Vanderbilt University Medical Center has been selected as one of 11 clinical centers in the United States to participate in a national study with the potential to improve brain health and psychosocial function in children with Type 1 diabetes (T1D).
The VUMC study arm, which received a $1.8 million, five-year National Institutes of Health award, will be led by a team from Monroe Carell Jr. Children’s Hospital at Vanderbilt featuring Sarah Jaser, PhD, professor of Pediatrics, and Lori Jordan, MD, PhD, professor of Pediatrics and director of the Pediatric Stroke Program.
“Children with Type 1 diabetes are at increased risk for neurocognitive complications, and the most affected skills include the ability to plan, working memory and the ability to conduct mental math,” said Jaser, who holds the William R. Long Directorship in Pediatric Psychology. “Those cognitive functions are critical to diabetes management. If those skills are impacted, it could make it difficult to manage diabetes.
“It can become a vicious cycle, leading to a downward spiral with the disease. We want to intervene or find ways to combat the neurocognitive issues at an earlier age so that we can hopefully prevent problems with diabetes management in adolescence and adulthood.”
The mechanisms underlying neural injury are unclear and neurocognitive outcomes have not been evaluated prospectively using a diverse sample of children.
Jaser said a cohort study of school-age children newly diagnosed with T1D and a comparison group of children without diabetes is necessary to characterize associations between T1D-related factors and neurocognitive outcomes as well as identify potentially modifiable factors that may mitigate cognitive declines.
Jaser and Jordan will work with Jill Simmons, MD, professor of Pediatrics in Endocrinology and Diabetes; Sumit Pruthi, MD, MBBS, chief of Pediatric Radiology and medical director of Diagnostic Imaging at Monroe Carell; Vanderbilt University School of Engineering faculty Adam Anderson, PhD, professor of Biomedical Engineering, and Bennett Landman, PhD, professor of Electrical and Computer Engineering; the Biostatistics Research Core at the University of Minnesota; project scientists at the National Institute of Diabetes and Digestive and Kidney Diseases; and the other centers to finalize the study protocol, including collection of neuroimaging, neurocognitive and blood glucose data, and development of neuroimaging harmonization plans.
The multidisciplinary team hopes to begin enrolling patients in 2025.
“This project has the potential to influence standards of clinical care for children with Type 1 diabetes and to pinpoint critical periods for prevention and intervention to improve brain health and function,” said Jordan. “An important element of our project includes looking at diverse racial, ethnic and socioeconomic groups.”
At Vanderbilt, the goal is to enroll 80 children ages 6-11 with new-onset T1D and 20 children without T1D. The cohort will be followed for a minimum of two years with the following aims:
- To prospectively evaluate how diabetic ketoacidosis presence and severity at onset predicts clinically meaningful cognitive differences over two years among a diverse sample of school-age children newly diagnosed with T1D and compared to children without diabetes.
- To prospectively evaluate how glycemic variables predict cognitive differences over two years among children with T1D, and this will be influenced by use of automated insulin delivery systems.
- To identify potentially modifiable risk and protective factors, including sleep duration and parental distress, that are associated with cognitive and psychosocial functioning.
Project leads said that the Pediatric Diabetes Program (PDP) at Monroe Carell is an ideal place to address the study aims because of the local, multidisciplinary expertise in behavioral research, including sleep and caregiver distress, neurocognitive testing, advanced research neuroimaging and strong community engagement in children with T1D.
“The PDP follows a diverse group of nearly 3,000 children with diabetes; 85% of these patients have Type 1 diabetes,” said Jordan. “Each year, the program sees about 275 new-onset Type 1 diabetes cases. With a long history of clinical Type 1 diabetes research, we are well positioned to contribute to the multicenter, longitudinal cohort study.”
The study, “Neurocognitive Complications of Pediatric Type 1 Diabetes: Identifying Modifiable Risk and Protective Factors” is funded by the National Institutes of Health.
Other participating centers include Barbara Davis Center (University of Colorado Denver), University of California Davis, Joslin Diabetes Center (Harvard University), University of Florida, Indiana University, University of Southern California, NYU, Washington University, University of North Carolina and Nemours Children’s (Florida).
