A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes

作者：Allan L. Reiss, Booil Jo, Ana María Arbeláez, Eva Tsalikian, Bruce A. Buckingham, Stuart A. Weinzimer, Larry A. Fox, Allison Cato, Neil H. White, Michael Tansey, Tandy Aye, William V. Tamborlane, Kimberly Englert, John W. Lum, Paul K. Mazaika, Lara C. Foland‐Ross, Matthew Marzelli, Nelly Mauras, Gabby Tong, Hanyang Shen, Zetan Li, Ryan Kingman, L. Levandoski, Julie Coffey, Rachel Bisbee, Amy Stephen, Kate Weyman, Keisha Bird, Kimberly Ponthieux, Juan Marrero · 发表于：Nature Communications · 年份：2022 · DOI：10.1038/s41467-022-32289-x · 被引用次数：33 · 研究领域：Diabetes Management and Research、Neonatal and fetal brain pathology、Cardiovascular Function and Risk Factors

Type 1 diabetes (T1D) is associated with lower scores on tests of cognitive and neuropsychological function and alterations in brain structure and function in children. This proof-of-concept pilot study (ClinicalTrials.gov Identifier NCT03428932) examined whether MRI-derived indices of brain development and function and standardized IQ scores in adolescents with T1D could be improved with better diabetes control using a hybrid closed-loop insulin delivery system. Eligibility criteria for participation in the study included age between 14 and 17 years and a diagnosis of T1D before 8 years of age. Randomization to either a hybrid closed-loop or standard diabetes care group was performed after pre-qualification, consent, enrollment, and collection of medical background information. Of 46 participants assessed for eligibility, 44 met criteria and were randomized. Two randomized participants failed to complete baseline assessments and were excluded from final analyses. Participant data were collected across five academic medical centers in the United States. Research staff scoring the cognitive assessments as well as those processing imaging data were blinded to group status though participants and their families were not. Forty-two adolescents, 21 per group, underwent cognitive assessment and multi-modal brain imaging before and after the six month study duration. HbA1c and sensor glucose downloads were obtained quarterly. Primary outcomes included metrics of gray matter (total a...