Inhaled Insulin Fills Gaps in Pediatric Diabetes Care: Jamie Wood, MD

The central promise of the newly approved inhaled insulin¹ (Afrezza; MannKind Corporation) for pediatric patients aged 6 to 17 years is an expanding treatment choice for children and adolescents with diabetes who struggle with needles, adhesive reactions, or the demands of insulin pump therapy. The treatment is the first needle-free insulin option for that age group in more than a century of insulin therapy.

Jamie Wood, MD, principal investigator of the INHALE-1 trial (NCT04974528) and medical director of pediatric diabetes at the University Hospitals Rainbow Babies and Children's Hospital, said the approval fills a gap that existing technologies have not been able to address for every family.

"All youth with diabetes deserve choices in how they manage their diabetes," Wood told The American Journal of Managed Care^®. "Some will manage their diabetes with multiple daily injections, some will manage it with automated insulin delivery pumps and continuous glucose monitors, and for some, those may not be the best option. They may need a different way. And so, with the approval of inhaled insulin for pediatrics, they have another choice."

Inside the INHALE-1 Trial

The FDA's decision was supported by INHALE-1, a 26-week, open-label, randomized phase 3 trial that enrolled 230 children and adolescents with type 1 or type 2 diabetes.² Using a prespecified sensitivity analysis of patients who completed the trial and used the inhaled insulin as directed, the study met its primary end point of noninferiority in hemoglobin A_1c change at 26 weeks. A 26-week extension phase, in which remaining patients on multiple daily injections were switched to Afrezza, provided an additional 52 weeks of combined safety and efficacy data, with no meaningful differences in lung function parameters observed between the 2 groups.

Wood described several populations she expects will benefit most from having this option. Children with significant needle phobia represent one clear niche. She recounted caring for a patient during the trial whose paralyzing fear of needles had made daily injections untenable. Being able to inhale mealtime insulin, while still receiving one daily basal injection, was transformative for him.

Other candidates include children who cannot tolerate the adhesives used in pump systems, whether from skin reactions or personal preference, and athletes who may find Afrezza's pharmacokinetic profile—a fast onset and rapid clearance from the system within roughly 1.5 to 3 hours—particularly advantageous around exercise.

How Inhaled Insulin Works

That fast-on, fast-off profile is a function of the delivery platform, which uses ultra-small particles to carry insulin deep into the lungs in a 2-second breath. Insulin enters the bloodstream within approximately 1 minute, with peak effect at 35 to 45 minutes, a profile designed to closely mirror the body's natural mealtime insulin response. For patients engaging in sports, Wood noted, the rapid clearance means mealtime insulin is largely out of the system before activity begins, reducing hypoglycemia risk.

Trial data also showed that patients on inhaled insulin reported higher treatment satisfaction compared with those who remained on rapid-acting injectable insulin, a meaningful finding in a population for whom adherence and quality of life are central to disease management.

Wood emphasized that inhaled insulin is not intended to replace automated insulin delivery or continuous glucose monitoring, which remain the standard of care. Rather, it is an additional tool and one she expects will find its place among families who, for any number of reasons, need something different.

"There's a lot of these little niche situations that I think inhaled insulin will fit into," she said, "but the bottom line is it's just adding to the choices that families can use."

References

1. Steinzor P, Grossi G. FDA approves inhaled insulin for children, adolescents with diabetes. AJMC^®. May 29, 2026. Accessed May 29, 2026. http://ajmc.com/view/fda-approves-inhaled-insulin-for-children-adolescents-with-diabetes

2. Haller MJ, Kanapka L, Monzavi R, et al; and the INHALE-1 Study Group. INHALE-1: a multicenter randomized trial of inhaled technosphere insulin in children with type 1 diabetes. Diabetes Care. 2026;49(1):179-187. doi:10.2337/dc25-1994