Mike: Participating in a Long-term Type 1 Diabetes Research Study To Stay Healthy While Helping Others

MikeMike has been physically active his whole life, participating in sports like skiing, racquetball, baseball, and football in high school and college. Now, at age 58, outside of his work in the mortgage industry, he participates in competitive ski racing in his home state of Ohio and in places like New York, Vermont, Colorado, and Canada. “It’s a lot of fun—a lot of exercise,” Mike states. He’s even had success on the race course: “I actually won a pair of racing skis.” He also enjoys doing other outdoor activities like hiking, roller blading, and biking in his home city of Cleveland. “I try to stay as active as possible,” Mike says, “as healthy as possible.”

Contributing to his good health is a long-term, landmark NIDDK-supported research study that Mike has been participating in for the last 35 years: the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) study. Mike, like other DCCT/EDIC participants, has type 1 diabetes. He credits his participation in DCCT/EDIC with helping him learn how to manage his type 1 diabetes on a day-to-day basis while living a full, active life.

A Diagnosis of Type 1 Diabetes

Mike remembers when he first had symptoms of type 1 diabetes. He was 16 years old, and his family was driving from Cleveland to a much-anticipated beach vacation in South Carolina. During the car trip, Mike was very thirsty and, as he recalls, “I was drinking what seemed like a gallon of iced tea, lemonade…. I’m just slugging it down and then within short order having to go to the bathroom.” His father was not too thrilled about having to make so many bathroom stops, and one stop was particularly memorable: “I came out of the bathroom and the family car was gone,” Mike says with a laugh. Turns out that after Mike’s mother and sister got into the car, his father took off without realizing they had left Mike behind. Fortunately, about 10 minutes later, the car pulled up, Mike got in, and the family made their way to the beach.

However, it wasn’t a great trip for Mike. “I just had no energy. There were days when I just sat around and didn’t feel like doing anything,” he recollects. Although he had no family history of type 1 diabetes, his mother was a nurse, so she recognized that his symptoms of excessive thirst, fatigue, and weight loss were hallmarks of the disease. He went to a general practitioner back in Cleveland who diagnosed him with type 1 diabetes—an autoimmune disease in which a person’s immune system destroys the cells that make the hormone insulin, which promotes the transport of sugar (glucose) from the bloodstream into the body’s cells where it is used as fuel. Over time, people with the disease can develop severe and often life-threatening complications, like eye, kidney, nerve, and heart disease.

Mike remembers when he first had symptoms of type 1 diabetes… “I just had no energy. There were days when I just sat around and didn’t feel like doing anything,” he recollects.

Mike didn’t get much information about how to manage his type 1 diabetes when he was first diagnosed because of the lack of tools and knowledge available in the mid- to late-1970s. Back then, there was debate about whether keeping blood sugar levels as low as safely possible would prevent the long-term disease complications. The debate didn’t matter much from a practical standpoint, though, because there were no available tools to help people achieve near-normal blood sugar levels—for example, blood sugar monitoring did not yet exist. Instead, people like Mike monitored their body’s sugar levels with urine tests, which had limited utility: they recognized high but not dangerously low sugar levels and reflected past, not current, sugar levels. Thus, at first, Mike was just given advice about managing his diabetes with diet and exercise, being told to watch what he ate and avoid foods with sugar. Then he started taking one or two shots of insulin a day.

That management regimen did not work well for him. Without a way to monitor his blood sugar levels, judging his body’s needs could be difficult. He recalls a bad experience at a high school marching band summer camp, where the extra exercise made it extremely challenging for him to manage his diabetes: “I must have lost 10 to 15 pounds in that week from physical activity,” he recalls. On top of the physical challenges, Mike also remembers feeling different from his friends because of his type 1 diabetes. For instance, because of the required medical forms, he had to delay getting his driver’s license, when his other driving-age friends were getting theirs. At that time, Mike didn’t know that things would eventually change for the better because of a new research study.

Joining the DCCT

Mike calls himself fortunate: “One of my family members worked with one of the doctors, Dr. Saul Genuth, who was the lead research doctor for the DCCT in Cleveland. We were at a family event [and I found] out that this doctor may be willing to see me.” With that, Mike was introduced to the DCCT and ultimately became one of its 1,441 volunteer participants.

The DCCT began in 1983 to address the debate about the importance of controlling blood sugar levels to prevent long-term complications in people with type 1 diabetes. Importantly, in the late 1970s and early 1980s, there was significant progress in developing new tools and tests needed for blood sugar control—such as meters for self-monitoring of blood sugar and insulin pumps—enabling a trial like the DCCT to be conducted.

Specifically, the DCCT compared the effects of “intensive” versus conventional treatment of blood sugar levels on the development of eye, kidney, and nerve disease. Participants in the intensive treatment group followed a regimen that included self-monitoring of blood sugar at least four times per day and at least three insulin injections per day or use of an insulin pump. The goal was to keep their blood sugar levels and hemoglobin A1c levels (HbA1c, a measure of average blood sugar levels over the previous 3 months) as close to normal as safely possible. Conventional treatment—which was the standard treatment at the time and similar to the regimen that Mike was using before he joined the DCCT—consisted of one or two insulin injections per day, with once-a-day urine or blood sugar testing.

When asked if it was a hard decision for him to enroll in the trial, Mike responds, “No, it wasn’t really hard because [of] the way I was feeling physically and knowing that things weren’t the way they should be.” Not knowing at that time whether one or the other treatment would have better outcomes, he also didn’t have much of a reaction when he found out that he was assigned—by chance—to the intensive treatment arm of the trial. “It was like, you’re either in Group A or Group B,” he says, meaning that neither group had much significance to him at the time.

Mike describes some of his early memories of being involved in the trial. Because he was in the intensive treatment arm, he says that the study “was strict on multiple testing and multiple injections, and constant follow-up.” As part of that follow-up, people in the intensive treatment arm visited the study center each month and were contacted even more often by phone to go over and adjust their treatment regimens. Mike remembers the DCCT study team being very accommodating of his busy schedule and making him feel like he was a partner in the research. “There were times I was on the phone with them in the evening,” he says. “They were great on just engaging and making you feel that you were part of things.”

Because the DCCT was determining if intensive blood sugar control could prevent the development of complications, Mike says that the researchers took many measurements at the start of the study so that they could then detect changes over time: “[They] were checking all kinds of things, from nerves to kidney function, eyesight…you name it and they were testing it.”

Mike states that even with implementing the more intensive treatment approach as part of the DCCT, his overall health didn’t improve immediately—it took him a year or two to feel like his diabetes was under good control. He explains that part of that was dealing with the mental aspect of having a chronic disease. “It’s not easy to say I’ve got this permanent [disease]—it’s never going to go away... and to be separate from the rest of the crowd.” For example, he said it was difficult being told around the time of his type 1 diabetes diagnosis to avoid foods with sugar, even though his peers had no such restrictions, so he would sometimes sneak a candy bar. “I’m thinking I’m fooling everybody,” he says, “and it was kind of satisfying, but then my blood sugar is up and I’m feeling lethargic.”

While in the trial, Mike experienced acute episodes of hypoglycemia, or dangerously low blood sugar, which is a limitation of implementing intensive insulin therapy. He recalls times when he would take insulin and then decide to do an outdoor activity like skiing or sled riding, which would lower his blood sugar levels even more and sometimes cause them to go too low. He depended on his friends to recognize the signs of hypoglycemia (e.g., being confused, dizzy, jittery), and give him a sugary drink to bring his blood sugar levels back up; sometimes he had to manage the hypoglycemia on his own. “That was the difficult part,” he states.

Why does Mike continue to participate in the DCCT/EDIC research study after all these years? “Honestly,” he says, “what motivates me the most is the avoidance of [diabetes] complications.”

DCCT Results

The DCCT ended after 10 years in 1993—a year earlier than planned—when the study proved that participants in the intensive treatment arm, like Mike, who kept their blood sugar levels close to normal, greatly lowered their chances of having eye, kidney, and nerve disease compared to people in the conventional treatment arm. These landmark findings changed the way type 1 diabetes is treated worldwide, making intensive blood sugar control early in the course of the disease the standard treatment.

For Mike personally, the importance of these impressive results didn’t really hit him until later in life. At the time, he was happy that his tests through the DCCT indicated that he didn’t have complications, but it didn’t change the fact that he was still living with a chronic disease. “It’s the look-back part that puts it in perspective,” he explains. Now with the wisdom of hindsight, he recalls the time before he joined the trial when his diabetes wasn’t in good control, like when he was in marching band camp, and sees how things could have gone quite differently. He now realizes that if he hadn’t started implementing intensive glucose control, “I could have been one of those people that started to have complications,” he states.

Continuing in the EDIC Study

When the DCCT ended, participants who had received conventional treatment were taught the intensive treatment regimen, and all were encouraged to use it. Nearly every DCCT participant, including Mike, volunteered for the follow-on EDIC study, which began in 1994 and is ongoing. EDIC was established to determine the long-term outcomes of reducing exposure of the body’s tissues and organs to high blood sugar levels. EDIC is an observational study, so participants independently see their own health care team and participate in annual follow-up visits with EDIC.

The annual follow-up visits allow EDIC investigators to collect information about Mike’s health. He explains that each year, the research team may do different measurements: “[One year], it’s testing kidney function…. The next year it may be nerve testing.” He says that sometimes the tests could take a lot of time and not be too much fun. What makes it easier, though, he says, is that these important tests continue to indicate that he is free of complications.

Because of Mike and the other dedicated participants, there continues to be a wealth of important information emanating from EDIC. EDIC has shown that, compared to people formerly in the DCCT’s conventional treatment arm, people in the former intensive treatment arm have a reduced risk of cardiovascular disease (such as heart attack and stroke), eye disease and related eye surgery, kidney disease and kidney failure, and nerve disease. They also have been living longer. These findings underscore current clinical practice guidelines recommending that people with type 1 diabetes practice early and intensive blood sugar control to improve their long-term health.

In addition to helping Mike stave off diabetes complications, his continuing participation in EDIC had an unexpected benefit related to finding a major health problem that likely resulted from a bacterial infection he had as a teenager before he developed type 1 diabetes. About 6 or 7 years ago, both the DCCT/EDIC study team and his personal endocrinologist “were hearing stuff within my heart and telling me to go to a cardiologist, and I ignored them for a couple of years,” Mike admits. Then, at one of his annual EDIC visits, the study team told him that the noise was getting worse. As a New Year’s resolution, he went to the cardiologist who broke the bad news: Mike had a damaged aortic valve. He was quickly scheduled for open heart surgery to replace it. “He [the cardiologist] said if I had waited probably 6 more months, I’d be having emergency surgery,” Mike recalls. The doctor told him that the damaged valve was probably caused by the bacterial infection he had as a teenager, and thus was unrelated to his diabetes. “So, I’m a survivor today of that [open heart surgery] and the longevity of diabetes,” he states.

When asked what it means to him to be part of a study that has changed so many lives for the better, Mike replies: “I feel good about it…. I want to continue because if there is anything more that can be learned or gained, I want to be able to be part of that, whether that be as a collective group or individually.”

Mike feels that so many years of intensively managing his type 1 diabetes during DCCT/EDIC, as well as leading a healthy, active lifestyle, helped him get through the surgery. “I actually skied 6 months after surgery,” he exclaims. A month after that, “My son and I drove out to the Grand Canyon and we hiked it. I was kind of proud of that.” The experience again made him realize what the DCCT has meant to his long-term health—he feels that if he had not started intensive control, his health today could be much worse, especially now knowing that he had underlying heart damage. Instead, he says, “I have more energy now than ever.”

Participating in a Long-Term Research Study

It’s been 35 years since the DCCT began in 1983, and over 90 percent of living DCCT/EDIC participants, including Mike, are still enrolled in the study. Why does Mike continue to participate in the DCCT/EDIC research study after all these years? “Honestly,” he says, “what motivates me the most is the avoidance of complications. [Losing] my eyesight is the number one thing that I worry about.” Thus, it’s a huge relief every time he gets a good bill of health from his eye tests done through EDIC.

"I’d encourage people that if they have a chance to do something research-wise to do it.”

Mike says that one of the biggest benefits of being in DCCT/EDIC was learning how to manage his type 1 diabetes daily. Now, instead of sneaking candy bars like he did as a teenager, he eats and does the activities that he wants, but knows he must be vigilant about checking his blood sugar levels. In other words, “I know how to adjust for some of the more day-to-day-stuff. I didn’t know that at the beginning [of the DCCT]. I have a better sense of it now—it’s only taken 30 years to figure it out,” he says with a laugh. Today, he continues to manage his type 1 diabetes with frequent blood sugar testing and insulin administration that he learned as part of the DCCT and has been able to keep his HbA1c levels below recommended levels, which has been shown by DCCT/EDIC to reduce his risk of long-term complications.

Mike’s personal experiences illustrate another important finding from DCCT/EDIC: overall, participants in the former intensive treatment arm have maintained a lower risk of complications for 25 years, even though after DCCT ended their blood sugar control gradually became indistinguishable from that of the participants in the former conventional treatment arm. (After the DCCT ended, blood sugar control in participants from the former intensive treatment group was not as good as it was during the trial, when they had the advantages of the clinical trial setting—although they still had better control than before the trial. At the same time, those in the former conventional treatment group improved their blood sugar control when they began implementing more intensive therapy after the DCCT.) This long-term benefit of a period of intensive blood sugar control has been termed “metabolic memory.” These findings emphasize the importance of implementing intensive blood sugar control from the earliest stages of diabetes. They have also spurred NIDDK-supported research to develop new tools and technologies to help people with type 1 diabetes achieve recommended levels of blood sugar control, like artificial pancreas technologies that aim to automate insulin delivery in response to blood sugar levels. Mike is fortunate to have enrolled in the DCCT/EDIC when he did—at a young age when he could learn about adjusting for “some of the more day-to-day stuff,” as he says, and incorporate intensive blood sugar control as routine practice.

When asked what it means to him to be part of a study that has changed so many lives for the better, Mike replies: “I feel good about it…. I want to continue because if there is anything more that can be learned or gained, I want to be able to be part of that, whether that be as a collective group or individually.” He also has a message for others: “I’d encourage people that if they have a chance to do something research-wise to do it.”

Finally, Mike has advice for people facing a recent type 1 diabetes diagnosis: “Don’t give up and put aside what it is that you like…. You can manage it [the disease] and manage to continue to live the way you want to.” For Mike, that means continuing to participate in ski racing and other outdoor activities. At the same time, he and the other DCCT/EDIC participants can take pride in knowing that their remarkable and continuing dedication to research is a key reason why people with type 1 diabetes are living longer, healthier lives than ever before.