[Diabetes-talk] Fw: [meters

[Mike Freeman]

----- Original Message ----- 
From: "Patricia LaFrance-Wolf" <plawolf at earthlink.net>
To: "Blind-Diabetics at Yahoogroups. Com" 
<blind-diabetics at yahoogroups.com>; "Acb-Diabetics at Acb. Org" 
<acb-diabetics at acb.org>; "Doc Mahaber Dr." <trinispice at dslextreme.com>; 
"Julie Cantrell" <JCantrell at juniorblind.org>; "Joy Steigel" 
<jstigile at sbcglobal.net>
Sent: Saturday, July 18, 2009 11:20 PM
Subject: [acb-diabetics] meters






July 19, 2009

Standards Might Rise on Monitors for Diabetics

By GARDINER HARRIS

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.



Arturo R Rolla

arolla at comcast.net

arolla at bidmc.harvard.edu

arolla at hms.harvard.edu



[Non-text portions of this message have been removed]



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