How Tzield and Early Screening Are Changing the Fight Against Type 1 Diabetes

Tzield is a prescription medication used to delay the onset of Type 1 diabetes. Rather than suppressing immunity across the whole body, it acts on T-cells, reducing their ability to destroy beta cells. The goal is to preserve remaining insulin production and delay the progression of Type 1 diabetes.

The FDA has expanded the approval of Tzield to include children aged 1 year and older, effective April 22, 2026. Tzield was previously limited to those 8 and older. This change gives families identified through early screening programs a new option to delay the onset of Type 1 diabetes for their toddlers and young children.

Stages of Type 1 Diabetes

Type 1 diabetes develops over years and is now described in three stages:

• Stage 1: Two or more islet autoantibodies present, normal blood sugar, no symptoms.
• Stage 2: Autoantibodies plus abnormal glucose regulation, but still no symptoms.
• Stage 3: Clinical diagnosis, symptomatic hyperglycemia requiring insulin.

Tzield is approved specifically for Stage 2, the “window of opportunity” when the immune system is attacking beta cells but there has not yet been a clinical diagnosis of diabetes.

Pivotal trials showed that a single 14-day course of Tzield can delay progression from Stage 2 to Stage 3 by about two years on average, with some individuals experiencing longer delays. Treated participants who later progressed to Stage 3 had a lower risk of developing diabetic ketoacidosis (DKA) at diagnosis.

Importance of Type 1 Diabetes Screening

Because Tzield is effective only in Stage 2, early identification matters. Type 1 diabetes can develop at any age, and knowing your child’s risk can be incredibly valuable. That’s where autoantibody testing comes in.

Autoantibody screening tests for four autoantibodies and identifies individuals with Stage 1 or 2 diabetes before symptoms appear.

Screening is often recommended for relatives of people with Type 1 diabetes or when providers suspect risk of Type 1 diabetes. Population-based screening programs are being discussed and piloted in some areas.

It is important for parents to discuss screening options with their child’s health care team, especially if there is a family history of Type 1 diabetes.

What Tzield Treatment Looks Like

Tzield treatment involves a single 14-day course of daily intravenous (IV) infusions. Administration requires access to infusion services and pediatric endocrinology follow-up. Families should expect daily visits to an infusion center for two consecutive weeks.

Throughout the treatment period, frequent lab tests and clinical checks are required, including blood counts and careful observation for side effects. Commonly reported side effects include temporary decreases in white blood cell counts, rash, headache and infusion-related reactions.

Benefits of Delaying Stage 3 Type 1 Diabetes

A delay of even two years in the onset of Type 1 diabetes is incredibly meaningful for toddlers and preschoolers. Those additional years can mean the following:

• Continued natural insulin production during critical periods of brain and physical development.
• Fewer years with the intensive demands of insulin therapy and glucose monitoring.
• Lower short-term risk of severe events like DKA and fewer severe hypoglycemic episodes.
• Reduced psychosocial and caregiver burden during early childhood.

Considerations for Families

Families considering Tzield for a young child should plan ahead for the two weeks of daily infusions. Before beginning treatment, families should have a discussion about the expected benefits, possible risks, alternative options and the child’s long-term care plan with their health care team.

Insurance coverage, prior authorization requirements and access to appropriate infusion centers can vary significantly, so it is important to plan ahead and get the process started early.

Lastly, keep emotional support in mind. Even with Tzield treatment, Type 1 diabetes remains a possibility. Counseling, peer support groups and early connections to diabetes education resources can help families navigate the emotional challenges that come along with a positive antibody screen.

In Summary

The expanded approval of Tzield for children aged 1 and older in Stage 2 Type 1 diabetes is an important step forward in the prevention and treatment of Type 1 diabetes.

If your child may be at risk of Type 1 diabetes, consider discussing autoantibody screening with your child’s pediatrician, and if Stage 2 diabetes is identified, ask a pediatric endocrinologist about whether Tzield is an appropriate treatment option.