Type 1 Diabetes
The Barbie doll comes equipped with a continuous glucose monitor and insulin pump.
The clearance of Tandem Diabetes Care’s Control-IQ Technology opens the door for new algorithms enabling hybrid closed-loop diabetes management systems.
The company now wants to accelerate the commercial rollout of a system for management of Type 1 diabetes.
While Dexcom reports that interruptions in the service are mostly under control, many customers are critiquing the company's poor messaging of the issue, which they say could be fatal.
This is the seventh FDA clearance for the longstanding mobile diabetes management platform.
A study published in the New England Journal of Medicine found that patients had an average of 2.6 more hours a day in their target glucose range compared to their peers using a sensor-augmented pump.
By making its registry easy to access, the nonprofit group is hoping to build a longitudinal cohort that includes patient experiences from every demographic.
According to Medtronic, the glucose management system's "Auto Mode" feature reduced the duration and frequency of hypoglycemic and hyperglycemic events.
Researchers built a secure app-based system that runs on an unlocked smartphone and connects to glycemic control devices from multiple manufacturers.
The Leona M. and Harry B. Helmsley Charitable Trust and JDRF provided the grant to the diabetes management company.