Device Dossier
CamAPS HX - Ambulatory insulin infusion pump software, patient-dosing
Device Dossier for CamAPS HX - Ambulatory insulin infusion pump software, patient-dosing (Ambulatory insulin infusion pump software, patient-dosing,…
- GMDN category: Ambulatory insulin infusion pump software, patient-dosing
Intended purpose
A mobile app intended for managing glucose levels in people with type 2 diabetes or those requiring subcutaneous insulin (non-type 1 diabetes), aged 18 years and older, using a fully closed loop approach. Additional restrictions may apply depending on the chosen continuous glucose monitor and insulin pump. CamAPS HX requires an insulin pump and a continuous glucose monitor (CGM) to fulfill its intended use. The list of supported insulin pumps and CGMs is provided in the user manual. CamAPS HX is intended for use with rapid or ultra-rapid insulin analogues including diluted analogues.
Functional description
mylife CamAPS HX is an app that runs on an android or iOS smart device. The app is designed to work with a pre-defined selection of the Sponsor's commercially available insulin pumps and is compatible with select continuous glucose monitors. The app also allows data upload to the cloud for data visualisation and remote monitoring. The CamAPS HX app is available to download from designated app portal(s).