The FDA delivered a green light to its first closed-loop, insulin pump-controlling smartphone app that can cover pregnant women with Type 1 diabetes.
CamDiab, the University of Cambridge’s diabetes software spinout, collected a 510(k) clearance from the agency for its adaptive CamAPS FX Android app, enabling its use by all people ages 2 and up.
The prescription artificial pancreas program takes in blood sugar data from a continuous glucose monitor and computes the proper amounts of insulin over the course of a day and night.
According to the company (PDF), CamAPS FX has already been used by more than 27,000 people in 15 countries following its previous CE mark and approvals in Europe, Australia and the U.K.
That includes an automated insulin delivery system assembled from Ypsomed’s connected pump and Abbott’s Freestyle Libre 3 wearable CGM, which made its debut across Europe and the U.K. debut last year. CamAPS FX is also compatible with Dexcom’s G6 sensor.
Diabetes overlapping with pregnancy can pose a unique set of maternal risks and neonatal complications, including potential birth defects as well as preterm delivery.
By offering automated, 24-hour background insulin dose management, artificial pancreas programs aim to keep blood sugar levels within a healthy range—a range that is narrower in pregnant women, according to researchers. A previous open-label study of CamAPS FX’s algorithms that included 16 pregnant participants showed fewer hypoglycemic episodes.