll share it right here, but be sure to come back after reading, because I want to ask about something.

Letter

Other than the fact that this was pretty much a form letter, I was actually happy to have received a response at all. Seriously, even if they’re not busy all the time, senators get requests from a seemingly endless stream of attention-grabbers and favor-seekers on a constant basis.

No, what really struck me were the two images at the bottom of the letter. You know, the Facebook and Twitter icons.

So I want to ask: What if a coordinated effort was put together to bombard Facebook and Twitter accounts of U.S. Representatives and U.S. Senators for the #StripSafely cause? It could start with House and Senate committee members responsible for FDA oversight, and perhaps move on to people with oversight of the U.S. Commerce department. Somewhere in there, we could get around to House Speaker John Boehner and Senate Majority Leader Harry Reid.

I don’t know… Maybe it all sounds a little too “Mr. Smith Goes to Washington”. But don’t we believe in our own cause just as much as Jimmy Stewart did in that movie? And I have to ask: Don’t you think that together, we could make some kind of impact? If there are so many people in on the #DSMA Twitter Chats every Wednesday, wouldn’t the same kind of numbers all tweeting or messaging at the same time, about the same thing, to the same people, get an elected official to take notice?

What do you think, Diabetes Online Community? Good idea? Bad idea? Feel free to leave your ideas below.

For more on this important issue, visit the Strip Safely central at www.stripsafely.com
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , , , | Comments (2)

Traces of Diabetes. What it means to me.

July 31, 2013 – 10:06 am

DSC00969

I guess all of us see something like this from time to time. Especially if you spend too much time looking down at the ground while you’re walking (subject for another post at another time). I saw this test strip as I was walking on the sidewalk in the neighborhood where I work.

Lots of people have talked about their experiences coming face-to-face with diabetes in the wild. Often it’s something innocuous like this; sometimes it’s a real life meeting with another PWD. Reactions seem to range from the funny to the poignant to the ironic. Let me tell you what it means to me when I see something like this.

Often, when I come across evidence that someone else with my condition is around, I’m almost… shocked. I go through about 98 percent of my life never coming into contact with anyone living with or affected by diabetes. Actually, I’m almost never coming into contact with anyone who wants to reveal those things. So I kind of forget that there are others out there. You would think that with all of the blogs, Twitter feeds, etc. I read, and my own participation in social media, it would be enough to help me remember that there are actual real people going through the same things that I do every day.

But still, when I saw that test strip, it was a big surprise. To me, it wasn’t something exciting as much as it was a slap in the face. Guess what? You’re not the only one, stupid. And no, you haven’t really connected with any PWDs in your part of the world yet.

I’ve tried, but all previous attempts just kind of fizzled. The reasons are many and varied, and in some cases, I’m the one to blame. I’d like to think that my biggest obstacle to connecting in real life with others like me is my schedule, which has been busier in the last two years than it was the previous ten. The truth is, it’s both an obstacle and an excuse. I don’t have a lot of extra time, but I have a little. Maybe that little extra time can be used for some grass roots effort somehow. I don’t know.

What I do know is that I’ve changed a lot in the past couple of years. If I want that change to be even more meaningful, I’m going to have to find a way to do something for others living with and affected by diabetes right here in my own community. I’ve just got to figure out how to make that happen.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , | Comments (6)

#DSMA July Blog Carnival. Test strip accuracy.

July 29, 2013 – 9:42 am

Let’s get right to it… One of the most basic things about our diabetes, and July’s DSMA Blog Carnival topic:

Blood glucose. It’s front and center when it comes to diabetes. It is how we get diagnosed and it is what we are trying to manage. An important tool we use to manage our blood glucose is our meter and its strips. But what happens if our meters aren’t giving reliable information? Let’s explore that this month as we discuss a topic from the June 26th chat Fill in the Blank. Weigh in on the following statement:

Test strip accuracy is important to me because______.

The easy answer is: Because our lives depend on it.

The more difficult, but very necessary analysis of what test strip accuracy is even more important, but leads to the same answer.

Let’s face it: Most of us don’t think too much about test strip accuracy once we’ve bought our blood glucose meters. Some of us received our meters from a doctor. Some of us went out and purchased a meter based on quality, or how it looks, or whether it has a function that lights up your test strip so you can check your BG at night without turning on the light. But for most of us, once we have a meter, we don’t stop to think much about the accuracy of the strips that we insert 3 or 4, or 10 or 12 times per day.

But we’re learning that there are reasons to be concerned about the accuracy of our test strips. Even the USA’s Food and Drug Administration, the agency of the government that has to approve all medical devices before they can be marketed or sold here, acknowledged that some test strips are not as accurate today as they were when they were approved for use in the first place. Furthermore, they have no method of removing inaccurate test strips from the market once they’re found to be inaccurate.

How does this happen? That’s the subject for another blog post. Instead, let me ask: How does that make you feel?

Raise your hand if you can live with using test strips that may be off by 50 or 100 points at any given time, based on any number of factors. Raise your hand if you it’s okay with you that heat or cold tolerances, or age, or humidity can skew the numbers on your meter display by enough to cause you to bolus a unit or more different from what you really need. Raise your hand if you’re perfectly fine with the idea that the company that developed the technology for the strips you’re using doesn’t have a plan to test the continuing accuracy of those strips (**Note: Some manufacturers do conduct ongoing tests on strips… many do not, and are not required to do so).

Think about it… millions upon millions of us, living with diabetes. Testing our blood glucose many times per day. Making decisions about diet and exercise and bolus amounts based on the numbers showing on our meters. Why? Because we want to believe that if medical technology has been approved for our use, the accuracy of that technology is above reproach. Do you see now why test strip accuracy is so important? It’s the baseline for countless decisions we make every day.

So without question, test strip accuracy means the world to myself and my loved ones. We want to know that the number on our glucose monitors is correct. Because our lives depend on it.

This post is my July entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at
http://diabetessocmed.com/2013/july-dsma-blog-carnival-3/

 
 
 

By StephenS | Posted in DSMA Blog Carnival | Also tagged , , | Comments (2)

More on #StripSafely.

July 17, 2013 – 10:19 am

StripSafely

No doubt you’ve already heard of the Strip Safely campaign. But maybe you’re still asking, “Stephen, what’s it all about? What can I do about it?”. Here’s the lowdown:

At a public meeting back in May, the U.S. Food and Drug Administration (the FDA) acknowledged that there are glucose meters and test strips out there that are no longer as accurate as they were when they were approved by the FDA in the first place. That’s a big deal, no?

What if I also told you that even though the FDA acknowledges this issue, they have no program to perform post-market testing or remove inaccurate test strips from the market? Bigger deal, yes?

Our very lives depend on the accuracy of the numbers that appear on our meter’s display. If we see too low a number… we dose too little insulin and wind up with high glucose, high A1c results, and higher risks for complications later. If we see too high a number… we could dose too much insulin and wind up with severe hypoglycemia, or even death. No pressure, FDA.

So Bennett Dunlap and a few others started the Strip Safely initiative, to shine a light on this issue and encourage everyone affected by it to agitate. Call or write your congressional representatives, senators, and even the FDA. Voice your concern. Help lead the charge for better outcomes through more accurate test strips.

Want to do your part? I thought you would. Visit the Strip Safely site at www.stripsafely.com. There you’ll find a number of great templates you can use to send your own letter or e-mail. There are also links to help you find your elected officials in Washington. You can stay up to date on this issue with the latest updates, and even take the Strip Safely quiz to test your knowledge of test strip accuracy. Or take the quiz and then read about what’s happening… your choice.

For the record, here is a sample of the letters I sent by e-mail to U.S. Representative Dutch Ruppersberger, and U.S. Senators Barbara Mikulski and Ben Cardin of Maryland:

Dear _______,

I’m a constituent who has been living with Type 1 Diabetes for the past 22 years. Because my pancreas doesn’t produce insulin on its own, I receive insulin through my insulin pump 24 hours per day.

How much insulin is administered is based on a number of factors. Most notably, my blood glucose. As you may know, people with diabetes check their glucose levels several times per day as a baseline for determining how much insulin to administer as a result of diet, exercise, stress, and a number of other factors.

I’ve recently learned that the Food and Drug Administration, at a public meeting, acknowledged that some glucose meters and test strips are not as accurate today as they were when they were approved for use in the first place. Furthermore, they have no method to deal with removal or review of potentially inaccurate products from the marketplace once they’re found to be inaccurate.

The issue is simple: If the readings on our meters are inaccurately low, we might wind up not taking enough insulin, which could result in dangerously high blood sugars. If our readings are inaccurately high, we might take too much insulin, which could result in hypoglycemia, insulin shock, and even death.

So we know that not all meters meet the +/- 20% standard set by the FDA in real world conditions. Some manufacturers are now delivering products into the market that put us at increased risk. The lack of an ongoing periodic post market audit of real world strip performance helps these manufacturers risk lives.

What I’m asking you and your fellow representatives/senators to do is to look into implementing a post market program of ongoing random sampling of glucose meters and test strips to insure that all brands consistently deliver the accuracy in the real world that they were approved to do.

Without question, meter and test strip accuracy means the world to myself and my loved ones. We want to know that the number on our glucose monitors is correct.
Because our lives depend on it. Won’t you help? Thanks so much for your consideration of this very important topic.
 
 
This is important. I’m going to say it again: Lives are at stake. I encourage you to get involved and help to save lives today.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (3)

It’s a numbers game anyway.

January 10, 2013 – 11:33 am

I was looking at the Baseball Hall of Fame voting from yesterday, and immediately my analytical mind starting crunching the numbers… baseball is a game loved by statisticians, anyway… Since blank ballots submitted count against players being considered, how would the voting change if those blank ballots were not submitted (then they wouldn’t count against the player)? How many more votes do Jack Morris and Craig Biggio need next year to crack the 75 percent threshold for enshrinement?

Then, since my mind has been on D overload the past several months, I started thinking about numbers and how they relate to diabetes. We all know that numbers are important. Hemoglobin A1c, meter readings, carb/insulin ratios, the whole bit.

But let’s look at some of the other stuff for a moment. I was diagnosed nearly 22 years ago. That’s a fair amount of time, and to the best of my calculation (these are approximations only), here are some overall numbers. I’m going with very conservative counts, so the amount of stuff used and the cost of everything is likely higher than this.

– I didn’t always do a great job of checking my blood glucose. So if I calculate only 2.5 times testing on average, per day, for 8,016 days since diagnosis, that’s 20,040 BG checks. At even 50 cents per strip (which is a very conservative number), that’s $10,020 spent on test strips alone.

– I was on multiple daily injections until almost 3 years ago. For most of that, I was on two injections per day. Then I was on one per day (Lantus) for a couple of years, then Lantus plus a bolus fast-acting insulin before each meal and snack. So again, let’s go with 2.5 per day as an average, for 19 years. That’s 17,350 injections! It’s hard to gauge the amount I spent on syringes, but I’ll try: 17,350 injections divided by 100 syringes in a box equals almost 174 boxes. The average cost per 100-count box is probably in the $24.00 per box range (a quick online check reveals it’s about $30.00 a box now). I’m counting the full price here because my various insurance coverages over the years mostly required me to pay 100 percent for them. So 174 boxes at $24.00 per box equals $4,176 spent on syringes.

– I can’t even begin to guess how much insulin I’ve used over the years, so I won’t even try here. But it’s a lot. And there’s no such thing as generic insulin in the U.S., so the cost is probably a lot. Though most of the cost has been covered through prescription plans. So let’s do it this way: My mail-order pharmacy dispenses 90 day supplies of insulin at an average cost to me over the last 22 years of $50.00 per 90 days. That’s 88 quarters of insulin at $50.00 per quarter, which comes to $4,400 dollars worth of life-giving juice.

– I’ve been on pump therapy for almost three years now. I’ve got a pretty good medical insurance plan at work, so the initial start-up cost for my MiniMed Paradigm® Revel™ pump was right around $500. The durable medical supplies portion of my plan helps me pay for infusion sets and reservoirs every 90 days, and my cost is about $90 per quarter. It’s been about 11 quarters since I started on the pump, so at that rate I’m at $990 for infusion sets and reservoirs and other incidentals (the inserter, IV prep, etc). I’m including the cost for the CGM that goes with my pump, even though I don’t use it all the time.

Total cost of everything above: $20,086

That’s just the big stuff. I could go on and on about doctor visits every 90 days, cost going to and fro seeing doctors and specialists and gathering stuff that I need, and that ill-timed emergency room visit in Dayton, Ohio a couple of years back.

What does all of this make you think about? How much everything costs over time? How about diabetes burnout? Does it make you want to do some number crunching of your own? Is there something I’ve left out? Feel free to add to the conversation by leaving a comment below.
 
 
 

By StephenS | Posted in Uncategorized | Also tagged , , , , | Comments (1)