FDA approval for Cambridge diabetes app
CamDiab has received authorisation from The Food and Drug Administration (FDA) for its advanced adaptive hybrid closed-loop app, CamAPS FX, as an ‘interoperable automated glycaemic controller device’ (iAGC).
The Android app – dubbed the world’s first artificial pancreas app – helps to manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy, the company claims.
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 has been extensively tested in clinical trials and prior to the FDA authorisation had already been CE-marked for use in the UK and the EU.
CamAPS FX creator Roman Hovorka is Professor of Metabolic Technology at the Institute of Metabolic Science and Department of Paediatrics at the University of Cambridge, where the technology 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.”
The FDA authorisation allows the use of CamAPS FX for individuals with type 1 diabetes aged two and older. Also, for the first time, the FDA has authorised the use of a closed-loop system during pregnancy CamAPS FX is already used by more than 27,000 people in 15 countries.
The app allows a compatible insulin pump and a compatible continuous glucose monitor to ‘talk to each other’, creating an artificial pancreas.
CamAPS FX is available in Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland and the UK and more countries are in the pipeline.