On November 7, the FDA announced clearance for Tandem’s Control-IQ technology for use by children ages two and older. Control-IQ is a software that inputs glucose readings from Dexcom’s continuous glucose monitor into Tandem’s insulin pumps and, in junction with the user’s insulin-to-carb ratios and daily trends, automatically increases, decreases, and suspends insulin delivery. Previously, the FDA had only cleared children of ages six and older to use Tandem’s Control-IQ.
This advancement represents the latest step toward greater access to hybrid closed loop systems of type 1 diabetes care. Hybrid closed loop systems refer to those like Control-IQ – a device that monitors the user’s blood glucose levels and communicates with an insulin delivery device to adjust insulin dosage autonomously.
Although Control-IQ demonstrates a strong capacity to improve blood glucose control, many diabetes patients lack knowledge and access to the technology. In a recent survey of people with type 1 diabetes by Dexcom, 45% of respondents indicated that they did not know what a hybrid closed loop system was or how it could benefit them.
As the capacity of diabetes care technologies increases – taking the wheel as the decision-maker over the patient – many patients may wonder what would happen if their devices were to make an error and seriously harm them. As of December 2022, the FDA received over 500,000 complaints about the Dexcom G6, Dexcom’s continuous glucose monitoring system (CGM). In late 2019, a woman brought wrongful death action against Dexcom, as her husband’s CGM failed to alert him of his hypoglycemia in time for him to act. This raises concerns for patients with limited capacity to take control and make decisions of their own, including young children and toddlers.
Nonetheless, the FDA’s updated clearance only came after a study released earlier this year showing that hybrid closed loop systems improved blood glucose control for children between the ages of two and five, especially overnight. It also follows recent clearance of Tandem’s Mobi – a smaller, more discrete insulin pump that the user controls from their phone. While Mobi is no more adept at automated insulin delivery than the normal models, intelligence is just one consideration in pursuit of seamlessly integrating diabetes care into the everyday lives of patients. Speaking practically, the aim to eliminate manual blood sugar checks exists because constant self-care is burdensome and exhausting. Likewise, so is wearing equipment all hours of every day. From the perspective of the patient’s daily experience, comfort and algorithmic advancement go hand-in-hand.
FDA clearance is distinct from FDA approval. While approval means that a product or treatment’s benefits outweigh its risks, clearance means that a product or treatment is substantially equivalent to a previously approved version.
That said, even if Tandem’s new products are to earn approval, FDA approval cannot entirely shield a device manufacturer from liability. FDA approval represents a floor for safety standards and is not enough to defeat a claim against a medical device or drug manufacturer on its own. In practical terms, the FDA’s standard gives diabetes patients and their caretakers both reason for ease and concern. On the one hand, one of the major appeals of closed loop technologies is that patients are free to spend less time manually checking their blood sugar and delivering insulin, especially overnight. On the other, ceding control to an algorithm may feel uncomfortable for some patients, especially those that have taken responsibility for their own care for a long time or are otherwise wary of the rapidly advancing technology.