New Recommendations

New Recommendations

NEW DIABETES DIAGNOSIS RECOMMENDATIONS
by Ed Bryant

On June 23, the American Diabetes Association

sponsored a telephone news conference in which members of

"the Expert Committee on the Diagnosis and Classification of

Diabetes Mellitus" presented their findings regarding the

need to revise diabetes diagnosis and classification, and

answered audience questions. Current estimates are that over 100

billion dollars a year (in direct and indirect costs), are poured

into treating diabetes and its complications. This figure

includes as much as 15% of managed care costs and 20% of the

Medicare budget. The committee, which started addressing this

problem in 1995, and finished this year, saw its report accepted

for publication in the professional journal "Diabetes

Care," Volume 20, No. 7, for July 1997.

First presenter was Dr. James Gavin, Senior

Scientific Officer of Howard Hughes Medical Institute, past

president of the American Diabetes Association, and the Chair of

the Expert Committee. Other presenters were: Dr. Frank Vinicor,

Director of the Office of Diabetes Translation, Centers for

Disease Control and Prevention; Dr. Richard Eastman, Director of

the Division of Diabetes, Endocrinology, and Metabolism, of the

National Institute of Diabetes, Digestive, and Kidney Diseases;

and Dr. George Alberti, Director of the Human Diabetes and

Metabolic Research Center, part of the World Health Organization,

Collaborating Center for Research and Development for Laboratory

Techniques and Diabetes.

Dr. Gavin reminded listeners of the seriousness

of diabetes, its impact on over 16 million Americans, and its

explosive growth (The past 30 years have brought more than a

tripling in the U.S. A.), and much of its cost has been for

treatment of its long-term complications. These complications are

driven largely by the high blood sugars of the disease, and we

now know they can be prevented or delayed by early and aggressive

treatment. Today we know more about diabetes than ever before.

This heightened understanding has caused us to reevaluate the way

diabetes is diagnosed and classified.

The current medical classifications and glucose

test levels that would indicate an individual has the condition

were last updated in 1979, and were based on then-current

knowledge. In 1979 we didn't know about the autoimmune aspects of

type I diabetes, we didn't know about genetic susceptibility, and

we had far less understanding of the sub-types of diabetes. We

have more than 16 years of new research to draw on. The Expert

Committee's work represents an update of what we knew about

diabetes back then. Conclusive data on population based research

show serious complications of diabetes beginning earlier than

previously thought, and at a lower level of blood sugar. With

what we know now, it is time to revise, so as to take better

advantage of the multiple opportunities for early intervention we

now possess.

The single most important recommendation made

by the committee is to move the "cut point" for a

diagnosis of diabetes, downward from its current 140mg/dl fasting

plasma glucose (FPG) to an FPG of 126. This 14-point drop, the

researchers argue, will catch more of the estimated 8 million

undiagnosed diabetics in the United States, perhaps up to 2

million, and catch them sooner than the current 7 to 10 years

after onset. A "normal" (non-diabetic) fasting plasma

glucose, they define as 110mg/dl or less.

The researchers addressed the problem of where

to place individuals whose blood sugars are above the new

"normal" cutoff of 110mg/dl FPG, but below the new

diagnostic point of 126mg/dl FPG, an intermediate stage. The

committee recommends two subdivisions of this new impaired

glucose homeostasis category: Impaired Fasting Glucose (IFG),

when the test results run between 110 and 126mg/dl, and Impaired

Glucose Tolerance (IGT) when the Glucose Tolerance Test (OGTT)

produces a reading of over 140 but less than 200mg/dl. This

latter group is known to be at risk of microvascular

complications, and for progression to full-blown type II

diabetes.

The committee also looked at Gestational

Diabetes (GDM), which only appears in pregnant women, and for

which different diagnostic criteria must be used. As many women

who experience GDM go on to type II diabetes, this classification

is of great interest. The old recommendation for universal

screening of all pregnant women has been replaced by an

assessment of risk factors such as family history of diabetes,

obesity, age at pregnancy (below 25 is considered low risk for

GDM), and ethnicity.

An important committee recommendation was that

the health care community should consider testing for diabetes in

all adults age 45 and above, with repeat testing at three-year

intervals. Individuals judged at high risk (obese, high blood

pressure, family history of diabetes, or of Hispanic, Asian, or

Native American or African ethnicity) should be tested more

regularly, and at a younger age. The new "cut point"

criteria, and recommended increase in testing activity would not

increase the number of diabetics, but would lessen the number of

those yet undiagnosed. Dr. Gavin pointed out, in response to a

question, that there are many people whose blood sugars would

fall into the "not normal" range, yet fall short of the

"cut point" for full-blown diabetes. Such people need

increased vigilance and counseling, as they are at risk.

The committee also recommends the universal

adoption of the FPG as standard diagnostic test for diabetes. The

OGTT (glucose tolerance test), a sensitive but expensive and

time-consuming test, has been used for some diagnoses, but not

others, with the results imperfectly mapping onto those produced

by the FPG. Also the FPG is convenient, easy to administer,

acceptable to patients, and very low in cost. (The HBA1C, or

glycosylated hemoglobin test, while an excellent monitoring tool,

is not recommended for diagnosis.)

Dr. Frank Vinicor, of the Centers for Disease

Control, spoke on the public health impact of diabetes

complications, and their preventability if diagnosed early. CDC

approved of the new recommendations, he reported, and he

anticipated their acceptance as government policy, both through

his agency and other groups concerned with public health and

epidemiology. Although the article and presentations were merely

"committee recommendations," the Expert Committee's

report has already been accepted (or is currently under review)

by a number of agencies, including the American Academy of

Physician's Assistants, the American Association of Clinical

Endocrinologists, the American Association of Diabetes Educators,

the American Diabetes Association, the American Dietetic

Association, the Canadian Diabetes Association, the Centers for

Disease Control, the Diabetes Treatment Centers of America, the

Endocrine Society, Joslin Diabetes Centers, the Juvenile Diabetes

Foundation International, the National Institute of Diabetes,

Digestive, and Kidney Diseases, and the International Diabetes

Center. Conference speakers said they expect their

recommendations to become standard in the next few years.

A statement Dr. Gavin made struck me as the

best possible explanation for the shift to new diagnostic

criteria. In his own words:

We feel passionately that people need to take

diabetes more seriously. Just because it doesn't hurt doesn't

mean it isn't hurting you. It's a disease that is completely

treatable, and we now know we can prevent or delay its

complications, with early effective treatment. For adults in

America, especially family members of people with diabetes and

other high-risk individuals, these people should be more vigilant

in getting checked for this disease on a regular basis, and

should try to reduce their risk, by maintaining ideal weight, and

seeking to control blood pressure and blood fat levels.

These new recommendations will not create new

patients with diabetes, but will move more of them from the

undiagnosed to the diagnosed category. Diagnoses, if these

recommendations are followed, will be greatly simplified, less

expensive, and we expect they will be made earlier, more often,

and will allow us to eliminate those instances where we diagnose

people late, often years after the onset of the disease, when

they already have complications.

It is our hope and our expectation that these

global recommendations will be embraced by the medical community

for the benefit of all patients with diabetes.