Update: Tandem Diabetes Corporation officially announced the commercial launch and availability of its t:slim X2 insulin pump with Control-IQ Technology. The company is emailing all in-warranty t:slim X2 pump users in the United States to begin the update process, which requires a Dexcom G6 sensor and the use of the Tandem online portal.
Last month, the FDA approved the Tandem Diabetes Care update to its t:slim X2 insulin pump Control-IQ technology, clearing the way for the first automated and interoperable insulin dosing system on the U.S. market. The approval marks another major step forward in the development of closed-loop insulin pump systems – which began in earnest with the release of the Medtronic Minimed 670G hybrid closed-loop insulin pump – and represents a major upgrade for the Tandem pump’s current users.
T1D Exchange sat down with Tandem Chief Commercial Officer Brian Hansen to discuss the approval, what it means for the type 1 diabetes community, and what the future of insulin pump development might hold.
The recent approval differs slightly from other FDA clearances in that Tandem actually received clearance for an algorithm, rather than a physical device. The t:slim X2 launched on the U.S. market in late 2016, and since then it has received regular device updates to its software and firmware, just as mobile phones are able to update their operating systems.
“Getting Control-IQ through this final phase was huge for us,” said Hansen in his interview. “Our first algorithm, Basal-IQ, which helped protect against hypoglycemia was super important. That product exceeded our expectations. It certainly showed the value in having an algorithm on a pump.”
Operating while connected to a Dexcom G6 continuous glucose monitor, the Tandem pump has been using its Basal-IQ algorithm to predict low blood sugars and adjust basal insulin delivery rates accordingly since that feature debuted in 2018.
The most recent approval brings a new dimension to the t:slim X2 pump, offering a new algorithm with the ability to make further adjustments to the basal rate based on CGM data, automatically deliver an insulin bolus each hour to correct for highs, and even strive to account for the different ways sleep and exercise can impact blood sugars and insulin uptake.
“So if you start to go high too quickly, it can actually give you a bolus to help you break your rise,” said Hansen. “That’s something that’s never been offered before by any other products out there.”
The importance of choice and open ecosystems in diabetes technology
“We’ve always been a huge fan of choice,” Hansen told us. “When you look at CGMs and you look at pumps and you look at algorithms, patients have options. Expecting that all three be delivered together in a structured format by a single company may not deliver a combination that is best for every patient. Everyone’s needs are different.”
Traditionally, diabetes-related and other medical devices have existed inside closed ecosystems, where each manufacturer’s products don’t communicate effectively – or at all – with each other.
Interoperability – the capability for devices from different manufacturers to communicate and even direct each other’s actions – unlocks more flexibility for patients and people with diabetes to choose the products most comfortable and helpful for them.
It also frees up device manufacturers to focus on an individual line of products. The Control-IQ FDA approval represents just such a scenario, where the agency approved the algorithm to work with devices from two other interoperable device categories, the Tandem t:slim X2 insulin pump and the Dexcom G6 iCGM – two different companies working in concert to optimize blood sugar control.
“Ideally what will happen in the future is patients will have a choice as to what devices and algorithms they’re connecting and using with their pump,” said Hansen. “Today it’s really a tiny ecosystem. It’s the Dexcom G6 iCGM, our t:slim X2 pump, and now the Control-IQ algorithm embedded in that pump. With the approval of other interoperable devices and algorithms, however, people with diabetes could have a broad range of options available to them in the future.”
Tandem will be rolling out the Control-IQ update to current t:slim X2 pump users this month, with only a short online training module required to get up and running. The update will require a prescription from the users physician. Down the line, the organization hopes to be able to work in concert with other devices or manufacturers, but nothing formal has been announced on that front.
T1D Exchange will continue to report on developments in this space, and appreciate Tandem and its leadership both for their continued work in improving the lives of those living, and for taking the time to sit down with T1D Exchange team during such a busy time for the organization.