Tandem Diabetes Care cruises to FDA OK of automated insulin delivery for toddlers

Helping toddlers manage their Type 1 diabetes—typically a difficult task, due to their constant growth and development, not to mention fussiness—may now be a bit easier.

The FDA has expanded its clearance for Tandem Diabetes Care’s Control-IQ algorithm, which connects to an insulin pump and continuous glucose monitor to automate the process of doling out insulin doses throughout the day. According to the agency’s announcement this week, the algorithm can now be used by people with Type 1 diabetes as young as 2 years old; the technology’s original 2019 clearance limited its use to those aged 6 and older.

The expanded clearance represents “the latest example of the FDA’s ongoing commitment to help advance the development and expansion of products that can improve the management of type 1 diabetes, especially for pediatric patients,” the regulator said.

The prescription-only Control-IQ algorithm creates what’s known as a hybrid closed-loop system to automate much of the diabetes management process, by connecting to both a Tandem insulin pump and a compatible third-party CGM system.

The algorithm analyzes glucose readings from the CGM and then translates those findings into adjustments to a user’s basal insulin dosage. It can also trigger a correction bolus dose of insulin if the algorithm predicts that the user’s blood sugar levels are on track to leave a healthy range.

Control-IQ performs any needed insulin adjustments every five minutes, and it can predict changes in glucose levels as far as 30 minutes in advance, according to its maker.

Tandem’s technology is currently compatible with Dexcom’s CGMs, and the company is now working with Abbott to add its FreeStyle Libre offerings into the mix, too, now that they’re cleared for integration with automated insulin delivery systems.

The FDA’s label expansion came after Tandem and Dexcom published a study earlier this year focusing specifically on toddlers’ use of their combined automated insulin delivery system.

The study recruited about 100 children with Type 1 diabetes who were between the ages of 2 and 5 and assigned them to either use the closed-loop system for three months or to stick with the insulin delivery method—relying on either a standard pump or multiple daily injections—that they’d been using before the study began.

After the 13-week study period, the kids in the high-tech Tandem-Dexcom group saw the amount of time they spent in a healthy glucose range increase from a baseline average of 57% to 69%. The control group, meanwhile, experienced a time-in-range increase of just one percentage point, from 55% to 56%, over the same period.

The Control-IQ technology was particularly helpful in keeping glucose levels stable overnight, as the toddlers assigned to use the artificial pancreas spent about 18% more time in range between the hours of 10 p.m. and 6 a.m. than the other cohort.

With the system now broadly available to that age group in the U.S., the FDA said it has also tasked Tandem with conducting a post-market surveillance study of Control-IQ among 2-to-5-year-olds to monitor the technology’s performance in real-world settings.