A device made here opens path for diabetic pilots

May 29—Like all pilots, flight student Natalie Schatton, 25, goes through various pre-flight steps before taking off at Phoenix Mesa Gateway Airport.

A student at the University of North Dakota's UND Aerospace Flight Training Center there, the Arizona State University graduate is in an accelerated commercial pilot program and dreams of becoming a pilot for American Airlines.

"I am in love with the training program," she said. "It's a rigorous school, but it's definitely worth it."

But before taking off for solo flights all over Arizona and practicing maneuvers, Schatton has something most pilots don't: a small device on the back of her arm that measures her blood sugar and communicates with her mobile phone.

It's a contiguous glucose monitor made by Dexcom in West Mesa that automatically checks blood sugar every five minutes.

If her levels start trending higher or lower than desired, an alert pops up on her phone, and she has snacks and juice available to bring her blood sugar higher.

For Schatton, who was diagnosed with Type 1 diabetes at age 10, the technology lets her pursue her dream of flying for a major commercial airline — just like her dad, who flies for American Airlines.

This career path has only recently opened for pilots like her.

No passengers, just students

Until 2020, the FAA restricted insulin-dependent diabetic pilots to working as flight instructors but not fly paying passengers.

Schotten grew up believing diabetes would keep her from commercial airlines, especially since she also has many friends in aviation and her mom was a flight attendant for United.

Insulin-treated diabetes is a disqualifying condition for FAA certification because the agency is concerned that pilots could experience a debilitating drop in blood sugar mid-air that might impact their ability to fly.

So dreamers like Schotten were barred from the airlines.

But that changed in 2020, when the FAA changed its policy and began issuing first- and second medical certificates to pilots who submitted CGM data and met other requirements.

Pilots had been pushing the agency and the American Diabetes Association filed suit.

One factor leading to the FAA's change of heart was the rise of continuous glucose monitors.

In the past, the only way to check blood sugar was with a finger prick to get a drop of blood to apply to a glucose meter — an effective but inconvenient process.

Contiguous glucose monitors allow diabetics to closely monitor their blood sugar in real time, making it easier to keep their levels consistently in target ranges,

More importantly, they compile and share reams of data on those levels.

That was key for the FAA's change of heart, as pilots who lobbied for the opportunity to fly commercially submitted years of monitor data to to open the door for special medical certificate issuances.

A study of pilots using the monitors for over 20,000 flight hours found that their glucose levels stayed above "red" ranges 99.86% of the time, and researchers did not record any incidents of pilot incapacitation over those years and thousands of hours.

They also found that out-of-range readings declined from 5.7% to 1.2% between 2013 and 2019.

Mesa firm a leader

The first CGM was released in 1999, after which the devices rapidly improved and are now mass produced by several medical device companies.

The market leader is Dexcom, which selected Mesa six years ago to be its U.S. manufacturing and global distribution hub.

Schatton's Dexcom monitors are almost certainly made in Mesa, where 15 million units are made annually.

The company has gone from 500

employees in Mesa three years ago to 2,000 today.

"It's one of our fastest growing locations in the world," said Barry Regan, vice president of global operations for Dexcom. "It's important for me to say how incredibly important Mesa is for the future."

Regan said the sky's the limit for Dexcom's growth, as more people with diabetes see the value in the devices for managing their health and access grows.

Last month, the Centers for Medicare and Medicaid Services expanded coverage of CGMs to include certain people with Type 2 diabetes as well as Type 1.

Globally, only 1% of people with diabetes use a CGM, according to Regan. Dexcom has been doubling its production every two-and-a-half years, he said.

Clearing the way

The first U.S. pilot with Type 1 diabetes to receive a first-class medical certificate was another local flyer, Scottsdale resident Pietro Marsala.

Marsala, 32, received his Type 1 diabetes diagnosis while in flight school in North Phoenix in 2012.

That meant he faced the prospect of missing out on his dream right when he seemed close to achieving it.

"That was probably the most crushing day in my life," he said.

After graduation from flight school, Marsala worked as a flight instructor with his third-class medical certification.

He said that as he spent thousands of hours in the sky teaching others how to fly, the absurdity of the old rules around diabetes and flying became apparent to him.

Marsala contacted the FAA and started a dialogue with the agency's medical staff, advocating for special allowances for diabetic pilots and submitting data from his CGM for study.

He said he'd dreamed of flying for American Airlines since he was a young boy but that the motivation to change the rules morphed at some point from fulfilling his personal dream to something larger.

"I'm out to prove a point that this can be done safely," he said. "I want others with diabetes to see this and not just the ones that want to become pilots."

"I wanted people, especially kids with diabetes, to not grow up and have that limitation simply because they take insulin."

Finally, Marsala received his ground-breaking first-class certification, but just before the pandemic shut down the airline industry. In 2021, however, he landed a job with regional carrier American Eagle.

He discloses his status to the captain when he flies and lets them know he'll be checking his blood sugar on his phone periodically.

In February, he was offered a job with American Airlines, his dream job. He continues to fly with American Eagle while he awaits his onboarding for the new job.

In March Dexcom honored Marsala by naming one of its production lines in Mesa "Pietro."

There's a huge banner greeting workers in the factory with Marsala's picture that says "every CGM that goes through these doors will change a life."

Regan said Dexcom wanted to honor Marsala to remind workers, many of whom have come from non-medical industries, that "we're not making consumer products. ... You're making a life saving medical device."

Full circle

One would-be pilot who heard Marsala's story was Schatton. She earned a bachelor's degree in sustainability, but she said she didn't see herself making a career in the field.

She read an article about Marsala and it "really caught me." She started researching the FAA's updated rules, and found out she could fly for the airlines.

"I jumped right in," she said.

Schatton said obtaining the medical certification required extra hoops that slowed down her training, but she's aiming to complete the program in December or early next year.

Schatton said she plans ahead of time before every flight, wakes up and eats when she needs to have her target glucose levels while flying.

She hasn't had any medical incidents.

Schatton said her routine is "just part of my life now" and "muscle memory," having had the condition since she was 10.

Marsala said that if Schatton is in training, she's gotten her medical certification and he would tell her "the hard part is done. ... Now focus on your training and keeping yourself healthy and the rest will fall into place.

"You'll be where you desire to be in a very short time, especially with the amount of movement that's happening within the industry right now."

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