By Nicholas Borgert

Prediabetes testing powers the prevention message
Adult onset diabetes isn’t just for older adults anymore. Driven by rising rates of obesity among young adults — and even adolescents — diabetes research and advocacy groups are promoting a new way to deal with an epidemic of Type 2 diabetes: identify those at risk by wider use of prediabetes testing.

Earlier this year, the U.S. Department of Health and Human Services, working with the American Diabetes Association, redefined the condition known as prediabetes. An expert medical panel assembled by HHS and ADA called for more testing of overweight people age 45 and older during regular office visits. Both the fasting blood glucose test and oral glucose tolerance test were recommended.

The ADA now estimates there are almost as many people with prediabetes (16 million) as with full-blown diabetes (17 million). The distinction is based on the blood sugar level of the patient.

Glucose levels of 109 mg/dl and below are considered in the normal range, indicating a person’s pancreas is producing sufficient amount and quality of insulin to absorb glucose. Blood sugar levels between 110 and 125 mg/dl indicate possible prediabetic conditions. Levels of 126 mg/dl are a sign of diabetes.

Three important incentives exist to warrant broader prediabetes screening, according to the HHS/ADA panel. First, elevated glucose levels in the prediabetes range increase the risk of heart attack and stroke by 50 percent. Second, progression to full-blown diabetes is not a given. Often, simple lifestyle changes can delay or prevent onset of Type 2 diabetes (90 to 95 percent of all diabetes cases). And finally, increased exercise and a healthier diet can lower elevated blood glucose levels to the normal range.

Dr. Kim Kelly, PharMD, Director of the Diabetes Program at LifeScan, a division of Johnson and Johnson, said the term “prediabetes” is a new means of identifying those previously classified as IGT/IFG.

“Even those below 110 (mg/dl) — the so-called normal range — can experience dramatic spikes in their glucose level that suggest impaired glucose tolerance,” Dr. Kelly said. “Prediabetes is a means of identifying a category of people at risk over a continuum of glucose levels.”

Prediabetes and the lifestyle factors that cause Type 2 diabetes, Dr. Kelly said, deserve an educational blitzkrieg that is aimed at everybody and confronts public policy issues. “We need to increase awareness that prevention (of diabetes) is much more cost-effective than treating it or treating the long-term complications of it,” he said.

Despite what he called a “general malaise” about glucose toxicity and control going back 20 years or more, doctors are now recognizing the need for more and more individuals to be screened, especially those who are overweight and sedentary, even if they are children.

“Diabetes has become a modern plague. If a change in terms can focus Americans on issues of weight loss and exercise, well, preventing diabetes is what it’s all about,” Dr. Kelly said.

That Type 2 diabetes is one of the most preventable diseases around gives hope to those seeking to reduce it.

“There is a major effort to identify people at higher risk to develop diabetes and try to intervene to prevent these people from getting diabetes,” said Nathaniel Clark, MD, MS, RD, national vice president for clinical affairs at the American Diabetes Association.

Age, relative weight and ethnic background are among the risk factors suggesting a prediabetes screening is appropriate, he said. But attempting to screen every American for prediabetes would be both impractical and inefficient.

“There is a clear need for greater awareness of diabetes risk among the public and within the medical community,” Dr. Clark said. Two recent studies confirm that a moderate weight loss of 8 to 10 lbs., and moderate increase in activity such as walking for 30 minutes five times a week are, in many cases, enough to delay or prevent diabetes, he said.

Early at risk testing
Then there are economic factors: questions about how to code charges related to prediabetes screening as well as educating payors who traditionally are reluctant to pay for screening tests. IVD manufacturers tend to encourage earlier and more frequent testing of the subset of the population with identifiable risk factors, rather than the general population.

The fructosamine test is a snapshot of blood glucose concentrations over the previous 2 to 3 weeks. The popular Hemoglobin A1c test (HbA1c) is a photo album of a patient’s glucose concentrations over three to four months. Highly sensitive, the microalbumin test serves as an early indicator of kidney involvement brought on by unconverted glucose in the blood. Susan Selgren, senior marketing manager for Bayer Diagnostics urinalysis products, points out that the ratio between albumin and creatinine in the microalbuminuria range is one of the earliest signs of kidney disease, with ratio testing enabling correction for variation in urine concentration.

“Without a doubt, diabetes is one of society’s most self-manageable diseases,” said Mike Sanfilippo, M.S., ASCP-SC, technical products manager at diagnostic test maker Polymedco. “Lifestyle changes such as exercise and diet are the big things we should be educating people about.”

Because it considers awareness so important, Sanfilippo said, his company is underwriting an educational effort reaching out to patients and physicians. “There’s a pool of about 16 million people who are showing signs of insulin intolerance. That population is almost totally treatable with lifestyle changes, and is reversible in almost every case,” he said.

“You can’t separate Type 2 diabetes from coronary heart disease,” according to Sanfilippo. Both, he said, are the result of basic carbohydrate overload reflected by insulin intolerance. Although CHD has other influences, having diabetes without a history of a coronary event is now considered a risk equivalent for a non-diabetic with an historical event.

“Slightly elevated fasting and/or postprandial glucose levels are the first indicator a doctor should be looking for during prediabetes testing of an overweight person,” Sanfilippo said. “But this testing is grossly underutilized today,” he said. “Only about 50 percent of the diabetic testing which should be performed, based on existing guidelines, is actually being done.”

As a public service, Polymedco has created a website on diabetes awareness. One-half of the website — http://www.diabetes-tests.com   — is devoted to patient education; the rest is geared to doctors. In addition, Polymedco supplies doctors with free brochures that ask and answer the most common questions about diabetes.

Hans Loyda, group marketing manager for diabetes products at Roche Diagnostics said that, “In addition to developing new tests for diabetes and prediabetes, Roche is devoting research and educational efforts to making better use of currently available reagents such as HbA1c.” That test, used in labs for a decade, is undergoing standardization efforts to assure greater uniformity in tests, lot to lot, and vendor to vendor. Both Loyda and Bill Marquardt, reagent product manager for diabetes products at Roche, believe that this will allow physicians to utilize the HbA1c product for more than just monitoring in diabetes: the new standardization should also enable HbA1c to be a viable candidate in the diagnosis and monitoring of prediabetes.

Nicholas Borgert is a freelance writer based somewhere out there.