A blood-glucose meter is crucial in helping a diabetic to monitor his/her exercise, food and medication several times a day. You would expect that these devices were regulated to be as accurate as possible.
Four years ago, health advocates and endocrinologists asked Food and Drug Administration to tighten its decades-old accuracy requirements, which allow blood-glucose meters—to test blood-sugar levels—to deviate by as much as 20 percent from the result that one would get from a laboratory test. Today, FDA tells us that because of “internal reasons,” it still will be at least another year before it will improve the standard and likely only to a 15 percent variance, says Alberto Gutierrez, who is FDA’s director of Office of In Vitro Diagnostics and Radiological Health.
“It’s taken a lot longer than we would have liked,” Gutierrez says. “This is still an ongoing process.”
A 15 percent variance might sound like an unacceptable variance when you deal with a potential life-and-death matter, such as blood-sugar levels. However, three doctors with whom we spoke, as well as representatives from American Association of Clinical Endocrinologists (AACE) and American Diabetes Association (ADA), tell us that tightening the accuracy requirement to 15 percent will make blood-glucose meters acceptably reliable. In fact, roughly 53 percent of the blood-glucose meters that are on the U.S. market already are within 15 percent variance, and some have a variance of less than 10 percent. The problem is that 47 percent of blood-glucose meters haven’t met the target of 15 percent variance, according to independent studies.
Unfortunately, consumers have no way to tell which ones meet which variance level unless they ask a doctor or have access to independent studies, says Timothy Bailey, who is the director of Advanced Metabolic Care & Research Institute and a member of the board of directors for AACE.
TAKING THE TEST. The major technological change among blood-glucose monitors in the past 4 years took place in test strips. Test strips now distinguish between glucose and other sugars, such as galactose, maltose and xylose. Previously, those nonglucose sugars created interference, or a higher reading than what it should be, in some blood-sugar meters. In turn, that nonglucose interference might lead you to inject a higher insulin dose than is necessary, which could cause coma or even death.
FDA received 13 reports of deaths that were connected to nonglucose interference between 1997 and 2009 but none since then. Six doctors with whom we spoke, as well as AACE and ADA, tell us that the nonglucose-interference problem is solved.
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The advances in test-strip technology are a positive step in making blood-glucose meters even more accurate, but consumers who rely on Medicare to pay for their diabetes-testing supplies might not be able to afford the latest test strips.
That’s because the American Taxpayer Relief Act of 2012 includes a provision that requires Centers for Medicare & Medicaid Services (CMS) as of July 1, 2013, to pay retail pharmacies the same price for blood-glucose-meter testing supplies as it pays to mail-order suppliers. The mail-order price is $22.47 for 100 test strips. That’s a far cry from the $77.90 that Medicare pays to pharmacies for 100 test strips. In other words, the price that Medicare will pay per strip will fall to about 22 cents regardless of where you buy. You should keep in mind that the best strips cost at least $1 apiece; strips of acceptable quality cost at least 40 cents each.
CMS didn’t monitor the quality of the products that beneficiaries received when the mail-order program went into effect in January 2011. However, a 2011 American Association of Diabetes Educators study found that after mail-order prices were cut, Medicare beneficiaries had fewer choices and limited access to diabetic-testing supplies, because the mail-order price wasn’t enough to pay for some products. AACE and ADA tell us that they fear that the same thing will happen starting in July 2013 to beneficiaries who use retail pharmacies for their supplies. Patients who rely on Medicare to pay for their testing supplies might not be able to afford the strips that have the best technology, Bailey says.
“Certain strips will be unavailable to beneficiaries, and that’s going to be awful,” he says.
We called six companies to see whether they would discuss pricing and whether they planned to make their testing supplies available (read: affordable) to Medicare recipients, but they all deferred to Advanced Medical Technology Association (AdvaMed), which is a trade association for medical suppliers. Unfortunately, AdvaMed wouldn’t talk about pricing strategies either, so we’ll have to wait until July 2013 to see what test strips are available to beneficiaries at the Medicare rate of 22 cents per strip.
LOSING CHEST STRAPS. Accuracy isn’t an issue in blood-glucose meters only. Manufacturers of heart-rate monitors still are introducing wrist-only, watch-style monitors as an alternative to traditional chest-strap heart-rate monitors, which can be cumbersome to wear while you exercise. However, in our hands-on evaluations, we found that even the latest wrist-only models deliver inaccurate readings. We believe that that’s because the watches tend to move around on wrists and lose their pulse reading. We didn’t find a monitor that solves the pulse-reading problem.
Omron’s HR-500U ($150), which was introduced in November 2012, is a notable wrist-only innovation, because it uses a unique optical sensor to measure the blood that flows through your capillaries and continuously calculate your heart rate instead of taking an intermittent pulse reading.
However, we found that the HR-500U still moved around the wrist and gave inconsistent readings at times. For instance, the HR-500U told us that our heart rate was 48, which is correct for a resting position. When we got up, though, it suddenly jumped to 72 during our handful of evaluations. That was incorrect, because that reading is too high from just standing after such a low resting rate. We called Omron for a response, but we hadn’t heard back as of press time.
The most unique heart-rate monitor that we’ve seen in the past 4 years is 4iiii’s Sportiiiis and Viiiiva combination ($199), which was introduced in July 2012. It’s a chest-strap heart-rate monitor that beams data to a thin receiver that can be attached to a pair of eyeglasses or sunglasses. The receiver flashes colored lights in the corner of the lens of your eyeglasses or sunglasses to indicate your current heart-rate zone and allows you to keep your eyes on the road while you run or ride a bicycle.
We gave this product a try, and it was easy to use. We easily saw the colored lights on our lens and instantly knew our heart-rate zone. At press time, we hadn’t heard of any other manufacturer that planned a similar device, but we’ll continue to monitor the situation.
Roy M. Wallack has written about fitness equipment and health monitors for 24 years. He is the Los Angeles Times’ fitness-gear columnist and the author of four books about fitness.