Inhaled insulin now FDA-approved for kids 6 and over with diabetes
Taisie Seigrist, a 15-year-old track and cross-country athlete in Oklahoma, was diagnosed with Type 1 diabetes five years ago.
“It was a big life shift,” Taisie’s mom, Jennifer Seigrist, told ABC News. “[She] spent a week in the hospital getting her blood sugars down and learning everything we could learn in a week, and … it's been a roller coaster.”
Learning to manage her new diagnosis meant Taisie needed to learn how to dose and inject herself with insulin, a necessary but painful process.
"I kept getting bruises, and so it really hurt,” said Taisie, one of the 364,000 kids and teens living with diabetes in the United States, according to according to the American Diabetes Association.
Two years ago, Taisie's doctor told her about a clinical trial testing the safety and effectiveness of inhaled insulin, an option only FDA-approved for adult use at that time.
Afrezza, the brand name of inhaled insulin, has been on the market for over a decade.
On Friday, the FDA expanded its approved use for kids 6 years and older who have Type 1 diabetes or those who require insulin with Type 2 diabetes — making it the first ever needle-free insulin option for pediatric patients, according to MannKind Corporation, the maker of Afrezza.
Dr. Jamie Wood, an endocrinologist and medical director of pediatric diabetes at Rainbow Babies and Children's Hospital in Cleveland, Ohio, was a lead investigator in the clinical trial.
Wood told ABC News this newest option is about giving families more choices in their diabetes treatment plan.
“It’s been my mantra for years when I’m working with people with diabetes and their parents, it that how they manage their diabetes or choose to manage their diabetes is up to them and they deserve choice.”
The clinical trial compared inhaled insulin to injected insulin and was designed to make sure it was safe for children, particularly that there was not any negative change in lung function with it’s use.
“We demonstrated in the trial that when you compare [inhaled insulin] to injected insulin, the results are about the same,” Wood said. "We were able to demonstrate with the pulmonary function testing through the 52-week timepoint as well that the pulmonary function was stable and there were no safety signals whatsoever for the pulmonary function.”
The most common side effects included low blood sugar, a risk when using any type of insulin, and temporary cough. It should not be used in any person who has asthma or other type of lung disease. It is not intended to treat diabetic ketoacidosis, and people using it are advised not to smoke.
“You can’t be smoking tobacco or marijuana, and you can’t be vaping either,” Wood said she counsels her patients.
Taisie and her mom were so happy how well she was managing her diabetes with inhaled insulin at mealtimes that they continued using it after the clinical trial ended, even though that meant paying out of pocket for the drug.
"Afrezza has really been life changing… being a teenager is hard on its own, but then you add in diabetes and all that brings with it, and so for us it's just been kind of a breath of fresh air," Seigrist said. “It has made such a huge impact on her life that we're willing to pay out of pocket until we can get it insurance approved.”
GoodRx shows Afrezza can cost over $2,000 a month, but MannKind said most people pay $35 or less per month through Medicare caps or by the manufacturer buying down commercial insurance costs. For people only paying with cash, they offer the drug for $99, a spokesperson for MannKind told ABC News.
Seigrist said this treatment option has also helped Taisie become more independent managing her diabetes.
“She's a lot more free, she, she feels like she can participate more with what everybody else is doing,” Seigrist said. “It's helped with her, the mental aspect of diabetes a lot. So she's being more independent with her care, she's taken better care of herself.”
Afrezza is dosed through a discrete inhaler, and the cartridges are color coded based on the three dosing options. Wood also said one advantage of using inhaled insulin is that dosing for carbohydrate corrections is not as precise as what’s needed for injected insulin.
“With inhaled insulin, it doesn’t need to be as precise, which is another very liberating concept for people with diabetes,” Wood said. “It moves away from that very time-consuming precise carb counting and our participants really appreciated that."
People with type 1 diabetes like Taisie who use inhaled insulin at mealtimes still need to use a long-acting form of insulin which is an injection. Inhaled insulin is shorter acting and mainly used to cover carbohydrate meals or help correct high blood sugar.
Patients or parents interested in this treatment option should talk to their child’s endocrinologist to learn more and decide what may be right for them.
Jade A. Cobern, MD, MPH, is a practicing physician, board-certified in pediatrics and general preventive medicine, and is a fellow of the ABC News Medical Unit.
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