Published November 22, 2022
By Dirk Hoffman
Kathleen E. Bethin, MD, PhD, clinical professor of pediatrics and her research team have been lauded by the Pediatric Diabetes Consortium (PDC) for their contributions to the PIONEER TEENS clinical trial sponsored by the Danish pharmaceutical company Novo Nordisk.
The purpose of the PIONEER TEENS international research study is to test the efficacy of a study drug (semaglutide) versus a placebo on controlling blood sugars in children and adolescents with Type 2 diabetes.
Bethin and her team received a formal thank you from the PDC in the form of a letter from the chair and vice chair of the consortium.
Among the comments in the PDC’s letter to Bethin were: “the contributions and discussion generated by you and your team during our monthly calls has been beneficial to all sites participating on this trial” and “your expertise and commitment to treatment of the pediatric Type 2 diabetes population is evident.”
“We recruited two patients near the study startup and one patient has screened eligible and remained in the study,” says Bethin, who sees patients at UBMD Pediatrics. “The PDC knows that it is a lot of hard work and were congratulating us. It is a great honor that it recognized our work.”
The study’s target is to randomize 132 subjects worldwide. As of Oct. 27, there were 63 sites globally, with 137 subjects having been screened and 66 having been randomized.
For the United States, 38 subjects have been screened and 17 randomized. Buffalo has screened two subjects and one is randomized and still in the study.
Bethin says the population for this trial is incredibly difficult to recruit because it is mostly patients with health disparities that end up with Type 2 diabetes and furthermore teenagers are hard to recruit. The age range for subjects in the PIONEER TEENS trial is 10-to-17.
“It’s a lot on the families too because in the beginning of studies they might have to come in once every two weeks and then it’s once a month and it finally gets more spread out at the end of the trial,” she says.
Trial participants have to keep logbooks — they self-measure their blood sugar levels at home.
“We have to keep reminding them we need this data as part of the study — so please do this, please take your medicine,” Bethin explains.
“We have an excellent team of research associates who really stay on top of reminding subjects that they have an upcoming appointment,” she adds. “They will call them if they have to have fasting blood work. They will call them early in the morning to remind them not to eat, not to take their medicine.”
Bethin says sometimes a subject’s blood sugar will have to be in a certain range for something like a mixed meal tolerance study so the research staff has to call them early in the morning and make sure their blood sugar is in the target range or tell them what to do if it’s not.
“Our team does a great job and it was well deserved that we got this recognition from the PDC,” she says.
The PDC is a multi-center group of leading pediatric diabetes treatment centers in the United States.
“It is made up of 30 to 40 groups that tend to be the best pediatric diabetes centers from all over the country,” Bethin says. “You have to be invited to join the PDC or be an affiliate. We are an affiliate of the PDC, which is another honor for our team.”
Teresa Quattrin, MD, UB Distinguished Professor of pediatrics, is also a sub-investigator.
Other members of Bethin’s research team from the Department of Pediatrics involved in the study are:
Steven E. Lipshultz, MD, the A. Conger Goodyear Professor and Chair of pediatrics, says he is proud of the work of Bethin and Mastrandrea and their research team.
“They are a national line leader, and this is again validated here. It is amazing how many great new therapies and ways to treat childhood diabetes have come from this program,” he says.
Bethin says the people of Buffalo greatly contribute to her successes as a clinical researcher.
“I think it is due to the commitment people have to research here and also probably the climate in Buffalo where people in general tend to be friendly and are willing to do things,” she says. “I think there is an atmosphere of wanting to help other people.”