Jacobsen Laura M, Felton Jamie L, Nathan Brandon M, Speake Cate, Krischer Jeffrey, Herold Kevan C
Departments of Pediatrics and Pathology, University of Florida Diabetes Institute, Gainesville, FL.
Department of Pediatrics, Herman B. Wells Center for Pediatric Research, and Pediatric Endocrinology, Indiana University School of Medicine, Indianapolis, IN.
Diabetes Care. 2025 Jul 1;48(7):1112-1124. doi: 10.2337/dc24-2908.
Established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2001, Type 1 Diabetes TrialNet (TrialNet) is an international consortium of clinical research centers that studies the development of type 1 diabetes and performs clinical studies aimed at delaying or preventing the disease. In recognition of NIDDK's 75th anniversary, this review will summarize the major findings, accomplishments, and future opportunities of its long-running program TrialNet. More than 20 intervention, observational, and mechanism-directed clinical studies have been conducted in collaboration with thousands of people living with type 1 diabetes and their families. New and repurposed immunotherapies have been successful in stages 2 and 3 of type 1 diabetes, contributing to the U.S. Food and Drug Administration approval of the first disease-modifying therapy to delay the onset of type 1 diabetes. Mechanistic findings continue to drive ongoing and future trial designs including novel combination therapies. TrialNet has several ongoing trials, with several for early stages of type 1 diabetes in development. There are new initiatives within TrialNet for community engagement, increasing clinical trial representation, personalizing treatments, and training the next generation of translational investigators.
1型糖尿病试验网（TrialNet）于2001年由美国国立糖尿病、消化和肾脏疾病研究所（NIDDK）设立，是一个临床研究中心的国际联盟，致力于研究1型糖尿病的发病情况，并开展旨在延缓或预防该疾病的临床研究。为纪念NIDDK成立75周年，本综述将总结其长期运行的项目TrialNet的主要研究结果、成就及未来机遇。该项目已与数千名1型糖尿病患者及其家属合作开展了20多项干预性、观察性和机制导向性临床研究。新型和重新利用的免疫疗法在1型糖尿病的2期和3期试验中取得了成功，促成了美国食品药品监督管理局批准首个延缓1型糖尿病发病的疾病改善疗法。机制研究结果持续推动正在进行和未来的试验设计，包括新型联合疗法。TrialNet有多项正在进行的试验，其中几项针对1型糖尿病早期阶段。TrialNet还有一些新举措，涉及社区参与、增加临床试验代表性、个性化治疗以及培养下一代转化研究人员。
