The San Diego-based automated insulin delivery system developer offers two differentiated pump platforms — the flagship t:slim X2 and the Mobi miniature durable pump — that feature sophisticated software and connectivity to the market’s leading continuous glucose monitors (CGMs). And it continues to build on them.
Between new integrations with updated CGM sensors, updated infusion technology and enhancements to its own automated insulin delivery platforms, the company has continued to roll out enhanced offerings for an increasingly wide range of people with diabetes.
In particular, the company’s new Control-IQ+ technology is driving it forward as its pump systems continue to improve.
Speaking to Drug Delivery Business News at the American Diabetes Association’s 85th Scientific Sessions, Tandem Director of Product Marketing Ben Mar explained the company’s aim to give people with diabetes options when it comes to managing their condition.
Why Control-IQ+ sets Tandem apart
Control-IQ+ represents the next generation of the company’s advanced hybrid closed-loop insulin delivery algorithm. It has compatibility with both the company’s pump offerings, the t:slim X2 and Mobi pumps. The company said the algorithm is now available for people with type 1 diabetes aged two years and older, as well as adults with type 2 diabetes.
New features include expanded weight (20-440 lbs) and total daily insulin (5-200 units) parameters. This accommodates a wider range of insulin requirements, Tandem says.
“It really broadens it and just works for that many more people,” Mar explained. “There were a few extra features built into it.”
Control-IQ+ also has enhanced extended bolus capabilities up to eight hours when turned on. It allows for better meal management with delayed glucose rise or prolonged eating. New temporary basal rate adjustments also address short-term glucose needs like exercise, stress or illness.
Mar explained that certain foods — pizza for example — might make a user want to deliver their bolus over a long period of time. Raising the extended bolus from two hours to eight hours enables that.
Additional features, he said, include an exercise mode for people to make adjustments to remain in range while exercising as well.
“We had to do a lot of clinical data, not just for type 2, but showing down to the younger ages,” Mar said. “We had to show that, not only with the changes that we’re making to insulin delivery that it was safe, but that it can also work across this broader population.”
Updates on CGM integration
Tandem’s pumps effectively work across the portfolios of the two leading CGM makers, Dexcom and Abbott. Its pairings for a long time included the Dexcom G6 and G7, as well as the Abbott FreeStyle Libre 2 Plus.
Recently, the company announced integration of the t:slim X2 with the Libre 3 Plus, the latest-generation Abbott sensor. Additionally, Tandem plans to pair its pumps with Abbott’s future dual glucose-ketone monitor.
The continued partnerships with CGM makers highlight the collaborative effort between diabetes companies to bring a wide variety of patients all-in-one management systems that adhere to their needs.
Mar echoed Pinsker’s earlier statement at ADA.
“For us, it’s really important to not only make improvements, such as the upcoming the latest CGM integrations, but also provide choice and options for people,” Mar said.
Updates on infusion sets
Last month, Tandem announced that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set.
The company won clearance for its SteadiSet Infusion Set, a wearable infusion set that delivers insulin from an insulin pump to the body. SteadiSet features an integrated inserter with a hidden needle designed for one-handed insertion. It received clearance to deliver insulin for up to three days of use. It provides adult patients with type 1 diabetes with continuous insulin delivery during the indicated use period.
Through CapBio, Tandem plans to submit a separate 510(k) submission to the FDA to extend the indicated use time to up to seven days. It doesn’t expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time.
Mar explained that the company intends to use the submission and clearance to gain confidence in the extended-wear version of the set. Then, it will commercialize the extended version.
“Essentially, these AID systems and the pumps are just amazing at providing benefits,” Mar said. “But infusion sets, overall, if you’re not getting the insulin reliably in your body, then the benefits of these really aren’t there. We’re really excited to make some meaningful developments on the infusion set side.”
Broadening the portfolio
Between the longstanding t:slim X2 and the Mobi pump, which Tandem added to its portfolio last year, the company continues to seek to bring differentiated options to people with diabetes.
“What we talk about a lot with people with diabetes, is diabetes is not a one-size-fits-all product,” Mar said. “It’s very personal in terms of how you manage your diabetes, and the form factors can have just as much of an impact on them as the algorithms themselves.”
There could be another option on the way, too. Tandem signaled its potential entry into the patch pump market, currently led by Insulet and its Omnipod portfolio, in 2023 with the acquisition of AMF Medical.
Switzerland-based AMF Medical developed the non-commercial Sigi patch pump system The system received FDA breakthrough device designation in 2022.
While the company can’t offer concrete details on the patch pump development or timeline, Mar said work continues on the product.
“We’re working really hard on that one,” he said. “We know there’s a lot of people that like the option of having a tubeless pump. We’re excited to be able to have Mobi give a tubeless option as well as part of that. But we’re working hard [on the patch pump].”
Elsewhere, Tandem has recently expanded its technology into the type 2 diabetes population and isn’t stopping there. A study shared at ADA highlighted the promise of the t:slim X2 with the previous-generation Control-IQ technology and the Dexcom G6 in keeping pregnant women with type 1 diabetes in their target glucose range.
“Our goal is to show that these AID systems are safe and effective with anyone with diabetes, no matter what type it is,” Mar said. “We’re hopeful.”
