The University Record, July 19, 1993

Landmark clinical trial provides good news for some diabetics

From the Michigan Diabetes
Research and Training Center

Investigators from the Michigan Diabetes Research and Training Center have concluded their participation in a landmark national clinical research trial involving people with diabetes.

The Diabetes Care and Complications Trial (DCCT) convincingly demonstrated that diabetics can significantly reduce the development and progression of the severe complications of the disease by closely monitoring their blood sugar levels and adjusting daily insulin doses. The conclusion that “metabolic control matters” has been hailed as the most significant discovery for diabetics since the discovery of insulin in the 1920s.

Results of the project were announced June 13 at the annual meeting of the American Diabetes Association by Douglas A. Greene, professor of internal medicine and chief of the Division of Endocrinology and metabolism, and an internationally recognized expert in diabetic neuropathy.

The $200 million study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD).

The research showed that “intensive therapy” may reduce diabetic eye problems by 76 percent, severe kidney problems by 35 percent to 56 percent, and painful nerve-related damage by 60 percent compared with the treatment routine currently prescribed for most people with diabetes.

The U-M was one of 29 national sites that followed 1,441 volunteer patients over 10 years. Greene brought the trial to the University shortly after he was named program director of the Diabetes Center in 1985. During the eight years Michigan researchers participated in the federally-funded trial, 39 patients were enrolled and followed in both experimental and control groups.

“In designing the study we had hoped to show at most a 30 percent reduction in the devastating long-term complications of diabetes, which cause thousands of people to go blind, lose their kidneys or have feet amputated each year. The results were more miraculous than we could have possibly hoped,” Greene noted.

“This is important because diabetes is not a high-profile disease and often fails to get the attention devoted to acute illnesses or high technology treatments. The results will change the standards of care physicians must use to treat diabetic patients.”

Diabetes is a metabolic disorder of unknown origin. Approximately 1.4 million Americans produce no insulin from their pancreas and require daily insulin injections for survival with their form of the disease known as Type I diabetes. More than 13 million Americans with Type II diabetes are able to produce some degree of insulin but are unable to use it efficiently. About one-third require insulin injections to manage their disease. The remainder are treated with exercise, diet and/or drugs.

The DCCT studied two groups of volunteers. The control group followed a standard regimen in which they tested their blood sugar once a day and followed standard advice about their diet and exercise. Subjects took one to two insulin injections per day and met occasionally with their physician for evaluation. This is the care most Type I diabetic patients currently receive.

The experimental “intensive therapy” group administered between three to five insulin injections daily or used an insulin pump to help maintain their sugar level at near normal. They worked closely with a health professional team of nurses, dietitians, social workers and physicians to manage their care, which included testing their blood sugar four to seven times every day. Patients were called by their health care team one or more times each week.

“Our dedicated team and the committed group of patient volunteers deserve an infinite amount of credit for the success of this ambitious study,” said Greene. “Cathy Martin, our nurse coordinator, was instrumental in ensuring study guidelines were met. The Michigan group had one of the very best patient compliance rates in the country.”

The study was conducted in Type I diabetics but the implication of the findings of the trial extend to the non-insulin dependent diabetic patient as well. Intensive therapy is not yet recommended in young children.

Although exciting, the new therapy is not without its problems. Diabetics using intensive treatment are three times more likely to suffer from hypoglycemia, or low blood sugar. As a result they risk passing out and injuring themselves or others. “The risks for each patient must be weighed against the benefits, and therapy individualized,” emphasized Greene.

The results of the study have major implications for the nation’s health care system, and the NIDDKD has appointed a national group charged with making recommendations for implementation of the results of the study. Roland G. Hiss, professor and chair of the Department of Postgraduate Medicine and Health Professions Education and chief of the Michigan Diabetes Center Demonstration and Education Division, is a member of the group.

The recommendations include six goals for assuring long-term adherence to intensive therapy through an integrated approach that includes patient and professional education, ongoing counseling and frequent, regular follow-up of patients and appropriate reimbursement for care.

The U-M Center recently was awarded $6.25 million in direct costs from the National Institutes of Health for its continued operation over the next five years.