In June, researchers from Quest Diagnostics published findings of a national study in The Journal of Clinical Endocrinology and Metabolism (JCEM), the leading clinical journal of the Endocrine Society. The research, which was conducted in collaboration with Dr. Emily K. Sims, a pediatric endocrinologist and associate professor of pediatrics at Indiana University School of Medicine and a national expert on type 1 diabetes, focused on recent advances in disease-modifying therapies for type 1 diabetes (T1D).

“US patterns in clinical islet autoantibody ordering and results show key differences after teplizumab regulatory approval” examined how the FDA approval of a new drug designed to delay the onset of T1D changed the way doctors screen for the disease in the United States.

Teplizumab, sold under the brand name Tzield, was approved for medical use in the United States in November 2022. Following the drug's approval, research found that healthcare providers were more likely to order a full panel of recommended T1D autoantibody tests when testing for T1D to provide a more accurate picture of a patient's risk compared to the individual autoantibody tests.

The study examined data from 28,206 nondiabetic individuals in the United States who were being screened for the risk of developing T1D. To establish a baseline to understand testing patterns prior to the drug’s availability, data from individuals tested between November 2017 and November 2018 was reviewed, as well as data from individuals tested immediately following the FDA approval, between November 2022 and November 2023.

Results of the study showed an increase in islet autoantibody testing of almost 2-fold from the pre-approval to post-approval period, mostly in adults and  dysglycemic children (defined as hemoglobin A1c of 5.7-6.4%). Moreover:

• Patterns of autoantibody ordering were found to have shifted to more comprehensive testing in the post-approval period: all groups showed an increase in orders for screenings including at least 4 biochemical antibodies
• Among dysglycemic children, multiple antibody positivity in the post-approval period was 35.6% higher than expected compared to the pre-approval period (P = .0003).
• The data would suggest that improvements have been made in awareness and education efforts to help identify children at high risk of developing T1D.  Other possible explanations include changes in referral patterns or early clinical presentations of T1D.

“The approval of a disease-modifying therapy changed how clinicians screen for T1D, and that’s encouraging.  What stands out to me is where the momentum hasn’t yet reached: healthy-glucose children seen in primary care.  Closing that gap is the next step, and it means making this testing a routine part of the care pathway rather than an exception.”  said Sanjay B. Dixit, Medical Director, Quest Diagnostics. “By broadening access to screenings, and helping patients receive intervention sooner, we can continue to encourage people to own their health and enable care to start with health – not sickness.”

As per the Centers for Disease Control and Prevention (CDC), T1D is an autoimmune disease affecting more than 2 million people nationwide. Screening for T1D typically features testing for islet autoantibodies, immune system proteins that mistakenly attack the insulin-producing beta cells in a person’s pancreas. These include insulin (IAA), islet antigen-2 (IA-2A), glutamic acid decarboxylase 65 (GADA), zinc transporter 8 (ZnT8A), or islet cell antigen (ICA). However, since T1D evolves over the years, it can be detected before symptoms occur by examining an individual for elevated autoantibody titers.