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New guidance outlines use of first immunotherapy for children newly diagnosed with type 1 diabetes

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New guidance outlines use of first immunotherapy for children newly diagnosed with type 1 diabetes

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For the first time, children ages 8 to 17 who are newly diagnosed with type 1 diabetes have access to an approved treatment that targets the underlying autoimmune disease, rather than solely managing blood sugar levels with insulin.

A national group of clinical trial investigators and pediatric diabetes specialists, led by a physician-scientist at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz, have published practical guidance to help care teams and families navigate this new option.

The treatment, teplizumab, is an immunotherapy that slows the immune system's destruction of the body's remaining insulin-producing cells. In June 2026, the U.S. Food and Drug Administration (FDA) expanded its approval to include children and adolescents ages 8 to 17 years recently diagnosed with stage 3 type 1 diabetes (the stage when symptoms appear and insulin is needed), to delay the decline in their own insulin production.

This new indication was granted under the FDA's accelerated approval pathway, based on the treatment's effect on preserving insulin production.

Teplizumab was already approved to delay the onset of stage 3 type 1 diabetes in people age 1 and older with stage 2 type 1 diabetes.

, an associate professor of pediatrics at the University of Colorado Anschutz School of Medicine and a physician-scientist at the Barbara Davis Center for Diabetes, led the development of the Diabetes Care perspective with a national group of co-authors.


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