How Teplizumab's Approval Changed Type 1 Diabetes Screening in America

In November 2022, the FDA approved teplizumab (brand name Tzield), a drug designed to delay the onset of Type 1 diabetes in people identified as high risk. The approval marked an important milestone—it was the first disease-modifying therapy for Type 1 diabetes available in the United States. But its arrival didn't just offer patients a new treatment option; it also changed how doctors approach screening for the disease.

Researchers from Quest Diagnostics, collaborating with Dr. Emily K. Sims, a pediatric endocrinologist at Indiana University School of Medicine and national expert on Type 1 diabetes, wanted to understand whether teplizumab's FDA approval affected screening practices. Their findings, published in The Journal of Clinical Endocrinology and Metabolism, reveal that it did—significantly.

The study analyzed screening data from 28,206 nondiabetic individuals in the United States who were tested for Type 1 diabetes risk. Researchers compared two periods: November 2017 to November 2018 (before teplizumab was available) and November 2022 to November 2023 (immediately after FDA approval).

The key finding: after teplizumab's approval, healthcare providers were more likely to order a full panel of recommended Type 1 diabetes autoantibody tests rather than testing for individual autoantibodies. This shift matters because a comprehensive autoantibody panel provides a more complete and accurate assessment of a person's risk for developing Type 1 diabetes—information that becomes particularly valuable when a treatment option like teplizumab exists.

Type 1 diabetes develops when the immune system mistakenly attacks the insulin-producing cells in the pancreas. Before diabetes symptoms appear, the body produces autoantibodies—immune proteins that target these cells. Testing for multiple autoantibodies helps identify people in the earliest stages of this process, when intervention may be most beneficial.

The availability of teplizumab gave doctors a reason to order more thorough screening: if they could identify high-risk individuals, those patients could make an informed decision about whether to pursue a treatment designed to slow disease progression. This shift in clinical practice demonstrates how a single therapeutic advance can reshape the entire landscape of how a disease is detected and managed.

Origin: Quest Diagnostics Newsroom (News report). Evidence: News report — unverified, pending corroboration. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.