Device Dossier

CamAPS FX - Ambulatory insulin infusion pump software, patient-dosing

Device Dossier for CamAPS FX - Ambulatory insulin infusion pump software, patient-dosing (Ambulatory insulin infusion pump software, patient-dosing,…

Intended purpose

The App is used to manage glucose levels in people with type I diabetes (including type 1 diabetes pregnancy), aged 1 year and older, using a hybrid closed-loop approach (automated basal insulin delivery with manual bolusing for meals) or for people 13 years and older using a fully closed loop approach (automated basal insulin delivery without the need for manual bolusing for meals). Additional age restrictions may apply depending on the chosen continuous glucose monitor and insulin pump.

Functional description

CamAPS FX is an app that runs on an android or iOS smart device.The app is designed to work with a pre-defined selection of commercially available insulin pumps and continuous glucose monitors. The app also allows data upload to the cloud for data visualisation and remote monitoring. The CamAPS FX app is available to download from designated app portal(s).

TGA Public Summary