NYTimes, Jul 19, 2009: Standards Might Rise on Monitors for Diabetics

The following was featured in this morning's New York Times which suggests that FINALLY, the FDA could tighten standards on accuracy for blood glucose testing supplies, which are up to 20% INACURATE (note, if you read the insert in each container of test strips, it becomes quickly apparent that most brands of meter are significantly less accurate at lower blood glucose levels than they are are at very high blood glucose levels -- ironic, considering that if accuracy is more critical, it will be at the lower end since actions are pretty much the same at the high end and seldom do high readings pertain to life-and-death decision making short of DKA, whereas quick decisions are critical in a case of hypoglycemia).

Standards Might Rise on Monitors for Diabetics
By Gardiner Harris, The New York Times
July 19, 2009

Federal officials may soon require improvements for the glucose monitors used by more than 11 million diabetics in the United States.

The rise in the use of home glucose monitors, even by hospitals, is pushing the action by the Food and Drug Administration, which for decades has followed international standards that allow the devices to be wrong by as much as 20 percent. Such a wide error rate can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma.

In June, the agency pressed the international group that sets the standards to tighten them. If the group refuses to act, the agency “may instead recognize other (higher) performance standards” on its own, according to a June letter from Dr. Margaret A. Hamburg, the agency commissioner.

A change in the international standards is the easiest and best option, officials said. The International Organization for Standardization, which sets the standards, can act quickly and broadly. But the F.D.A. can change the rules itself through a more time-consuming and cumbersome process.

Officials said they would keep pushing until monitor accuracy improves, a promise that diabetes doctors cheered. In a May letter, the American Association of Clinical Endocrinologists formally asked that the agency act on the issue.

“Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened,” the letter said.

Khatereh Calleja, a spokeswoman for the Advanced Medical Technology Association, which represents monitor manufacturers, responded, “We think the present standard is working.”

Diabetes has been diagnosed in 18 million people in the United States, and another 6 million are estimated to have the disease without knowing it. It is the seventh leading cause of death and costs the United States an estimated $174 billion a year, with the federal Medicare program spending $1 billion on diabetes test strips alone.

Of particular concern to federal officials is the increasing use of home glucose monitors in hospitals. A landmark 2001 study published in The New England Journal of Medicine found that using insulin to maintain low blood sugar levels in critically ill patients, even those without diabetes, reduced hospital deaths by 34 percent — a result so astonishing that hospitals around the world soon adopted the practice.

But instead of buying the highly accurate and expensive glucose monitors used in the study, many hospitals bought cheaper home models never approved for hospital use. More recent studies have shown that critically ill hospital patients whose glucose levels were kept low suffered more problems — the opposite result from 2001.

The difference, F.D.A. officials said, may have resulted because many patients in the second study were checked with home monitors.

“We think this technology is not up to par for some of the protocols we see out there” like hospital treatment of critically ill patients, said Dr. Alberto Gutierrez, deputy director of the agency’s in vitro diagnostics office. “We feel passionately that this is an important issue.”

Besides having a wide error rate, many home monitors give the wrong result if patients are taking certain drugs like Tylenol or even vitamin C. The Accu-Chek monitors made by Roche can be confounded by drugs commonly used in dialysis. Julie A. Vincent, a Roche spokeswoman, said, “Every blood glucose monitor on the market has some limitation or interferences.”

The F.D.A. issued warnings about the drug-related problems, but doctors complain that they have a hard time keeping straight which drugs conflict with which monitors.

“In the hospital setting, you really don’t know how many deaths are due to things that may be related to meter accuracy,” said Dr. Richard Hellman, a former president of the endocrinology group. “I don’t know how common it is, but I don’t think it’s rare.”

A study by government researchers found that when comparing tests from five different popular monitors, results varied by as much as 32 percent. For a class science project recently, Morgan DiSanto-Ranney, 16, of Bishop O’Connell High School in Arlington, Va., bought seven different glucose monitors and had her father, a diabetic, use all of them.

“What I found was that almost all of the meters were off from one another by 60 to 75 points,” Morgan said in an interview. Two of the meters — Ascensia Breeze and Ascensia Breeze II, both made by Bayer — differed by an average of 62 points, she said.

Staci Gouveia, a Bayer spokeswoman, said her company’s monitors meet federal requirements. “If the F.D.A. standards change, Bayer will work with the F.D.A. to meet their requirements and assure the accuracy and effectiveness of our meter,” Ms. Gouveia said.

Morgan’s mother is Emilia DiSanto, a staff investigator for Senator Charles E. Grassley, Republican of Iowa. Briefed on Morgan’s test and other studies, Mr. Grassley sent a letter to the F.D.A. in June asking officials to review the problem.

As a result of her project, Morgan’s father lost faith in glucose monitors. “He doesn’t use them as much anymore,” she said.

That reaction is exactly what federal officials are hoping to avoid by quietly pressing manufacturers to improve accuracy. Multiple studies make clear that diabetics who routinely use monitors are healthier and suffer fewer serious complications than those who do not.

Manufacturers have long complained that any requirement to improve accuracy would lead them to raise prices, which would discourage use.

“If we decrease the use of meters, you will have some fairly dire consequences to health,” Dr. Gutierrez said, but requiring stricter accuracy standards “seems a reasonable and safe practice to do.”

Every year, the F.D.A. receives reports of several deaths and thousands of injuries related to glucose monitor failures, but the reports represent only a fraction of the actual toll. Insulin-dependent diabetics slip into unconsciousness once a year on average, and 40 percent suffer seizures or coma in their lifetimes because of low blood sugar levels, according to the American Diabetes Association, which has long advocated stricter accuracy standards for monitors.

“Insulin is a dangerous drug, and if someone makes the wrong decision about its use because of a bad test, they could die,” said Dr. David Sacks, an associate professor of pathology at Harvard Medical School.

URL for this article:
http://www.nytimes.com/2009/07/19/health/policy/19monitor.html

Tags: 2009, FDA, Margaret Hamburg, glucose meters, tighter standards

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Replies to This Discussion

Yes of course the faster measurements are a lot less accurate.
Fascinating article. But I am horrified that meters are permitted to be that far off yet still meet the FDA standard.

So at the risk of igniting a firestorm -- what is the most accurate at home glucometer? I hate to think that I have blindly relied upon a certain brand of meter for years and years when there might have been a better alternative available.
I think all the major brands are likely similar...I will go out on a limb to say Lifescan, Abbott and maybe the new Aqamatrix meters (Wave/Jazz). Think the standards need to be higher to ensure better products. Have not tried the later, but would like to...have read they are very accurate...maybe the accuracy we are saying we want (2%; compensates for variables in the sample like Vit C and Hg levels, etc.). Saw Walsh was on their board...always a good sign. Would really like to see a new study comparing all the major meters...will search tomorrow to see if that has been attempted:) Would also like to hear from others what they have read and experienced. I have used many and settled on Abbott for a few years already....always looking for better product! Well me way tired:))) going to bed. Good night all!
I know that I've been using many different meters, and they are typically 20 points off from each other, using the same blood sample in each meter strip within seconds from each other.

I have also tested my BG five times within a few seconds, using the same blood sample and the SAME meter, and have received results about 20 points apart.

It's just something that I've learned to figure out by "body" feelings alone, I guess.
Just wanted to point out that being 20% off isn't necessarily 20 points. Just in case anyone thinks it a good idea to second-guess the meter. Which, generally, is not a good idea because some readings are off, some are spot on, some are moving quickly in response to insulin on board. And, although up to 20% variance is allowed, that doesn't mean the meter will be off by that amount each time.

A blood glucose reading of 80 could actually be 64-96.
A blood glucose reading of 200 could actually be 160-240.

Now, the interesting arguments I've heard from people associated with the meter companies is that most meters have a 10% margin of error. And, even at 20%, would we change our treatment? Well, if the 20% is still within the 70-130 mg/dl safe zone, probably not. But that's not a comforting thought when a false reading fails to indicate hypoglycemia or puts us outside acceptable highs.
Agree w/ your points...numbers in some ranges would not effect treatment...but, in others - could precipitate problems. I use my meter readings to determine what I will do and ...I want normal w/ very little variability. When a meter is unreliable it effects treatment goals...and if we know it, makes us shoot for "safe zones" which translate into less than euglycemia...all I am saying is SOMEONE be innovative and break from the pack to offer a way more accurate machine w/ the tools required to better manage my treatment! Talk to a few diabetics...get an idea of what we want! In a market economy that will translate into sales..in a humanist society...that is doing the right thing:)...especially when you are making billions sucking off of sick people! Sorry...a little anger there;) not in my Budda nature.
Found article on DiabetesNetl talking about the inadequacies in meters...first off, inaccuracy in results and then ineffectiveness of pattern recognition (use of data)...they suggest getting on the manufacturers backs and changes in regulation which include accountability for providing effective (lower hga1cs) data analysis by the meter! This short article summarizes a strategy to remedy meter problems...much like analysis of EKGs was remedied in the past. It appropriately emphasizes that data needs to be effectively analyzed for testing to make any sense! With the advent of CGMS...we need accuracy and better software to analyze all the data!
Completely agreed, Patricia.

This is a horrifying issue that I never fully appreciated. Our diabetes care depends upon accurate data, yet I never realized that glucometers could pass FDA muster and be 20% off. I am willing to sacrifice some accuracy for a reasonably priced home glucose test, but 20% is well outside my comfort level.

This issue needs to be pushed to the forefront of diabetes advocacy issues immediately. In the meantime, how can we all find data that shows how accurate (or inaccurate) glucometers are?
Thanks for the article, Scott. Meter inaccuracy is a critical issue & one that has been nagging at me for a while. The OTC A1c tests are also not accurate compared to lab tests. I worry more people will come to relie on them. Wildly inaccurate meters coupled with inaccurate home A1c tests--prescription for failure.

Hard to believe that any other industry would be allowed a +- of 20% error, let alone one that people's lives depend on.

Agree that speed of reading is a large price to pay for accuracy. Bells & whistles that we don't need with many meter features. Notice that these haven't increased the cost.

Today accurate meters. Tomorrow reasonably priced test strips. Hey, we can dream, right?
I'm sure that she is not a diabetic neither her relatives:

Khatereh Calleja, a spokeswoman for the Advanced Medical Technology Association, which represents monitor manufacturers, responded, “We think the present standard is working.”

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