Michael Haller, MD, discusses safety and use for inhaled insulin in T1D

Michael Haller, MD, MSCI, professor and chief of pediatric endocrinology at the University of Florida, emphasized the growing clarity around the safety profile of inhaled insulin in pediatric patients with type 1 diabetes (T1D).

“The safety features of inhaled insulin are now quite clear,” said Haller. “There is a per-label instruction to check FEV₁ [forced expiratory volume in first second of expiration] before and then after starting inhaled insulin. What we saw in the pediatric study was that there was actually less of a decline in FEV₁ in the patients [with] inhaled insulin than there was in the patients [with] injected insulin, which just adds to the data set indicating that it really is safe.” He noted that the technosphere particle is entirely excreted through the urine and does not appear to pose long-term risks to lung function.

This conversation builds on Haller’s earlier discussion of the INHALE-1 trial, which supported MannKind’s August 2025 FDA filing for pediatric approval of Afrezza. Together, these insights point toward a future where inhaled insulin could play a broader role in pediatric diabetes care.^1,2

As Haller explained, one of the biggest challenges remains payer coverage in pediatrics, because Afrezza is still awaiting an FDA label for children. Until then, some families pay out of pocket. Despite this hurdle, Haller finds the therapy especially effective for active patients prone to sports-related hypoglycemia. “They can be confident that it is completely cleared within 1 hour of dosing and they are not going to end up hypoglycemic out on the football or soccer field or while swimming a race.”

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He also highlighted the potential role of inhaled insulin in managing challenging meals and easing early treatment transitions. “I personally think that is going to play well with a lot of families as they adjust to life with diabetes,” he said, envisioning a scenario where newly diagnosed children might rely on just one long-acting injection plus inhaled insulin for meals.

Looking ahead, Haller sees promise in combining inhaled insulin with semiautomated pumps, especially with Bluetooth-enabled devices on the horizon. Such integration could reduce the mental burden of constant carbohydrate counting and meal dosing. “I could definitely see a space for inhaled insulin in the future where it is used almost entirely as a meal announcement for these algorithms—giving the insulin a head start—and then letting the pump do the rest of the work.”

Michael Haller, MD, reports relevant disclosures to MannKind, SAB BIO, and Sanofi.

References

1. Fitch J. Michael Haller, MD, discusses inhaled insulin and Afrezza data for type 1 diabetes. Contemporary Pediatrics. August 7, 2025. Accessed August 18, 2025. https://www.contemporarypediatrics.com/view/michael-haller-md-discusses-inhaled-insulin-and-afrezza-data-for-type-1-diabetes
2. MannKind Corporation reports second quarter 2025 financial results and provides business update. Press release. MannKind Corporation. August 6, 2025. Accessed August 18, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-reports-second-quarter-2025-financial