The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system.
Tandem Diabetes Care’s Control-IQ Technology acts as a new feature for the company’s t:slim X2 insulin pump (which was also cleared by the FDA back in February). The controller algorithm allows the pump and its connected system to automatically adjust insulin delivery when connected to an alternate controller-enabled insulin pump and an integrated continuous glucose monitor.
The agency based its decision on data from a randomized controlled clinical trial consisting of 168 Type 1 diabetes patients, which showed the automated controller to determine and deliver its doses safely and effectively with little user intervention. The agency said it also reviewed the tech’s communication capabilities with respect to reliability, cybersecurity and fail safes.
Still, the agency noted in its announcement of the clearance that users of the automated tool should not be consider it to be infallible.
“Even though the system has been assessed for reliability, incorrect and inappropriate calculation, and command, delay of insulin delivery can still occur,” the agency wrote. “Other risks associated with use of the interoperable controller can include incorrect insulin delivery as a result of loss of communication between connected devices, or from exploitation of cybersecurity vulnerabilities. These associated risks can lead to low blood glucose (hypoglycemia) or high blood glucose (hyperglycemia, including diabetic ketoacidosis).”
In addition to establishing a new 510(k) pathway for similar interoperable controllers down the road, the authorization comes with a batch of so-called special controls that demonstrate specific interoperability, cybersecurity and clinical relevance requirements for future devices within this device category.
WHY IT MATTERS
Diabetes patients can already manage their blood sugar using a range of different devices, but compatibility issues between competing manufacturer’s devices keep users from mixing and matching diabetes management technologies. Although Tandem Diabetes’ controller isn’t the first approved by the agency to automate insulin delivery, its flexibility paves a path for patients to construct a system that best suits their individual needs.
“Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the Type 1 diabetes community and a critical step forward in making day-to-day life better for people living with the disease,” the Juvenile Diabetes Research Foundation (JDRF), a global Type 1 diabetes research organization actively supporting the development of safer homebrew management systems, said in a statement.
“This is the second hybrid closed-loop system on the market and the first algorithm authorized as an interoperable automated glycemic controller, which means it could be a component of an open-protocol system. People with different devices could use the algorithm and manage their glucose levels in a way that works best for them. … Today’s announcement is yet another reason why health plans should cover all FDA authorized diabetes management tools, to help people with [Type 1 diabetes] manage this life-threatening disease.”
THE LARGER TREND
The diabetes management system landscape has been fairly active since the FDA clearing its first closed-loop insulin delivery system back in 2016, with academic papers outlining reliable device-agnostic systems and market players announcing convenience-driven device integrations. Notably, it was just a few months after clearing Tandem Diabetes Care’s interoperable pump that the agency was forced to come out with an official warning to patients and providers by cases involving devices and software that were either unvetted or unauthorized for integration with other products.
“Today’s action continues the agency’s ongoing efforts to work with the diabetes community to help ensure the safety and efficacy of innovative and customizable diabetes management systems that may help patients better tailor their treatments to their individual needs,” Dr. Tim Stenzel, director of the office of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement.