The FDA today gave De Novo authorization for a Tandem Diabetes Care (NSDQ:TNDM) glycemic controller that is compatible with a variety of continuous glucose monitors and insulin pumps to control Type 1 diabetes.
Diabetes advocates are hailing today’s authorization as paving the way for a complete automated insulin dosing (AID) system — a true artificial pancreas. AID systems typically consist of a pump, a continuous glucose monitor (CGM) and software to control the system of compatible devices.
A recent National Institutes of Health-funded study found that a system controlled by the newly authorized Tandem Control-IQ controller was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes. The system in the study combined Tandem’s t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, the recently approved G6 CGM. Control-IQ is designed to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly.
Control-IQ is the also first such controller that can be used with other diabetes devices that are designed to be integrated into a customizable for an automated insulin delivery system, the type of system that people with Type 1 diabetes and their families have been cobbling together themselves out of frustration with existing systems on the market.
When used with a compatible iCGM and an alternate controller-enabled insulin pump, (ACE pump) Tandem’s Control-IQ controller can automatically increase, decrease and suspend delivery of basal insulin based on insulin delivery history, iCGM readings and predicted glucose values, according to the FDA.
The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount, the agency said. The FDA previously approved other software to automatically control insulin delivery as part of a single, predefined diabetes management system as a class III, high-risk device.
The Control-IQ Technology controller was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“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,” said Dr. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in a news 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.”
The NIH-funded trial randomly assigned 168 Type 1 patients ages 14 or older to either the Tandem device or treatment with the G6 CGM and another insulin pump that did not automatically adjust insulin. Patients in the Control-IQ arm increased the amount of time in glucose level range (70-180 mg/dL) by an average of 2.6 hours a day and showed improvements in time spent with high and low blood glucose, hemoglobin A1c and other measures compared to the control group.
No severe hypoglycemia events were observed in either group, but diabetic ketoacidosis occurred in a Control-IQ patient due to a problem with the equipment that delivered insulin. A previous problem with the Control-IQ’s handling of CGM data, which temporarily halted use of the software, was resolved in March.
Even though the system has been assessed for reliability, incorrect and inappropriate calculation, and command, 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 low blood glucose (hypoglycemia) or high blood glucose (hyperglycemia, including diabetic ketoacidosis).
With the authorization of the interoperable Control-IQ Technology controller and the establishment of some special controls, the FDA has created a new regulatory classification for this type of device. This means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process.
Shares in TNDM were up 0.96% to $58.24 in late-morning trading.