Type 1 Diabetes Patients Often Miss Vital Screening
Over half of children diagnosed with type 1 diabetes may not receive the autoantibody tests needed to confirm their condition.
Updated on Oct. 30, 2026 in Diabetes
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Between 2017 and 2025, over half of U.S. children diagnosed with type 1 diabetes did not receive essential autoantibody testing. This screening is critical for confirming autoimmune diagnoses and identifying children who might qualify for emerging treatments like Tzield.
Why it matters
Autoantibody testing is necessary to distinguish type 1 diabetes from other forms of the disease and is now a prerequisite for assessing eligibility for immunomodulatory therapies. Improving testing rates is essential for ensuring children receive accurate diagnoses and timely access to modern clinical options.
A retrospective analysis of 68,439 children diagnosed with type 1 diabetes between 2017 and 2025 shows only 48.8% received at least one autoantibody test. While testing rates increased over the study period, clinicians note that 10% to 15% of children may test negative for all measured autoantibodies.
The players
Epic Research
An organization that conducts large-scale clinical data analysis using the Cosmos dataset.
FDA
The federal agency responsible for evaluating the safety and efficacy of medical treatments and expanding drug indications.
The details
Autoantibody tests identify specific immune system proteins that target pancreatic beta cells, confirming the autoimmune nature of type 1 diabetes. Because these tests provide the biological evidence required to screen for eligibility for therapies like Tzield, which can delay disease progression, clinicians emphasize their diagnostic value. However, the study notes that 13.7% of insulin autoantibody tests yielded indeterminate results, complicating the diagnostic process for some patients.
Timeline
The Epic Research study analyzed electronic health records from 2017 through 2025.
The FDA first approved Tzield in 2022 to help delay the onset of stage 3 type 1 diabetes.
In April 2026, the FDA expanded the Tzield indication to include children as young as one year old.
The FDA granted accelerated approval for Tzield in children ages 8 through 17 in June 2026.
Health Landscape
The use of autoantibody testing is evolving as clinical practice moves toward earlier identification and intervention. These findings from the Cosmos dataset highlight a gap between standard diagnostic practices and the requirements for newer, targeted autoimmune therapies.
If your child has been diagnosed with type 1 diabetes, it is worth discussing with your pediatrician or endocrinologist whether autoantibody testing was performed. These results help clarify the diagnosis and confirm whether your child meets the criteria for currently available immunomodulatory therapies.
The takeaway
Autoantibody testing is a foundational diagnostic tool that remains underutilized in pediatric care. Parents should feel comfortable asking their medical team about the specific tests conducted at diagnosis to ensure they have the full picture regarding the cause of the disease and potential treatment paths.
Further reading
For more on diagnostic standards and clinical guidelines, visit the Diabetes section.
Source note: This article includes information reported by Managedhealthcareexecutive.
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