Have you had type 2 diabetes for less than five years? Are you at least 30-years old? If so, you may qualify for the GRADE Study, (The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study). Recently launched by the National Institute of Health (NIH), 37 centers around the country are participating in this Study, including the Naomi Berrie Diabetes Center at Columbia University Medical Center.
GRADE is a large long-term research study that will compare the effectiveness of four FDA-approved drugs that are commonly used to treat type 2 diabetes (T2D) when used in combination with metformin, the first-line treatment for T2D. The purpose of the study is to determine which one of the four, each from a different class of drugs, works best.
“We already know that people with T2D will probably need another medication to control their glucose levels at some point,” said the Berrie Center’s Pat Kringas, RN, BSN, MA, CDE and head research coordinator for the GRADE Study. “But it’s not clear what that next drug should be. This study will help us understand how different combinations of medications affect T2D over time. We hope to set a new national standard for the treatment of this disease.”
From a patient’s point of view, there are many good reasons to participate in the GRADE Study. Subjects will receive at no cost quarterly checkups, treatment, medicine, lab tests and supplies for as long as they are in the study, which will run for up to 7 years. There is no placebo in this study. Participants will randomly receive one of the four, already commonly prescribed second-line drugs for the treatment of T2D. Also, by participating in a government research study of this magnitude, subjects will ultimately be contributing to a better treatment plan for other people with T2D in the future.
“In every critical, public health research study like this one,” said Dr. Harvey Schneier, Associate Clinical Professor of Medicine and GRADE Study physician at the Berrie Center, “you see the benefits of your participation sometime in the future. In this study the benefits are there right from the beginning. For one thing, you will be receiving your care at the Naomi Berrie Diabetes Center, one of the finest comprehensive diabetes centers in the world.” Dr. Robin Goland, the Co-Director of the Berrie Center, is Principal Investigator for the Berrie Center site for the GRADE Study.
Added Pat Kringas, “We coordinate care and keep people on track at quarterly visits, where we follow subject’s A1C levels and other parameters of diabetes control. When you have a diabetes team that is working with you—when you have this amount of support—chances are you’re going to do better managing your diabetes overall, just by virtue of being in a study.”
To be sure, it’s not easy to qualify—even in a city like New York where it is estimated that 1 in 8 people have T2D. To participate you have to 1) have received a diagnosis of T2D within the last 5 years, 2) be at least 30-years old and 3) have an A1C greater than or equal to 6.8 per cent.
“It is a little like finding a needle in a haystack,” said Camille Hausheer, Berrie Center research assistant, whose job it is to recruit patients for the GRADE Study. It is a full-time, hands-on, bilingual effort to find people to participate. So far, she has pre-screened hundreds of people. “Little by little we’re getting the word out about the GRADE Study. We’ll find them,” said Camille.
If you or someone you know is interested in participating in the GRADE Study at the Naomi Berrie Diabetes Center please contact Patricia Kringas, firstname.lastname@example.org, 212-851-5449.