UK-based digital health company CamDiab has received the US Food and Drug Administration (FDA) authorisation for its advanced adaptive hybrid closed-loop app, CamAPS FX.
CamAPS FX is an advanced adaptive hybrid closed-loop app approved as an interoperable automated glycaemic controller device (iAGC).
The Android app connects a compatible insulin pump and a compatible continuous glucose monitor to create an artificial pancreas.
CamAPS FX is indicated to automatically adjust insulin delivery in individuals with type 1 diabetes, aged two years and above, based on their sensor glucose readings.
It leverages an adaptive, self-learning control algorithm to autonomously compute and direct insulin delivery to maintain desired glycaemic levels.
The CamAPS FX technology was developed by Roman Hovorka, professor of metabolic technology at the University of Cambridge Institute of Metabolic Science.
Roman Hovorka 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.”
CamDiab said that CamAPS FX is the world’s first artificial pancreas app that helps manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy.
Also, the closed-loop algorithm is already approved for use in the UK and the EU and was used by more than 27,000 people in clinical trials across 15 countries worldwide.
CamAPS FX is currently available in Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland and the UK with more countries in the pipeline.
