Device Dossier

Diabetes patient management software

Device Dossier for Diabetes patient management software (Diabetes patient management software, Class IIb, sponsor Medtronic). ARTG record, intended…

Intended purpose

Software only mobile application intended to communicate and connect with compatible CGMs and the InPen smart insulin pen and installed on compatible mobile devices for the purpose of managing diabetes. Provides a primary display for SG and insulin dose information, which are then used to make therapy decisions. The app collects and displays information on insulin previously delivered by the InPen Injector as well as current and past glucose values. The dose calculator feature uses these data to recommend bolus doses of insulin

TGA Public Summary