| Diabetes, the fourth-leading cause of death by disease, and its complications are estimated by the American Diabetes Association to cost the U.S. heathcare system $100 million annually.
Clearly, not enough is being done to uncover, treat and eradicate this pervasive of all chronic diseases.
How can the lab help? While the majority of glucose testing is performed by individual diabetic patients, many important measures that add to the quality and longevity of a diabetic’s life are being overlooked. For example, the fasting blood glucose numbers for a diabetes diagnosis were changed recently by the American Association of Clinical Endocrinologists from 140 to 126. Too many diabetics are ignoring their need for regular hemoglobin A1C, microalbumin and lipids tests.
In this month’s disease management section, we look at a few new and overlooked solutions for diabetes management. From home hemoglobin A1C tests to non-invasive glucose monitors, there’s a lot to keep track of. We hope this new section helps.
| Diabetics get wired
Diabetics who have been looking forward to communicating their blood glucose test results to their doctors’ via the Internet will be pleased to hear that the wait will soon be over.
In November the Food and Drug Administration cleared a device that allows diabetics to communicate with their caregivers through a phone line that ties into a web site. The result should be fewer trips to the physician’s office for diabetic patients without a corresponding decrease in communication with their caregiver.
The appliance, made by Health Hero Network Inc., a privately held e-health company in line to connect their glucose meter to a secure data center that can be accessed by clinicians through the Internet. It is the first time the FDA has cleared such a device.
The Health Buddy appliance, with an LCD screen and buttons, employs the same technology that retailers use to process credit card approvals. Health Hero has developed interfaces so that five of the most popular glucose monitors can download information to the web site. The monitors that can interface are: LifeScan One Touch Profile, LifeScan One Touch II, MediSense Q.I.D., Roche’s Accu-Chek Advantage and Bayer Glucometer DEX. Health Buddy collects and transmits patient biometric data, gathered by blood glucose meters, and makes it viewable via the Internet to the patient’s healthcare provider.
| The Health Buddy also transmits to the patient personalized healthcare reminders and questions from their care provider. The multiple choice or yes-and-no questions can range from the very specific to, "How are you feeling today?" Care managers can then log onto the Health Hero website to assess their patient’s responses. Responses are graphically depicted to indicate a patient’s signs and symptoms, behavior and trends. Information is downloaded automatically in the middle of the night. A blinking screen on the Health Buddy in the morning means there are new questions for the patient to answer. The system is designed to help healthcare professionals focus on and modify the treatment plans of patients who require more intense monitoring.
An ongoing dialogue between caregiver and patient combined with biometric readings creates a more complete picture of the overall health status of chronically ill patients, which is key to keeping them healthy and out of the hospital," said Steve Brown, founder and CEO of Health Hero.
Although it is FDA-cleared, Health Hero use is not currently reimbursed for by Medicare or insurance. The company is targeting the managed care market where the HIPPA-compliant system could be used as a tool to better monitor patients’ health while cutting costs. The technology is currently being used at a number of sites including Mercy Healthcare Sacramento (part of Catholic Healthcare West) and Santa Clara County IPA and Medical Group in San Mateo, Calif.
|Early diagnosis makes a difference
Dr. James Rosenzweig, an endocrinologist and internist, is the associate director of adult diabetes at the Joslin Clinic and director of the offices of disease management of the Joslin Diabetes Center in Boston. He talks with CLP about the benefits of early diagnosis and new drugs available for treatment.
Q. Why is diabetes so dangerous?
Q. How often should people be screened?
Q. Why is it so complicated?
Q. Why are so many different body parts affected by diabetes?
Q. Is insulin the only treatment?
Q. What study was that?
High lipid levels may increase gum disease risk in diabetics
People with poorly controlled type 2 diabetes are at increased risk of periodontal (gum) disease, according to results of a recent study. The study, published in the November issue of the Journal of Periodontology, explains why diabetics are more likely to experience severe gum disease.
Thirty-five participants, a mix of diabetics and non-diabetics, took part. Diabetics who did not have their disease under control were found to be at higher risk for gum disease, based on dental exams. Researchers found that poorly controlled diabetics respond differently to bacterial plaque at the gum line than well-controlled diabetics and non-diabetics. This may be due to elevated serum triglycerides. Diabetics who do not control the disease have more harmful proteins (cytokines) in their gingival tissue that can cause destructive inflammation of the gums. In addition, growth factors, or beneficial proteins, are reduced, which interferes with the healing response to infection. Researchers detected high levels of cytokines in the mouths of people whose diabetes was poorly controlled.
Keeping diabetes under control means more than monitoring blood sugar levels, according to the study’s lead researcher, Christopher Cutler, DDS Ph.D. at the Baylor College of Dentistry, Texas A & M University Health Science Center in Dallas. For example, diabetics often have high blood levels of fats, like cholesterol and triglycerides. Cutler believes that the link between diabetes and poor oral health may have more to do with these fats than blood sugar levels.
"It’s been known for quite a while that poorly controlled diabetics have a higher incidence and severity of periodontal disease, but there was very little understood about the mechanism," Cutler said. "What this study does, and what a follow up study in December’s Journal of Periodontology does, is it starts to define why people with uncontrolled diabetes have problems with wound healing and fighting infection." It appears that the elevated serum lipids in the form of triglycerides are what is impairing wound healing and increasing the inflammatory response to infection in diabetics, Cutler said.
In addition to elevated serum glucose, people with diabetes have elevated serum lipids because their metabolism of lipids is less efficient as a result of the disease. Instead of excreting the lipids, they stay in the bloodstream. The high lipid count directly affects the function of the monocytes and macrophages, which circulate in the blood and tissue respectively, to fight infection and clean up after a wound. Monocytes and macrophages release substances that promote wound healing and cytokines that attract other white blood cells to the infection site. However, in poorly controlled diabetics and people who eat too much fat, these monocytes and macrophages are changed and the net result is that wound healing is impaired and tissue destruction is increased, Cutler said.
"One thing that we know about the oral cavity is the first sign of disease is often seen [there], with a lot of different diseases. This is why we think with diabetes, one of the first symptoms is this gum disease," Cutler said. The tissues in the mouth are the first to see infectious agents that come into the body. The cells in the mouth proliferate very quickly in order to rejuvenate. As a result, when there are changes in the body, often it is first seen in the mouth.
Gum disease itself may be able to cause a hyperlipidemia, according to Cutler. This means it would contribute to the cycle of elevated serum triglycerides and impaired wound healing because the infection around the teeth is thought to cause the breakdown of lipids as a result of the release of cytokines.
To avoid periodontal disease, it is important for diabetics to get their diabetes under control. "What that means is going back to your internist or endocrinologist, and asking him or her to measure levels of lipids in your blood, and there is a clinical test called glycosylated hemoglobin and that is extremely important to determine the long term history of diabetic control," Cutler said. Like everyone else diabetes should make sure they floss and brush everyday, and see their dentist twice a year. "Gum disease is preventable in most patients, even with diabetes, if they practice very meticulous dental hygiene and see their dental hygienist," Cutler said.
|Lab plays important role in diabetes management according to AACE president
Diagnosed diabetics are busy people. Their lives are a continuous series of activities related to monitoring and controlling glucose levels. What may seem initially a daunting set of responsibilities, an array of tests, levels, averages, medication and meters, can be made more manageable and comprehensible for the diabetic by a clinician or laboratorian.
Richard A. Dickey, M.D., F.A.C.P., F.A.C.E., is president of the American Association of Clinical Endocrinologists, an organization dedicated to maintaining the tightest standard of practice in endocrinology, diabetes and metabolism. A practicing endocrinologist in Hickory, N.C., Dickey sees laboratorians as playing a critical role in helping diabetics control their disease. Laboratory technicians need to understand what patients with diabetes are facing and help them accept and control their disease to avoid complications.
"When you are in there drawing blood and talking to the patient, there is a lot of counseling that goes on," Dickey said. "The patient thinks they are just going there to have their blood drawn or their urine tested, but there is a lot more support going on." Laboratorians and clinicians, who are educated about diabetes will have a better understanding of what the patient is going through.
"Lab techs need to know the criteria for diabetes," Dickey said. "They need to understand the concept of glucose tolerance tests. They also need to know the signs and symptoms of diabetes itself."
Diabetes knowledge is important since its worldwide incidence is growing all too quickly. Dickey noted that we are getting fatter as a world and as a nation. "Type 2 diabetes, which accounts for 85 to 90 percent of all diabetics, are almost always overweight," Dickey said. Extra weight causes insulin resistance, which eventually results in diabetes, for patients who are genetically programmed to get the disease.
In June 1997 the American Diabetes Association (ADA) lowered its criteria for a diabetes diagnosis from a fasting, plasma glucose of 140 to 126. Overnight this increased the number of diabetics by 50 percent. Of course, the majority of those affected did not know they were now diabetics.
"Many doctors didn’t notice either," Dickey said. "I see patients repeatedly who have had values between 126 and 140 since the criteria changed. The ADA made the change because physicians and researchers found that if they waited until patients had a fasting glucose of 140 or above, it was too late. Those patients already exhibited diabetic complications, in terms of neuropathy, nephropathy and retinopathy.
The so-called, graying of American, is another factor contributing to the growing number of diabetics. Type 2 diabetes is a disease of the old and of the overweight. So these two trends – an increased life expectancy and more overweight people – are a recipe for more diabetes. The more people over age 65, the more people with diabetes. "In this population, the incidence of diabetes is approximately 15 to 20 percent, whereas in the general population it is around 5 to 7 percent," Dickey said.
There are several important laboratory tests that must be performed on a regular basis for diabetics to monitor their blood glucose levels and lipids. The hemoglobin A1C test, which measures glycosylated hemoglobin, provides a panoramic view of an individual’s blood sugar levels over two to three months.
Dickey advocates that the hemoglobin A1C test should be performed about every three months, unless the patient is unstable or in the process of changing treatment. Dickey likes to give his patients a range to shoot for when they take the test because it makes the results easier to understand. "You tell the patient they should be aiming to get it down to seven percent. Normal is four to six [percent], but it helps if they have a number in mind," Dickey said.
Because so many diabetic patients had trouble remembering the name of the hemoglobin A1C test, Dickey and others at the AACE created the name, GlucoseAverage, a trademarked term to represent the concept of overall control of blood glucose.
GlucoseAverage is also represented by the results of taking a fructosamine test, which reflects overall changes in blood glucose changes over a one-to-two week period.
The AACE is trying to standardize the methodology for these tests within the next two years. A standard should help alleviate the problems that stem from using multiple methods. When different methods are used, the numbers can differ by plus or minus one percent, which can confuse patients.
"I’m sure lab personnel will be participating in achieving the goal of standardizing the test and making sure everybody understands the concept of a GlucoseAverage," Dickey said.
Lipid measurement is another important laboratory test, according to Dickey. These should be done once a year, as long as the patient is stable. "You need to do a lipid profile. You can’t just do a total cholesterol because, for example, if a patient’s total cholesterol is 200, but their HDL is 25, this is not good," he said. "A low HDL (high density lipoprotein) is unhealthy, a high LDL (low density lipoprotein) is unhealthy, a high triglyceride is unhealthy, a high cholesterol may be unhealthy, it depends on what the ratios of the others are." There are direct methods for measuring LDL, but they are generally not necessary unless the patient has a marked increase in cholesterol or triglycerides.
"In the patient with diabetes, they need to get the lipid panel and find out of they have hypertriglyceridemia, and if so how high it is, because if it is over 1,000 this is very risky for pancreatitis," Dickey said. "If it is under 1,000 but over 300, it may be related to lack of control of diabetes. It should be treated in either case. The goal should be to get it below 200."
An ideal LDL for a diabetic patient is below 100, while non-diabetics can get by with an LDL level below 130. Diabetics need to keep their LDL level low because a high LDL creates a very high risk factor in diabetics. The AACE guidelines for lipids will be published in the March/April issue of Endocrine Practice. Its Diabetes Guidelines will be published in the January/February issue of the journal, and on its web page, www.aace.com .
Another important lab test for diabetics measures microalbumin, although Dickey reports there is no such thing. "There is albumin, a form of protein, the predominant protein excreted in the urine and in our circulation," Dickey said. Everyone has minute amounts of albumin in their urine, however dipstick and routine urine tests will not detect it until it is at a significant level, 100 or 150 milligrams per day. Microalbumin is the term for a test that detects an above-normal level of protein in the urine. An elevated urine albumin level is one of the first signs that diabetics are experiencing kidney damage.
Dickey recommends a yearly microalbumin test for patients who have had type 1 diabetes for 10 years and for those who have had type 2 diabetes for five years. "If a patient has just gotten diabetes, it is usually not worth doing," Dickey said. "But in the type 2 diabetic, five years after diagnosis they usually have had the disease for 10 years, so you do it." Microalbumin detection is an sign that kidney damage may be going on, but fortunately, there are measures that can be taken to limit that damage. "We can give that patient medication that will reduce by 50 percent the rate of progression of damage to the kidney," Dickey said. "The better you control the diabetes, the less rapid that damage will occur in the kidneys or anywhere else."
In addition to performing the tests necessary for diabetics to manage their disease, another key aspect of diabetic patient management is the sharing of information between labratorians and physicians, Dickey said. When working together, the lab technician can help the physician do a better job, understanding the tests, and in the reporting of results. The physician can assist the laboratorian in understanding why specific tests are done, how to interpret them and at what value.
"Lab technicians should invite physicians to their meetings, to help them understand medicine, to give formal lectures, to teach and provide teaching-assisted devices," Dickey said. Clinicians and labratorians also need to be aware of valuable resources available for learning about medical conditions, including diabetes. Dickey said laboratorians and diabetic team members need to share journals and media materials as a way to continue their education, enhance care and increase knowledge. Navigating the maze of diabetes treatment may seem overwhelming for the newly diagnosed patient faced with a disease that has no known cure and can have severe complications. By being knowledgeable about the disease and the tests integral to its management, labratorians can provide a vital resource for patients. "The patients have to be encouraged and supported in accepting their diagnosis and then going through all the trouble that it is to try to do what is right for diabetes," Dickey said.
— Melissa Mac
Furby and Miss America help launch home test for Hemoglobin A1C
While diabetes rages as the nation’s seventh leading killer and increasingly targets children, studies show that many diabetic patients ignore an important blood-sugar monitoring that doctors deem critical to long-term management of the disease – the Hemoglobin A1C test. To help counter this lack of compliance among many patients in taking this laboratory test, BioSafe Diagnostic Products of Lincolnshire, Ill., has introduced a new HbA1c test kit that enables patients to collect their own blood samples for lab analysis and physician interpretation. The new test uses rehydrated dried blood samples that produce readings as accurate as tests conducted with liquid samples.
The landmark 1993 Diabetes Control and Complications Trial study showed that maintaining proper blood sugar control can reduce the risks of diabetes-related complications – including blindness, kidney failure and nerve disease – by a range of 35 percent to more than 70 percent. Hemoglobin A1c testing is one of the best ways to determine overall blood sugar control. Despite its importance, however, numerous studies show that patients are ignoring the test. The American Diabetes Association recommends that diabetics have a Hemoglobin A1c test at least twice a year and optimally every three months for insulin users.
"Recent surveys suggest that a majority of people with diabetes are still not having the tests done even once a year," said Thomas Pitts, M.D., immediate past-president of the American diabetes Association’s Great Lakes Region. "And so we have more work to do."
"Until now, people with diabetes have typically had to follow up a doctor’s appointment with a second trip to a lab or clinic to have their blood drawn for the GbA1c test," said Hank Warner, president of BioSafe Diagnostics Products. "That’s where the system would often break down – people just wouldn’t go. BioSafe’s new HbA1c test uses state-of-the-art technology to make the test more accessible to patients – thereby increasing opportunities for compliance. And because it can be done in advance of a patient’s next doctor’s appointment, that visit can be more productive.
"Studies have confirmed that the HbA1c test is the best test for a healthcare provider to tell if a patient’s blood sugar is under control," said Stuart Rollin Weiss, M.D., endocrinologist with the San Diego Endocrine and Medical Clinic. "However, too many people with diabetes don’t comply with this critical test."
To help increase awareness of the HbA1c test’s important role in managing diabetes, BioSafe has launched a public education effort to reach out to the diabetic community with brochures, videos and other materials. Miss America 1999, Nicole Johnson, an insulin-dependent diabetic, will serve as the spokesperson for the campaign launch.
To help increase compliance with the HbA1c test, particularly among children, the company is working with Tiger Electronics Ltd./Hasbro Inc., to create a "doctor" finger puppet based on Furby, one of the world’s best-selling toys. Children are typically affected with Type I (insulin-dependent) diabetes, the disease’s more severe form. Through an exclusive agreement with the toy company, all diabetes patients will receive a Furby finger puppet when they purchase a BioSafe HbA1c test kit. In addition, those who comply with the recommended number of four tests a year will receive a complimentary electronic Furby toy.
Through its BioSafe Foundation, the company also will make its Furby finger puppet available for outside sale in order to raise money for diabetes research, education and treatment. The Foundation intends to raise $3 million in its first year.
The BioSafe HbA1c test marks the first time the company’s proprietary micro-sample technology has been applied to diabetes management. Other tests currently available are a Total Cholesterol Alkaline Phosphaseae (BAP) for osteoporosis management, and Prostate Specific Antigen (PSA) for prostate cancer screening. Within the next 12 months three additional tests are scheduled for release: a liver enzyme panel (GGT, AST, ALT), BUN and Creatinine (kidney function) and TSH (thyroid stimulating hormone).
BioSafe Diagnostic Products, Inc., a privately-held company founded in 1995, develops and markets diagnostic products and services using proprietary micro-sampling technology.
|New England Patriots rookie defensive back tackles diabetes
Diabetes may be one the nations most debilitating diseases, but it hasn’t stopped New England Patriots rookie Tony George from his dream of playing professional football.
George, who discovered his Type I diabetes in 1991 when he was a sophomore in Cincinnati’s Winton Woods High School, worried that his condition might hamper his professional football career. Instead he went on to become a Parade magazine All-American player. In high school he had 17 interceptions and 187 tackles as a defensive safety and 17 touchdowns as a wide receiver. After high school, George won a scholarship to the University of Florida where he was honored as a defensive back by the All-Southeast Conference.
George monitors his blood sugar three times a day and self-administers insulin shots twice a day. "From the day I was diagnosed, that’s been a part of my life, part of my regimen. I try to be as disciplined as I can in doing whatever it takes to make myself healthy," George said.
George and the New England Patriots were key supporters in educating the public about diabetes during November’s American Diabetes Month.
Glycohemoglobin testing offers proven benefits and helps diabetes management
Diabetes, a chronic, yet treatable condition, is growing in epidemic proportions. There are an estimated 16 million Americans with diabetes — roughly 6 percent of the population — yet one-third of them (approximately 5 million people) are undiagnosed. Unfortunately, the consequences of uncontrolled or undiagnosed diabetes can be severe. In the United States, diabetes is the leading cause of the following:
• Blindness—18,000 new cases each year
•End-stage renal disease—28,000 new cases per year
•Non-traumatic lower limb amputations—56,000 amputations each year
The direct and indirect costs of diabetes are estimated at a staggering $100 billion a year in the United States alone.
Recent medical studies, including the landmark Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study, demonstrate the benefit of tight glycemic control or intensive therapy. Intensive therapy delays the onset and slows the progression of diabetic complications in both type 1 and type 2 diabetics. Glycohemoglobin testing is used in conjunction with intensive therapy to track long-term glycemic control.
Glycohemoglobin or GHb, also known as hemoglobin A1C, forms when glucose attaches to adult hemoglobin (HbA) through a process called, glycosylation. GHb accumulates within red blood cells throughout their life. Thus, a single GHb value serves as an integrated index of glycemic control over the previous two to three months. Furthermore, GHb levels provide the best estimate of mean blood glucose values available today; a 1 percent change in GHb corresponds to a 30 mg/dL change in mean blood glucose. A value of less than 7 percent GHb is the goal for intensive control. The American Diabetes Association recommends biannual or quarterly testing.
Bio-Rad Laboratories’ new generation of analytical systems, the Variant II, provides clinicians with the GHb results needed for effective diabetes management. This platform incorporates primary sample tube handling with chromatographic analysis and data management capabilities. Results are traceable to the DCCT through annual certification by the National Glycohemoglobin Standardization Program.
Medical alert jewelry for diabetics makes a fashion and medical statement
Jewelry designer Susan Eisen has had Type 1 diabetes for the past eight years. She is also very picky about the jewelry she wears.
Putting these two together has resulted in her latest creation — Lifetag, medical identification jewelry that maintains a diabetic person’s privacy while providing immediate awareness of the disease to emergency medical personnel. Because many diabetics dislike current medical identification jewelry, they wear nothing to alert others of their disease or condition. Eisen, an El Paso, Texas native, researched her creation by speaking with diabetics and emergency medical personnel. She found out that there are three major reasons diabetics avoid ID jewelry. There is nothing appealing on the market. Alert jewelry they have worn in the past does not hold up to the rigors of daily use. Some people just don’t like wearing jewelry.
Eisen’s Lifetag design is small, so it provides a less public way for diabetics to maintain discrete health safety. It features a recognizable medical alert symbol and has a stick-on back, allowing it to be attached to existing jewelry, or to a watchband, key, pager or driver’s license.
The catalyst for Lifetag happened four years ago when she went to the Joslin Diabetes Center in Boston for a check-up. For the first time, Eisen was asked if she wore any kind of medical identification jewelry.
"And that’s when it kind of hit me," Eisen said. "I’m a jeweler, and I don’t wear any. It’s my job to find something that I like. That’s what I do for a living. It was a personal challenge, but I found there was a need, a huge market for the product among people like me who are diabetic, or who have Alzheimer’s or kidney disease."
When information on Lifetags hit the street in El Paso, Texas, initial interest was from Eisen’s loyal jewelry customers. Now, Eisen said, as a result of an Internet presence, everyone from diabetes educators, doctors, nurses, and camp directors have called about the identification tags.
In addition to diabetes, the tags are available for a variety of medical conditions and languages including English and Spanish. Disease conditions for which Lifetags are available include seizures, Alzheimer’s, medications, pacemaker, dialysis, asthma, emphysema, allergic and Coumadin. They come with a wallet card that lists the doctor’s name and medication type. For emergency medical personnel, the jewelry is critical. "We are their biggest nightmare," Eisen said. "When they find us, or anybody with a disease, it (the ID), would get them straight to the point. It really would save your life if you were diabetic and you had one of these on." — by Melissa Mac
GlucoWatch non-invasively monitors diabetics’ blood glucose up to 26 times a day
A new noninvasive glucose monitoring device that diabetics can wear like a watch may be hitting the market as soon as March.
In December, an advisory panel to the U.S. FDA recommended approval of the GlucoWatch, a watch-like device that helps diabetics monitor blood sugar levels. The FDA usually follows the advice of its advisory panels.
GlucoWatch, made by Cygnus Inc. of Redwood City, Calif. (www.cygn.com) would allow type 1 and type 2 adult diabetics to monitor their glucose levels noninvasively. Diabetics would still use the traditional finger stick method to calibrate the device twice a day. If it receives final FDA approval, Cygnus expect to sell the device for $250 and the replaceable AutoSensors for $4 each.
Following a three-hour warm-up period, GlucoWatch provides up to three glucose readings per hour for 12 hours after a single-point calibration with a standard home monitor. It uses reverse iontophoresis to collect glucose samples through intact skin. The glucose molecules are collected in gel collection discs that contain the enzyme glucose oxidase and are part of the single-use AutoSensor. As glucose enters the discs, it reacts with the glucose oxidase in the gel to form hydrogen peroxide. A biosensor in contact with each gel collection disc detects the hydrogen peroxide and generates an electronic signal. The monitor uses the calibration value previously entered by the patient to convert the signal into a glucose measurement. The glucose measurement is then displayed on the monitor and stored in memory.