The insulin pump has come a long way since the first prototypes were developed in the 1960s. James S. Hirsch explores the riveting history of this integral piece of technology and shares his own experiences with this device.

We have entered the Golden Age of the insulin pump. It’s been a long time coming.

After decades of disappointment, insulin pumps are living up to the expectations of their early advocates, who believed that these devices could transform the treatment of type 1 diabetes. Thanks to continued improvements in the functionality, safety, and wearability of pumps, they are finally gaining much broader acceptance among consumers. 

But this insulin pump story has a twist. While the machines themselves have certainly improved, their Golden Age is due in part to a different technology. Continuous glucose monitors (CGM) can now transmit glucose readings to the pump, which can adjust the insulin delivery automatically to minimize high or low blood sugars. Medtronic, Tandem, and, most recently, Insulet – the three biggest players in the field – now offer these automated insulin delivery systems, which integrate algorithms and wireless technology to support human decision-making. 

This combining of the sensor with the pump is also known as a hybrid closed-loop system – “hybrid” because users still have to give the pump essential information, including how much insulin to deliver before meals and how much food will be consumed. 

The hope is that the hybrid system is the last step toward a fully closed-loop system, in which the glucose sensor and the pump function like an artificial pancreas, requiring no engagement from the user. 

I call this the “Look-Ma-No-Hands” approach to diabetes management, and it remains the Holy Grail of type 1 care.

Even if that goal remains elusive, the pump industry is thriving.

The third quarter of 2021 saw record revenue for insulin pumps – $859 million worldwide, a 22% increase from year-ago sales, and a 68% increase from four years ago, according to Close Concerns, a healthcare information company. Tandem Diabetes Care, whose survival was in doubt five years ago, has now taken the industry by storm; it said that in 2021, it shipped 128,312 pumps, a 41% increase from a year ago. The Insulet Corporation, which makes the Omnipod patch pump for insulin and other injectables, struggled for years, but in 2021, the company surpassed $1 billion in sales for the first time and more than doubled its earnings, to $16.8 million, compared to the year before.

The future appears to be even brighter. Grand View Research, a market research firm, estimates that the global insulin pump market will increase in sales from an estimated $4.6 billion in 2021 to $8.3 billion in 2028. 

These buoyant results gratify Freddi Fredrickson, whose personal and professional lives have closely intertwined with the insulin pump.

Fredrickson was a diabetes nurse educator in 1980 when she went on her first pump as part of a study to determine the technology’s impact on long-term diabetes-related complications – the pumps had only been on the market for a couple years, making her a pioneer. She then joined MiniMed in 1983 as the pump company’s seventh employee, and she held numerous jobs over a distinguished 24-year career while working closely with Al Mann, the preeminent visionary in the field. 

MiniMed, which was later bought by Medtronic, quickly became the industry leader, where it remains to this day, but it still fell short of its early goals. “We wanted pumps to become the standard of care,” but that didn’t happen, Fredrickson told me in a telephone interview from her home in the Los Angeles area. She said that physicians wouldn’t prescribe a medical device they didn’t understand; educating patients was difficult; and insurers were reluctant to cover an expensive, largely unproven technology. 

Fredrickson still uses an insulin pump, making her one the world’s longest continuous users of the device – remarkably, she has worn one for 42 years out of her 61 years with diabetes. Numerous studies, she said, have shown the benefits of pumps, but the glucose sensors have made all the difference as an ideal complement to pump therapy. After all these decades, she can’t quite believe that pump therapy’s original goals may be realized – she called it “amazing.”

“I’m just so surprised that it's finally becoming the standard of care,” she said.

I have my own long history with insulin pumps, mostly positive but also challenging and complicated. I’m now on my fourth different pump from four different pump companies, and I recently began the Tandem Control IQ hybrid system, which I use with my Dexcom G6. While I believe in pumps and continuous glucose monitors, I think their benefits are sometimes misstated. I’ve met pump advocates over the years – I call them pump evangelists – who believe that these machines, now reinforced with continuous glucose monitors, will revolutionize diabetes care.

Call me a cautious evangelist. 

I was diagnosed with type 1 diabetes in 1977 and saw my first pump in 1979 or 1980, when I was a counselor at a summer camp in Missouri for kids with diabetes. A guy showed up to talk about his insulin pump, and the contraption was memorable. It reminded me of a World War II walkie-talkie that I had seen in movies: fancy technology, but large, bulky, and cumbersome; and something that I would never want to hang on my belt. (The prototypes for the insulin pump, developed in the 1960s, were strapped on like a backpack.)  

That first pump that I saw was probably the same model that Freddi Fredrickson wore. Its official name was the Autosyringe but, weighing 17 ounces, was nicknamed the “big blue brick.”

The guy who came to our camp had a decent pitch for this oversized medical apparatus. Back then, we used vials of insulin and syringes, which meant two shots a day (that was the standard of care). But with the pump, no more shots! Just strap it on, and you’re good to go. 

As I later learned, the pump had other advantages, including the possibility of improved management of blood sugars. At the time, our long-lasting insulin was NPH or Lente, which would take effect after several hours but – depending on which one you used – would peak six, eight, or 12 hours later. 

This meant that we were always worried about when our insulin was peaking: Unless we were offsetting that peak with food, our blood sugars would crash. We were, in effect, feeding our insulin instead of our bodies. In retrospect, it was a terrible way to treat diabetes, but it was the best we had.

Pumps, in theory, solved that problem. The medical term for an insulin pump is “continuous subcutaneous insulin infusion” – a terrible name that only a doctor could love. But it includes a keyword, “continuous.” A healthy pancreas continuously releases a small amount of insulin, day and night – known as background insulin – and then it increases that insulin release when food is consumed. 

And that is what a pump does. In its simplest form, it’s a machine that pushes insulin through a tube and into your body, flowing through a cannula that rests beneath your skin. The tubing and cannula make up the insertion set that must be replaced every three days. (The patch pumps deliver insulin without the tube, and they also must be replaced every three days.) 

A pump releases a small amount of insulin on a continuous basis, which is the basal rate, and then users can press a few buttons to deliver more insulin before eating food, which is the bolus. Presto! Your pump mimics a healthy pancreas. Daily injections couldn’t do that, at least not when pumps were first introduced, and that led pump advocates to believe these devices would become the standard of care.

Expectations were high. Freddi Fredrickson said that in the early 1980s, there were 23 pump companies worldwide, all attracting premier scientists and engineers, all determined to revolutionize diabetes care.  

But whatever the medical advantages of these early pumps, they faced significant hurdles in the marketplace. The most obvious one, as noted, was their size, but even as pumps got smaller, the whole idea of attaching something to your body was foreign – I don’t recall anyone talking about “wearables” in the 1980s and ‘90s. What’s more, technology was something that happened in your home or your workplace, not something you carried with you. (iPhones were introduced in 2007.) Many patients simply didn’t want a device attached to their body and didn’t want to sleep with a small machine in their pajama pocket. (In writing my book “Cheating Destiny,” I interviewed one woman who said her husband wouldn’t have sex with her when she was attached to her pump. She got a divorce and found a more forgiving partner.) Other patients didn’t want a plastic tube snaking out of their pocket or their sleeve, turning an otherwise invisible condition into something quite visible. 

Pumps were complicated. They required significant education and training, for clinicians as well as patients. Like any complicated technology, they had glitches and required troubleshooting. They were also expensive. There were safety concerns as well, even with built-in safety features. What if your pump went haywire and started pushing buckets of insulin into your body. A reasonable fear? Probably not. But for all we knew, the thing could kill you. 

Another obstacle: doctors had little reason to promote pumps. They were not compensated to train their patients on them, weren’t willing to invest their own time in understanding how these intricate machines worked, and didn’t want their clinics burdened with phone calls when the pumps broke down. To some extent, these hurdles remain.

But perhaps what hurt pumps the most was that their advantages eroded as other therapies improved. The first insulin pens were introduced by Novo Nordisk in 1985, and they were far more convenient and discreet than syringes and vials; and they were followed by next-gen “smart pens,” which made dosing insulin that much easier – all of which hurt the selling proposition of pumps. Then in 2001, a new insulin, glargine, was introduced in the United States by Aventis under the brand name Lantus, and it offered patients nearly 24 hours of a consistent, long-lasting basal insulin. No more peaks! New and better types of basal insulins have since been developed, and they too undermined one of the central advantages of pumps.

While precise numbers are hard to come by, it does not appear that pumps ever exceeded more than 30% of the type 1 market in the United States. They never made significant inroads among those with type 2 who use insulin, and they never became the standard of care. Many pump companies came and went. Even having a great brand name, like the Cozmo or the Asante Snap, couldn’t keep them on the market. 

I too had little use for pumps, all the more so because I’m a dedicated technophobe. But I had a surprising change of heart. When you flip your car on a Massachusetts highway because your blood sugar is low, you’ll try something different.

Stay tuned for parts 2 and 3 coming soon.

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