The People Behind the Numbers
Meet seven of the 1,441 volunteer participants who helped make the decade-long Diabetes Control and Complications Trial the most influential diabetes study to date. They have also taken part in a 20-year follow-up that's still producing results.
Carolyn Wolf, RD: "I Could Benefit Other People With Diabetes"
Photograph by Scott Stewart
Before the landmark Diabetes Control and Complications Trial (DCCT), Carolyn Wolf was not a huge fan of diabetes dos and don'ts. "At that time, they gave us only so many calories. I could be compliant with injections, but staying to a particular calorie allotment was difficult," she says. "I felt like I was in prison when I was on that type of therapy."
While studying to become a dietitian, Wolf had an internship at a hospital. "I saw firsthand people with long-term complications," she says. "It was very frightening to me." Wolf wanted to do everything she could to avoid that fate.
After reading an ad in a Detroit newspaper, Wolf thought DCCT could give her an edge against diabetes. "I was really jazzed to be in a research study," she says. "It was a perfect way to learn how to take care of my diabetes. Plus, if this study proved to be something good, I could benefit other people with diabetes in the future."
Wolf was randomized to the intensive therapy group. "It really was intense," she says. "Weekly calls, monthly visits, lots of tests. It just went on and on. We were pricked and probed and prodded." But the most challenging part, she says, was the hypoglycemia, which occurred more often in participants aiming for lower glucose levels.
The best part of the intensive program, according to Wolf, was that it offered the flexibility she craved, as the insulin regimen could be tailored to her lifestyle. "I think the study did improve my health physically and emotionally because I felt so normal," she says. "I could go out and have a drink, and it was no big deal. From a psychological perspective, I was healthier."
Fred Gaede: "I Was Going to Be the Master of This Disease"
Photograph by Gary Landsman
Fred Gaede says he's probably one of DCCT's oldest participants. In 1987, when he signed up for the study, he was about to turn 40. "I didn't realize there was a cutoff at 40," he says. "Once they decided they wanted me, they sped up the evaluation process. … I got randomized the day before my 40th birthday." Gaede was thankful he made it in, just under the wire. "I knew I didn't know enough about my diabetes, and I'd had it for 11 years," says Gaede, who thought DCCT offered "a good way to learn about my situation."
Though Gaede was placed in the conventional treatment group, his self-care practices got a tune-up. "The standard treatment was probably still better than what many diabetics were getting at the time," he says, including regular doctor visits and exams and two insulin injections per day instead of one.
Gaede's A1C dropped from 7.5 to 7 percent by the study's second year. "I was taken to the woodshed by the doctors because they thought I wasn't following the protocol and was going intensive," he says. But no, Gaede was following the rules, and that was enough to get results. When DCCT ended, Gaede went immediately into intensive therapy, first with multiple daily injections and later with a pump. "The benefit to me is that [DCCT] helped me decide I was going to be the master of this disease," he says. "I don't want [diabetes] to determine what I can and can't do."
Jack Manning: "Nothing's Holding Me Back"
Photograph by Gary Landsman
By starting DCCT at just 13 years old, Jack Manning became one of the trial's youngest participants. "I was a little tiny kid. I started high school and I was 90 pounds," says Manning. "My regimen was two injections of NPH; that was it. I was having some bad experiences, with either low blood sugar or super high." That all changed once Manning was randomized to the intensive treatment group at the Yale University site. "Being young when it started, I was learning, for the first time, everything they were teaching," he says.
Manning took his participation in the study very seriously. "[DCCT] was going to help everyone," he says. "For as crappy and annoying as some of the testing was, that was what my focus was and is." Though it was tough, Manning says being in DCCT offered a few perks. "Every three months I had to go to the DCCT clinic. I got to skip school," he says, which was a pretty good deal. Some of the tests could be fun, too. "The one test I remember was an IQ test—put a round peg in a square hole," he says. "There were also inkblot photos, which I found interesting."
Manning is now a police officer in Annapolis, Md., and faces new on-the-job challenges. "I'm still learning how to manage the stress side of it," he says. "For no reason, once I put that blue uniform on, it affects my blood sugar." Once a year, he travels from Maryland to Connecticut for his checkup for the long-term follow-up to the study. "I have been lucky—things are going really well," he says. "I'm going on 40 years with diabetes. I'm a foot officer in a busy city. Nothing's holding me back."
JC Estensen: "I'm My Own Best Doctor"
A family friend told 17-year-old JC Estensen's father, a doctor, about DCCT shortly after Estensen's diagnosis of type 1 diabetes. That was back when JC still used urine test strips. "I was as far from being a model patient as you could imagine," he recalls.
"My biggest concern at the time: How would I be randomized?" he recalls. "God forbid I'd get the experimental group. Tight control didn't align with my lifestyle!"
As chance dictated, he was randomized into the intensive group. He had eight days of training to pick up on the multiple checks and shots, the recording and the tracking. Despite his protestations about intensive therapy, he turned out to be a diligent scientist. He used a double-ended color pencil to log blood glucose results below 70 mg/dl in blue and above 120 mg/dl in red.
Over the years, there were many tests; the questionnaires could be tedious. "Attitude played a lot in how you dealt with it," he says. So did black humor (anybody want to join his Dead Pancreas Society?), especially during his raucous college years. But there was a sense of collaboration.
"I never felt like a lab rat," he says, enjoying close relationships with the study team at the International Diabetes Center at Park Nicollet near Minneapolis, including principal investigator Richard Bergenstal, MD. "I was as much a part of the learning as they were."
Today, he's satisfied with his multiple injections and a low-carb eating plan. The regimen works to keep him at a normal A1C level, whether he's traveling for his job as an advertising creative director or racking up powder days downhill skiing at Big Sky. He has absorbed a key lesson of DCCT: "Not to take anything away from those who have the degrees, but I'm my own best doctor."
Greg Neely: "It Goes Back to Helping Others"
While listening to the radio in the 1980s, Greg Neely heard an advertisement that would change his life. DCCT was looking for volunteers. "I could do that," Neely recalls thinking. "Be a guinea pig for a study." Neely believed it would be satisfying to help other people and that maybe he could "benefit from this cutting-edge medicine."
Neely was immediately drawn into the culture of the study. "What impresses me this many years later was the excitement of the medical team. They were excited about the prospect of what this study might show," he says. "It reinforced that I was doing the right thing." He was randomized to conventional treatment. It was a little disappointing that he wasn't put into the intensive therapy group, he recalls.
Still, Neely was glad to be in the study, even though "some of the tests they did weren't particularly pleasant," he says. For example, to test for retinopathy, they dilated his pupils and then blasted him with bright flashes of light, 40 to 50 in each eye. Despite the ouch factor, Neely gives those tests a lot of credit. "I probably went years and years without an eye exam before the study," he says. "I think the eye checks saved my eyes."
The day Neely learned about the study's positive results, he was given an award for participation. "I proudly framed that certificate," he says. "To know I was one of the 1,441 volunteers, it's a good feeling. It goes back to helping others; that's my definition of success."
Tracy Waters, RN: "Do the Things That You Want to Do"
Photograph by Chris Bohnhoff
Tracy Waters was 17, had lived with diabetes since age 2, and liked the idea of getting free care and supplies. Also, being part of something that could help others seemed like a good thing.
Randomization raised some concerns. "I was hoping and praying to be in the experimental [intensive] group," she says. "I wanted that challenge. I wanted to help."
She got her wish at the Mayo Clinic and dove into the barrage of tests. She recalls the eye exams and the attendant who gently held Tracy's eyes open with Q-tips while she viewed flashing lights. The annual review of her eating patterns with a dietitian asking about every food she ate, how much, how often. Having to click a button as fast as she could to test her motor skills.
And then there was daily diabetes management. Sharing her logbook weekly could be stressful. "It was challenging to show and to explain. Was I being honest or not being honest? I tried, but they caught me—they'd check my [meter]," she says. Still, she knew that it was for her own good and for the integrity of the study, and that the team supported her. She still thinks of study coordinators LaVou Schmidt, RN, and Georgia Ziegler, RD, as second mothers.
Waters has continued with intensive therapy, using multiple injections because a pump might get in the way. Inspired in part by the study and encouraged by the study team, she went to college later in life and became a nurse; she now works in outpatient orthopedic surgery.
She knows that intensive diabetes management and the flexibility it provides are worth it. "Even when it takes more time to do, it makes life easier," Waters says. "I can go for a long bike ride. I don't have to eat at noon." From experience, she also knows to be kind to herself. "Life gets in the way. Try to be as normal as you can. Do the things that you want to do."
Michelle Nagle, RN: "You Can Make a Difference"
Photograph by Ryan Donnell
"It was monetary," says Michelle Nagle, citing a common reason that people consider enrolling in clinical trials—free supplies and medical care. "At the time, my insurance was tenuous at best."
Nagle met the study eligibility criteria and awaited randomization. "I hoped that I would be in the experimental [intensive therapy] group. Still, I was just diagnosed and still had some kind of faith that it could be cured," she says. She was disappointed to find out she would receive standard care. But she reassured herself that it was standard—not substandard—care. Now, looking back, she says, "The accountability required of the experimental group might have been trying."
She seized the opportunity to learn intensive insulin therapy when EDIC began. In 1993, Nagle started pumping. "It was nice not having to poke myself with syringes and carry insulin around," she says. There was more math involved because she started to count carbs.
Her management, like many people's, wavers a bit between office visits, but the visits seem to renew her determination. Nagle had a rough patch while going through a divorce, when her A1C climbed to double digits. She got back on track, and her A1C is average compared with the other participants'. She's developed some complications and had laser surgery treatment last fall for retinopathy. Knowing that EDIC provides the gold-standard tests and assessments for complications is reassuring, because any other problems will be spotted early.
"You can make a difference," Nagle says about participating in research. She sees that in her job as a nurse at a cancer center, too. "I'm a firm believer in volunteering. And when you help other people, you're more inclined to take care of yourself."