Diabetes device developers turn their sights to type 2

Abbott, Dexcom, Insulet, Medtronic and more are developing next-gen sensors, pumps and algorithms to offer new options for hundreds of millions of diabetes patients.

More than 90% of people with diabetes have type 2 diabetes, but most of the diabetes technology on the market is for type 1 patients.

That’s something diabetes device developers are hoping to change as they adapt miniaturized, automated type 1 technology for the much larger type 2 patient population. The International Diabetes Federation projects that approximately 783 million people will be living with diabetes by 2045.

“The people who need insulin therapy in type 2 also deserve to have a much easier, reduced burden,” Insulet CEO Jim Hollingshead said in an interview shortly before his company’s Omnipod 5 became the first automated insulin delivery (AID) system cleared by the FDA for type 2 last year.

More AID systems are in development, while continuous glucose monitor (CGM) makers are also bringing more options to type 2 diabetes patients.

“We have much work to do as an industry to really bring to the type 2 population the technologies and brands that are pretty well covered and supplied into that smaller type 1 population,” Abbott EVP of Diabetes Care Chris Scoggins said as his company pushed forward with type 2 tech last year.

What is different about developing tech for the type 2 population?

Diabetes device companies had already developed much of the technology needed for the type 2 population. In fact, many type 2 patients were using type 1 systems off label before regulatory authorization.

Insulin pumps, for example, don’t need hardware changes to expand to type 2, but the algorithms that ensure the safe and effective delivery of insulin need adjustments. Insulin can cause serious complications if under- or over-delivered.

Some type 2 patients don’t even need insulin, unlike type 1, which always requires dosing to make up for a patient’s inability to naturally produce enough insulin. Type 2 patients may need more insulin over time as the chronic disease progresses.

Tandem Diabetes Care President and CEO John Sheridan said it’s “a natural evolution” to bring AID systems beyond type 1 and into the type 2 population. His company’s Control-IQ+ AID algorithm won the second FDA clearance for type 2 patients in February.

Insulet and Tandem both recruited more than 300 subjects for clinical trials to win their type 2 clearances.

Insulet also targeted health equity in its trial, Hollingshead said, with the type 2 population often featuring significant ethnic and socioeconomic diversity. The system, which needed to keep A1c in range and avoid an increase in hypoglycemia in the study, delivered “very efficacious, very safe” results with no adverse effects and “terrific clinical benefit,” including reduction of diabetes distress, Hollingshead said.

Medtronic plans to follow Insulet and Tandem with an FDA submission for type 2 this year.

Beta Bionics, which developed the iLet bionic pancreas, has FDA clearance for type 1 diabetes. Expanding a type 1 diabetes system’s indication to type 2 is “exceedingly important [but] tough,” co-founder Ed Damiano said on a panel in March.

Beta Bionics has a couple thousand users managing their type 2 diabetes with the iLet off-label, Damiano said, and his company may seek an indication for that population.

Another notable AID developer that hasn’t yet moved into type 2 is Sequel Med Tech. The company is beginning commercial efforts for its Twiist system after integrating the pump with Abbott CGMs. While Twiist’s current indication covers type 1, CEO and co-founder Alan Lotvin said the company is kicking off a clinical trial for type 2.

The window may be closing for potential AID competitors. Embecta received FDA clearance for a disposable, open-loop type 2 patch pump last year, but killed the product within months instead of pushing toward its goal of launching an automated system for type 2.

“The pump market has continued to evolve, and we anticipate that competition in closed-loop type 2 indicated products may continue to intensify and our offering would require incremental investments to be market competitive,” Embecta CEO Dev Kurdikar explained at the time. “… Upon FDA clearance of our open-loop pump … we performed a market check to identify potential opportunities that would allow us to monetize the asset. Since that did not surface any viable options, we acted promptly to discontinue the program.”

Meanwhile, Modular Medical is commercializing its MODD1 product, a 90-day patch pump that features new microfluidics technology for low-cost pumping of insulin for type 1 and type 2. Users can monitor the pump activity with their cell phone and do not need an external controller. The pump uses a single-use, disposable battery.

Modular Medical’s aim is to bring a reliable, smaller form factor at a low cost to serve those “neglected by the industry,” CEO Jeb Besser said in an interview.

“Our target is not the ultra-sophisticated, super-high-functioning user,” he said. “There are lots of products on the market today that do a good job of serving that user.”

Type 2 tech beyond AID systems

The developers of CGMs that integrate with those insulin pump technologies also have their eyes on the type 2 opportunity.

Dexcom and Abbott’s CGMs have been available for the type 2 population for years, but have now launched over-the-counter (OTC) CGMs for type 2 patients who don’t use insulin.

Dexcom won the first such FDA clearance with its Stelo glucose biosensor. The company estimates approximately 25 million type 2 patients in the U.S. don’t use insulin but could benefit from CGM use. Someone who currently has insulin dependence has to worry about controlling glucose in the present, Dexcom Chair and CEO Kevin Sayer said after winning that clearance, while a person who doesn’t use insulin might not have complications today, but could face blindness, heart attacks, kidney failure and amputations in the future.

Those patients “need a better tool now,” he said.

Abbott soon followed with FDA over-the-counter clearances for its Lingo biosensor and Libre Rio sensor, the latter of which is indicated for type 2 patients who aren’t on insulin and manage diabetes through lifestyle modifications.

Dexcom EVP and Chief Operating Officer Jake Leach said in an interview that his company is taking a two-pronged approach toward type 2 diabetes: make products easier to use, and generate clinical evidence to support the expansion.

“You have to generate that evidence to show the benefits that CGM can provide,” he said. “There were questions in the beginning, like will someone with type 2 diabetes benefit from CGM like those with type 1? We were very confident they would, but we had to generate the evidence and that evidence generation continues. … The addressable market is very large. It’s our job to figure out how to get people the CGMs that they need.”

What to watch for in the type 2 market

Insulet and Tandem have launched their type 2 AIDs, and Medtronic’s MiniMed 780G submission is expected to reach the FDA soon. Medtronic and Tandem are also developing patch pumps.

Senseonics has developed the long-term implantable Eversense E3 CGM for both type 1 and type 2 diabetes. The implant offers 365 days of continuous glucose monitoring and has an integrated CGM (iCGM) indication, meaning it can pair with AID systems in the future.

Dexcom is working on a next-gen CGM that will be 50% smaller, packing more powerful electronics into a thinner, lower-circumference form factor.

“The more powerful electronics means it can handle three different readings at the same time,” Sayer said, noting the device was in feasibility studies when we interviewed him in January. “It’ll be a while — like a couple years — before that is through all of our work process.”

And at Insulet, Hollingshead said the team is working on improved algorithms for more automation and enhanced form factors.

“People living with diabetes deserve to have better and simpler care,” he said. “That’s where we’re going.”