New analysis provides tool for identifying young diabetes patients who need intensive treatment
Innovations in Pediatrics - Spring 2016
ROSE GUBITOSI-KLUG, MD, PHD
Division Chief, Endocrinology & Metabolism, UH Rainbow Babies & Children’s Hospital; Associate Professor of Pediatrics, Case Western Reserve University School of Medicine
Youth-onset type 2 diabetes is a growing clinical problem, spurred by America’s epidemic of childhood obesity. Unfortunately, there are currently few good approaches for managing these patients. The first and largest randomized clinical trial addressing the issue was the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, reported in The New England Journal of Medicine in April 2012. It found that almost half of participants in the study, all with type 2 diabetes, could not maintain adequate glycemic control while taking metformin alone.
“Within a year, almost 50 percent of them had failed treatment,” says Rose Gubitosi-Klug, MD, PhD, Chief of Endocrinology & Metabolism at University Hospitals Rainbow Babies & Children’s Hospital. “This was surprising, because most adults do pretty well on oral medications for five to 10 years. These young ‘type 2s,’ however, were no longer responding to oral medications very early on.” Dr. Gubitosi-Klug joined the
TODAY study in November 2015, as principal investigator at UH Rainbow Babies & Children’s Hospital.
Now, however, a new analysis of data from the TODAY study is pointing to a more effective predictor for managing these patients. Researchers writing recently in the journal Diabetes Care report that children and adolescents with type 2 diabetes can be divided into two groups, based on their HbA1c levels after a few months on metformin therapy. These levels, in turn, predict the likelihood of treatment success.
Paul McGuigan, RN, a certified diabetes educator and nurse coordinator for the TODAY study, both at UH Rainbow Babies & Children’s Hospital and nationally, was a co-author of the Diabetes Care study.
“Our analysis shows that type 2 diabetes is heterogeneous, with some individuals who are more or less likely to have durable glycemic control on oral therapy,” McGuigan says. “It also shows that HbA1c, after a few months of metformin monotherapy, was the strongest predictor of response.”
For both McGuigan and Dr. Gubitosi-Klug, the new analysis reinforces the importance of early diagnosis of type 2 diabetes in children and teens – and early, aggressive treatment to get HbA1c levels down.
“We believe identifying these kids even earlier, treating them promptly and closely monitoring their A1c levels, may have long-lasting benefits on the progression to requiring additional therapies,” Dr. Gubitosi-Klug says.
It also suggests that current HbA1c targets may be too high for this unique group of young patients.
“In clinical practice, typically the goal is to achieve A1c levels less than 7 to 7.5 percent,” Dr. Gubitosi-Klug says. “But maybe we should be targeting lower. The current study suggests that perhaps we need to push the clock back and be more aggressive once patients are diagnosed or identified as ‘prediabetes.’”
“The bottom line is that teens with type 2 diabetes who don’t attain a nondiabetes A1c after a few months on metformin are at increased risk of losing glycemic control,” McGuigan adds. “The clinician caring for these youth should not be reassured with an A1c that is ‘in target.’”
Building on the TODAY study, Dr. Gubitosi-Klug, McGuigan and their colleagues at other children’s hospitals have begun planning for another study aimed at identifying optimal treatment for children and teens with type 2 diabetes. They’ll continue looking more closely at patients who respond well, while at the same time monitoring the impact of multiple oral medications on glycemic control.
“Many of these oral medications are approved for type 2 diabetes in adults, but none of them have been well studied in pediatrics,” Dr. Gubitosi-Klug says. “There’s a huge knowledge gap. But there’s also a hopeful message here. There are kids who respond really well. We need to know who they are, why they do well and how that can be achieved for all youth.”
For more information about UH Rainbow Babies & Children’s Hospital’s role in the ongoing TODAY study, contact Dr. Gubitosi-Klug or Paul McGuigan at Peds.Innovations@UHhospitals.org.
The research referenced in this article was funded by a grant from the National Institutes of Health to Case Western Reserve University School of Medicine.