FDA authorizes marketing of first interoperable insulin dosing controller
The FDA on Friday authorized marketing of the Tandem Diabetes Care Control-IQ interoperable, automated insulin dosing algorithm, the first dosing controller that can be used with other interoperable diabetes devices, allowing people with diabetes to create a customizable automated insulin delivery system, according to an agency press release.
This FDA authorization paves the way for integrated continuous glucose monitoring systems and alternate controller-enabled infusion pumps, or ACE insulin pumps, to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system, also known as an artificial pancreas.
“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,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life.”
Other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system (as a class III, high-risk device). The Control-IQ Technology controller, which is designed to communicate with other compatible diabetes device components that are also designed to be integrated into a modular system, was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
Improved glucose response
The FDA reviewed data from a clinical trial of 168 children and adults with type 1 diabetes who were randomly assigned to use either the Control-IQ Technology installed on a Tandem t:slim X2 insulin pump, or a CGM and insulin pump without the Control-IQ Technology for 6 months. As Healio previously reported, participants spent an average of 2.6 fewer hours per day in hyperglycemia and 13 fewer minutes per day in hypoglycemia when compared with individuals using sensor-augmented insulin pump therapy. In reporting findings from the randomized controlled trial, which included participants aged 14 to 71 years initially using either insulin pump or multiple daily injection therapy, the researchers noted that the beneficial effects associated with the closed-loop insulin delivery system were observed during daytime and nighttime and were particularly prominent in the second half of the night. The findings were published in The New England Journal of Medicine in October.
“What is so exciting about this study is that, compared with other closed-loop insulin delivery systems, we have 11% increased time in range, which is a least 2.6 hours per day, the frequency of hypoglycemia and hyperglycemia were reduced in all study subjects and the benefits were achieved in the first month of the study and consistently sustained throughout the 6 months of the trial,” Carol Levy, MD, clinical director of the Mount Sinai Diabetes Center, told Healio when the findings were published. “The rate of use was 92% throughout the trial, which is huge. We really see durability of use and benefit. It was an incredibly exciting trial to be a part of for those reasons.”
The study also demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on interoperable CGM readings, with limited user intervention outside of mealtimes. The FDA also assessed the ability of the controller to communicate with all parts of the system with appropriate reliability, cybersecurity and fail-safe modes.
FDA advises caution
Even though the system has been assessed for reliability, the FDA noted that incorrect and inappropriate calculation, command and delay of insulin delivery can still occur. 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 hypoglycemia or hyperglycemia.
Along with this authorization, the FDA is establishing criteria, called special controls, which outline specific regulatory requirements that, when met along with general controls, provide a reasonable assurance of device safety and effectiveness for devices of this type.
“For this device, those controls include requirements related to reliability, device interoperability, cybersecurity and clinical relevance,” the FDA stated in the release. “With the authorization of the interoperable Control-IQ Technology controller and the establishment of these special controls, the FDA has created a new regulatory classification for this type of device, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.” – by Regina Schaffer
Disclosures: Levy reports she has received grants from Abbott Diabetes, Dexcom, the Helmsley Foundation, JDRF and Lexicon. Stenzel is the director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health.