For many years, Cheryl Raab was almost in a state of denial about her Type 2 Diabetes. “I was taking the medications that were prescribed by my primary care provider,” she says, “but beyond that, I hadn’t altered my lifestyle at all.” On a day-to-day basis, Raab, a nurse at Yale New-Haven Hospital, felt fine.
Diabetes is a condition that, along with medication, requires patients to make positive changes in their exercise and eating habits to maintain their long-term health. Those changes began to come more easily for Cheryl once she began participating in the GRADE study.
Yale is one of nearly 40 sites nationwide for the GRADE study
, which is funded by the National Institutes of Health. In the study, researchers are conducting a comparison of medications that are used as a second-line therapy, after treatment with metformin, for people with Type 2 Diabetes. Some diabetes patients, like Raab, require a second medication when metformin does not do enough to decrease their A1C and blood sugar levels and control their diabetes.
Cheryl’s primary care physician connected her with the GRADE study, where she then met Patricia Gatcomb, APRN, a nurse practitioner who coordinates the study at the Yale site. For Raab, one of the biggest benefits of joining the GRADE study was personal care from diabetes specialists, including study co-investigator, Silvio Inzucchi, MD, director of the Yale Diabetes Center, who oversees the care for patients enrolled in the study.
Patients also visit Gatcomb regularly, who can spend time with study volunteers, listening to their concerns, and discussing how best to manage their diabetes, above and beyond the care they receive from their primary care provider. “Having Patty as a person to talk to has made it easier for me to accept the fact that yes, I do have diabetes,” says Raab. Gatcomb also gave Raab advice on how to tackle the lifestyle changes she would need to make to control her diabetes. “She gave me a book when I first met her called Just One Thing. That’s the idea: don’t try to change everything all at once. Start with one thing you can change, then move on to the next thing. It is much easier to be successful that way.”
Since participating in the study, with Gatcomb’s help, Cheryl has made several positive changes to maintain her health and keep her diabetes under control. Now, “I track my steps, stairs, and my calorie expenditures,” she says. While spending time at home working on her computer, she made sure she would get up frequently, and walk, or climb stairs. “I am surprised I didn’t wear a path into the floor in my house” from walking so much, she says.
Beyond the personalized attention to their diabetes care, patients enrolled in the GRADE study receive several other benefits. The care, education, the medications, as well as the supplies are provided at no cost for the duration of their time in the study, which lasts about four years. Participation in the study also involves no experimental medications, and only examines second-line therapies that patients would be likely to use anyway. Raab herself has also encouraged friends of hers who also are managing their diabetes to see if they are eligible for the GRADE study, so that they can also benefit as she feels she has. “Once patients come in and we explain what we are doing, why we are doing it and how we are doing it, I have not had anyone that has said this is not for me,” says Gatcomb.
The GRADE study seeks to enroll 5,000 patient volunteers nationwide, with a goal of enrolling 150 patient volunteers at Yale. To be eligible for the study, patients must have had diabetes for less than ten years, and have received only metformin for blood sugar control. Patients’ must have an A1C level where it has become appropriate to add a second agent to their medication regimen.
For patient volunteers like Raab, participating in GRADE is about more than better managing their own diabetes. “Experts in diabetes on a national level will be looking to the results of this study when we are done,” says Gatcomb, with the anticipated results likely to impact future guidelines for treating diabetes. For Raab, that is an important aspect of participation. “This is something I can do for society to hopefully give back to benefit others,” she says, “to participate in this research so people can figure out what is the best course of treatment.”