An artificial pancreas developed from research at the University of Cambridge has received FDA (the US Food and Drug Administration) approval for use by individuals with Type 1 diabetes aged two and older, including during pregnancy.
CamAPS FX, produced by University of Cambridge spin-out company CamDiab, is an Android app that can be used to help manage glucose levels.
The app allows a compatible insulin pump and a compatible continuous glucose monitor to ‘talk to each other’, creating an artificial pancreas.
The CamAPS FX closed loop algorithm was given FDA authorisation on 23 May. It had already been CE-marked for use in the UK and the EU, and currently has 27,000 users.
CamDiab was founded by Roman Hovorka, professor of metabolic technology research at the University of Cambridge, where the app was developed.
He said: “We set out to help people with type 1 diabetes and their families live better lives and we’re delighted that the FDA has reviewed the safety and effectiveness of CamAPS FX and has given the technology its approval.
“It has been extensively tested and we’re proud that it is considered by many to be the best algorithm out there.
“Randomised clinical trials have shown a significant increase in time in range and a reduction in HbA1c without increasing the risk of low glucose levels, and improved well-being.”
