Glucose meter results matter because our lives matter. Why does accuracy matter to you?
We invite you to listen to this week’s DSMA Live: ‘Rents. Bennet moved to the other side of the microphone to tell us about his day on the panel of ”Verifying the Performance of Blood Glucose Monitors following FDA Clearance”. Bennet spearheaded the Strip Safely campaign and in addition to telling us about how his grassroots efforts culminated in his involvement in Monday’s meeting in Bethesda, Maryland. He also tells us what inspired him to start the campaign and what we all can do to get involved and advocate similarly for people with diabetes.
by Diabetes Mine & Friends
The Diabetes Technology Society held an impressive meeting in D.C., the second one of its kind in four months aimed at discussing the existing problems with glucose monitoring accuracy.
Last week he spoke at the DTS meeting on September 9th in Washington DC. He brought a bit of humor to a very serious issue by telling the audience that the “FDA has superpowers”. He then went on to challenge the FDA to use some of those superpowers to ensure the safelty of people living with diabetes. Here is a video clip of his speech:
So, to tie this all together: the United States does not currently have any mandatory (or voluntary!) post-market surveillance program to ensure the accuracy and quality of blood glucose meters and blood glucose test strips. What’s more, a considerable number of test strips and meters currently on the market – particularly low-cost generics — have been demonstrated not to live up to the already lax ISO standards detailed above. David Klonoff and DTS are attempting to bring industry, government and insurance players together to establish a mandatory post-market surveillance program, modeled on other successful standardization efforts like those for cholesterol screenings and HbA1c tests, but even the best-case scenario is still likely to take years. In the meantime, CMS’s competitive bidding program, which heavily (if not entirely) favors low-cost, generic test strip manufacturers that have been demonstrated to have higher quality concerns, has already been rolled out. (Indeed, according to its official comments at the meeting, CMS’s official treatment goals for its Type 2 population do not include aggressive prevention of hyperglycemia; thus CMS does not see a reason that meters necessarily need to be accurate in higher ranges – a subject I will discuss in a separate article later.)
Are you concerned? You should be. To find out more about both the issue and how to express your support/get involved (including contacting your state senators and representatives), visit the patient-advocacy site Stripsafely.org and the meter quality page at http://diabetescareproject.org/.
StripSafely is the initiative to bring awareness to the issue of test strip accuracy. I’m hoping to help bring attention to the StripSafely efforts by helping to make you an advocate for the cause. You are not being asked to make a donation.
If you could just take a moment to read more about the efforts and then follow StripSafely onFaceBook, Twitter and on their website, you’ll be supporting people who I completely trust to help the diabetes community have a voice in the fight to change the current levels of accuracy acceptability.
If a SMBG system is inaccurate and provides a false reading, it puts a patient at risk of dosing too much or too little insulin. If this occurs and too much insulin is given, it can bring blood glucose levels down to dangerously low levels, putting the patient at risk of severe hypoglycemia and possible hospitalization. It is therefore critical that SMBG systems are accurate and provide patients and caregivers with the right information to make informed treatment decisions.
Globally, there is a growing body of evidence that shows some SMBG systems on the market today do not consistently provide accurate results.
Lots of people base major insulin decisions off that one blood glucose, they cannot afford strips with better accuracy, cannot afford to test more then 2(or so) tests a day. At the very least, those strips should meet the minimum 20% guidelines by the FDA. Because their lives depend on it.
Where does the “big stick” part come in? Well, this is where YOU, the people, get to go (get off your rear end) & exercise your citizen rights.
I looked it up. Apparently, it’s 95% of the time, not 98%. This means, testing 10 times a day, there’s a 59% chance that all the results are within the +/- 20% (or +/- 15 mg/dL for readings lower than 75 mg/dL) for a day, a 2% chance for the week, and and even sadder “this is not going to happen” for the year.
I’ve been trying to think of an appropriate metaphor to explain the importance of test strips with respect to diabetes management but my mind keeps going back to the plane crash sequence from Die Hard 2. In it, the bad guys recalibrate sea level for one of the plane’s automated landing programs by 200 feet. Because the weather is bad, the pilots have to rely on their technology to land safely. But, since the bad guys tinkered with the system, when the plane thinks it’s at 200 feet, it’s actually crashing into the runway.
I do 80. I don’t drive at 90 if it’s the end of the workday and I’m heading home. My afternoon drops can be interesting/scary. And even though I don’t have a difficult commute, I still won’t drive home in the afternoon if it’s under 100 without eating/drinking something. There’s many a time I’ve sat in my office after closing; slurping down some juice, just so I can go home. I do that because, I know the strips aren’t accurate. I do that because I don’t want to have an accident. I do that because – what if I had an accident and hurt someone else?
Am I in range or not? Do I correct something or am I ok? And I don’t just want to be ‘in range’. I want to be in the lower end of being ‘in range’ – that’s where I feel the best. Is my meter so off that I’m high all the time and my risk of long-term complications doubles? Seriously? Who am I going to sue for that?
To compound the problem, the push for greater strip and meter accuracy coincides with a nearly 70% reduction by Medicare in their reimbursement amounts for a vial of 50 strips, which went into effect on July 1, 2013. Private insurers are almost certain to follow the government’s lead, and what retail suppliers, whether OTC or mail-order, will do to maintain some profit margin is not yet clear. What does seem clear however, is that there is diminished financial incentive to develop a more accurate meter or test strip..
We think this is a critical issue, especially with the recent 68% price cut in the amount Medicare will pay for glucose strips. In our view, this change will hurt patients in the long run. First, it could mean that unproven and potentially lower-quality manufacturers will become the primary suppliers of test strips for people with diabetes on Medicare. Private insurance providers could follow in Medicare’s footsteps and adopt these changes, which could mean limited choices for all patients. Second, the dramatic price cuts stand to reduce the ability of companies to develop next-generation, advanced glucose testing products. We hope the decision is a not permanent, as we also do not see it significantly benefitting healthcare expenditures in the long term (i.e., most healthcare expenditures on diabetes in the US go to hospital visits and services, not to technologies like glucose meters and strips). –AB
Medicare and the FDA (Food and Drug Administration) are choosing to lower costs at the expense of your health. They are allowing cheap and faulty blood sugar test strips into the marketplace. Test strips that have been proven — the FDA admits – to give inaccurate glucose readings.
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And – An MDR should have been submitted for this complaint.
That means one was not.
That is NOT OK.
How accurate is your blood glucose meter?
A major study found that almost half of meters do not meet the minimum required standards:
For blood sugars over 75 mg (4.2 mmol): Accurate within 20%. For example, if your blood sugar is 200 mg (11 mmol), the meter must read between 160 (8.8 mmol) and 240 (13.3 mmol) at least 95% of the time.
For blood sugars under 75 mg (4.2 mmol): Accurate within 15%. For example, if your blood sugar is 60 mg (3.3 mmol), the meter must read between 51 (2.8 mmol) and 69 (3.8 mmol) at least 95% of the time.
I spent the 4th of July writing letters to my senators, my representative, and the FDA. I can’t think of a better way to have spent our national holiday than by exercising my right to influence my elected representatives. The models for my letters were from the Strip Safely website along with Meri’s letter at Our Diabetic Life.
También es importante considerar la precisión de los resultados, este es todo un tema ya que no contamos con información suficiente sobre qué tan preciso es un aparato y es posible que medidores de glucosa que no cumplen con los requerimientos de precisión estén circulando en el mercado. Existe una iniciativa llamada StripSafely que hace un llamado a las autoridades en Estados Unidos para que se tomen acciones al respecto, esto nos beneficia a todos.
However, studies show that 25% or more of the meters already on the market don’t even meet the existing accuracy standards, and that pre-market accuracy requirements are not sufficient because there’s no way to make sure these products remain accurate once they’re on the shelves for PWDs to buy.
Technology and advances in insulin analogues have vastly improved our diabetes management, but we’re still reliant on two important things to keep us alive: insulin and blood glucose testing. They work in symbiosis. When a blood glucose reading isn’t accurate, the dosing choices diabetics make can have disastrous consequences, both short and long term.
I am writing to you because while I might have said as a teenager, “I’d die if I don’t get that!” I actually could die if I don’t have accurate test strips.
I play Russian Roulette every time I take my dosage.
On a highway. I had to make a decision about taking insulin for the 124 or eating a snack for the 82 before I got behind the wheel. It’s the kind of decision I make 6-8 times per day and I’m usually basing it on that number.
If you will humor me, let me explain why this is important to me. If my child pokes his finger and the meter shows his blood sugar is 400, (which is very high, but happens easily when his insulin pump site is kinked or torn out,) if the meter company is complying with FDA regulations, the number could actually be anywhere between 320 and 480. Why does this make a difference to us? If my son thinks he is 400, and gives himself insulin accordingly, to bring him down to his target of 100…but in reality has a blood sugar of 320…that would mean he would be giving himself too much insulin. In fact it would be enough insulin to bring his blood sugar down to 20.
Some people can’t be alive with a blood sugar of 20.
I’ll keep it short, because I want you to go and read and do something that will help you and me and all of us.
(Why are you still here? GO!)
I am a certified diabetes educator and also a friend of many people with diabetes, both type 1 and type 2. I am also a researcher conducting a study in individuals with type 2 diabetes focusing on blood glucose monitoring. I cannot tell you how many messages I receive from patients confused and upset that their blood glucose values vary dramatically between tests and between meters. These people are working so hard to improve their glucose control and are diligently testing and confirming their values, just to learn that the range can be so incredibly different. This past week a patient had a blood glucose value of 548, she called frantic trying to decide what she should do. She then tested on a second meter she had at home and the value was 323. When I told her that I was not at all surprised by the drastically different value she was in shock.
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.
In recent weeks, there has been a lot of diabetes news on meter accuracy and the Strip Safely campaign to push the FDA to reconsider test strip accuracy and I couldn’t agree more with the need for this campaign! If test strips are allowed to remain with a 20% inaccuracy rate, that means that a 300 blood sugar is actually somewhere between 240 and 360. Or, try a 90m/ml, could be wandering down to low blood sugar, which is too big of a discrepancy, as it relates to treating with injected insulin.
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?
We DESERVE accuracy. There are enough variances in diabetes without worrying if our test strips are giving us accurate results as well.
Why did I title it “Strip Tease”? Well for one, to grab your attention, and another because that’s how I have felt multiple times when testing myself lately. It has felt like a tease, like I see a number on my meter that I don’t believe is really correct and it’s saying “Nahny nahny boo boo, guess where your BG is at!” and that’s a scary game to play. That is why test strip accuracy is frustrating because it’s not accurate.
I didn’t even know test strip accuracy was something to be concerned about. Type 1 Diabetics (well all diabetics really) have enough to worry about on a daily basis, why do we now additionally have to deal with trust issues with our meters. I don’t know of any chronic illnesses where the treatment can be within a 20% range. Heck, I’m an accountant and there is no way the IRS would be OK with a 20% variance and that is just money, not a life or death situation.
It’s horrifying when you start realizing how loose some of the regulations are on things that impact the life and death decisions that we make every day. Calorie information on food labels can be as much as 20% off and what that means for carb counting… who knows. Our blood glucose meters are only asked to be +/- 20% of the “true” value. When we are dosing our insulin based almost entirely on the grams of carbohydrates in what we are eating and our blood glucose value before eating, such degrees of inaccuracy can cause dangerous situations.
Now that I am dosing my daughter, these “allowances” are frightening. She is only 5 and hasn’t yet developed the ability to sense and/or report when she feels low or high. If a 20% error happens with either her blood glucose value or the carbs she is eating (or both) and I use that information to determine how much insulin to give her, that mistaken amount of insulin could kill her.
Test strips are crazy little creatures and I find them all over the place. Sometimes, human error accounts for crazy, nonsense readings (like eating Skittles to treat a low and then testing… and then your meter says HI… thanks, sugar residue), but other times? It’s the strips and/or meter.
You could be using a meter that’s horribly inaccurate, and you’d never know it. All those unexplained highs and lows, and that roller coaster you’re on, could have an explanation . . . and a solution! A new meter! Now certainly, the best scenario here is that the FDA enforce this standard, but since they don’t, it’s up to you to educate yourself.
How can we control our diabetes when one of the things we rely on most (glucose testing) can’t be trusted? How can people properly dose their insulin when they’re essentially blindfolded? How can folks who use diet and exercise to control their diabetes do a good job without accurate information from their meters? We can’t. We need independent testing of test strips to insure our safety.
Do you “strip safely?” Inquiring minds want to know. No, I’m not getting all types of personal here or trying to make you laugh, this is all about keeping us safe. Right now, test strips can be anywhere from 10 to 20% off the mark when it comes to accuracy in blood sugar readings – And that’s not good enough!
Consider taking a few moments out of your day to help spread awareness. There is strength in numbers!
The parameters that are set by manufacturers are not good enough. Too many times we get readings that are out of range. You think to yourself… that seems weird …
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.
As a person with diabetes we rely on technology to keep us alive. Not just the tech that makes our medicine, but the tech that we rely on to decide how much insulin to dose. At a recent public meeting the FDA acknowledged that there were some FDA cleared blood glucose meters and strips that do not meet the accuracy standards for which they were approved.
The balancing act of administering just the right amount of insulin at the right time is something all people with diabetes (or parents of kids with diabetes) must perfect – and the amounts of insulin and timing change…
High-wire aerialists use a balancing pole to assist them in negotiating a thin wire stretched across two elevated points.
People with diabetes use glucose meters and test strips to navigate the thin wire that is diabetes.
Do you see why this important. How much lower than 27 could she have been. That could be the difference in grabbing juice or glucose tablets, or grabbing the Glucagon Shot and calling 911! How about we go the other way. Let’s say my daughter(‘s) have a blood sugar of 400+. I correct based on that number but it’s really 320? Big difference! Yes, let me show you. At 400 my 7-year-old would get 1.8 units of insulin. If she was really 320, it would be 1.25. That is figuring a 20% margin for error. If the strips are even less accurate, then we are talking a difference of a half of unit, or 3/4 of a unit. With a little girl, that a huge difference. The difference in a little girl waking up feeling well, or a little girl in a hospital room and parents wondering if there child will live. Get my point.
Lorraine & Bennet introduce the StripSafely Social Media campaign and talk with guest about why strips accuracy matters. Listen on Blog Talk Radio or iTunes.
Having two successful pregnancies with pre-existing diabetes was a massive accomplishment for me. It required checking my blood glucose levels 12-15 times per day for years – the months leading up to conceiving, the long haul of pregnancy, and the early days of caring for each child.
I test my BG levels to keep myself safe, both now, and to prevent future complications. I can only do that when I’m armed with the best possible information
why don’t I have a meter that gives me an accurate reading of my blood sugar?
Think about it: would you buy a scale that’s 20 percent off? Your 145 pounds on the scale might really be 113, 127, 165 or 173 pounds, or anywhere in between. Would you drive a car whose speedometer gave the speed up to plus or minus 20 miles per hour? How useful would a watch be that was sometimes too fast and sometimes too slow and you didn’t know when it was which?
The FDA needs to use that information to hold test strip manufacturers to the FDA’s own standards. The FDA accuracy rules are loose enough as they are. If a manufacturer can’t meet those standards, they shouldn’t be allowed to sell their product.
Home meters have to rely mostly on their test strips for accuracy. Strips are easily affected by variation in manufacturing, temperature, climate, altitude and freshness (age).
TEST STRIPS AND POLITICS
By Gary Scheiner MS, CDE
Medicare, in its infinite wisdom, is slashing prices (cutting reimbursement by more than two thirds) for blood glucose test strips starting this July. And because private health insurance tends to follow Medicare’s lead, there could well be a ripple effect into the greater diabetes community (although some payers cut prices made to companies long ago). Medicare’s decision will not only affect people with diabetes. It will also affect manufacturers who rely on test strip sales to fund things like new product development and educational programs. And that will have an effect on healthcare providers who are already strapped for time, as well as the pharmacies we use for obtaining our supplies.
The oft-unspoken truth is that private insurers often take direction from what Medicare does. The federal coverage has long had an influence on commercial carriers, and Medicare’s physician fee schedule has long been a model of sorts for health plans to follow when setting up their own payment rates for providers across the U.S.
This could have a profound impact on the future of diabetes devices and products. Research and innovation have the potential to see hindrances as a result of these cost changes, say industry watchers like those at Close Concerns. What companies spend on R&D to develop new products is usually based off a certain percentage of the company’s profits, so logically if less is being made, they may spend less to create innovative new D-tools.
At this point, I’d just take a meter that gives me the same result twice in a row. (Because in the last 23 years, I’ve seen some wicked variability that meter companies should hang their heads in shame over.) I’d even allow it to be 5 points off in either direction.
In fact, the biggest contributor to inaccuracy is the strips. Here’s the process as simply as I can put it: glucose interacts with an enzyme on the strip, releasing electrons. Another agent on the strip, called the “mediator,” turns these electrons into an electrical current. The greater the glucose concentration, the greater the current. That current then speeds through the strip. Finally, an algorithm (formula) in the meter converts the current into a concentration of glucose. And voila! You get a number.
But there’s a long list of factors that affect meter/strip accuracy:
– Meter calibration, coding, enzymes and mathematical algorithms (all different in different meters)
– Variable enzymes in strips
– Mediator oxidation and strip freshness/age
– Strips differ somewhat, lot to lot, with somewhat different precision ranges for each lot
– Strips differ in well size (the space in a strip that holds the blood)
– Interfering substances in one’s blood from medications (something as simple as Tylenol), and every manufacturer’s nightmare, hematocrit — that percentage of red blood cells in blood, which can interfere with the electrical current
– Environmental conditions: temperature, climate, altitude
– Lack of meter maintenance
– User error – forgetting to code the meter or coding it incorrectly; not washing hands before testing (there may be some sugar residue on your fingers or sweat on hands); leaving strips exposed to air too long; or using expired strips
Accuracy. This is many people’s top concern when choosing a meter. And yet, we don’t report it in this guide. Independent accuracy testing is expensive, complicated, and rare. Diabetes Forecast, for example, doesn’t test or recommend products because the American Diabetes Association is a nonprofit organization without a laboratory or expertise in lab comparisons of products. Where the data do exist, in the form of manufacturers’ tests, accuracy is reported in different ways. Some companies report accuracy as a “regression line,” involving correlation coefficients, slopes, and Y-axes. Others report in a friendlier table format using percentages.
Those measures of accuracy are apples and oranges. “It’s not possible [for a consumer] to do a direct comparison of how accurate one meter is to another,” says Katie Serrano, supervisory biologist and diabetes branch chief at the Food and Drug Administration’s Center for Devices and Radiological Health. “We’ve seen cases where cheaper meters don’t necessarily have all the bells and whistles, but have better accuracy.” She says users have to evaluate all of the features that are important to them.
Blood glucose meters, which millions of diabetics rely upon to regulate their blood sugar, have become less costly and easier and less painful to use.
But they haven’t become more accurate, a top Food and Drug Administration official said May 21 at a meeting of researchers analyzing studies that show wide variation in the performance of the machines used to measure blood glucose levels.
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.