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Biomarkers in type 1 diabetes: application to the clinical trial setting

Tooley, James E.; Herold, Kevan C.

Current Opinion in Endocrinology, Diabetes and Obesity: August 2014 - Volume 21 - Issue 4 - p 287–292
doi: 10.1097/MED.0000000000000076

Purpose of review Biomarkers of type 1 diabetes (T1D) are important for assessing risk of developing disease, monitoring disease progression, and determining responses to clinical treatments. Here we review recent advances in the development of biomarkers of T1D with a focus on their utility in clinical trials.

Recent findings Measurements of autoantibodies and metabolic outcomes have been the foundation of monitoring T1D for the past 20 years. Recent advancements have led to improvements in T-cell-specific assays that have been used in large-scale clinical trials to measure antigen-specific T cell responses. Additionally, new tools are being developed for the measurement of β cell mass and death that will allow for more direct measurement of disease activity. Lastly, recent studies have used both immunologic and nonimmunologic biomarkers to identify responders to treatments in clinical trials.

Summary Use of biomarkers in the study of T1D has largely not changed over the past 20 years; however, recent advancements in the field are establishing new techniques that allow for more precise monitoring of disease progression. These new tools will ultimately lead to an improvement in understanding of disease and will be utilized in clinical trials.

Department of Immunobiology and Internal Medicine, Yale University, New Haven, Connecticut, USA

Correspondence to Kevan C. Herold, MD, Yale University, 300 George St, #353E, New Haven, CT 06520, USA. Tel: +1 203 785 6507; fax: +1 203 785 7903; e-mail:

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