Eli Lilly, one of the Big Three insulin makers that’s had its eyes on diabetes technology for several years, is making moves to launch a new insulin pump and automated insulin delivery (AID) system in the United States.
Interestingly, this is not the proprietary pump that Lilly’s diabetes division had been co-developing for several years alongside its connected insulin pen. Rather, Lilly has announced a new collaboration with Switzerland-based Ypsomed, which already markets a unique, ultra-thin icon-driven insulin pump outside the U.S.
The deal grants Lilly exclusive rights to commercialize the YpsoPump in the U.S. once the latest model is submitted and approved by the Food and Drug Administration (FDA). It also sets the stage for a future smartphone-based AID system combining the YpsoPump with the Dexcom CGM (continuous glucose monitor) via a controlling algorithm that automates insulin dosing.
“This is the first in-depth technical cooperation between an insulin pump manufacturer and a pure insulin company,” said Thomas Kutt, head of investor relations for Ypsomed Holdings AG in Switzerland. “There is a lot of potential to improve and advance (technology) that is sustainable for people with diabetes.”
One major downside for potential users is that this future AID system would only be compatible with Lilly’s insulin brands, so it may not appeal to those devoted to competing insulins like Novolog, Fiasp, or Apidra.
Here’s a look at the existing and future diabetes tech on tap from Ypsomed, based on the status of their product pipeline in November 2020.
Pronounced Yipp-so-med, this company has been around longer than many may realize.
Back in the 1980s, Ypsomed developed and launched the Disetronic H-Tron — one of the first insulin pumps ever available — alongside the initial Minimed pump that was later acquired by Medtronic. Disetronic was discontinued in 2003 after it was sold to Roche, and that insulin pump evolved into the Accu-Chek Spirit pump.
Ypsomed went on to sell other medtech, including infusion sets, and eventually became a distributor for the tubeless Omnipod pump (made by Insulet) internationally before launching its own mylife YpsoPump in 2016. That is now available in more than 20 countries outside the U.S.
Not yet available in the U.S., the YpsoPump uses traditional tubing but is more compact and flexible to use than most anything on the market today. The company claims, “It features the best of 30 years of Swiss medical device engineering.”
- About the size of a standard business card, it’s quite discreet and weighs only 83 grams including a full reservoir and batteries onboard.
- Its black and white touchscreen display uses icons designed to be super-intuitive. For safety, it has a main lock screen with a three-step unlock sequence.
- The main screen displays three icons: knife and fork for meals, a data graph for all the pertinent info, and an insulin cartridge with number to indicate how much insulin is left in the reservoir.
- It uses a 1.6 mL (160 units) glass cartridge insulin reservoir that can accommodate either a self-filled cartridge with any leading insulin brand or a prefilled cartridge of Novo Nordisk-branded rapid-acting insulin, known as NovoRapid outside the U.S.
- It includes a practical quick bolus button on the side, eliminating the need to pull out the pump for use in every situation.
- Ability to change an infusion set attached to your body without needing to change the reservoir holding insulin
- Bluetooth-enabled for data sharing, and the existing model uses easily-replaceable triple A batteries (future-gen models could potentially be plug-and-charge).
- The full list of technical specs of the current model includes two programmable basal rates ranging from .01 to 40 units per hour.
The company also recently launched a companion mylife mobile app, available on both iOS and Android, that connects to a cloud-based platform. The app can be used for data review and also for bolus calculation and setting pump functions.
A 2018 clinical study in Germany showed that this “novel touchscreen pump” was safe, effective, and satisfying for adult users in real-world situations.
The current model will not be launched in the U.S., but with the new Lilly partnership, it’s possible an updated version of that YpsoPump will eventually debut, weaved in with Dexcom CGM connectivity. It’s TBD on whether that will actually happen, before the new AID is submitted for FDA review in 2022.
In other countries, Ypsomed plans to begin rolling out its next-generation technology starting in 2021.
During an exclusive presentation at our fall 2020 DiabetesMine D-Data ExChange event, Ypsomed detailed the company’s plans for the next 2 years overseas:
mylife Assist: Based on the Dexcom integration announced in May 2020, Ypsomed plans to tie CGM data into the mylife mobile app for quick-glance info and decision-making. This is planned for the first half of 2021, outside the U.S.
mylife Dose: With CGM data already on board, Ypsomed plans to launch a bolus calculator function and remote bolusing from the smartphone app overseas in late 2021. To date, FDA regulators have not yet allowed this functionality on any devices in the U.S.
YpsoLoop: This would be an additional closed loop functionality offered by Ypsomed, separate from what is now in development with Lilly. The company tells us they have not yet decided on which smart algorithm might be used, but they have many options to consider, including Dexcom’s own TypeZero algorithm.
While both Assist and Dose are planned for 2021, the YpsoLoop system isn’t planned until mid-2023 at the earliest.
Ypsomed has confirmed that part of its agreement with Lilly for U.S. distribution is to offer the new system compatible with Lilly-brand insulins only.
“This exclusivity in the U.S. is what we offered Lilly, and that’s the way it is,” Ypsomed’s Kutt told DiabetesMine. “Outside the U.S., we prefer an open system and solution that offers freedom of choice.”
That’s a huge red flag for some, given it would be the only pump developed to work solely with one insulin manufacturer’s brands, with no plans to offer compatibility with other insulin products in the future.
Lilly communications manager Maggie Pfeiffer said they’re working with Ypsomed to develop 1.6 mL cartridges for Lilly’s rapid-acting insulins that will be compatible with the new YpsoPump-based AID system.
No decision has been made on whether they will sell the YypsoPump without closed loop functionality, or how other features like CGM data integration will be handled in a final product, Pfeiffer said.
“Ypsomed is responsible for the development and submission of their pumps to U.S. regulators, and simultaneously we will work to make our commercialization decisions regarding which pumps help us achieve the mission of improving outcomes,” she said. “While we have not finalized our commercial plans for the pump, we believe automated insulin delivery technology is the best way to provide value to people living with diabetes.”
To date, Ypsomed has been a champion of interoperability. They’ve shown commitment to the goal of allowing diverse devices to work as pieces in a “plug and play” setup, and were in fact the first company to sign up for the JDRF Open Protocols Initiative launched in 2017.
Ypsomed’s spokesman Kutt said that alongside this new deal with Lilly, they still plan to pursue the FDA path toward interoperability, a designation called “ACE (alternate controller enabled) infusion pumps” that would assure future YpsoPump models could work with multiple CGMs and likely different algorithms for insulin dosing.
The company’s goal is to build a global base of 100,000 pumpers in 5 years’ time, he added.
Here at DiabetesMine, we’re always thrilled to see new diabetes tech options that can simplify management of this complex condition. But to be honest, we’re disappointed by the decision to create an AID system that locks users into one specific brand of insulin — especially with insulin pricing so out of control in this country. We’re hoping for true freedom of choice for people with diabetes across the globe.