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Vol. LXV, No. 20
September 27, 2013

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Three Decades Later
Diabetes Study Volunteers Still Find Reward in Participation
Participants in the NIDDK-funded Diabetes Control and Complications Trial and its follow-up, the Epidemiology of Diabetes Interventions and Complications, celebrate 30 years of the landmark trial.

Participants in the NIDDK-funded Diabetes Control and Complications Trial and its follow-up, the Epidemiology of Diabetes Interventions and Complications, celebrate 30 years of the landmark trial.

Photo: Peter Papoulakos

Thirty years ago, Elizabeth Rude joined a type 1 diabetes study called the Diabetes Control and Complications Trial so she could get the free supplies. What she received from participating in the NIDDK-funded DCCT and its follow-up, Epidemiology of Diabetes Interventions and Complications, was so much more.

“I am a much healthier person because of participating in this study,” Rude said. “I have had type 1 diabetes for 38 years and I have no complications. I attribute this to being on intensive insulin therapy for so long and having such excellent support from the folks at the study.”

Her fellow participant Judi Boland concurs. “I have learned so much about my condition and how to take the best care of myself to avoid complications,” she said.

In addition to improving her own health, Boland’s participation and that of the other study volunteers has paved the way to crucial knowledge about the long-term effects of early intensive treatment for type 1 diabetes.

At a symposium for the 30th anniversary of the DCCT/EDIC, held recently as part of the American Diabetes Association’s scientific sessions, Rude and many other participants—along with hundreds of diabetes scientists and practitioners—heard the latest results of the study. Nearly two decades after the randomized trial ended and all participants were transitioned into intensive therapy, participants initially in the intensive therapy group were about 60 percent less likely to have heart disease and stroke, 50 percent less likely to have impaired kidney function and 50 percent less likely to be in the severe, vision-threatening stages of diabetic eye disease.

“By following people for 30 years, we’ve found out incredibly important things, both about the effects of the therapy and also about the course of type 1 diabetes in today’s world with contemporary therapy. The results are very hopeful,” said Dr. Judith Fradkin, director of NIDDK’s Division of Diabetes, Endocrinology and Metabolic Diseases. “Diabetes is a lifelong disease, so what matters to people is what’s going to happen over the course of their life. With this study, we’ve shown that about 6.5 years of early intensive therapy pays continuing dividends over several decades—in healthier lives.”

DCCT participants were initially randomly divided into two groups. About half received intensive therapy and the other half the standard therapy of the time. Rude was randomly assigned to the intensive treatment group, Boland to the standard. After the DCCT ended and EDIC began, the standard therapy group received training on intensive therapy. Both groups then received diabetes management from providers of their choosing, most using intensive diabetes treatment, which—thanks to the DCCT results—has become the improved standard treatment.

Dr. Saul Genuth, professor of medicine at Case Western Reserve University, has helped lead the study from the beginning. “This 30-year (and still counting) study shows the scientific and clinical power of the partnership between loyal research participants, investigators and sustained sponsorship by the NIDDK to improve understanding and outcomes of a once-crippling major disease,” he said.

Both Rude and Boland said the volunteer experience was rewarding in ways beyond health. Both formed a close bond with nurse Barbara Batey Schaefer at Northwestern University, one of the study sites. “Any time I have questions about my health (diabetes or otherwise), I contact her,” Boland said. “Barb came to my wedding—she is a good friend.”

Boland said she’d encourage anyone interested in volunteering for an NIH-funded clinical trial to do it. “It’s worth every minute spent filling out paperwork, answering questions, getting all sorts of medical tests done,” she said. “The results of the trial might change the course of medical treatment and improve the life of someone in the future.”

For Rude, hearing the results gives her own experience even greater impact. “It is great to be reminded that what I and all the participants have done is a huge deal and has made the lives of countless others better and healthier,” she said. “How many people can say they’ve been a part of a study that has changed the way a disease is treated across the entire country?”

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