Standards Might Rise on Monitors for Diabetics By GARDINER HARRIS

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.

Lilly Diabetes Drug Shows a Life-Extending Promise

August 5, 2008
Lilly Diabetes Drug Shows a Life-Extending Promise
By ALEX BERENSON
Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer?
Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference. In the trial, called Accord, patients with Type 2 diabetes were prescribed Byetta or any of several other diabetes medicines. Patients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug.
The finding, presented in June, has generated a stir among diabetes researchers, although so far it has attracted little public notice. Neither Eli Lilly or Amylin, the companies that jointly market Byetta, is publicizing the findings, in part because no one is sure whether the reduction in the death rate is real or a chance finding. Only about 825 patients in the 10,000-patient Accord trial took Byetta, and those who did were likelier to be healthier than other patients.
“We don’t know whether it’s the drug or the healthy participant,” said Dr. Michael Miller, professor of biostatistics at Wake Forest University and the lead statistician on the Accord trial.
The trial’s finding came as a surprise even to Lilly and Amylin, said Dr. James Malone, the global medical director of Byetta for Lilly.
“We were not aware of the results before they were presented at A.D.A., and I was sitting in the audience and my jaw just dropped,” Dr. Malone said. The trials that Lilly and Amylin have conducted on Byetta, have not shown a reduction in mortality in patients taking the medicine, but they were not intended to do so.
Although Byetta has been a moderate success in the market, with sales expected to reach about $700 million this year, prescriptions are short of what analysts had forecast when the medicine was introduced in 2005.
For the Accord finding to be proved, it must be tested in a large trial that would compare the cardiac health and overall death rates of thousands of patients, half receiving Byetta and half receiving a placebo. So far, Lilly and Amylin have not committed to undertaking such a trial, which would take years and cost tens of millions of dollars.
Further complicating the issue is that the two companies are working a reformulated version of Byetta, which could be injected once weekly instead of twice daily, and they may prefer to run the trial on the new medicine, which has not yet been approved by the Food and Drug Administration.
Dr. Malone said the two companies hoped to make a decision on holding a large mortality trial by the end of the year.
Even so, the finding adds to an emerging body of evidence that Byetta — the first in a new class of diabetes medicines called incretin mimetics — may work better than other diabetes medicines, at least for people who can tolerate its side effects, which can include severe nausea.
Byetta is less likely than other diabetes medicines to cause hypoglycemia, or dangerously low blood sugar. In addition, while most diabetes medicines cause patients to gain weight, patients on Byetta typically lose several pounds each year on the medicine. Weight gain is associated with cardiovascular problems, the most common causes of death for people with diabetes.
“My suspicion is that when you look at the determinants of mortality, which were weight gain and hypoglycemia in that study, Byetta would be the antimortality drug, because it’s associated with weight loss and less hypoglycemia,” said Dr. Alan Garber, an endocrinologist and professor of medicine at Baylor.
In addition, animal trials offer some evidence that Byetta may directly benefit the heart, Dr. Malone said.
Byetta, generically called exenatide, is a synthetic version of a protein originally discovered in the venom of a lizard, the Gila monster. It encourages digestion and the production of insulin. Byetta is currently approved for use alongside other diabetes drugs, and Lilly and Amylin have asked the F.D.A. to approve it as a monotherapy as well.
When Byetta was introduced in 2005, prescriptions for it grew rapidly. But for the last year, Byetta prescriptions have been roughly flat at about 250,000 a month.
Doctors say that some patients cannot tolerate the nausea that Byetta can cause and others do not like injecting the medicine twice daily. Concerns about pancreatitis, an inflammation of the pancreas that can be fatal in rare cases, have also hurt the drug, although Byetta has not been proved to cause pancreatitis.
Dr. Joel Zonszein, an endocrinologist at Montefiore Medical Center in the Bronx, said some primary care doctors do not like to prescribe Byetta because they must teach patients how to give injections, a time-consuming process. “It is a drug that is difficult to prescribe,” Dr. Zonszein said.
Meanwhile, prescriptions for Januvia, a medicine in pill form from Merck that works in a somewhat similar way as Byetta, have taken off since Merck introduced it in October 2006. More than 500,000 patients a month are being given prescriptions for Januvia or Janumet, which combines Januvia with a second diabetes medicine in a single pill.
“Januvia has been effectively marketed in the primary care community,” said Dr. John Buse, vice chairman for the Accord study and professor of medicine at the University of North Carolina, Chapel Hill. “I think there is some misunderstanding about the relationship between Januvia and Byetta among primary care providers.”
Dr. Buse said that the data from Accord was intriguing but not enough to persuade him that Byetta could reduce deaths in diabetes patients.
“The number of patients in Accord that were treated with exenatide was a very small proportion of the total patients in Accord, and they got exenatide relatively late in the trial,” he said. He said he hoped Lilly and Amylin would decide to invest in the trial necessary to test Byetta’s effect on mortality.
“They need to do it,” he said.

Diabetes

Diabetes Overview
Diabetes is a life-long disease marked by high levels of sugar in the blood.
Reference from A.D.A.M.
Back to TopCauses
Diabetes can be caused by too little insulin (a hormone produced by the pancreas to control blood sugar), resistance to insulin, or both.
To understand diabetes, it is important to first understand the normal process of food metabolism. Several things happen when food is digested:
A sugar called glucose enters the bloodstream. Glucose is a source of fuel for the body.
An organ called the pancreas makes insulin. The role of insulin is to move glucose from the bloodstream into muscle, fat, and liver cells, where it can be used as fuel.
People with diabetes have high blood sugar. This is because their pancreas does not make enough insulin or their muscle, fat, and liver cells do not respond to insulin normally, or both.
There are three major types of diabetes:
Type 1 diabetes is usually diagnosed in childhood. The body makes little or no insulin, and daily injections of insulin are needed to sustain life.
Type 2 diabetes is far more common than type 1 and makes up most of all cases of diabetes. It usually occurs in adulthood. The pancreas does not make enough insulin to keep blood glucose levels normal, often because the body does not respond well to the insulin. Many people with type 2 diabetes do not know they have it, although it is a serious condition. Type 2 diabetes is becoming more common due to the growing number of older Americans, increasing obesity, and failure to exercise.
Gestational diabetes is high blood glucose that develops at any time during pregnancy in a woman who does not have diabetes.
Diabetes affects more than 20 million Americans. About 54 million Americans have prediabetes. There are many risk factors for diabetes, including:
A parent, brother, or sister with diabetes
Obesity
Age greater than 45 years
Some ethnic groups (particularly African Americans, Native Americans, Asians, Pacific Islanders, and Hispanic Americans)
Gestational diabetes or delivering a baby weighing more than 9 pounds
High blood pressure
High blood levels of triglycerides (a type of fat molecule)
High blood cholesterol level
Not getting enough exercise
The American Diabetes Association recommends that all adults over age 45 be screened for diabetes at least every 3 years. A person at high risk should be screened more often.
Back to TopSymptoms
High blood levels of glucose can cause several problems, including frequent urination, excessive thirst, hunger, fatigue, weight loss, and blurry vision. However, because type 2 diabetes develops slowly, some people with high blood sugar experience no symptoms at all.
Symptoms of type 1 diabetes:
Increased thirst
Increased urination
Weight loss in spite of increased appetite
Fatigue
Nausea
Vomiting
Patients with type 1 diabetes usually develop symptoms over a short period of time, and the condition is often diagnosed in an emergency setting.
Symptoms of type 2 diabetes:
Increased thirst
Increased urination
Increased appetite
Fatigue
Blurred vision
Slow-healing infections
Impotence in men
Back to TopSigns and Tests
A urine analysis may be used to look for glucose and ketones from the breakdown of fat. However, a urine test alone does not diagnose diabetes. The following blood glucose tests are used to diagnose diabetes:
Fasting blood glucose level -- diabetes is diagnosed if higher than 126 mg/dL on two occasions. Levels between 100 and 126 mg/dl are referred to as impaired fasting glucose or pre-diabetes. These levels are considered to be risk factors for type 2 diabetes and its complications.
Random (non-fasting) blood glucose level -- diabetes is suspected if higher than 200 mg/dL and accompanied by the classic symptoms of increased thirst, urination, and fatigue. (This test must be confirmed with a fasting blood glucose test.)
Oral glucose tolerance test -- diabetes is diagnosed if glucose level is higher than 200 mg/dL after 2 hours (This test is used more for type 2 diabetes.)
You should also ask your doctor how often to you need your hemoglobin A1c (HbA1c) level checked. The HbA1c is a measure of average blood glucose during the previous 2 to 3 months. It is a very helpful way to determine how well treatment is working.
Ketone testing is another test that is used in type 1 diabetes. Ketones are produced by the breakdown of fat and muscle, and they are harmful at high levels. The ketone test is done using a urine sample. High levels of blood ketones may result in a serious condition called ketoacidosis. Ketone testing is usually done at the following times:
When the blood sugar is higher than 240 mg/dL
During acute illness (for example, pneumonia, heart attack, or stroke)
When nausea or vomiting occur
During pregnancy
Back to TopTreatment
There is no cure for diabetes. Treatment involves medicines, diet, and exercise to control blood sugar and prevent symptoms and complications.
LEARN THESE SKILLS
Basic diabetes management skills will help prevent the need for emergency care. These skills include:
How to recognize and treat low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia)
What to eat and when
How to take insulin or oral medication
How to test and record blood glucose
How to test urine for ketones (type 1 diabetes only)
How to adjust insulin or food intake when changing exercise and eating habits
How to handle sick days
Where to buy diabetes supplies and how to store them
After you learn the basics of diabetes care, learn how the disease can cause long-term health problems and the best ways to prevent these problems. People with diabetes need to review and update their knowledge, because new research and improved ways to treat diabetes are constantly being developed.
SELF-TESTING
If you have diabetes, your doctor may tell you to regularly check your blood sugar levels at home. There are a number of devices available, and they use only a drop of blood. Self-monitoring tells you how well diet, medication, and exercise are working together to control your diabetes and can help your doctor prevent complications.
The American Diabetes Association recommends that premeal blood sugar levels fall in the range of 80 to 120 mg/dL and bedtime blood levels fall in the range of 100 to 140 mg/dL. Your doctor may adjust this depending on your circumstances.
WHAT TO EAT
You should work closely with your health care provider to learn how much fat, protein, and carbohydrates you need in your diet. A registered dietician can be very helpful in planning dietary needs.
People with type 1 diabetes should eat at about the same times each day and try to be consistent with the types of food they choose. This helps to prevent blood sugars from becoming extremely high or low.
Persons with type 2 diabetes should follow a well-balanced and low-fat diet.
HOW TO TAKE MEDICATION
Medications to treat diabetes include insulin and glucose-lowering pills called oral hypoglycemic drugs.
Persons with type 1 diabetes cannot make their own insulin, so daily insulin injections are needed. Insulin does not come in pill form. Injections that are generally needed one to four times per day. Some people use an insulin pump, which is worn at all times and delivers a steady flow of insulin throughout the day. Other people may use a new type of inhaled insulin.
Insulin preparations differ in how quickly they start to work and how long they remain active. Sometimes different types of insulin are mixed together in a single injection. The types of insulin to use, the doses needed, and the number of daily injections are chosen by a health care professional trained to provide diabetes care.
People who need insulin are taught to give themselves injections by their health care providers or diabetes educators.
Unlike type 1 diabetes, type 2 diabetes may respond to treatment with exercise, diet, and medicines taken by mouth. There are several types of medicines used to lower blood glucose in type 2 diabetes. They fall into one of three groups:
Medications called oral sulfonylureas that increase insulin production by the pancreas.
Medications called thiazolidinediones that help increase the cell's sensitivity (responsiveness) to insulin.
Medications that delay absorption of glucose from the gut. These include acarbose and miglitol.
There are some injectable medicines used to lower blood sugar. They include exenatide and pramlintide.
Most persons with type 2 diabetes will need more than one medication for good blood sugar control within 3 years of starting their first medication. Different groups of medications may be combined or used with insulin.
Some people with type 2 diabetes find they no longer need medication if they lose weight and increase activity, because when their ideal weight is reached, their own insulin and a careful diet can control their blood glucose levels.
It is unknown if hypoglycemic medicines taken by mouth are safe for use in pregnancy. Women who have type 2 diabetes and take these medications may be switched to insulin during pregnancy and while breastfeeding.
Gestational diabetes is treated with insulin and changes in diet.
EXERCISE
Regular exercise is especially important for people with diabetes. It helps with blood sugar control, weight loss, and high blood pressure. People with diabetes who exercise are less likely to experience a heart attack or stroke than diabetics who do not exercise regularly. You should be evaluated by your physician before starting an exercise program.
Here are some exercise considerations:
Choose an enjoyable physical activity that is appropriate for your current fitness level.
Exercise every day, and at the same time of day, if possible.
Monitor blood glucose levels before and after exercise.
Carry food that contains a fast-acting carbohydrate in case you become hypoglycemic during or after exercise.
Carry a diabetes identification card and a mobile phone or change for a payphone in case of emergency.
Drink extra fluids that do not contain sugar before, during, and after exercise.
Changes in exercise intensity or duration may need changes in diet or medication dose to keep blood sugar levels from going too high or low.
FOOT CARE
People with diabetes are prone to foot problems because of the likelihood of damage to blood vessels and nerves and a decreased ability to fight infection. Problems with blood flow and damage to nerves may cause an injury to the foot to go unnoticed until infection develops. Death of skin and other tissue can occur.
If left untreated, the affected foot may need to be amputated. Diabetes is the most common condition leading to amputations.
To prevent injury to the feet, people with diabetes should adopt a daily routine of checking and caring for the feet as follows:
Check your feet every day, and report sores or changes and signs of infection.
Wash your feet every day with lukewarm water and mild soap, and dry them thoroughly.
Soften dry skin with lotion or petroleum jelly.
Protect feet with comfortable, well-fitting shoes.
Exercise daily to promote good circulation.
See a podiatrist for foot problems or to have corns or calluses removed.
Remove shoes and socks during a visit to your health care provider and remind him or her to examine your feet.
Stop smoking, which hinders blood flow to the feet.
Back to TopSupport Groups
For additional information, see diabetes resources.
Back to TopExpectations (prognosis)
With good blood glucose and blood pressure control, many of the complications of diabetes can be prevented.
Studies have shown that strict control of blood sugar and blood pressure levels in persons with diabetes helps reduce the risk of kidney disease, eye disease, nervous system disease, heart attack, and stroke.
Back to TopComplications
Emergency complications include diabetic hyperglycemic hyperosmolar coma.
Long-term complications include:
Diabetic retinopathy
Diabetic nephropathy
Diabetic neuropathy
Peripheral vascular disease
Hyperlipidemia, hypertension, atherosclerosis, and coronary artery disease
Back to TopCalling Your Health Care Provider
Go to the emergency room or call the local emergency number (such as 911) if symptoms of ketoacidosis occur:
Increased thirst and urination
Nausea
Deep and rapid breathing
Abdominal pain
Sweet-smelling breath
Loss of consciousness
Go to the emergency room or call the local emergency number if symptoms of extremely low blood sugar (hypoglycemic coma or severe insulin reaction) occur:
Weakness
Drowsiness
Headache
Confusion
Dizziness
Double vision
Lack of coordination
Convulsions or unconsciousness
Back to TopPrevention
Maintaining an ideal body weight and an active lifestyle may prevent the onset of type 2 diabetes. Currently there is no way to prevent type 1 diabetes.
Back to TopReferences »
Standards of medical care in diabetes--2007. Diabetes Care. Jan 2007;30 Suppl 1:S4-S41.
Larsen PR, Kronberg HM, Schlomo M, et al. Williams Textbook of Endocrinology. 10th ed. St. Louis, Mo: WB Saunders; 2003:1427-1468, 1485-1504.
Armstrong C. ADA Releases Standards of Medical Care for Patients with Diabetes. Am Fam Physician. Sept 2006; 74(5); 871-874.
Caballero E. Prediabetes. J Clin Endocrinol Metab. Jan 2007; 92(1); 15A-16A.See All References »
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