THE UKPDS: GOOD NEWS FOR PEOPLE WITH TYPE 2 DIABETES

by Richard Hellman, MD., FACP, FACE

What the Diabetes Control and Complications Trial (DCCT) Showed

In 1993, the National Institutes of Health released the results of a 10-year study of people with type 1 diabetes. The findings of the study, which is known as the Diabetes Control and Complications Trial, were extraordinarily encouraging.

Researchers found that among people who received "intensive treatment:"

* Progression of retinopathy (diabetic eye disease) was slowed by more than 50 percent;

* Development of nephropathy (diabetic kidney disease) was decreased by nearly 50 percent; and

* Clinically significant neuropathy (diabetic nerve damage) was reduced by 60 percent.

Patients whose diabetes was closely managed learned to adjust their insulin doses to keep blood sugar levels as normal as possible. Their treatment included at least three injections of insulin a day, blood glucose testing at least four times a day, and a diet and exercise plan.

Until recently, however, there has not been a similar large-scale study to answer whether or not people with type 2 diabetes would also experience positive results from closely managing their disease.

United Kingdom Prospective Diabetes Study (UKPDS)

The UKPDS was the first large-scale longitudinal study of people with type 2 diabetes that was conducted on the scale of the DCCT. And since about 90% of people with diabetes have type 2, the results of this study have been eagerly awaited.

The UKPDS began in 1977 and extended for 20 years, with the results published in the fall of 1998. The study compared conventional versus intensive therapy in more than 5,000 newly diagnosed patients with type 2 diabetes.

Patients in the study were randomly divided into three treatment groups, those who were treated with:

* Diet alone;

* Diet plus non-intensive drug therapy; and

* Diet plus intensive drug therapy (using either insulin, sulfonylureas or metformin), as well as nutrition counseling, exercise therapy and patient education.

All patients in the study, including those whose diabetes was closely managed, visited physicians in a regular community setting, rather than an artificial research environment. So, the medical treatment was provided to patients by their primary care physicians, with nurses, nutritionists, and others on their medical teams delivering further support. This is relevant because most people with type 2 diabetes in the U.S. receive their medical care from a primary care physician, as well. Thus, the findings from the UKPDS study are applicable to American patients with type 2 diabetes.

The major question asked by the UKPDS study was whether close management of blood glucose levels could substantially reduce the risk of complications from type 2 diabetes. The results clearly showed that the answer to this question was a definite YES:

* Close management to keep blood sugar levels within the normal range reduced by 25% the damage to small blood vessels in the eyes and kidneys that frequently occurs in people with diabetes.

* Such treatment may also lessen the nerve damage that can lead to limb amputation.

* Although the study did not prove a direct link between reducing high blood sugar and a reduction in the incidence of heart disease, it did find that when blood pressure is reduced, the risk of cardiovascular disease is significantly lowered. This is important because more than 60% of people with type 2 diabetes suffer from high blood pressure.

One subject that was not addressed by the UKPDS was the importance of frequent self blood glucose monitoring. Only one group, those patients on multiple insulin injections, had mandatory glucose monitoring. Although patients were permitted to do home testing of blood glucose levels, the key therapy decisions were based on the patients' glucose levels when visiting their doctors. In this way, the UKPDS was different from both the DCCT study and our own study [see below].

It was clear from the UKPDS study, however, that reducing blood glucose levels can significantly lessen complications from type 2 diabetes. In the U.S., frequent self glucose monitoring is an important tool in helping patients adjust their diet and medication in order to "fine-tune" their control. Thus, if patients enrolled in the UKPDS study had followed all aspects of close management of glucose levels as is usually practiced in the U. S., one would expect even greater benefit in terms of preventing complications.

A U.S. Study on Patients with Type 2 Diabetes

Although our study, "The Effect of Intensive Treatment on Risk of Death or Renal Failure in NIDDM or IDDM," was smaller in scope than the UKPDS, my colleagues and I, at Heart of America Diabetes Research Foundation, studied both patients with both type 1 and type 2 diabetes. Our study was conducted in a private setting and showed the value of a more intensive and comprehensive form of therapy in both types of diabetes.

We followed 209 patients for an average of more than 11 years and compared their outcomes to a comparable group of 571 patients.

Our long-term patients had a 22% lower death rate overall and a 40% lower rate of severe kidney failure as well. Even more exciting was the fact that our lower-risk patients who were under 65 years of age at the start of our study had a 64% lower death rate, and the type 2 diabetics in this group had a 57% lower death rate.

Among the differences between our study and the UKPDS was our greater involvement during critical moments of care, often medical or surgical emergencies, when control of glucose levels is both most difficult and most important. Also, we provided early screening for cardiac disease for our patients, an important and often neglected area of diabetes care.

Also, we used a more intensive and flexible approach to normalizing the blood sugars, and as a result, were more successful than the UKPDS study at maintaining good glucose control throughout our 14-year study. Our level of glucose control overall was nearly as good as the results achieved by the DCCT study.

We view self-blood glucose monitoring as an essential ingredient for quality care for several reasons. It provides important feedback for both patient and physicians, so therapy can be tailored to the individual patient needs and allow a more flexible life-style.

Also, it becomes a "safety net" since important and unexpected changes in blood sugar levels are, unfortunately, far too common and often without any accompanying symptoms. Self-blood glucose monitoring is truly a patient safety issue.

Steps the Patient Can Take

Sadly, many patients with type 2 diabetes are not receiving the level of treatment they require to help prevent complications from the disease. Because of the burdens on today's medical system, doctors are often hindered from spending as much time as they might wish on disease management. In addition, some states and insurance carriers place limits on financial reimbursement for diabetes education and testing materials.

One good piece of recent news is that Medicare now covers the cost of blood glucose meters and strips for patients with type 2 diabetes, whether or not they are taking insulin. (Previously, reimbursement was limited only to patients on insulin therapy.) Furthermore, Medicare is expected to enact legislation that will reimburse patients for the education they need in order to learn how to manage their disease.

For patients with type 2 diabetes who may not be receiving the support they need to closely manage their disease to help prevent complications, the following are important steps to take:

* Make certain you are being treated by a health care professional who makes a commitment to diabetes disease management. If the doctor hasn't already suggested that you meet with a diabetes educator and nutritionist, ask for referrals.

* Working with health care professionals, follow their advice regarding diet, exercise, blood glucose monitoring and medication.

* Learn what steps you can take (relating to diet and/or medication) if your blood sugar levels fluctuate out of the normal range.

* Seek referral to a specialist if your doctor isn't taking your symptoms seriously enough.

The future is brighter than ever for people with type 2 diabetes. Although close disease management can be complicated and is time-consuming, patients should be heartened by the fact that such treatment is now of proven value. The goal of all doctors treating patients with type 2 diabetes should be to significantly reduce the incidence of complications from the disease and to provide a long, vital, and enjoyable life for all patients.

NOTE: Dr. Hellman is Clinical Professor of Medicine at University of Missouri, Kansas City, where he is also an endocrinologist and diabetes specialist in private practice. His articles have been published in "New England Journal of Medicine" and "Diabetes Care." He has served in numerous national positions within the American Medical Association and the American Diabetes Association.