How Teplizumab Approval is Changing Type 1 Diabetes Screening in the US

A new study shows that access to a disease-modifying therapy has shifted how and who gets tested for islet autoantibodies—the early warning signs of Type 1 diabetes. But important gaps remain.

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Key takeaways

Islet autoantibody testing increased significantly in the US after teplizumab was approved, suggesting greater awareness of the value of early detection.
Adults and children with blood sugar abnormalities are being screened more often, but screening of healthy children through primary care remains limited.
Testing patterns are becoming more aligned with clinical guidelines, though challenges in reaching all at-risk groups persist.
Early detection through autoantibody screening is now clinically meaningful because it can identify people before symptoms develop—when intervention may be possible.

What This Study Looked At

Researchers examined US autoantibody testing patterns before and after teplizumab received regulatory approval. They reviewed results from over 28,000 people without diabetes, comparing testing practices in the period before approval to patterns afterward. The goal was to understand how access to a disease-modifying therapy might influence screening decisions in real clinical practice.

More People Are Being Screened

Following teplizumab approval, islet autoantibody testing increased overall, with the vast majority of orders now including multiple antibody markers—a more comprehensive approach. This shift suggests that clinicians increasingly recognize the value of identifying Type 1 diabetes in its earliest stages, before the immune system has destroyed enough insulin-producing cells to cause symptoms.

The increase was particularly pronounced in two groups: adults and children showing signs of dysglycemia (abnormal blood sugar). Among dysglycemic children specifically, the proportion with multiple positive antibodies was 35.6% higher after approval than before, indicating more thorough screening in this higher-risk population.

Where Screening Still Lags

Despite these gains, the study revealed an important gap: primary care providers are still not routinely screening healthy children without blood sugar abnormalities. This matters because autoimmune Type 1 diabetes can develop in anyone, regardless of current glucose levels. Expanding screening to include normoglycemic children would require better integration of testing into standard pediatric care pathways.

The findings suggest that while clinical awareness has grown, especially among specialists and in high-risk groups, systemic barriers to universal early detection remain.

Why This Matters

For years, Type 1 diabetes was only detected after symptoms appeared—often when significant damage had already occurred. The arrival of teplizumab, which can delay disease onset in people with autoantibodies, changed the equation. Now there is a clinical reason to find autoantibodies before symptoms start.

This study shows that the healthcare system is responding to that opportunity, at least in certain populations. But it also highlights work ahead: to ensure that all children at genetic risk, not just those already showing metabolic changes, have access to early detection screening.

Evidence label

Source: The Journal of clinical endocrinology and metabolism. Evidence type: PubMed indexed literature. 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.

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.

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