Tubeless insulin pump receives FDA clearance for people with diabetes
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The FDA in August cleared a tubeless insulin pump for use by people with diabetes who use insulin, according to a press release.
The Accu-Chek Solo micropump (Roche Diabetes) was granted 510(k) clearance from the FDA. According to the product page on the Roche Diabetes website, the insulin pump system is tubeless, small and lightweight. Users can place the device on four different infusion sites on the body. The device is detachable, allowing people with diabetes to change the infusion site when necessary. A handheld diabetes manager provides data and includes a bolus advisor to enter glucose values. Bolus insulin can be delivered with and without the use of the diabetes manager.
“We are pleased to see our latest innovative pump system cleared by the FDA”, Marcel Gmünder, global head of Roche Diabetes Care, said in a press release. “We are proud of our teams who have been steadfast in their activities to accomplish this important achievement for our Accu-Chek Solo system and appreciate the close collaboration with the authority.”
Roche Diabetes will provide an update on next steps and a timeline for the launch of the Accu-Chek Solo at a future date.
Reference:
Accu-Chek Solo Micropump. Available at https://diabetes.roche.com/hcp-gb/insulin-delivery-systems/accu-chek-solo. Accessed September 5, 2023.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
It’s been an exciting time for insulin pump innovations. In 2022, the Omnipod 5 became available, which was the first and is still the only tubeless automated insulin delivery system in the U.S. Earlier this year, we saw the FDA approvals of the automated insulin delivery systems Medtronic 780G and Beta Bionics iLet, which are now in patients’ hands. Soon to be available, the Tandem Mobi will use the Control-IQ algorithm, but this system only has 5 inches of tubing and everything will be controlled through a smartphone.
Making it an even more exciting 2023, we now have the FDA approval of the Accu-Chek Solo as an interoperable alternate controller enabled pump. This offers another tubeless insulin pump option that was previously available only outside the U.S. It’s different from Omnipod in that part of it is durable and not discarded with each pod change. There are some other interesting differences, such as being able to do quick boluses directly from the device instead of the controller and a longer cannula option (6 mm or 9 mm). At present, it is not integrated with any continuous glucose monitor for automated insulin delivery.
The reason I am enthusiastic about it is because the market is changing with interoperability. In the existing landscape, if you want to use the Medtronic 780G algorithm, you must use the Medtronic pump. It is also like that for Tandem’s Control-IQ, Beta Bionics iLet and Insulet’s Omnipod 5. But many of us dream of the day when people can choose their preferred pump, their preferred automated insulin delivery algorithm and their preferred CGM. With interoperable CGM, alternate controller enabled insulin pumps and algorithms, this future state will be here soon.
Tidepool Loop is an FDA-approved algorithm that runs from a mobile app. It offers more customization with insulin settings and targets, but it does not yet have a pump partner for commercialization. My hope is with more insulin pump options, such as the Accu-Check Solo, that Tidepool Loop will find partners to work with and there will be more options for people with diabetes to meet everyone’s needs and preferences.
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