Type 1 diabetes (T1D) is a chronic autoimmune disease that leads to destruction of beta cells, loss of insulin production, and dependence on insulin therapy for survival. The majority of patients with T1D, more than 75%, have poorly controlled glycated hemoglobin (HbA1c) > 7%, leading to cardiovascular disease, kidney disease, retinopathy, and metabolic syndrome. Approximately half of newly diagnosed children present with life-threatening diabetic ketoacidosis, which is a result of acute, severe hyperglycemia. This suggests that T1D often is unrecognized until overt hyperglycemia occurs. But, before progressing to the clinical stage, T1D progresses through asymptomatic stages in which HbA1c remains normal, and insulin treatment is not yet needed. The immunologic and metabolic features during these asymptomatic stages may help identify persons at risk of developing clinical T1D before overt hyperglycemia occurs and lifelong insulin therapy is required. Recent evidence suggests that emerging immune agents can delay the decline in beta cell function, highlighting the importance of identifying patients at risk. On November 17, 2022, the US Food and Drug Administration (FDA) approved teplizumab-mzwv, a first-in class anti-CD3 monoclonal antibody, to delay the onset of stage 3 T1D in adults and pediatric patients over 8 years old at-risk of disease progression (ie, those who currently have stage 2 T1D). Common adverse reactions of teplizumab-mzwv include lymphopenia, rash, leukopenia, and headache.
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