Diabetes management is something that many must deal with on a day-to-day basis. About 16 million Americans suffer from diabetes mellitus, a chronic disease in which the pancreas produces too little or no insulin, impairing the body's ability to turn sugar into usable energy.

In recent years, the Food and Drug Administration has approved a fast-acting form of human insulin and several new oral diabetes drugs, including the most recent, Rezulin (troglitazone), the first of a new class of drugs called insulin sensitizers. This drug is designed to help Type II diabetics make better use of the insulin produced by their bodies and could help as many as 1 million Type II diabetics reduce or eliminate their need for insulin injections.

While it is treatable, diabetes is still a killer. Thus, diabetes management is extremely important. The fourth leading cause of death in America, diabetes claims an estimated 178,000 lives each year. So the treatment is aimed at holding the disease in check, reversing it where possible, and preventing complications.

There are two main types of diabetes, Type I and Type II. Insulin-dependent, or Type I, diabetes affects about 5 percent of all diabetics. It's also known as juvenile diabetes because it often occurs in people under 35 and commonly appears in children or adolescents.

Type II, or non-insulin-dependent, diabetes is the most common type. It results when the body produces insufficient insulin to meet the body's needs, or when the cells of the body have become resistant to insulin's effect. While all Type I diabetics develop symptoms, only a third of those who have Type II diabetes develop symptoms. Many people suffer from a mild form of the disease and are unaware of it. Often it's diagnosed only after complications are detected.

At the heart of diabetes control are dietary management and drug treatment. The increasing emphasis on the importance of a healthy diet, the availability of glucose monitoring devices that can help diabetics keep a close watch over blood sugar levels, and the wide range of drug treatments enable most diabetics to live a near-normal life.

Managing the diet is easier now because of food labeling regulations that went into effect in 1994 (see "The New Food Label: Coping with Diabetes" in the November 1994 FDA Consumer).

Aside from dietary considerations, one of the primary ways to manage diabetes is through insulin injections. The first insulin for diabetes was derived from the pancreas of cows and pigs. Today, chemically synthesized human insulin is the most often used. It is prepared from bacteria with DNA technology. Human insulin is not necessarily an advantage over animal insulin, and most doctors don't recommend that patients on animal insulin automatically switch to human insulin. But if they do switch, dosages may change. Human insulin is preferred for those patients who take insulin intermittently.

Injections aren’t the only form of insulin management. Now there are also oral diabetes drugs. There are four classes of oral diabetes drugs that are now available. The oldest class, sulfonylureas (SFUs), act on the pancreatic tissue to produce insulin. The newest one is Glimepiride, approved by FDA in 1996.

Because SFUs can become less effective after 10 or more years of use, other drugs often are needed. Also, there is some controversy regarding SFUs; some of these agents have been shown in studies to contribute to increased risk of death from cardiovascular disease.

A newer class is the biguanides, including Metformin, which was approved by FDA in 1995. This drug acts by lowering cells' resistance to insulin, a common problem in Type II diabetes.

A third class is the alpha-glucosidase inhibitors, which include Precose, approved by FDA in 1995, and Miglitol, approved in 1996. These drugs slow the body's digestion of carbohydrates, delaying absorption of glucose from the intestines.

In January 1997, FDA approved the first in a new class of diabetes drugs, Rezulin. The new medicine helps Type II diabetics make better use of their own insulin by resensitizing body tissues to the insulin. Parke-Davis, a division of Warner-Lambert of Morris Plains, N.J., plans to begin marketing the drug by summer 1997.

The drugs are not without side effects. Metformin, for example, can cause serious cramps and diarrhea, and it can't be used in people with kidney problems. "So if you have to go on this drug, you need to have kidney function tests," Santiago says.

Metformin is also contraindicated in patients with liver dysfunction. "It should be used only in healthy patients, and it's not for the elderly," Misbin says.

Precose is less effective but usually safer to use than Metformin, he points out. Precose's one major side effect is flatulence. Precose stops, or delays, absorption of carbohydrates and in doing so delivers glucose and other carbohydrates, which cause gas, Santiago explains. "Flatulence can occur when the drug is used at high doses, but this can be reduced by beginning the drug at a low dose and going up ... a 'start-low, go-slow' approach."

The bottom line in diabetes control still hinges on patients' ability to manage the disease themselves. Although drug treatment makes a difference to many diabetics and their quality of life, the modern diabetes treatments are still "not ideal." Hopefully, continuing research will someday find the answer to the diabetes dilemma.