June 2026 brought two separate FDA decisions that, together, represent a meaningful shift in how children with Type 1 diabetes can be monitored and treated.
On June 12, the FDA cleared the Dexcom Stelo continuous glucose monitor (CGM) for over-the-counter use in children as young as 2 years old — the first OTC CGM ever cleared for a pediatric population. And also on June 12, the FDA granted accelerated approval to teplizumab (Tzield; Sanofi) for a new indication: slowing the loss of insulin production in children and adolescents aged 8 to 17 who were recently diagnosed with Stage 3 Type 1 diabetes.
These two developments address different stages and aspects of the same disease, one making it easier for families to track glucose levels without a prescription, and the other giving newly diagnosed children a disease-modifying therapy option that did not exist before.
Why This Matters
Type 1 diabetes is a lifelong autoimmune disease in which the immune system destroys the insulin-producing beta cells of the pancreas. An estimated 1.9 million Americans live with Type 1 diabetes, with a significant share diagnosed in childhood. Unlike Type 2 diabetes, Type 1 has no lifestyle-driven cause and no cure. Management has historically consisted entirely of insulin replacement, keeping glucose levels in range through multiple daily injections or an insulin pump, guided by continuous glucose monitoring.
These two approvals change what is available to families. One makes glucose monitoring more accessible without the barrier of a prescription or insurance prior authorization. The other introduces the first therapy that targets the disease’s underlying mechanism — the autoimmune destruction of beta cells — rather than simply replacing what those cells would have produced.
The OTC Children’s CGM: What the Stelo Clearance Means
According to HCPLive reporting on the June 12 FDA announcement, the FDA cleared Dexcom’s Stelo Glucose Biosensor System for OTC use in children aged 2 and older who do not use insulin. This expands a clearance that previously existed for adults without insulin use.
The Stelo is designed for real-time blood glucose monitoring without the need for a prescription. It can be purchased directly by consumers and is intended for children managing blood sugar through diet, exercise, and oral medications, as well as those who want to understand how food and physical activity affect glucose levels.
“Children deserve access to the best tools available to manage their health,” said Michelle Tarver, MD, PhD, Director of the FDA’s Center for Devices and Radiological Health, in the agency’s announcement. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”
This is an important distinction: the Stelo OTC clearance is for children not currently on insulin. Children with Type 1 diabetes using insulin will continue to use prescription-level CGMs (like the Dexcom G7) that integrate with insulin pumps and have more intensive monitoring features. The OTC clearance primarily benefits children with Type 2 diabetes or prediabetes — and those at risk for blood sugar fluctuations from other causes — whose families have previously faced barriers accessing CGM technology without a prescription.
Teplizumab for Stage 3 Type 1 Diabetes: The First Disease-Modifying Treatment
The FDA’s June 12, 2026 accelerated approval of teplizumab (Tzield) for Stage 3 Type 1 diabetes in patients aged 8 to 17 is the more clinically transformative of the two decisions.
What the stages mean: Type 1 diabetes is a staged disease. Stage 1 is the presence of autoantibodies with normal glucose. Stage 2 is autoantibodies plus dysglycemia (abnormal glucose levels but no clinical symptoms). Stage 3 is the onset of clinical diabetes — the point at which symptoms appear and insulin treatment begins.
What teplizumab does: Teplizumab is an anti-CD3 monoclonal antibody. It works by targeting and partially exhausting the autoimmune T cells that attack and destroy the insulin-producing beta cells in the pancreas. By limiting this autoimmune destruction, teplizumab preserves residual beta cell function, allowing the pancreas to continue producing some insulin even after diagnosis.
The pivotal PROTECT trial enrolled 328 newly diagnosed Type 1 patients aged 8 through 17 within six weeks of diagnosis. Participants received two 12-day infusion courses — one at baseline and one at 26 weeks. Those who received teplizumab showed significantly better preservation of beta cell function, measured by stimulated C-peptide levels at 78 weeks, compared to placebo.
According to Patient Care Online, Mahtab Niyyati, MD, acting associate director at the FDA’s Division of Diabetes, Lipid Disorders and Obesity, stated: “Based on robust evidence of safety and effectiveness, this accelerated approval provides a chance for pediatric patients with recently diagnosed Stage 3 type 1 diabetes to alter the course of their disease.”
What Preserved Beta Cell Function Means Clinically
Teplizumab does not cure Type 1 diabetes. Children who receive it still need insulin. But preserving some residual beta cell function — even for one to two years longer than without treatment — is clinically meaningful in several ways:
- Lower insulin requirements
- Better glycemic control with less hypoglycemia (dangerous low blood sugar)
- A longer window of the “honeymoon period,” when some natural insulin production reduces the intensity of insulin management
The Pediatric Endocrine Society notes that the drug is given as a 14-consecutive-day IV infusion cycle at baseline and again at 26 weeks, and that prescribers must monitor for Epstein-Barr virus and cytomegalovirus reactivation, cytokine release syndrome in the first five days, and transient drops in lymphocytes and neutrophils.
The approval is accelerated, meaning a post-marketing confirmatory study is required.
Where Teplizumab Has Been and Where It Is Going
Teplizumab was first FDA-approved in November 2022 for individuals aged 8 and older with Stage 2 Type 1 diabetes — to prevent or delay progression to Stage 3. In April 2026, that Stage 2 indication was extended to children as young as 1 year old. The June 2026 action is the first approval for Stage 3 disease, meaning teplizumab can now be used across multiple stages of T1D in pediatric patients.
This progression matters: it means a child could potentially receive teplizumab at Stage 2 to delay clinical onset, and again at Stage 3 to preserve beta-cell function after diagnosis.
Who Qualifies for Each Approval?
Dexcom Stelo OTC CGM: Children aged 2 and older who do not use insulin. No prescription required. Available for purchase directly by consumers.
Teplizumab (Tzield) for Stage 3 T1D: Children and adolescents aged 8 to 17 who have been recently diagnosed (within 6 weeks) with Stage 3 Type 1 diabetes. Administered by infusion in a clinical setting. Requires a physician’s prescription and monitoring for adverse effects.
What You Can Do Now
- If you are the parent of a child with Type 2 diabetes or prediabetes, talk to your pediatrician or endocrinologist about whether the Dexcom Stelo OTC CGM is appropriate for monitoring your child’s glucose levels.
- If your child has been recently diagnosed with Type 1 diabetes (within the past six weeks) and is between 8 and 17 years old, ask their pediatric endocrinologist about teplizumab (Tzield) and whether they are a candidate for treatment.
- If your child was previously diagnosed with Type 1 diabetes more than six weeks ago, they likely fall outside the current approval window for Stage 3 teplizumab, but your endocrinologist can advise on whether clinical trial participation is an option.
Cost and Access: What Patients Should Know
The Dexcom Stelo OTC CGM can be purchased without a prescription at major retailers and online. Without insurance, the cost of CGM sensors is approximately $90 to $100 per month. Some insurance plans cover OTC CGMs, but coverage varies — check with your insurer.
Teplizumab (Tzield) is an infusion drug that requires administration in a clinical setting. Insurance coverage for teplizumab has historically been a significant access barrier. Sanofi has a patient assistance program for eligible patients; families should contact their endocrinologist or the manufacturer for current access program details.
What Happens Next
The accelerated approval for teplizumab in Stage 3 requires a post-marketing confirmatory study. Sanofi has ongoing clinical research programs. The OTC CGM market for children is likely to expand as additional manufacturers seek similar clearances. MedicalDaily will report on confirmatory study results and any guideline updates from the American Diabetes Association or Pediatric Endocrine Society.
The Bottom Line
June 2026 delivered two meaningful changes for children living with Type 1 diabetes and those at risk. A prescription barrier for glucose monitoring in non-insulin-dependent children has been removed with the OTC CGM clearance. And for newly diagnosed children ages 8 to 17, teplizumab is now the first FDA-approved therapy that targets the autoimmune destruction underlying their disease, not just its metabolic consequences. Families should discuss both developments with their pediatric endocrinologist.
