A giant leap for diabetics New glucose monitors bring the science closer to an artificial pancreas

By Terri Yablonsky Stat Special to the Tribune...Published August 27, 2006

A little known side effect of child diabetes is nervous sleeplessness in parents, who monitor their children's blood glucose throughout the night.

But the state of diabetes technology is on the verge of a breakthrough that already is paying huge dividends.

The continuous glucose monitors recently approved by the Food and Drug Administration bring diabetics one step closer to an artificial pancreas, which will be a stunning achievement in management of insulin dependent diabetes for adults and children.

Helen and Wes Maciorowski of Naperville have been working as a tag team to manage (*)Nine (9)year old son Bennett's Type 1 diabetes since he was 4, taking turns sleeping in shifts at night.

They bought a Guardian RT monitor last November and a system upgrade in June. They still do finger pricks to calibrate the device and double check accuracy, but already it has made accurately managing his condition easier and given them more sleep and peace of mind.

The alarm equipped monitor checks blood every five minutes. Previously, they checked his blood manually 18 to 24 times a night. "If he's going low, you give glucose and recheck in 20 minutes. His management is very intense," said Helen, a doctor in internal medicine at Lutheran General Hospital in Park Ridge, (*)Illinois.
"It's removed the stress," she said. Though she is still cautious, "I can go to bed."

More than 21 million Americans have diabetes and must regularly check their blood glucose levels several times a day. Maintaining control of blood glucose is critical to avoid complications, such as blindness, kidney failure, heart attacks and amputations.

Continuous glucose monitors read glucose levels on a real time basis using a small sensor inserted under the skin, which transmits data to a handheld device. The sensor also tells a patient whether the glucose level is trending up or down, so medication, diet and exercise can be adjusted accordingly.

The Guardian from Medtronic is one of a handful that have been approved by the FDA, with others under review. Though not technically approved for children, the monitors are used "off label" for them.

These sensors already are combined with insulin pumps, which supply the essential hormone as needed. Eventually a computer controller will be added to create a closed loop system, also known as an artificial pancreas.

This will control glucose levels by providing the right amount of insulin at the right time, much as the pancreas does in people without diabetes.

"The development of the artificial pancreas is going to be a quantum leap forward for people with diabetes," said Aaron Kowalski, director of strategic research projects at the Juvenile Diabetes Research Foundation in New York.

"This closed loop system will have tremendous influence, because it will reduce blood sugar levels to near normal, and the risk of complications will go down significantly," Kowalski said. "That will be a tremendous step forward for people with diabetes and for the U.S. health care system."

Kowalski said he expects to see the first generation closed loop system within five years. "It will happen in steps. We'll tie insulin delivery to glucose sensing and make the administration of insulin automatic, initially during portions of the day--overnight for example--then move toward complete automation."

Until insurers can be convinced of their reliability, the monitoring systems will be an expensive burden on patients and families.

For example, the original device cost the Maciorowskis $2,790. The monthly cost for sensors is $350, plus $14 for adhesives for the transmitter. Then the upgrade this year adds another $1,000 outlay.

But, as Helen Maciorowski said, "A good night sleep with peace of mind is priceless."
Copyright © 2006, Chicago Tribune
Highlights &*) added by page author

Diabetes drugs evaluated

Associated Press...Posted Tuesday, July 17, 2007

Older, cheaper diabetes drugs are as safe and effective as newer ones,  concludes an analysis that is good news for diabetics and may further hurt sales of Avandia, a blockbuster pill recently tied to heart problems.

The clear winner: metformin, sold as Glucophage  and generically for about $100 a year.

It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol.

It looks to be the safest,” said Dr. Shari Bolen, a Johns Hopkins University researcher who led the review, which was published online Monday by the Annals of Internal Medicine.

Consumer Reports also published a consumer guide of the results. Besides metformin, it rates glipizide and glimepiride, sold as Amaryl and Glucotrol, as best bets.

“This is truly significant information for the millions of people with diabetes struggling to control their disease, but also struggling with the high cost of their medications, ” said Gail Shearer, project director of Consumer Reports Best Buy Drugs.

All diabetes pills can cause problems, so patients should pick the medication based on what side effects matter most in their own situation, the guide advises.

Diabetes is epidemic, afflicting more than 18 million Americans or 7 percent of the population. Most have Type 2, which occurs when the body makes too little insulin or cannot use what it does produce. Being overweight raises this risk.

The federal Agency for Healthcare Research and Quality commissioned the analysis of diabetes drugs in 2005, long before a study published in May suggested Avandia, made by GlaxoSmithKline PLC, raised the risk of heart attacks. The new analysis says that evidence is insufficient to settle this issue.

The goal was to do the first in-depth comparison of oral medications that have come out in the last decade, as well as older ones like sulfonylureas that have been sold for 50 years. The report did not evaluate insulin or other injected diabetes drugs.

Researchers reviewed more than 200 published studies and obtained unpublished information from some drug companies and the federal Food and Drug Administration.

They found that most oral diabetes drugs lower “A1c” levels — a key measure of high blood sugar — by about one percentage point — from 8 to 7, for example (5 is normal for non-diabetics).

Taking two medications can improve blood sugar control, but also costs more and can raise the risk of side effects.

Despite heavy marketing for newer drugs, which cost as much as $262 a month, “we didn’t find any benefit” unless a patient could not tolerate an older one , Bolen said.

Other results:

—Metformin and acarbose (sold as Precose) do not increase weight. Others add 2 to 11 pounds.

—LDL or bad cholesterol drops by about 10 milligrams per deciliter of blood with metformin and increases by that amount with Avandia or Actos, made by Takeda Pharmaceuticals.

—Glimepiride, glipizide, glyburide and repaglinide lead to too-low blood sugar more often than other drugs do.

—Metformin and acarbose more often cause diarrhea and other digestive problems than the others.

• Actos and Avandia slightly raise HDL or good cholesterol.

• Actos and Avandia significantly raise the risk of heart failure.

Avandia’s safety will be debated at an FDA hearing on July 30. GlaxoSmithKline says Avandia is safe but has not denied reports that sales have fallen about 30 percent since May 21, when a study linked it to heart attacks.

Company spokeswoman Mary Anne Rhyne said the analysis published Monday was done before one study had been completed that showed Avandia to better control blood sugar than two rival medications.

However, several diabetes specialists said the results are no surprise. The conclusions mirror those of an expert panel that leading U.S. and European diabetes groups convened last year, said Dr. David Nathan, diabetes chief at Massachusetts General Hospital. He has received speaker fees from several diabetes drug makers.

Metformin is “an incredibly inexpensive generic drug, which is why we found it so appealing, ” Nathan said.

But it can cause a rare but dangerous side effect called lactic acidosis, the buildup of lactic acid in the blood. It also should not be given to diabetics who have moderate kidney disease or heart failure.  This is true of many other diabetes pills, too.

A key question is how well any of these drugs prevent long term consequences, said Dr. Brian Strom, epidemiology chief at the University of Pennsylvania and a consultant to several diabetes drug makers.

“Part of what makes the Avandia question so important is it’s been assumed that Avandia will decrease mortality” by better controlling blood sugar long-term — not raise the risk of heart attacks or death, he said. Right now, “the data aren’t there — we don’t know one way or another.”

Highlights by page author

Are You At Risk?

Take this quiz from the American Diabetes Association to assess your personal risk for diabetes or its complications. Write in the points next to each statement that is true for you. If a statement is not true, put a zero. Then add your total score.

1. I am a woman who has had
a baby weighing more than
9 pounds at birth.Yes = 1--­
2. I have a sister or brother
with diabetes.Yes = 1­--
3. I ,have a parent with diabetes.Yes = 5­--
4. My weight is equal to or above
that listed on the chart, above.Yes = 5­--
5. I am under 65 years of age
and I get little or no exercise.Yes = 5­--
6. I am between 45 and
64 years of age.Yes = 5­--
7. I am 65 years old or older. Yes = 9­--

Total score
For more specifics relative to your riskVisit here

If you scored three(3) to nine(9) points You are probably at low risk for diabetes now. Keep your risk low by losing weight if you are overweight, being active most days, and eating lowfat meals that are high in fruits and vegetables and whole grain foods.

If you scored ten (10) or more points You are at high risk for having diabetes. Talk with your doctor about your risk factors and ask him to test you for diabetes at your next office visit.

For more information on your personal risk factors, check out Diabetes PHD (personal health decisions), a new interactive tool on the American Diabetes Association's website, access here See "ONE WAY TO REDUCE YOUR DIABETTES RISK"below.

TAKE THE TEST YOU CAN TAKE TO YOUR DOCTOR

Do You Know Your Alc?

If you have diabetes, your doctor has probably given you the HbA1c test-or Alc, for short. The test provides an average of your glucose (blood sugar) measurements, expressed as a percentage, over the previous six to (*) twelve (12) weeks. The higher your glucose levels, the higher the percentage, as chart shows

.

5            6            7
         Target
90      135      170

8                         9
      Suboptimal
205                     240

10            11            12
         Poor
275         310         345

Average Plasma Glucose (mgldL)

Even a one (1%) rise is undesirable and increases your risk of diabetes related complications, such as eye disease, heart disease,Nerve damage, Kidney disease, and stroke.

Your doctor will use this test, along with your home blood glucose monitoring, to make adjustments to your diabetes treatment.

• How often should I have my Alc level tested?
• What do my results mean?
• Do I need to make a change in my medications to achieve better control?
• How can I improve my blood glucose readings?

(*)To Learn more about the Alc test and how to monitor glucose levels. Go to webmd.com

and search for "diabetes.
WebMD the Magazine | January/February 2006

Did You Know?

•  Type 1 diabetes usually is diagnosed in children and young adults, yet it can start at any age.
It Occurs when the pancreas produces no insulin, a hormone the body needs to use sugar in the blood.
•  Obesity is a major risk factor for developing type 2 diabetes (in which the pancreas still makes insulin, but the body has become resistant to its effects).
•  Both types of diabetes can have similar symptoms: abnormal thirst and hunger,excessive urination, weight loss, blurred vision, nausea, and fatigue.

Know Your Numbers

•  One study found that in people with type 2 diabetes, every (*)One (1%) rise (above target levels) in A1c added (*)Eighteen percent (18%) to their risk of heart disease.

•  (*)Thirty (30) minutes of moderate physical activity a day, coupled with a (*)Five percent(5%) to (*) Ten percent (10%) reduction in body weight, resulted in a (*)Fifty Eight percent(58%) reduction in diabetes in people at risk for the disease,according to a recent study.

•  About (*) Twenty point Eight (20.8) million Americans have been diagnosed with diabetes,about (*)Seven percent (7%) of the population.

Glossary

glucose:  A simple sugar found in the blood. It is the body's main source of energy.
pancreas:  An organ behind the lower part of the stomach (about the size of a hand) that makes insulin the body can use glucose for energy.
insulin:  A hormone produced by the pancreas that helps the body use glucose for energy. The beta cells of the pancreas make insulin.
Scroll down to "General Glucose Guidelines heading for more important information.

Smoking May Raise Diabetes Risk

Cigarette smokers (*) "may be" almost three times more likely to get type 2 diabetes, according to a recent study. The researchers theorized that smokers tend to have more abdominal fat than people who have never smoked, and higher levels of fat in the abdomen are associated with greater risk for diabetes.
Source: Diabetes Care

From the WebMD Diabetes Health Center, including information from THE CLEVELAND CLINIC. and the National Institutes of Health
(*)&Highlights added by page author.

Two of the most prevalent consequences of diabetes are eye disease and foot problems. Here is what you need to know to fight both.

Diabetic Retinopathy
The most prevalent eye disease for people with diabetes is diabetic retinopathy, which affects the eye’s retina.

“The retina is the part of the eye that records the images we see, like film in a camera. Those images are transmitted through the optic nerve to the brain,” says Connie McRill, M.D., a consulting ophthalmologist to Charlestown, a community in Maryland built and managed by Erickson.

“There are two forms of this disorder, non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR).  In NPDR, the more common form, fluid leakage causes vision problems. PDR is the more advanced form in which new blood vessels proliferate. They can bleed a lot and damage vision,” says McRill.

Diabetic retinopathy is the second leading cause of blindness in the U.S.  Partly because it usually doesn’t show any symptoms, especially in the early stages, and when symptoms do develop, like spots floating in front of the eyes,they’re easily ignored.

“You must schedule and keep regular eye exams if you’ve been diagnosed with diabetes. Once a year is fine if your diabetes is controlled; if not, you should be seen as often as every six weeks. There are medicines and laser surgeries for both NPDR and PDR you can ask about,” says McRill.

“Keep close control of your blood sugars with diet and exercise. Sometimes I think exercise—stimulating blood flow and oxygen to the eyes—is even more important for people with diabetes. It doesn’t have to be aerobic; it can be chair exercises, tai chi, there’s always something.

Moving on to Feet
“People with diabetes should regularly inspect their feet for any cuts or openings; they can be a doorway for viruses and bacteria to enter.  If you can’t do it yourself, have someone—a doctor or a loved one—do it,” says Terry Cooke, D.P.M., a full time staff podiatrist.

Improperly clipping toenails or ill (*) poor)fitting shoes that rub or chafe, are two potential dangers.  “Up to (*) Fifteen (15) percent of people with diabetes develop diabetic ulcers in their feet,” says Cooke.

Cooke notes that reduced sensitivity to pain is common in people with diabetes and often leads to major problems. “Don’t walk barefoot. You could step on something in the house like a nail and not even know it. You might not notice that chafing shoe until you’re hobbling.”

“You might have to abandon your soothing foot soak; because of reduced pain sensation, it’s easy to burn yourself with too-hot water. To test water temperature, use your elbow. It’s more likely to still have nerve sensations than your feet or fingertips,” Cooke says.

Minor Problems Can Turn Major
Seemingly minor foot problems can lead to major consequences if not treated in a timely and effective manner, so don’t ignore corns, ingrown nails, or anything else. “Nearly 25 percent of people with diabetes will have an amputation,” says Cooke, but adds, “Doctors can reduce that number with better education and treatment.”

“Unfortunately, most primary care doctors don’t have the time to do a foot exam. A podiatrist should definitely be a part of every older person’s health care team. We’re trained to look for diabetes-related foot problems and can sometimes spot diabetes before an internist by examining someone’s feet”, says Cooke.

If your sugar is controlled, twice a year visits are recommended. Otherwise, you should arrange appointments every other month,” she adds.

Ask your primary care physician for referrals today and make sure an ophthalmologist with experience in diabetes and a podiatrist become part of your health team.

Diabetes: The other "silent killer"

Undetected, it ravages bodies in an unfettered fashion.

Weight control and exercise are two of the most effective tools to combat diabetes.

High blood pressure long has been referred to as the "silent killer," because patients suffering from the illness often don't realize they have a problem until their organs are seriously damaged.

Like high blood pressure, diabetes is a disease that sneaks up on millions of Americans. It's increasingly recognized as a major cause of death and disability, yet many who suffer from diabetes are unaware they even have it until they experience a debilitating side effect of the disease.

This disorder damages many tissues. Most complications involve the cardiovascular system (heart disease and stroke, for example). Other problems caused by diabetes include blindness, kidney disease, nerve damage, impotence, amputations, inability to fight infection and complications in pregnancy (including birth defects).

The trouble is, because many aren't aware they even have diabetes, the illness damages the body in an unfettered fashion before being discovered.

Type 2 diabetes is by far the most common form of the disease.

Those at higher risk include elderly people, people with a family history of diabetes and overweight folks. Certain ethnic groups, such as Hispanics, blacks, Native Americans and those of Pacific Island heritage, also are at higher risk.

The good news:  Diabetes responds nicely to behavior modification.

Two of the most effective tools for combating the illness are" weight control and exercise".

In fact, our nation's growing obesity problem is linked to the increase in diabetes over the past few decades. Numerous studies have shown a strong association between increasing fitness and decreasing one's risk for diabetes.

Are you at risk?

The best way is find out is to be evaluated by your doctor, who can perform the appropriate blood tests and interpret them for you.

You also can pick up a glucose monitoring kit at the drugstore and check your blood yourself.

Be sure to fast for a minimum of eight hours before you perform the test  to ensure that any food eaten recently will not alter the results. Follow the kit's directions, and use the Guidelines below(*)to see how you stack up against the general glucose guidelines from the National Institutes of Health.

General glucose guidelines